The United Kingdom has given temporary approval to the Pfizer-BioNTech vaccine for 12-15-year-olds after the government body that assesses medicines said it had “carefully reviewed clinical trial data” in this new age group.
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) has concluded the Pfizer/BioNTech COVID-19 vaccine is “safe and effective” for older children, it said as it issued a regulatory approval of the drug on Friday. The move leaves the door open for a vaccination campaign for British schoolchildren, the Guardian newspaper reported on Friday.
Children and adults over 16 were already approved for the Pfizer shot.
On the efficacy of the shot and the study preceding its approval, it was said: “Over 2000 children aged 12-15 years were studied as part of the randomised, placebo-controlled clinical trials. There were no cases of COVID-19 from 7 days after the second dose in the vaccinated group, compared with 16 cases in the placebo group. In addition, data on neutralising antibodies showed the vaccine working at the same level as seen in adults aged 16-25 years. These are extremely positive results.”
Like all the four coronavirus vaccines presently in use in the United Kingdom at present, the authorisation is one covering “temporary supply” only, given the products have not yet gained what the MHRA calls “marketing authorisation” — that is, legal permission to be used in Britain. The Human Medicines Regulations 2012 regulation 174 allows for the normal procedure on assessing medicinal products to be sidestepped when the government is responding to “the suspected or confirmed spread” of pathogens, toxins, chemical agents, or nuclear radiation.
While the temporary supply authorisations do not have a built-in expiry, the MHRA issues them on the basis that they remain valid until they are either withdrawn or a full market authorisation — the usual, slower route for medicine approval — is issued.
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Commenting on the MHRA’s decision, chief executive Dr June Raine said in a statement seen by Breitbart London: “We have carefully reviewed clinical trial data in children aged 12 to 15 years and have concluded that the Pfizer/BioNTech COVID-19 vaccine is safe and effective in this age group and that the benefits of this vaccine outweigh any risk.
“We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines and this surveillance will include the 12- to 15-year age group.
“No extension to an authorisation would be approved unless the expected standards of safety, quality and effectiveness have been met.”
Adding to these comments, Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said: “There has been a thorough assessment and review of this data which was also looked at specifically by the CHM’s Paediatric Medicines Expert Advisory Group… We have concluded that based on the data we have seen on the quality, effectiveness and safety of the vaccine, its benefits do outweigh any risk. The MHRA will continue to scrutinise all of the suspected side effects data received through the rigorous surveillance programme in place through the Yellow Card scheme and other safety surveillance measures for all of the COVID-19 vaccines used in the UK.”
The approval doesn’t mean the jab will actually be rolled out to children, however. Now the MHRA has greenlit the medicine for the young, a separate body, the Joint Committee on Vaccination and Immunisation (JCVI), will then have to recommend it to the government.
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