The agency said the study showed that the vaccine produced a comparable antibody response in 12- to 17-year-olds to that seen in young adults aged 18 to 25 years (as measured by the level of antibodies against SARS-CoV-2).

“In addition, none of 2,163 children receiving the vaccine developed Covid-19 compared with four of 1,073 children given a dummy injection,” the EMA said.

The CHMP said that, given the limited number of children and adolescents included in the study, the trial could not have detected new uncommon side effects or estimated the risk of known side effects such as myocarditis and pericarditis.

“However, the overall safety profile of Spikevax determined in adults was confirmed in the adolescent study,” the EMA said. “The CHMP therefore considered that the benefits of Spikevax in children aged 12 to 17 outweigh the risks, in particular in those with conditions that increase the risk of severe Covid-19.”

The most common adverse effects in 12- to 17-year-olds were similar to those experienced by people aged 18 and above, the EMA said.

“They include pain and swelling at the injection site, tiredness, headache, muscle and joint pain, enlarged lymph nodes, chills, nausea, vomiting, and fever,” the agency added.

These effects were usually mild or moderate and improved within a few days, the EMA said.

On December 6, 2022, the MHRA granted authorisation for administration of the Pfizer-BioNTech Covid-19 vaccine (Comirnaty) to infants and children aged between six months and four years.

The decision was endorsed by the UK’s Commission on Human Medicines.

It will be for the Joint Committee on Vaccination and Immunisation to determine whether the vaccine will be recommended for use in this age group as part of the UK’s Covid-19 vaccination programme.

The recommendation is for the vaccine to be administered at a lower dose than the ten-microgram one given to five- to 11-year-olds. The younger children will be given three micrograms.

Three doses would be administered, with the first two doses given three weeks apart, followed by a third dose given at least eight weeks after the second dose.

The MHRA said the new authorisation was given after a review of data from an ongoing clinical trial involving 4,526 participants.

“The common, expected side effects (reactogenicity) were in-keeping with what can be anticipated from a vaccine in this age group,” the agency said.

On August 17, the MHRA had extended its conditional marketing authorisation for the Moderna vaccine to allow its use in Britain for 12- to 17-year-olds.

The Moderna vaccine was already authorised for use for 12- to 17-year-olds in Northern Ireland under the CMA extension granted by the EMA on July 23.

On April 14, the MHRA approved the Moderna vaccine for administration to six- to 11-year olds. The vaccine was approved for administration to children aged six to 11 years in Northern Ireland under the updated authorisation granted by the EMA on March 2.

The UK government had said on February 16, 2022, that Covid vaccination would be offered to all children aged five to 11 years. This followed similar announcements in Scotland, Wales, and Northern Ireland.

Sajid Javid said he had accepted guidance from the JCVI that all five- to 11-year-olds should be able to receive the Pfizer-BioNTech vaccine.

The JCVI said: “Although this age group is generally at very low risk of serious illness from the virus, a very small number of children who get infected do develop severe disease.”

The JCVI said it had advised “a non-urgent offer” of two ten microgram doses of the Pfizer-BioNTech paediatric vaccine to five- to 11-year-olds who were not in a clinical risk group. There should be an interval of at least 12 weeks between doses, the JCVI said. (In December 2021 the JCVI had already recommended that the Pfizer-BioNTech vaccine be offered to at-risk 5- to 11-year-olds and this rollout began at the beginning of February 2022.)

The committee said its intention in extending its recommendation to all 5- to 11-year-olds was to “increase the immunity of vaccinated individuals against severe Covid-19 in advance of a potential future wave of Covid-19″.

The JCVI added: Vaccination of children aged 5 to 11 who are not in a clinical risk group is not expected to have an impact on the current wave of Omicron infection. The potential benefits from vaccination will apply mainly to a future wave of infection; the more severe a future wave, the greater the likely benefits from vaccination. Conversely, the less severe a future wave, the smaller the likely benefits from vaccination.”

The committee said it considered its advice about vaccinating 5- to 11-year olds who were not in a clinical risk group as a “one-off pandemic response programme” and added: “As the Covid-19 pandemic moves further towards endemicity in the UK, JCVI will review whether, in the longer term, an offer of vaccination to this, and other paediatric age groups, continues to be advised.”

The one-off programme ran until the end of August 2022.

The UK government said in September 2022 that “subject to further clarification”, on-going eligibility in 2022/23, after the one off-programme, was expected to be for children in the academic years where children are aged 11 or 12 years.

Children in high-risk groups who turned five years of age after August 2022 would become eligible for primary vaccination and could also receive a booster during the autumn programme, provided it was at least three months since their second (or third) primary dose, the government said.

On December 3, 2021, the TGA in Australia provisionally approved the Pfizer-BioNTech vaccine for children aged five to 11 years. The rollout began on January 10, 2022.

“This decision follows the provisional approvals granted by the TGA to Pfizer for the use of Comirnaty in individuals 12 years and older on 22 July 2021 and the booster dose for use in adults 18 years and older on 26 October 2021,” the TGA said when announcing the approval.

The administration said five- to 11-year-olds would be given a lower dose than that given to people aged 12 years and older (10 micrograms instead of 30 micrograms). The vaccine would be supplied in an orange vial rather than the grey or purple vials used to supply the higher dose and would be given in two doses at least three weeks apart.

“Provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia,” the TGA said. “The approval is subject to certain strict conditions, such as the requirement for Pfizer to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment.”

On September 29, 2022, the TGA provisionally approved a three-microgram paediatric dose of Pfizer-BioNTech’s Covid-19 vaccine for children aged six months to under five years.

“The government’s decision on the use of this vaccine in this age group will be informed by advice from the Australian Technical Advisory Group on Immunisation,” the TGA said.

The Australian government said on February 23, 2022, that it had accepted advice from the ATAGI to make the Moderna vaccine available for children aged six years and older from February 24. The vaccine was at that time already available to children and adolescents aged 12 years and above.

The TGA approved the administration of Moderna to children aged six years and above on February 17.

For children aged between six and 11 years, the paediatric dose of Moderna is half the dose currently provided for people aged 12 years and above: two 50-microgram doses administered eight weeks apart, or three doses for immunocompromised children.

The government said the recommended eight-week interval could be shortened to four weeks for children at risk of moderate to severe Covid-19, for example those with underlying health conditions. The interval could also be shortened in the case of a Covid-19 outbreak or before international travel, the government added.

In Denmark, since July 1, 2022, it has no longer been possible for children and young people under the age of 18 to get the first Covid vaccination, and, from September 1, 2022, it was no longer possible to get the second vaccination.

The Danish Health Authority said: “Children and young people only very rarely become seriously ill from Covid-19 with the Omicron variant.

“Quite a few children with a particularly increased risk of a serious course will still have the option of vaccination, after an individual assessment by a doctor.”

Sweden’s Public Health Agency said on January 27, 2022, that the medical benefit for the individual child with a general vaccination against Covid-19 for children aged five–11 years was currently small.

“Therefore, for the spring term 2022 the authority is not recommending general vaccination of children under 12 years of age in Sweden,” the agency said.

“A general vaccination from the age of five is also not expected to have any major effect on the spread of infection at present, neither in the group of children aged 5–11 nor among other groups in the population.”

The director-general of the agency, Karin Tegmark Wisell, said: “We will continue to follow the issue. We are constantly assessing the state of knowledge and the development of the pandemic in Sweden and the rest of the world, and a new position will be taken on this issue before the autumn term.”

The health agency said that children were at a significantly lower risk of developing severe Covid-19 disease compared with adults.

“In general, the younger the child, the lower the risk,” the agency said. “Since the end of October 2021, the Swedish Public Health Agency has been recommending general vaccination against Covid-19 from the age of 12 in Sweden. This is based on the benefit to the individual child.”

Covid-19 vaccination has been recommended in Sweden since the end of December 2021 for children between the ages of five and 11 who are particularly susceptible to respiratory infections.

Sweden’s health agency decided in September 2022 to stop recommending Covid-19 vaccination for healthy children aged between 12 and 17 years.

The new decision will come into effect from November 1, 2022.

”The reason is the very low risk of serious illness and death from Covid-19 in children and young people,” the agency said.

From November 1 only children in special groups who have an increased risk of developing Covid-19 will be offered Covid vaccination.

Head of the unit for vaccination programmes at the health agency Sören Andersson said: ”Overall, we see that the need for care as a result of Covid-19 has been low among children and young people during the pandemic, and has also decreased since the Omicron virus variant began to spread.

”At this stage of the pandemic, we do not see a continued need for vaccination in this group.”

The health agency said that for people aged 18 years and above, the recommendation for adults (that people should take three Covid vaccine doses) would still apply.

The FDA expanded the emergency use authorisation for the Pfizer-BioNTech vaccine to include adolescents aged 12 to 15 years on May 10, 2021. It was the first authorisation in the US for use of a Covid vaccine for this age group.

The FDA said it had determined that the vaccine had met the statutory criteria to amend the EUA, and that “the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population”.

The administration said that from March 1, 2020 to April 30, 2021, approximately 1.5 million Covid-19 cases in individuals aged 11 to 17 years had been reported to the CDC.

“Children and adolescents generally have a milder Covid-19 disease course as compared to adults,” the FDA said.

The Pfizer-BioNTech vaccine would be administered to 12- to 15-year-olds as a series of two doses, three weeks apart as in the case of people aged 16 years and above, the FDA said.

The FDA said that immune response to the vaccine in 190 participants aged between 12 and 15 was compared to the immune response of 170 participants aged between 16 and 25 years.

“In this analysis, the immune response of adolescents was non-inferior to (at least as good as) the immune response of the older participants,” the FDA said.

The FDA said it conducted an analysis of cases of Covid-19 occurring seven days after the second vaccine dose among participants aged between 12 and 15 years.

“In this analysis, among participants without evidence of prior infection with SARS-CoV-2, no cases of Covid-19 occurred among 1,005 vaccine recipients and 16 cases of Covid-19 occurred among 978 placebo recipients,” the FDA said.

The FDA said it concluded that, based on the available data “it is reasonable to believe” that the Pfizer-BioNTech vaccine “may be effective in individuals 12 through 15 years of age”.

Pfizer said the FDA based its decision on data from a Phase 3 clinical trial in which 2,260 participants aged 12 to 15 years were enrolled.

Results from the trial were were published in The New England Journal of Medicine on May 27.

A total 2,260 children aged 12 to 15 years of age received two injections, 21 days apart, of 30 micrograms of BNT162b2 or a placebo (1,131 children received BNT162b2 and 1,129 received a placebo).

Robert W. Frenck, Jr et al. said that BNT162b2 had a “favourable safety and side-effect profile”, with mainly transient mild-to-moderate reactogenicity. The side effects were predominantly injection-site pain (in 79 to 86% of participants), fatigue (in 60 to 66% of participants), and headache (in 55 to 65% of participants). There were no vaccine-related serious adverse events and few overall severe adverse events, the researchers said.

Among the 1,983 trial participants who could be evaluated, and did not have evidence of previous SARS-CoV-2 infection, no cases of Covid-19 with an onset of seven or more days after the second dose were observed among BNT162b2 recipients (1,005 children) and 16 cases were observed among placebo recipients (978 children).

In the group that included all 2,229 participants in the cohort who could be evaluated, regardless of whether they had evidence of previous SARS-CoV-2 infection, no Covid-19 cases were observed among BNT162b2 recipients from seven days after the second vaccine dose and 18 cases were observed among placebo recipients.

After dose 1 and before dose 2, three Covid-19 cases were noted (within 11 days after dose 1) among BNT162b2 recipients, as compared with 12 cases among placebo recipients. No cases of severe Covid-19 were observed in the age cohort studied.

Pfizer had announced on March 25 that the first children in the paediatric trial of the Pfizer-BioNTech Covid vaccine had received their initial vaccine doses. The first doses were given to the cohort aged five to 11 years.

Pfizer said that Phase 1 of the trial was an “open-label, dose-finding study” to identify the preferred dose level(s) of BNT162b2 from up to three different levels (10, 20, and 30 micrograms) with an option for three micrograms, in three age groups (five to 11 years, two to five years, and six months to two years.

The primary endpoints of the study were to evaluate the safety and immunogenicity of the vaccine, Pfizer said. “Vaccine effectiveness in the study will be inferred through immunobridging to the 16- to 25-year-old population from the pivotal Phase 3 trial,” the company added.

Pfizer said that children younger than six months of age might subsequently be evaluated once an “acceptable safety profile” had been established.

On May 28, the European Commission announced that its CMA for the Pfizer-BioNTech vaccine had been expanded to include children aged 12 to 15. This followed a recommendation by the CHMP to authorise use for the 12–15 age group. The extended authorisation is valid in all 27 EU member states. The vaccine had already been approved for use in adults and adolescents aged 16 years and above.

The EC’s decision was also based on data from the Phase 3 trial involving 2,260 children.

Each EU member state can decide whether or not to administer the vaccine to individuals in the 12-15 age group, the EMA said.

The Pfizer-BioNTech vaccine was the first Covid-19 vaccine to receive authorisation in the EU and is the first to have its CMA extended to adolescents.

In Germany, the STIKO has said that only children and adolescents with certain pre-existing conditions should be given the Pfizer-BioNTech vaccine.

The committee said on May 10 that it was only recommending the vaccine for children and adolescents with a condition that raises their risk of a developing a serious case of Covid-19. It cited obesity, immunosuppression, heart defects, chronic lung disease or kidney failure, and diabetes, and children and adolescents with trisomy 21

The STIKO, which is an independent advisory group, also recommends vaccinating children and adolescents who are in close contact with relatives or other people who are at high risk of severe Covid-19 but cannot be vaccinated themselves.

The committee said it was not currently recommending use of the Pfizer-BioNTech vaccine for 12- to 17-year-olds without pre-existing conditions, but advised that the vaccine could be administered after medical advice and with “individual risk acceptance”.

In the UK the JCVI has recommended Covid-19 vaccination for some children and adolescents. The committee said on July 19: “From today, the JCVI is advising that children at increased risk of serious Covid-19 disease are offered the Pfizer-BioNTech vaccine.

“That includes children aged 12 to 15 with severe neurodisabilities, Down’s syndrome, immunosuppression, and multiple or severe learning disabilities.”

The Pfizer-BioNTech vaccine is the only vaccine that has been authorised for children in the UK, for those aged 12 years or older.

The JCVI said it was also recommending that children and young people aged 12 to 17 who live with an immunosuppressed person should be offered the vaccine.

“Under existing advice, young people aged 16 to 17 with underlying health conditions which put them at higher risk of serious Covid-19 should have already been offered vaccination,” the JCVI said.

The committee said that, based on the current evidence, it was not currently advising routine vaccination of children outside of these specified groups.

“As evidence shows that Covid-19 rarely causes severe disease in children without underlying health conditions, at this time the JCVI’s view is that the minimal health benefits of offering universal Covid-19 vaccination to children do not outweigh the potential risks,” the committee said.

The committee has since reiterated this viewpoint, stating on September 3 that, while the health benefits from Covid vaccination for healthy children aged 12 to 15 years were “marginally greater than the potential known harms”, the margin of benefit was considered too small to support universal vaccination of healthy 12- to 15-year-olds at this time.

“Given the very low risk of serious Covid-19 disease in otherwise healthy 12- to 15-year-olds, considerations on the potential harms and benefits of vaccination are very finely balanced and a precautionary approach was agreed,” the JCVI said.

Wei Shen Lim said: “Children aged 12 to 15 years with underlying health conditions that put them at higher risk of severe Covid-19 should be offered Covid-19 vaccination. The range of underlying health conditions that apply has recently been expanded.”

Previously, the JCVI advised that children with severe neurodisabilities, Down syndrome, immunosuppression, profound and multiple learning disabilities, and severe learning disabilities, or who were on the learning disability register, should be offered Covid-19 vaccination.

The committee said that, following consideration of updated data on hospital admissions and deaths, it now advised that 12- to 15-year-olds with the following conditions should also be offered the vaccination:

• haematological malignancy;
• sickle cell disease;
• type 1 diabetes;
• congenital heart disease;
• chronic respiratory disease;
• chronic heart conditions;
• chronic conditions of the kidney, liver, or digestive system;
• chronic neurological disease;
• endocrine disorders;
• immunosuppression;
• asplenia (the absence of a spleen) or dysfunction of the spleen, and
• serious genetic abnormalities that affect a number of systems.

“Children with poorly controlled asthma and less common conditions, often due to congenital or metabolic defects where respiratory infections can result in severe illness, should also be offered Covid-19 vaccination,” the JCVI added.

On September 13, the chief medical officers (CMOs) in the UK’s four nations recommended that the Covid vaccination programme be extended to 12- to 15-year-olds. The UK’s Health Secretary, Sajid Javid, said he accepted the CMOs’ recommendation.

The CMOs said that healthy children should be offered a single dose of the Pfizer-BioNTech vaccine and the rollout should begin as soon as possible.

The CMO for England, Chris Whitty, said that vaccination of 12- to 15-year-olds would “reduce education disruption”. It was for ministers to decide whether to accept the CMOs’ recommendation that Covid vaccination be offered to that age group, he added.

He said the CMOs thought it was “an important and potentially useful additional tool to help reduce the public health impacts that come through educational disruption”.

Pfizer and BioNTech said they were also planning studies to further evaluate their vaccine in people with compromised immune systems.

On July 23, 2021, the TGA in Australia announced that it was extending its provisional approval of the Pfizer-BioNTech vaccine to include children and adolescents aged 12 to 15 years.

The ATAGI recommended that the following groups of children among those aged 12–15 years should be prioritised for vaccination:

• children who are immuno-compromised and those with specified medical conditions that increase their risk of severe Covid-19 (including severe asthma, diabetes, obesity, cardiac and circulatory congenital anomalies, neuro developmental disorders, epilepsy, and trisomy 21 (Down syndrome),
• Aboriginal and Torres Strait Islander children, and
• all children aged 12–15 years in remote communities.

The advisory group said preliminary evidence suggested that children and adolescents had a lower susceptibility to SARS-CoV-2 compared to adults, and played a lesser role in transmission at a population level.

“Healthy children also have a much lower risk of severe illness from Covid-19 than adults, and typically exhibit a mild course of illness,” the ATAGI said.

“Several publications have reported, however, that children, adolescents and young adults with underlying medical conditions have an increased likelihood of developing severe disease and complications when infected with SARS-CoV-2.”

Only a limited number of studies provided data on these risk associations stratified by selected specific medical conditions, the ATAGI added. Most other published studies reported only by broad disease groups, it said.

On November 10, 2021, the TGA announced that it had granted a provisional determination for Moderna’s Covid vaccine in relation to the proposed use of the vaccine for children aged 6 to 11 years. The vaccine is currently provisionally approved for use for people aged 12 years and above.

“The granting of this determination means that Moderna Australia Pty Ltd is eligible to apply to vary the provisional approval for the vaccine for use in younger children,” the TGA said.

The TGA said Moderna Australia had submitted data for provisional approval and the TGA was assessing use of the company’s vaccine for children aged 6 to 11 years.

Moderna had also submitted an application to the TGA about use of its Covid vaccine as a booster dose and this was under evaluation, the TGA said.

On March 16, 2021, Moderna announced that the first participants in a trial to test its vaccine on children had received their initial doses.

The company stated: “In Part 1, each participant ages two years to less than 12 years may receive one of two dose levels (50 μg or 100 μg). Also in Part 1, each participant ages six months to less than 2 years may receive one of three dose levels (25 μg, 50 μg and 100 μg).

“An interim analysis will be conducted to determine which dose will be used in Part 2, the placebo-controlled expansion portion of the study.

“Participants will be followed through 12 months after the second vaccination. Vaccine effectiveness will either be inferred through achieving a correlate of protection, if established, or through immunobridging to the young adult (ages 18-25) population. Evaluation of vaccine safety and reactogenicity is also a primary endpoint of the study.”

Moderna announced on June 10, 2021, that it had asked the FDA to grant the company an EUA for use of its Covid-19 vaccine for adolescents.

The company said it had also filed for authorisation with Health Canada and would make similar applications to other regulatory agencies around the world.

On May 25, 2021, Moderna issued a statement about its ‘TeenCOVE’ Phase 2/3 study, in which more than 3,700 participants aged 12 to 17 years inclusive were enrolled in the US.

The company said there were no symptomatic cases of Covid-19 among those who received two doses of the vaccine and no significant safety concerns were identified. There were four Covid-19 cases in the placebo group.

Vaccine efficacy of 93% in seronegative participants was observed starting 14 days after the first dose, Moderna said.

“Because the incidence rate of Covid-19 is lower in adolescents, a secondary case definition based on the CDC definition of Covid-19 was also evaluated to include cases presenting with milder symptoms,” the company added.

“Using the CDC definition, which requires only one Covid-19 symptom and a nasopharyngeal swab or saliva sample positive for SARS-CoV-2 by RT-PCR, a vaccine efficacy of 93% after the first dose was observed.”

Moderna said most adverse events were mild or moderate in severity. The most common local adverse event was injection site pain and the most common systemic adverse events after the second vaccine dose were headache, fatigue, myalgia, and chills.

In Britain, a trial in which the AstraZeneca-Oxford vaccine was being tested on children was halted because of the reports of blood clotting in adults who received the vaccine.

A spokesperson from the University of Oxford said: “Whilst there are no safety concerns in the paediatric clinical trial, we await additional information from the MHRA on its review of rare cases of thrombosis/thrombocytopaenia that have been reported in adults before giving any further vaccinations in the trial.

“Parents and children should continue to attend all scheduled visits and can contact the trial sites if they have any questions.”

Children and teenagers aged 6–17 years had been enrolled in the trial, which was set to involve 300 children (up to 150 participants aged 6–11 years and up to 150 aged 12–17 years). Those placed in the control group were being given a meningococcal vaccine, not a saline placebo.

The Oxford researchers argue that, because a saline placebo has no adverse effects, participants who had adverse reactions would know that they had received the AstraZeneca-Oxford vaccine.

“It is critical for this study that participants remain blinded to whether or not they have received the vaccine, as, if they knew, this could affect their health behaviour in the community following vaccination, and may lead to a bias in the results of the study,” the researchers said.

The same vaccine dose was being given as in the trials involving adults. The first doses were given to children aged 12–17 years. Data was to be reviewed before the vaccine was given to younger children.

The researchers said that, because this was the first time the AstraZeneca-Oxford vaccine had been tested on children, only healthy children were being enrolled. “It is likely that, in future studies, children with pre-existing conditions will be enrolled,” they said.

The Oxford researchers said a small number of children had developed serious Covid-19 symptoms and required hospital admission (more than 700 in the first wave in the UK).

“Many of these children had pre-existing medical conditions which made them more susceptible to the effects of a virus which affects the lungs,” the researchers said.

They added that paediatricians have also seen a new inflammatory syndrome emerge, called PIMS-TS, which appears to be associated with Covid-19 disease and often occurs a few weeks after SARS-CoV-2 infection.

The syndrome could make children very unwell and some had suffered multi-organ failure, the researchers said, adding that the number of children affected by the syndrome in the first wave of Covid -19 was fewer than one hundred.

In May 2021, the Ministry of Health and Prevention in the United Arab Emirates (UAE) approved the emergency local use of the Pfizer-BioNTech vaccine for children between the ages of 12 and 15 years.

In November, the ministry approved the emergency local use of the vaccine for children between the ages of five and 11 years.

In India, four Covid vaccines have been approved for use for children and adolescents aged 12 years and above: Covaxin, which is a whole-virion inactivated virus vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research’s National Institute of Virology in Pune; Zydus Cadila’s DNA vaccine ZyCoV-D; Corbevax, a protein subunit vaccine manufactured by Hyderabad-based Biological E. and developed in collaboration with scientists at the Texas Children’s Hospital Center for Vaccine Development and the Baylor College of Medicine in the US; and Covovax, manufactured by the Serum Institute of India (SII). Covovax is the brand name used in India for Nuvaxovid (NVX-CoV2373), originally developed by the American biotechnology company Novavax.

Novavax and the SII announced on March 22 that the Drugs Controller General of India (DCGI) had granted emergency use authorisation for Covovax for 12- to 17-year-olds.

Nuvaxovid/Covovax is a subunit vaccine in which a purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike protein. The gene is inserted into a baculovirus that is then introduced into cells of the fall armyworm moth. The spike proteins are harvested from the moth cells and are assembled into nanoparticles. The vaccine contains a saponin-based adjuvant.

Covaxin was the first Covid vaccine that was been rolled out for children and adolescents in India (initially only for 15- to 18-year-olds). This rollout began in January 2022. The government gave permission for 12- to 14-year-olds to be vaccinated with Corbevax from March 16.

On April 26, Bharat Biotech announced that Covaxin had received emergency use approval for administration to children aged six to 12 years.

The company said the vaccine had been proven to be safe, well-tolerated, and immunogenic in a phase 2/3 study in children aged two to 18 years.

“Neutralising antibodies in children were 1.7 times higher than in adults,” Bharat Biotech said.

India’s union government said it had made its decision about 12- to 14-year-olds “after due deliberations with scientific bodies”.

In an article publised in The Wire Science on March 15, Banjot Kaur reported that these “scientific bodies” did not include the National Technical Advisory Group on Immunisation (NTAGI).

“The NTAGI is one of the bodies whose clearance is required before a vaccine, approved by the drug regulator, can become part of the national COVID-19 vaccination drive,” Banjot Kaur wrote.

“The Centre’s approval for Corbevax is the first to defy this step of the vaccine clearance process, at least according to the public record.”

 

 

Vaccination certificates and restrictions on the unvaccinated

Many countries rapidly introduced regulations that allowed those who had received Covid vaccination access to certain places and facilities and denied such access to those who had not been vaccinated. Entry to numerous countries became dependent on a person’s vaccine status.

While most countries have now relaxed their restrictions, some, including Singapore, Indonesia, and Myanmar, are still not allowing entry to unvaccinated visitors. Except for limited exceptions, unvaccinated travellers are still not permitted to enter the US, Pakistan, or the Philippines. Singapore is still severely restricting the activities of the non-vaccinated in the country.

 

On May 21, 2022, Israel scrapped all entry regulations at its borders, doing away with PCR testing, proof of vaccination, and quarantine requirements and its ‘green pass’ is no longer required to enter premises.

WHO spokesperson Margaret Harris said on April 6, 2021, that the WHO was saying it would not like to see vaccination passports as a requirement for entry to or exit from countries “because we are not sure at this stage that the vaccine prevents transmission”.

Harris added that vaccine passports might not be an effective strategy as not everyone had access to vaccines and there were groups in society that were excluded.

At its meeting on January 13, 2022, the International Health Regulations (2005) Emergency Committee listed actions it considered to be critical for all countries in relation to the Covid-19 pandemic.

The committee stated that countries should not require proof of vaccination against Covid-19 for international travel “as the only pathway or condition permitting international travel given limited global access and inequitable distribution of Covid-19 vaccines”.

It added that state parties should consider a risk-based approach to the facilitation of international travel “by lifting or modifying measures, such as testing and/or quarantine requirements, when appropriate, in accordance with the WHO guidance”.

International traffic bans should be lifted or eased “as they do not provide added value and continue to contribute to the economic and social stress experienced by States Parties”, the commitee said.

The committee said that the failure of travel restrictions introduced after the detection and reporting of the Omicron variant to limit the international spread of Omicron demonstrated “the ineffectiveness of such measures over time”.

It added: “Travel measures (e.g. masking, testing, isolation/quarantine, and vaccination) should be based on risk assessments and avoid placing the financial burden on international travellers in accordance with Article 40 of the IHR [International Health Regulations].”

There were demonstrations against vaccine passports and mandates in Canada and the US and in Israel, France, Spain, Austria, Britain, Switzerland, Italy, Ireland, the Netherlands, Portugal, Luxembourg, Greece, Romania, and Croatia. Australia became the focus of international attention because of the harsh crackdown on protests in Melbourne, where hundreds of demonstrators were arrested.

Canada’s prime minister, Justin Trudeau, invoked the country’s Emergencies Act to suppress the truckers’ Freedom Convoy blockades.

Trudeau said on February 14, 2022, that the blockades, which had been set up in protest over Covid-19 vaccine mandates and passports, were illegal, and added: “If you’re still participating the time to go home is now.”

The Emergencies Act was passed in 1988, but this is the first time it has been enacted. Trudeau said it would be used to “strengthen and support law enforcement agencies at all levels across the country”.

Once an emergency is declared, the Act goes into effect immediately, but the decision still needs parliamentary approval.

The Act would give police additional tools to “restore order in places where public assemblies could constitute illegal and dangerous activities such as blockades and occupations as seen in Ottawa, the Ambassador Bridge, and elsewhere”, Trudeau said.

The “tools” provided under the Act included strengthening the authorities’ ability to impose fines or imprisonment, he added.

The federal government has also threatened to freeze the personal and corporate bank accounts of protesting truckers and suspend the insurance on their vehicles.

Trudeau’s decision to invoke the Emergencies Act was welcomed by those who are against the blockades, but there has been outrage over his move in many quarters both at home and abroad.

The Canadian Civil Liberties Association said the protests did not meet the standard for invoking the Emergencies Act.

The Emergencies Act can only be invoked when a situation “seriously threatens the ability of the Government of Canada to preserve the sovereignty, security and territorial integrity of Canada” & when the situation “cannot be effectively dealt with under any other law of Canada.”

— Canadian Civil Liberties Association (@cancivlib) February 15, 2022

The premier of Alberta, Jason Kenney, said the Alberta government was opposed to the invocation of the Act. “We have all of the legal tools and operational resources required to maintain order,” Kenney tweeted. “The Act would add no relevant additional powers or resources.”

Speaking on behalf of the Freedom Convoy shortly before Trudeau’s announcement, Tamara Lich said: “First of all, we are not afraid. In fact, every time the government decides to further suspend our civil liberties our resolve strengthens and the importance of our mission becomes clearer.

“We will remain peaceful, but planted on Parliament Hill until the mandates are decisively ended. We recognise that there is a democratic process within which change occurs. We have never stepped outside of that process, nor do we intend to.”

Lich added: “The right to peaceful protest is sacrosanct to our nation. If that principle is abandoned the government will reveal itself as a true tyranny and it will lose all of its credibility.”

The protesting truckers have made the following demands of Canada’s federal and provincial governments:

• that they terminate vaccine passports and all other obligatory vaccine contact-tracing programmes or inter-Canada passport systems;
• that they terminate Covid vaccine mandates and respect the rights of those who wish to remain unvaccinated;
• that they “cease the divisive rhetoric attacking Canadians who disagree with government mandates”; and
• that they “cease to limit debate through coercive measures with the goal of censoring those who have varying or incorrect opinions”.

Austria also came under the spotlight when the government introduced lockdown restrictions specifically for the unvaccinated. It then extended the restrictions to the whole population and there were reports that Covid vaccination would be made mandatory in the country.

In Greece, citizens over the age of 60 were told to book their appointment for a first Covid vaccination by January 16, 2022. Those who failed to comply would be fined €100 a month and would risk jail if they didn’t pay, the government said.

On August 3, 2021, the mayor of New York, Bill de Blasio, announced that access to indoor dining, indoor fitness facilities, and indoor entertainment facilities was to be restricted – in the case of workers and customers – to those who had received at least one dose of a Covid vaccine.

“The only way to patronise these establishments indoors will be if you’re vaccinated; at least one dose,” De Blasio said. “The same for folks in terms of work, they’ll need at least one dose.”

De Blasio said the new policy would be phased in over the following weeks and the final details would be announced and implemented in the week of August 16. Inspection and enforcement would start in the week of September 13. “We’ll be issuing a mayoral executive order and a health commissioner’s order,” De Blasio said.

He said that if people in New York wanted to participate fully in society, they had to get vaccinated.

“ … I want you to imagine the notion that, because someone’s vaccinated, they can do all the amazing things that are available in this city,” De Blasio said.

“This is a miraculous place, literally full of wonders and, if you’re vaccinated, all that’s gonna open up to you. You’ll have the key; you can open the door.

“But if you’re unvaccinated, unfortunately, you will not be able to participate in many things … It’s time for people to see vaccination as literally necessary to living a good and full and healthy life.”

De Blasio argued that the new policy would guarantee a much higher level of vaccination in New York City. “And that is the key to protecting people and the key to our recovery,” he said.

On July 21, 2021, police in Athens used tear gas and water cannons to disperse protesters demonstrating against the Greek government’s plans to make Covid vaccination mandatory for staff in nursing homes and other care facilities.

There was widespread outrage in France over the country’s ‘pass sanitaire’, which showed proof of vaccination, a recent negative SARS-CoV-2 test or past SARS-CoV-2 infection. On January 6, 2022, the French National Assembly approved a bill to transform the ‘health pass’ into a stricter ‘vaccine pass’.

France’s Constitutional Council approved the vaccine pass, which required people aged 16 and above to show proof of vaccination to enter public places like bars, restaurants, and cinemas.

In Montelimar, hospital staff began an indefinite strike in protest against compulsory Covid-19 vaccination.

The vaccine pass was suspended in France from March 14, 2022.

Israel introduced its ‘green pass’ in February 2021. The system expired on June 1, but was later reinstated.

The health ministry announced on August 29 that, as of October 1, 2021, the pass would expire six months after the holder received their second or third Covid vaccine dose.

The ministry also announced that, as of September 3, there would be an exemption from a week-long quarantine for people who had received a third Covid vaccine dose a week earlier if they were returning to Israel from countries considered to have a low or moderate risk of Covid infection.

The exemption also applied to those who had received a second vaccine dose within the previous six months, the ministry said.

The Israeli prime minister, Naftali Bennett, accused those who were eligible to get vaccinated but had not done so of endangering those around them and the freedom of every Israeli citizen. He urged people to persuade others to get vaccinated.

Bennett said people who had been vaccinated would be able to fly to “clean” countries and, on their return to Israel, if their PCR test was negative, they would be exempt from quarantine. The non-vaccinated would have to quarantine for a week, no matter which country they were returning from, and they would have to cover the cost of any PCR tests, he said.

Citizens of the United Arab Emirates who had not received a Covid vaccine booster dose were banned from international travel from January 10, 2022.

The UAE’s Ministry of Foreign Affairs and International Cooperation (MoFAIC) made the announcement in coordination with the National Emergency Crisis and Disasters Management Authority (NCEMA) on January 1.

International travel would only be permitted for unvaccinated citizens in the following categories: those medically exempted from taking the vaccine, “humanitarian cases”, and citizens who are travelling “for medical and treatment purposes”, the ministry said.

Abu Dhabi now requires people entering the city to show proof of booster shots. Visitors are no longer considered fully vaccinated unless they have received a booster at least six months after their second vaccine dose. People wishing to enter Abu Dhabi must also have tested negative for SARS-CoV-2 within the previous two weeks.

IBM developed a Digital Health Pass, using blockchain technology, that stores details about people’s vaccination status and the results of PCR tests.

The pass is designed “to enable organisations to verify health credentials for employees, customers and visitors entering their site based on criteria specified by the organisation”, IBM says.

“Once a vaccine is administered, an individual would be issued a verifiable health credential via the IBM Digital Health Pass that would be included only in that individual’s encrypted digital wallet on their smartphone.”

Iceland was the first country in the Schengen area to issue Covid-19 vaccination certificates, which are given to citizens who have received the full number of vaccine doses.

The country launched an electronic system that enables people to obtain a vaccination certificate online.

“The aim is to facilitate the movement of people between countries so that individuals can present a vaccine certificate at the border and are then exempt from Covid-19 disease control measures in accordance with the rules of the country concerned,” the Ministry of Health said.

Iceland said it would recognise all Covid-19 vaccination certificates issued by EEA/EFTA countries.

On June 1, 2021, the European Commission said the technical gateway for use of the new EU Digital Covid Certificate had gone live, one month ahead of deadline, and seven member states had already started to issue the certificates.

The EC said the system should facilitate free movement inside the EU. “It will not be a pre-condition to free movement, which is a fundamental right in the EU,” the commission said. “Being vaccinated will not be a pre-condition to travel. All EU citizens have a fundamental right to free movement in the EU and this applies regardless of whether they are vaccinated or not.”

The commission added: “Already today, seven member states – Bulgaria, Czechia, Denmark, Germany, Greece, Croatia and Poland – have decided to connect to the gateway and started issuing first EU certificates, while certain countries have decided to launch the EU Digital Covid Certificate only when all functions are deployed nationwide. Therefore, more countries will join in the coming days and weeks.”

Available in digital format or on paper, the certificate records whether people have been vaccinated against Covid-19, recovered from the disease, or recently tested negative for SARS-CoV-2. The Commission proposed that the validity period for tests should be 72 hours for PCR tests and, where accepted by a member state, 48 hours for rapid antigen tests.

The EC said the gateway provided for the verification of the security features contained in the QR codes of all certificates. “This will allow citizens and authorities to be sure that the certificates are authentic. During this process, no personal data is exchanged or retained.”

The commission said the certificate contained necessary key information such as name, date of birth, date of issuance, relevant information about vaccination, test, or recovery from Covid-19, “and a unique identifier”.

It said the data remains on the certificate and is not stored or retained when a certificate is verified in another member state.

“The certificates will only include a limited set of information that is necessary. This cannot be retained by visited countries,” the EC stated. “For verification purposes, only the validity and authenticity of the certificate is checked by verifying who issued and signed it. All health data remains with the member state that issued an EU Digital Covid Certificate.”

On January 27, 2021 the Council of Europe’s parliamentary assembly adopted Resolution 2361, which states that Covid vaccination in EU member states is not mandatory, that no one should be pressured to get themselves vaccinated, and that there should be no discrimination against anyone for not being vaccinated.

Excerpt from the text of Resolution 2361 about Covid-19 vaccines adopted by the Council of Europe’s parliamentary assembly.

The business magnate and self-appointed expert on pandemics Bill Gates (pictured below) wants digital certificates contained in quantum-dot tattoos to be introduced to identify who has been tested for SARS-CoV-2, who has been vaccinated against it, and who has recovered from Covid-19.

Researchers at the Massachusetts Institute of Technology (MIT) have shown that their new dye, which consists of nanocrystals called quantum dots, can remain for at least five years under the skin. The dye emits near-infrared light that can be detected by a specially equipped smartphone.

The dots are only about four nanometres in diameter, but they are encapsulated in microparticles that form spheres about 20 microns in diameter. This encapsulation allows the dye to remain in place, under the skin, after it is delivered by a microneedle patch.

Several airlines, including Etihad Airways, Emirates, Saudia, and Gulf Air trialled a digital travel pass developed by the International Air Transport Association (IATA), which shows whether passengers have been vaccinated and/or have tested negative for SARS-CoV-2.

Writing in the Weekend Australian published on February 7, 2021, Christine Kellett quoted the Minister for Government Services, Stuart Robert, as saying it was “highly likely” that vaccination certificates would be required for international travel.

“There is still a range of decisions for governments to make, it’s highly likely that a certificate will be required for international visitors to Australia and we will continue to work with our international counterparts on our framework for vaccination certificates,” Kellett quoted Robert as saying.

The CEO of the Australian airline Qantas, Alan Joyce, said that proof of Covid vaccination would be compulsory for international air travel on board his aircraft.

The CEO of the International Air Transport Association (IATA), Alexandre de Juniac, said at the time of Joyce’s comment that his stance was a “bit premature” and that testing was more critical than vaccines.

Air New Zealand announced on October 3, 2021, that, from February 1, 2022, it would require customers travelling on its international network to be fully vaccinated, but it has since dropped the requirement.

AirAsia has also dropped its requirement for passengers to be vaccinated.

There is a petition on change.org against mandatory vaccination for international travel, which has been signed by more than 34,000 people.

The UK-based independent tour operator Tradewinds Travel said it would no longer do business with Qantas. “We are not anti-vaccination, but we are pro-choice,” the company said in a statement. “There is a huge difference between coercion and making a free choice.”

The British cruise firm Saga said it would not accept any guest who had not received a Covid vaccination.

“We have taken the decision to introduce the requirement that all guests must be fully vaccinated,” Saga stated on its website. “This means that guests must have received their full two doses of the Covid‑19 vaccination at least 14 days before travelling with us.”

Cruise passengers would be required to bring evidence of vaccination with them at the time of boarding, Saga said. No one who was exempt from vaccination would be accepted on a Saga cruise.

Authorisations in the US, Britain, and Australia

The mRNA-1273 vaccine manufactured by the American company Moderna, and the single-dose Covid vaccine developed by the Johnson & Johnson subsidiary Janssen Biotech are being administered under emergency use authorisations granted by the FDA.

On August 23, 2021, the FDA approved the Biologics Licence Application (BLA) submitted by the German biotech firm BioNTech for the mRNA BNT162b2 vaccine. This was the first approval of a BLA for a Covid vaccine in the US. The vaccine had earlier only been administered under an emergency use authorisation (EUA).

“The vaccine has been known as the Pfizer-BioNTech Covid-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of Covid-19 disease in individuals 16 years of age and older,” the FDA said.

“The vaccine also continues to be available under emergency use authorisation, including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”

The fact that the EUA is still in force means that there will now be two versions of the vaccine in use: the licensed vaccine, Comirnaty, and the EUA-authorised vaccine that has been administered to date. The licensed vaccine is not yet available. The brand name Comirnaty had not previously been used in the US, but it has been used in Europe and Australia.

In a letter to Pfizer, the FDA’s chief scientist, Denise M. Hinton, said: “The licensed vaccine has the same formulation as the EUA-authorised vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns.

“The products are legally distinct with certain differences that do not impact safety or effectiveness. ”

Robert Malone tweeted: ” … Along with licensure comes liability for the manufacturer. If one receives a vaccine labelled under the EUA (old stock) – it is under EUA. If you get a vaccine from a bottle labelled COMIRNATY, it is approved and there is liability from the manufacturer.”

All the Covid vaccines being administered under an EUA have a “liability shield”, Malone explains.

The director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, said: “Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities.”

The FDA said it had reviewed updated data from the clinical trial that supported the EUA and included a longer duration of follow-up in a larger clinical trial population.

“Specifically, in the FDA’s review for approval, the agency analysed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the Covid-19 virus infection within a week of receiving the second dose,” the FDA said.

“The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.”

Based on results from the clinical trial, the vaccine was 91% effective in preventing Covid-19 disease, the FDA said.

The FDA said that more than half of the clinical trial participants were followed up for safety outcomes for at least four months after the second dose and, overall, about 12,000 recipients were followed up for at least six months.

In its approval letter to BioNTech the FDA said: “We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA [Biologics Licence Application], including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion.”

Pfizer and BioNTech plan to seek licensure of a third dose of their Covid vaccine for people aged 16 years and above and for administration of the vaccine for children and adolescents aged 12 to 15 years “once the required data out to six months after the second vaccine dose are available”.

Just before the FDA’s approval of the Pfizer-BioNTech vaccine Peter Doshi wrote an opinion piece in which he said there was “no legitimate reason to hurry to grant a licence to a coronavirus vaccine”.

Doshi says the FDA should have demanded adequate, controlled studies with long-term follow-up, and made data publicly available, before granting full approval to any Covid-19 vaccine.

The FDA should be demanding that the companies complete the two-year follow-up, as originally planned, Doshi said. “Even without a placebo group, much can still be learned about safety,” he wrote.

“They should demand adequate, controlled studies using patient outcomes in the now substantial population of people who have recovered from Covid.”

Doshi is critical of the FDA’s decision not to convene its advisory committee to discuss the data ahead of approving the Pfizer-BioNTech vaccine.

“Last August, to address vaccine hesitancy, the agency had “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public,” Doshi wrote.

He said that, prior to the publication on July 28, 2021, of a preprint entitled ‘Six Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine’, his view and that of about thirty clinicians, scientists, and patient advocates, was that there were simply too many open questions about all Covid-19 vaccines to support approving any in 2021.

“The preprint has, unfortunately, addressed very few of those open questions, and has raised some new ones,” Doshi wrote. It reported decreased appetite, lethargy, asthenia, malaise, night sweats, and hyperhidrosis as new adverse events attributable to BNT162b2 that were not identified in earlier reports, but provided no data tables showing the frequency of these, or other, adverse events, Doshi added.

“In the preprint, high efficacy against ‘severe Covid-19’ is reported based on all follow-up time (one event in the vaccinated group vs 30 in placebo), but the number of hospital admissions is not reported so we don’t know which, if any, of these patients were ill enough to require hospital treatment.”

On the vaccine preventing death from Covid-19, there was too little data to draw conclusions, Doshi said. The crucial question, however, was whether the waning efficacy seen in the primary endpoint data also applied to the vaccine’s efficacy against severe disease, he added.

“Unfortunately, Pfizer’s new preprint does not report the results in a way that allows for evaluating this question,” Doshi said.

“Here we are, with FDA reportedly on the verge of granting a marketing licence 13 months into the still ongoing, two year pivotal trial, with no reported data past 13 March 2021, unclear efficacy after six months due to unblinding, evidence of waning protection irrespective of the Delta variant, and limited reporting of safety data.”

The Pfizer-BioNTech vaccine was granted a temporary authorisation for emergency use by the MHRA in the UK on December 2, 2020.

On December 30, the MHRA also approved the AstraZeneca-Oxford vaccine, which was co-invented by the University of Oxford and its spin-out company, Vaccitech. The authorisation is for emergency use for individuals aged 18 years and above.

In January 2021, the agency also approved the Moderna vaccine for emergency use for individuals aged 18 years and above. The MHRA recommended administration of the second dose 28 days after the first.

On May 28, the MHRA approved the use in Britain, under a conditional marketing authorisation, of the Janssen Biotech vaccine. The agency said the UK government had secured 20 million doses of the vaccine.

The MHRA said that the vaccine met “the expected standards of safety, quality and effectiveness”. The Commission on Human Medicines had reviewed the MHRA’s decision and endorsed it, the agency added.

The MHRA said the CMA was valid only in Britain only and was approved via the European Commission (EC) Decision Reliance Route. This is when the marketing authorisation application made by the company references the decision made by the CHMP. The MHRA reviews the application, taking the EC’s decision into consideration, before making an independent decision about the quality, safety, and effectiveness of the vaccine.

The Janssen Biotech vaccine is authorised in Northern Ireland under the CMA granted by the EMA on March 11, 2021.

On February 3, 2022, the MHRA granted conditional marketing authorisation for Nuvaxovid.

The approval authorises the administration of two doses of Nuvaxovid in people aged 18 years and above.

The CMA is only valid in Britain. Nuvaxovid is authorised in Northern Ireland under an emergency use authorisation granted by the EMA on December 20, 2021.

On April 14, 2022, the MHRA announced that it had approved the use in the UK, under a CMA, of the Valneva Covid-19 vaccine (VLA2001). This was the first approval to be given to the Valneva vaccine, which was developed by a company in France. It is the sixth Covid-19 vaccine to be granted an MHRA authorisation and the first inactivated whole-virus Covid-19 vaccine to be approved by the agency.

The MHRA approved the vaccine for administration to people aged 18 to 50 years, with the first and second doses to be taken at least 28 days apart.

The Ministry of Health and Prevention of the United Arab Emirates and the National Health Regulatory Authority in Bahrain granted EUAs for the Valneva vaccine on May 13, 2022, and February 28, 2022, respectively.

On May 19, Valvena said the EMA had accepted the filing of a marketing authorisation application (MAA) for VLA2001.

“Acceptance of the MAA means VLA2001 is advancing from the rolling review process and beginning the formal review process by the EMA’s Committee for Human Medicinal Products,” the company added.

Valvena said it expected to receive a positive CHMP opinion in June 2022. If the CHMP did give a positive opinion, the EC would review the recommendation and provide a final decision on the MAA, the company added.

“If granted by the EC, the centralised marketing authorisation would be valid in all European Union member states as well as in Iceland, Liechtenstein, and Norway,” Valvena said.

Valvena had announced on May 16, 2022, that it had received a notice from the EC of intent to terminate the advance purchase agreement (APA) for VLA2001.

The company said the APA provided the EC with a right to terminate the agreement if VLA2001 had not received a marketing authorisation from the EMA by April 30, 2022.

“Based on the terms of the APA, Valneva has 30 days from May 13, 2022 to obtain a marketing authorisation or propose an acceptable remediation plan,” Valvena said.

Valvena said on April 25, 2022, that it had received a further list of questions from the EMA’s CHMP. The company said it had submitted its responses on May 2 and believed that those responses adequately addressed the remaining questions.

The European Commission has granted CMAs for the Pfizer-BioNTech, AstraZeneca-Oxford, and Moderna vaccines.

The Therapeutic Goods Administration (TGA) in Australia announced on January 25, 2021, that it had granted provisional approval for the Pfizer-BioNTech vaccine BNT162b2 (Comirnaty) for use for individuals aged 16 and older (it has since provisionally approved the vaccine for children and adolescents aged 12 to 15).

On February 16, it announced that it had also granted provisional approval for use of the AstraZeneca vaccine for individuals 18 years and older. Both approvals are valid for two years.

The TGA said the AstraZeneca vaccine should be given in two separate doses. “TGA’s regulatory approval allows the second dose to be administered from four to 12 weeks after the first,” the administration said.

“The Australian Technical Advisory Group on Immunisation has recommended that the interval between first and second dose is 12 weeks. However if this interval is not possible, for example because of imminent travel, cancer chemotherapy, major elective surgery, a minimum interval of four weeks between doses can be used,” the TGA added.

Both approvals are subject to certain conditions, such as the requirement for the companies to continue providing longer term efficacy and safety information to the TGA from their ongoing clinical trials and post-market assessment.

Both vaccines had been shown to prevent Covid-19, the TGA said, but it was not yet known whether they prevent transmission or asymptomatic disease.

The TGA provisionally approved the Moderna vaccine for use in Australia on August 9. It announced on January 20, 2022, that it had also provisionally approved the Nuvaxovid vaccine. The approval was granted to Biocelect Pty Ltd (on behalf of Novavax Inc.).

The TGA said Nuvaxovid was provisionally approved for administration to people aged 18 years and above and it was recommended that the vaccine be given in two doses administered three weeks apart.

The vaccine was provisionally approved for primary vaccination only, the TGA said. “Studies for use of Nuvaxovid as a booster dose and in paediatric patients are ongoing, so the vaccine does not have regulatory approval for these purposes at this stage,” the administration added.

The TGA added that Novavax and the Australian government had announced an advance purchase agreement for 51 million doses of Nuvaxovid in January 2021.

On June 7, 2022, the VRBPAC voted 21–0, with one abstention, in favour of granting an EUA for the Novavax Covid-19 vaccine for administration to people aged 18 years and above.

On July 13, the FDA issued an emergency use authorisation for the vaccine.

The FDA said the vaccine was assessed in a randomized, blinded, placebo-controlled study conducted in the United States and Mexico.

“The effectiveness of the vaccine was assessed in clinical trial participants 18 years of age and older who did not have evidence of SARS-CoV-2 infection through six days after receiving the second vaccine dose, ” the FDA said.

“Among these participants, approximately 17,200 received the vaccine and approximately 8,300 received saline placebo.”

The FDA said that, overall, the Novavax vaccine was 90.4% effective in preventing mild, moderate or severe Covid-19, with 17 cases 9 occurring in the vaccine group and 79 in the placebo group.

“No cases of moderate or severe Covid-19 were reported in participants who received the vaccine, compared with nine cases of moderate Covid-19 and four cases of severe Covid-19 reported in placebo recipients,” the FDA said.

“In the subset of participants 65 years of age and older, the vaccine was 78.6% effective. The clinical trial was conducted prior to the emergence of Delta and Omicron variants.”

The trade name Nuvaxovid has not yet been approved by the FDA.

In its briefing document for the VRBPAC meeting, the FDA raised the issue of the potential risk of myocarditis and/or pericarditis associated with the administration of NVX-CoV2373.

The FDA stated that “the events of myocarditis/pericarditis are concerning for a causal association with NVX-CoV2373 for the following reasons”:

• five events were reported within two weeks of vaccination,
• only one event had a clearly identified alternative etiology (Covid-19) strongly associated with myocarditis, and other events had only circumstantial evidence of potentially plausible alternative etiologies, and
• four of the events occurred in young men, a subject population known to be at higher risk for mRNA Covid-19 vaccine-associated myocarditis.

“Additionally, identification of multiple potential vaccine-associated cases in a premarket safety database of ~40,000 vaccine recipients raises concern that if causally associated, the risk of myocarditis following NVX-CoV2373 could be higher than reported during post-authorisation use of mRNA Covid-19 vaccines (for which no cases were identified in pre-authorisation evaluation),” the document added.

The FDA’s EUA for Moderna’s mRNA-1273 was issued on December 18, 2020, and allows the vaccine to be distributed in the US and to be given to individuals aged 18 years and older.

On February 27, 2021, the FDA issued an EUA for the Janssen Biotech vaccine. This allows the vaccine to be distributed in the US for use in individuals aged 18 years or above.

The FDA said the safety data supporting the EUA included an analysis of 43,783 participants enrolled in a randomised, placebo-controlled study being conducted in South Africa, Mexico, the US, and several countries in South America.

“The participants, 21,895 of whom received the vaccine and 21,888 of whom received saline placebo, were followed for a median of eight weeks after vaccination,” the FDA said. “The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted 1–2 days.”

Of 39,321 trial participants, 19,630 received the vaccine and 19,691 received a saline placebo.

“Overall, the vaccine was approximately 67% effective in preventing moderate to severe/critical Covid-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical Covid-19 occurring at least 28 days after vaccination,” the FDA said.

“Additionally, the vaccine was approximately 77% effective in preventing severe/critical Covid-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical Covid-19 occurring at least 28 days after vaccination.”

There were 116 cases of Covid-19 in the vaccine group that occurred at least 14 days after vaccination, and 348 cases of COVID-19 in the placebo group during the same time period.

There were 66 cases of Covid-19 in the vaccine group that occurred at least 28 days after vaccination and 193 cases in the placebo group during the same time period. Starting 14 days after vaccination, there were 14 severe/critical cases in the vaccinated group versus sixty in the placebo group. Starting 28 days after vaccination, there were five severe/critical in the vaccine group versus 34 cases in the placebo group.

Headlines vaunt progress, but there are concerns about safety

Most of the mainstream media vaunt the progress being made in the vaccination drives and are actively engaged in promoting Covid vaccination.

It’s argued that the benefit of vaccination outweighs the risk of adverse events. Adverse reactions are downplayed, even by those suffering them. However, while many of these reactions are short-lived, others are long-lasting and extremely severe. Social media is awash not only with reports of serious health problems occurring after Covid vaccination but also with stories of post-vaccination deaths. It’s impossible to obtain accurate data about adverse events as there is serious underreporting.

As of May 28, 2023, VigiBase listed 5,061,704 reports of adverse events following Covid vaccination, including 25,281 deaths (listed under ‘General disorders and administration site conditions’).

There is a separate listing, under the same category, of 2,249 reports of sudden death along with 454 reports of sudden cardiac death, 199 reports of brain death, 170 reports of cardiac death, 19 reports of premature baby death, 15 reports of neonatal death, six reports of “clinical death”, five reports of sudden infant death syndrome, and three reports of “sudden unexplained death in epilepsy”.

Of the 5,061,704 reports of adverse events after Covid vaccination listed on VigiBase as of May 28, 2023, 306,861 were reports of cardiac disorders, 229,976 were reports of vascular disorders, and 218,754 were reports of blood and lymphatic system disorders.

Reproductive system and breast disorders (extract):

Pregnancy, peurperium (postpartum), and perinatal conditions (extract):

VAERS DATA

The database of the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (VAERS) in the US now lists 1,559,995 adverse event reports after Covid vaccination, but 33,704 reports are described as ‘no adverse event’.

According to the latest published data, 35,302 deaths after Covid vaccination have been reported to VAERS. (The figure is lower than the 35,387 reported last week.)

The statistics are dated up to May 19, 2023, and include adverse reactions reported after administration of the bivalent boosters.

Including adverse reactions reported after administration of the bivalent boosters, 7,143,721 individual-symptom events are listed (many reports include more than one symptom).

There are 78,700 reports described as vaccination failure and 71,580 listed as “drug ineffective”. There are 35,925 reports of an expired product being administered, 33,785 reports of a product storage error, 29,968 reports of an inappropriate schedule of product administration, 26,403 reports of off-label use, 13,649 reports of a product being administered to patient of an inappropriate age, 11,218 reports of an incorrect dose being administered, 9,415 reports of an extra dose being administered, 8,295 reports of an incorrect product formulation being administered, and 7,528 reports of a “poor quality product” being administered.

VAERS now has a separate category, ‘COVID19-2’, which contains data about the bivalent boosters. In this category, there are 32,230 reports of adverse reactions up to May 19, but 4,295 reports are listed as ‘no adverse event’.

There are 275 reports of death after vaccination (174 after administration of the Pfizer-BioNTech vaccine and 101 after administration of the Moderna vaccine), and 407 reports of permanent disability (251 after administration of the Pfizer-BioNTech vaccine and 156 after administration of the Moderna vaccine). A total 129,584 individual-symptom events are listed.

In the ‘COVID19-2’ category, there are 5,416 cases of Covid-19 and 5,007 reports separately listed as a positive SARS-CoV-2 test, 4,758 reports of a product storage error, 2,241 reports of an expired product being administered, 2,044 reports of the incorrect product formulation being administered, 1,409 reports of underdosing, 1,269 separate reports of an incorrect dose being administered, 761 reports of the wrong product being administered, 721 reports of an extra dose being administered, 425 reports of an inappropriate schedule of product administration, 388 reports of a product being administered to patient of an inappropriate age, 379 reports of a “poor quality product” being administered, and 309 reports of a “product preparation issue”.

As of May 10, 2023, 56.4 million people in the US had received a bivalent booster dose.

The CDD says on the ‘COVID-19 Vaccinations in the United States’ web page that the update published on May 11 is the “final update” of vaccination statistics on that page

It says that, on June 15, 2023, a new page displaying updated vaccination data will be available.

The data provided on CDC COVID Data Tracker: Vaccine Confidence and COVID VaxView is complex. The at-a-glance table provided on the ‘COVID-19 Vaccinations in the United States’ web page is not available on these pages.

ALL THE FOLLOWING Data ARE from both COVID VACCINE categories combined

There is a recently added disclaimer on the wonder.cdc.gov website. It states: “At the request of European regulators, CDC and FDA have removed certain data fields (country codes; reported symptom case narrative free text; diagnostic laboratory data free text field; illness at time of vaccination free text field; chronic conditions free text medical history field; allergies free text field) from foreign VAERS reports which were submitted to VAERS and may not comply with European regulations. Domestic (U.S.) VAERS reports are not affected by this process.”

According to the latest data, VAERS received 17,481 reports of death after Covid vaccination from US states and territories or a location reported as unknown and 17,821 from foreign locations.

The 35,302 total includes the 174 reported deaths after administration of a Pfizer-BioNTech booster and 101 after administration of a Moderna booster.

According to VAERS, a total 22,267 deaths followed administration of the Pfizer-BioNTech vaccines, 10,101 followed administration of the Moderna vaccines, and 2,882 followed administration of the Janssen Biotech vaccine (this is a lower total than the 3,005 figure reported last week). In 244 cases, the name of the vaccine manufacturer was not specified in the report.

A total 4,149 of the reported deaths occurred on the same day as vaccination, 3,142 occurred the following day, 579 occurred within seven days, 1,615 occurred within ten to 14 days, and 2,782 occurred within 15 to 30 days.

According to Worldometers.info there had been 1,164,934 deaths from Covid-19 in the US as of May 26, 2023.

According to the CDC’s Covid data tracker, 676,728,782 Covid vaccine doses had been administered in the US as of May 10, 2023.

On VAERS 934,132 reports (up to May 19 and in all locations) relate to adverse events after administration of the Pfizer-BioNTech vaccines (4,483,692 individual-symptom events), 529,114 refer to the Moderna vaccines (2,222,612 individual-symptom events), 97,798 refer to the Janssen Biotech vaccine (442,405 individual-symptom events), 304 reports relate to the Novavax vaccine (1,276 individual-symptom events), and 11,968 relate to an unknown vaccine manufacturer (48,519 individual-symptom events).

The total number of reported adverse reactions resulting in permanent disability is put at 66,198. VAERS lists, as of May 19, 47,315 cases after administration of the Pfizer-BioNTech vaccines, 15,669 after administration of the Moderna vaccines, 3,300 after administration of the Janssen Biotech vaccine, and 12 after administration of the Novavax vaccine. In 358 cases, the vaccine manufacturer was not specified.

As of May 19 VAERS lists 11,397 reports of seizures after Covid vaccination. Some other adverse reactions such as generalised tonic-clonic seizure (1,294), seizure-like phenomena (645), and partial seizures (316) are listed separately.

There are 13,921 reports of a pulmonary embolism and 10,649 reports of thrombosis, with separate listings for specific types of thrombosis, such as deep vein thrombosis (9,106), pulmonary thrombosis (1,174) and cerebral venous sinus thrombosis (988). There are 208,719 reports of people being diagnosed with Covid-19 and 60,411 separate reports of a SARS-CoV-2 test being positive

There are 9,687 reports of a cerebrovascular accident, 12,691 reports of sleep disorders, 14,131 reports of herpes zoster (plus 1,756 other herpes zoster reports listed separately, including herpes zoster reactivation), 2,402 reports of blindness, and 3,526 reports of deafness. As of May 19 there were 25,029 reports of tinnitus.

Miscarriages, stillbirths, and menstrual disorders

There are also 3,598 reports of spontaneous abortion (miscarriage) listed on VAERS as of May 19 along with 161 reports of stillbirth, 15,931 reports of heavy menstrual bleeding, 4,244 reports of intermenstrual bleeding, 9,406 reports of irregular menstruation, and 4,914 reports of delayed menstruation.

The National Institutes of Health (NIH) in the US has awarded one-year supplemental grants totalling $1.67 million to five institutions to explore potential links between Covid-19 vaccination and menstrual changes. One project will focus specifically on adolescents.”Some women have reported experiencing irregular or missing menstrual periods, bleeding that is heavier than usual, and other menstrual changes after receiving Covid-19 vaccines,” the NIH said.

 

The VAERS database is quite difficult to search. The independent OpenVAERS website is easier to navigate.

There are 3,318 reports of Guillain-Barré syndrome (GBS) listed on VAERS as of May 19, 2023, and 7,615 cases included in the reports of adverse reactions after Covid vaccination on VigiBase as of May 28, 2023.

GBS is a rare immune disorder that causes nerve inflammation and can result in pain, numbness, muscle weakness and difficulty walking. It can occur after an infection or the administration of other vaccines, including influenza vaccines.

The CDC said in the update to its website on April 12 that, as of April 7, 2022, about 313 preliminary reports of GBS had been identified on VAERS after administration of the Janssen-Biotech Covid vaccine. As of April 7, more than 18.6 million does of the vaccine had been administered in the US, the CDC added.

The cases had largely been reported about two weeks after vaccination and mostly in men, many aged 50 years and older, the CDC said in April.

The agency is no longer updating the GBS data in the ‘Selected Adverse Events Reported after Covid-19 Vaccination’ section of its website.

“Based on a recent analysis of data from the Vaccine Safety Datalink, the rate of GBS within the first 21 days following J&J/Janssen COVID-19 vaccination was found to be 21 times higher than after Pfizer-BioNTech or Moderna (mRNA COVID-19 vaccines),” the CDC said in its August 23 update. “After the first 42 days, the rate of GBS was 11 times higher following J&J/Janssen Covid-19 vaccination. Analysis found no increased risk of GBS after Pfizer-BioNTech or Moderna (mRNA Covid-19 vaccines).”

Researchers in Britain have identified a link between a first dose of the AstraZeneca Covid-19 vaccine and a rise in cases of Guillain-Barré syndrome.

The scientists conducted a population-based study of National Health Service data in England and also examined surveillance data from UK hospitals. They published their findings in the journal Brain.

They said the data they analysed suggested “a clear and plausible excess of GBS cases” occurring within 42 days after administration of a first dose the AstraZeneca Covid-19 vaccine.

The researchers found that 996 cases of GBS were recorded in the national immunoglobulin database from January to October 2021.

“A spike of GBS cases above the 2016–2020 average occurred in March–April 2021,” Michael P. Lunn et al. reported.

The researchers report that 198 GBS cases occurred within six weeks of the first-dose Covid-19 vaccination in England (0.618 cases per 100,000 vaccinations) and 176 of these cases occurred after administration of the AstraZeneca vaccine.

Twenty-one of the cases occurred after administration of the Pfizer-BioNTech (tozinameran) vaccine and one occurred after administration of the Moderna vaccine.

“The 6-week excess of GBS (compared to the baseline rate of GBS cases 6–12 weeks after vaccination) occurs with a peak at 24 days post-vaccination,” Lunn et al. reported. “First-doses of ChAdOx1 nCoV-19 [the AstraZeneca vaccine] accounted for the excess.”

Twenty-three GBS cases were reported within six weeks of any second Covid-19 vaccine dose.

The researchers said their data gave an estimate of 5.8 excess GBS cases per million first doses of the AstraZeneca vaccine and no measurable excess of GBS associated with first doses of the Pfizer-BioNTech vaccine.

“The absolute number of excess GBS cases from January–July 2021 was between 98–140 cases for first-dose ChAdOx1 nCoV-19 vaccination,” Lunn et al. reported. “First-dose tozinameran and second dose of any vaccination showed no excess GBS risk.”

The researchers said that detailed clinical data from 121 GBS patients were reported in the separate multicentre surveillance dataset during the same timeframe and no phenotypic or demographic differences were identified between vaccine-associated cases of GBS and those that were not associated with vaccination.

“Analysis of the linked NID/NIMS dataset suggests that first-dose ChAdOx1 nCoV-19 vaccination is associated with an excess GBS risk of 0.576 (95% CI 0.481-0.691) cases per 100,000 doses,” Lunn et al. reported.

“However, examination of a multicentre surveillance dataset suggests that no specific clinical features, including facial weakness, are associated with vaccination-related GBS compared to non-vaccinated cases.

“The pathogenic cause of the ChAdOx1 nCoV-19 specific first dose link warrants further study.”

The researchers said the reason for the association between ChAdOx1 nCoV-19 vaccination and GBS was unclear.

“Covid-21 infection does not have a strong, or possibly any, increased risk of GBS, and the lack of increased risk associated with tozinameran vaccination implies that it is unlikely that the Covid-19 spike protein is the causative factor for the increased risk,” Lunn et al. said.

It was logical to suggest that the simian adenovirus vector used in the AstraZeneca vaccine may account for the increased risk, they added.

In a report of the ACIP meeting held on July 22, 2021, the number of reports of GBS after administration of the Janssen Biotech vaccine was put at 100. Ninety-five of the cases were reported to be serious and there was one fatality. The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended a change to the product information for the AstraZeneca-Oxford vaccine to include a warning “to raise awareness among healthcare professionals and people taking the vaccine of cases of Guillain-Barré syndrome (GBS) reported following vaccination”.

The agency also said in its safety update about the AstraZeneca-Oxford vaccine on September 8 that the product information would be updated to include GBS as a side effect.

The EMA said that, as of July 31, 833 cases of GBS had been reported worldwide after administration of the AstraZeneca-Oxford vaccine. About 592 million doses of the vaccine had been administered worldwide by that date, the agency said.

“Based on the assessment of these data and taking into account neurological expert advice, PRAC concluded that a causal relationship between Vaxzevria and GBS is considered at least a reasonable possibility and that GBS should therefore be added to the product information as a side effect of Vaxzevria,” the EMA said.

The EMA said that the frequency category allocated for GBS was “very rare” (i.e. occurring in less than 1 in 10,000 people). The agency said the PRAC recommended that the existing warning in the package leaflet should be updated with the following advice: “Patients are asked to talk to their healthcare professionals before they are given Vaxzevria if they previously had GBS after being given Vaxzevria”.

The EMA also said in its September 8 update that pain in the legs and arms or stomach and influenza-like symptoms had also been included in the product information as side effects of the AstraZeneca-Oxford vaccine.

On July 12, Johnson & Johnson said that it had updated its Covid-19 vaccine fact sheets to include information (required by the FDA) about cases of GBS and the signs and symptoms of the syndrome. “Updates with this new information will be implemented in other regions of the world according to local regulatory procedures,” the company said.

The company noted that most cases of GBS occurred within 42 days after vaccination. It said that the chance of people developing GBS after administration of the Janssen Biotech vaccine was “very low”.

Fact sheet for recipients and caregivers

Fact sheet for healthcare providers administering the vaccine

The fact sheet for vaccination providers now also also includes thrombosis with thrombocytopenia and capillary leak syndrome in its list of possible severe allergic reactions to the Janssen Biotech vaccine.

A total 533 cases of GBS after administration of the Janssen Biotech vaccine are listed on VAERS up to May 19, 2023.

Bell’s palsy

There are 7,006 reports of Bell’s palsy listed on VAERS as of May 19, 2023, and there are 11,677 cases listed on VigiBase up to May 28, 2023.

Bell’s palsy, which is also known as acute peripheral facial palsy of unknown cause, is a condition that causes a temporary weakness or paralysis of the muscles in the face. It causes one side of the face to droop or become stiff. In most cases, Bell’s palsy is temporary and symptoms usually start to improve within a few weeks, and there is usually full recovery in about six months. A small number of people continue to have Bell’s palsy symptoms for life. In rare cases, both sides of the face become paralysed.

There are 16,928 other reports categorised as facial paralysis listed on VigiBase along with 4,906 reports of facial paresis. There are 9,325 reports categorised as facial paralysis on VAERS, along with 2,032 reports of facial paresis.

There are also 224 reports of “facial asymmetry” listed on VAERS.

The FDA said in its briefing document about the Moderna vaccine for the VRBPAC meeting on December 17: “Throughout the safety follow-up period to date, there were three reports of facial paralysis (Bell’s palsy) in the vaccine group and one in the placebo group. Currently available information is insufficient to determine a causal relationship with the vaccine.”

The FDA added: “There were no other notable patterns or numerical imbalances between treatment groups for specific categories of adverse events (including other neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to mRNA-1273.

“There are currently insufficient data to make conclusions about the safety of the vaccine in subpopulations such as children less than 18 years of age, pregnant and lactating individuals, and immunocompromised individuals.”

It added that, of the seven serious adverse events in the mRNA-1273 group that were considered as related by the investigator, the FDA considered three to be vaccine related: intractable nausea and vomiting (one participant), and facial swelling (two participants).

“For the serious adverse events of rheumatoid arthritis, peripheral edema/dyspnea with exertion, and autonomic dysfunction, a possibility of vaccine contribution cannot be excluded,” the FDA said. “For the event of B-cell lymphoma, an alternative etiology is more likely. An SAE [serious adverse event] of Bell’s palsy occurred in a vaccine recipient, for which a causal relationship to vaccination cannot be concluded at this time.”

The FDA said that the serious adverse events were uncommon (1% in both treatment groups) and “represented medical events that occur in the general population at similar frequency as observed in the study”.

The FDA also reported on four cases of Bell’s palsy that occurred in the vaccine group during the Pfizer-BioNTech trial. No cases occurred in the placebo group. The FDA says it will recommend surveillance for cases of Bell’s palsy among those vaccinated.

According to the FDA, the four cases did not represent a frequency above that expected in the general population. The FDA referred to the cases, which occurred at three, nine, 37, and 48 days after vaccination, as “non-serious adverse events”.

“One case (onset at three days post-vaccination) was reported as resolved with sequelae within three days after onset, and the other three were reported as continuing or resolving as of the November 14, 2020, data cut-off with ongoing durations of 10, 15, and 21 days, respectively,” the FDA states.

“The observed frequency of reported Bell’s palsy in the vaccine group is consistent with the expected background rate in the general population, and there is no clear basis upon which to conclude a causal relationship at this time, but FDA will recommend surveillance for cases of Bell’s palsy with deployment of the vaccine into larger populations.”

12- to 17-year-olds

In a report posted online as an early release on July 30, 2021, Anne M. Hause et al. from the CDC’s Covid-19 response team said that, as of July 16, 2021, there had been 9,246 reports to VAERS that related to 12- to 17-year-olds who had received the Pfizer-BioNTech vaccine.

A total 8,383 (90.7%) of these reports related to non-serious adverse events and 863 (9.3%) related to serious adverse reactions, including deaths, Hause et al. said.

Approximately 8.9 million 12- to 17-year-olds in the US had received the Pfizer-BioNTech vaccine as of July 16, Hause et al. said.

Fourteen 12- to 17-year-olds died after receiving the Pfizer-BioNTech vaccine, the researchers said. Four of them were aged 12–15 years and ten were aged 16–17 years.

The cause of death has not been determined in six of the cases. Of the eight other cases, two of the deaths are believed to have been from an intracranial haemorrhage, two from a pulmonary embolism, one from heart failure, and one from hemophagocytic lymphohistiocytosis and disseminated mycobacterium chelonae infection. Two of the deaths were suicides.

“Impressions regarding cause of death did not indicate a pattern suggestive of a causal relationship with vaccination; however, cause of death for some decedents is pending receipt of additional information,” Hause et al. said. “ACIP conducted a risk-benefit assessment based in part on the data presented in this report and continues to recommend the Pfizer-BioNTech Covid-19 vaccine for all persons aged ≥12 years.”

Hause et al. said their report had several limitations. “First, VAERS is a passive surveillance system and is subject to underreporting and reporting biases; however, under EUA, health care providers are required to report all serious events following vaccination,” the researchers wrote.

“Second, medical review of reported deaths following vaccination is dependent on availability of medical records, death certificates, and autopsy reports, which might be unavailable or not available in a timely manner.

“Third, lack of a statistical safety signal in planned monitoring does not preclude a safety concern.”

The flaws in the VAERS and other reporting systems are highlighted at length by those who consider that the systems are of no use and rush to point out that anyone can report an adverse effect without evidence that there is a link with vaccination. Those labelled as “anti-vaxxers” are accused of hyping the adverse-event statistics, making fake reports, and fostering vaccine hesitancy.

While correlation does not equal causation, and reports on VAERS and similar databases needs to be treated with caution, the statistics can be an important warning signal about the risks associated with a particular drug or vaccine, particularly when numerous reports accumulate.

Knowingly filing a false VAERS report is a violation of US federal law, punishable by fine and imprisonment.

The CDC warns: “When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. VAERS receives reports on all potential associations between vaccines and adverse events.

“Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that vaccine caused the event.”

In the caveats noted on the VAERS website, it is stated: “The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine.”

It is added, however: “While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable.

“Most reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.”

There is serious underreporting of adverse reactions to Covid vaccination.

PFIZER DOCUMENTS

In its post-authorisation analysis, which was released as a result of a Freedom of Information Act (FOIA) request, Pfizer gives a breakdown of the 42,086 reports of suspected adverse reactions to its Covid-19 vaccine that were made up to February 28, 2021, (158,893 individual-symptom events).

Pfizer states that 25,379 of the reports were medically confirmed and 16,707 were “non-medically confirmed”. The reports included 1,223 deaths.

The company states in its analysis: “Due to the large numbers of spontaneous adverse event reports received for the product, the MAH [marketing authorisation holder] has prioritised the processing of serious cases, in order to meet expedited regulatory reporting timelines and ensure these reports are available for signal detection and evaluation activity.”

The reference to the estimated number of doses of the Pfizer-BioNTech vaccine that were shipped worldwide from December 1, 2020, to February 28, 2021, was redacted when the post-authorisation analysis was first released on November 17, 2021.

It is unredacted in the version of the document released on April 1, 2022, in which it is stated: “It is estimated that pproximately 126,212,580 doses of BNT162b2 were shipped worldwide from the receipt of the first temporary authorisation for emergency supply on 01 December 2020 through 28 February 2021.”

The following sentence is also unredacted in the document released on April 1. “To date, Pfizer has onboarded approximately 600 additional fulltime employees (FTEs). More are joining each month with an expected total of more than 1,800 additional resources by the end of June 2021.” In the redacted document released in November 2021, the numbers in the sentence are not visible.

Most of the reports of suspected adverse reactions (34,762) were received from the US (13,739), the UK (13,404), Italy (2,578), Germany (1,913), France (1,506), Portugal (866), and Spain (756). The remaining reports came from 56 other countries.

Pfizer says that the greatest number of adverse events in the overall dataset were in the following categories: general disorders and administration site conditions (51,335 adverse events reported), nervous system disorders (25,957), musculoskeletal and connective tissue disorders (17,283), gastrointestinal disorders (14,096), skin and subcutaneous tissue disorders (8,476), respiratory, thoracic and mediastinal disorders (8,848), infections and infestations (4,610), injury, poisoning and procedural complications (5,590), and investigations (3,693).

 

The document containing the Pfizer analysis was in the first batch provided to the organisation ‘Public Health and Medical Professional for Transparency Documents’ (PHMPT) after it submitted an FOIA request to the FDA for all of the data within Pfizer’s Covid-19 vaccine biological product file.

PHMPT sued the FDA, which released the first batch of documents after a federal judge ordered that it must comply with the FOIA request.

Lawyer for PHMPT Aaron Siri said in a Substack post that the FDA asked a federal judge to make the public wait until the year 2076 to disclose all of the data and information it relied upon to licence the Pfizer-BioNTech Covid-19 vaccine.

“Literally, a 55-year delay, Siri wrote. “My firm, on behalf of PHMPT, asked that this information be disclosed in 108 days – the same amount of time it took for the FDA to review and license Pfizer’s vaccine.”

Siri said that the court (the US District Court for the Northern District of Texas) ordered the parties to submit briefs in support of their respective positions by December 6.

“The FDA’s brief, incredibly, doubles down. It now effectively asks to have until at least 2096 to produce the Pfizer documents. Not a typo. A total of at least 75 years, Siri said.

“Other than producing an initial ~12,000 pages in around two months, the FDA thereafter only wants to commit to producing 500 pages per month. The FDA also disclosed that it actually has approximately at least 451,000 pages to produce.”

On January 6, 2022, district court judge Mark T. Pittman rejected the FDA’s request to produce the request documents at a rate of 500 pages per month.

The judge ordered the agency to produce the “more than 12,000 pages” articulated in its own proposal on or before January 31, 2022, and to produce the remaining documents at a rate of 55,000 pages every thirty days, starting on or before March 1, 2022.

“To the extent the FDA asserts any privilege, exemption, or exclusion as to any responsive record or portion thereof, FDA shall, concurrent with each production required by this Order, produce a redacted version of the record, redacting only those portions as to which privilege, exemption, or exclusion is asserted,” Justice Pitman said.

Siri said in a Substack post: “This is a great win for transparency and removes one of the strangleholds federal ‘health’ authorities have had on the data needed for independent scientists to offer solutions and address serious issues with the current vaccine program – issues which include waning immunity, variants evading vaccine immunity, and, as the CDC has confirmed, that the vaccines do not prevent transmission.”

In an order issued on February 2, Justice Pittman said the FDA must release the Pfizer documents according to the following schedule (on the first business day of each month, not once every thirty days):

• 10,000 pages per month for the first two months (due on or before March 1 and April 1, 2022),
• 80,000 pages per month for the following three months (due on or before May 2, June 1, and July 1, 2022),
• 70,000 pages the next month (due on or before August 1, 2022),
• then 55,000 pages on or before the first business day of each month thereafter.

He added that the FDA could “bank” any processed pages in excess of its monthly quota. For example, if the administration produced 90,000 pages in May 2022 (or 65,000 pages in September 2022), it would bank 10,000 pages.

If, in a subsequent month, the FDA was unable to produce the full amount of pages required, it could apply the banked pages toward its quota for that month, Justice Pittman said.

Pfizer says its safety database contains cases of adverse events reported spontaneously to the company, cases reported by the health authorities, cases published in the medical literature, cases from Pfizer-sponsored marketing programmes and non-interventional studies, and cases of serious adverse events reported from clinical studies regardless of causality assessment.

“The limitations of post-marketing adverse drug event reporting should be considered when interpreting these data,” Pfizer said.

“Reports are submitted voluntarily, and the magnitude of underreporting is unknown.”

There were 1,002 cases of anaphylaxis among 1,833 “potentially relevant” reports, Pfizer said.

Pfizer said that no post-authorisation adverse event reports had been identified as cases of vaccine-associated enhanced disease (VAED), including vaccine-associated enhanced respiratory disease (VAERD).

“An expected rate of VAED is difficult to establish so a meaningful observed/expected analysis cannot be conducted at this point based on available data,” Pfizer said. “The feasibility of conducting such an analysis will be re-evaluated on an ongoing basis as data on the virus grows and the vaccine safety data continues to accrue.”

The search criteria used to identify potential cases of VAED for the analysis included MedDRA preferred terms (PTs) that indicated a lack of effect of the vaccine or were potentially indicative of severe or atypical Covid-19, Pfizer added.

As of February 28, 2021, 138 cases, reporting 317 potentially relevant events, were retrieved, the company said.

Of the 317 relevant events, the most frequently reported events were drug ineffectiveness (135), dyspnoea (53), diarrhoea (30), Covid-19 pneumonia (23), vomiting (20), respiratory failure (eight), and seizure (seven).

Overall, there were 37 people with suspected Covid-19 and 101 with confirmed Covid-19 following one or both doses of the vaccine, Pfizer said, adding that 75 of the 101 cases were severe, resulting in hospitalisation, disability, life-threatening consequences, or death.

“None of the 75 cases could be definitively considered as VAED/VAERD,” Pfizer said. “In this review of subjects with Covid-19 following vaccination, based on the current evidence, VAED/VAERD remains a theoretical risk for the vaccine. Surveillance will continue.”

Pfizer says there were 413 reports of adverse events in women who were pregnant or breastfeeding at the time of vaccination. Eighty-four of the cases were considered to be serious. A total 274 of the cases occurred during pregnancy. There were 25 reported miscarriages. Two neonatal deaths and one intrauterine death were reported.

Pfizer details what it describes as Adverse Events of Special Interest (AESIs). These include the following cardiovascular AESIs: