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expert reaction to MHRA extending the UK approval of the Pfizer-BioNTech COVID-19 vaccine to allows its use in 12- to 15-year-olds

The Medicines and Healthcare products Regulatory Agency (MHRA) has today authorised an extension to the current UK approval of the Pfizer-BioNTech COVID-19 vaccine to allow its use in children aged aged 12 to 15.


Prof Adam Finn, Professor of Paediatrics, University of Bristol, said:

“As expected, MHRA have authorised the use of the Pfizer-BioNTech vaccine from the age of 12 years as FDA and EMA have done previously.  This permits the vaccine to be used in this age group but does not decide whether or not to do so and, if it is decided to do so, which adolescents to offer it to and when.

“The key question to address now is whether it is actually necessary to immunise children in order to protect them from the infection (or whether vaccinating adults only would be sufficient to control spread of infection as seen in Israel) and in order to prevent further disruption to their education and social development.  Reports of cases of delta variant infection in schools this week are clearly of concern in this context.

“In the short term giving available vaccine doses to children would mean diverting them from adults who are at higher personal risk and who probably represent a higher onward transmission risk.  In addition, inducing strong protection with vaccines takes two doses and some time and is therefore not a quick fix for outbreaks.

“As the vaccine is now being widely used in the USA in teenagers, we can expect to receive a lot more information on safety from there soon and we hope and expect that this will be reassuring.

“Meantime, there is an urgent need to define more clearly which of the many children with comorbidities who have been shielding these many months are really at enhanced risk of serious illness when they get this infection so that they can be offered vaccination without delay and that work is in progress.”


Prof Russell Viner, Professor of Adolescent Health, UCL, said:

“This is very welcome news and will be particularly important for teenagers who are clinically vulnerable. Having a license doesn’t mean the vaccine should be used for all teenagers however. Decisions about wider use in teenagers need to carefully balance the benefits and risks and the ethical issues involved in vaccinating children. The early reports about myocarditis in young men need to be properly investigated and may not be related to the Pfizer vaccine, however they provide a warning that we should not rush into these decisions.”


Prof Dominic Wilkinson, Consultant paediatrician & Professor of Medical Ethics, University of Oxford, said:

“The news that the UK regulator, the MHRA, has just approved the Pfizer COVID vaccine for 12-15 year olds is unsurprising. The US, Canada and the EU have recently made similar decisions, and Moderna has submitted an application to the FDA for approval of the use of its vaccine in young people.

“This news is likely to prompt questions about whether the vaccine rollout in the UK should be extended to children and adolescents.

“However, there are ethical reasons for thinking that it would be premature to extend our vaccine rollout to those under 16.

“First, it is not yet clear that COVID vaccines are in the best interests of children and young people.

A vaccine can be in someone’s best interests if the benefit outweighs any side effects.

“Children have much less severe illness from coronavirus than adults. This is good news of course, but it means that the balance between benefit and risk from vaccines is difficult to assess. So far, trials of the COVID vaccines are reassuring, but those studies only gave the vaccine to about 3,000 young people (aged 12 to 17). They are not large enough to identify rare events. For example, we do not know whether there is a risk of serious blood clots in young people who have COVID vaccines.

If there is a risk, we simply cannot say yet whether that risk is higher or lower than the risk that young people face from COVID-19.

“Secondly, and perhaps even more importantly, there is a serious problem of vaccine supply globally. There are current surges in COVID cases in a number of poorer countries where only a very small proportion of the population has been vaccinated.To put it simply, 99% of COVID deaths occur in adults over the age of 55 and those people with other underlying illness. There are millions of people at high risk of dying from COVID-19 who do not currently have access to effective vaccines.

We urgently need to increase the supply of the vaccine to vulnerable people at high risk in countries with the greatest need. It is unethical to give vaccines to people at very low risk in our own country when there are others overseas at much higher risk who are dying.

“For the time being, we should not be extending our COVID vaccination programs to include children.”

Dr Jonathan Pugh and Professor Julian Savulescu also contributed to the above comment.



All our previous output on this subject can be seen at this weblink:



Declared interests

Prof Adam Finn: “AF is an investigator in trials and studies of several COVID19 vaccines including Oxford-AZ, Pfizer, Janssen and Valneva and advises the UK government and the WHO on COVID19 and other vaccines.  He receives no personal income for this work and is remunerated solely through his employment by the University of Bristol.”

Prof Dominic Wilkinson: “No conflicts of interest.”

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