BACK

U.S. FDA authorising Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents

This article was published on
May 11, 2021

This explainer is more than 90 days old. Some of the information might be out of date or no longer relevant. Browse our homepage for up to date content or request information about a specific topic from our team of scientists.

It has been announced that the U.S. Food and Drug Administration (FDA) has expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to include adolescents from 12 to 15 years old.

It has been announced that the U.S. Food and Drug Administration (FDA) has expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to include adolescents from 12 to 15 years old.

Publication

What our experts say

Context and background

Resources

Media briefing

Media Release

Expert Comments: 

Prof Adam Finn

It is important that we have confirmation of the safety and adequacy of immune responses of COVID19 vaccines in children – particularly because there are some children who are at enhanced risk of serious illness because they have underlying health conditions that render them more vulnerable.

However, most children who get SARS CoV2 infection do not get seriously and, indeed, most don’t get sick at all.  Although the importance of children in transmission of the virus within the community is not entirely clear, the evidence we have suggests that it is not great, especially where younger children of pre-school and primary school age are concerned.  Accordingly immunising children is a low priority and if vaccine-induced protection in the adult population is high from high uptake, good persistence of protection and sustained protection against viral strains as they evolve to evade immunity, then it may not be necessary to immunise children in a general way at all.  This is even more likely for young children than adolescents.  At this point in the pandemic, when there are global shortages of vaccines and very large numbers of people at high risk of severe disease – mostly elderly – worldwide who remain unimmunised – a priority for them but also for us – is to prevent large epidemic waves like the one currently playing out in India.  Those outbreaks pose a global threat as they drive evolution of vaccine-resistant variants and their dissemination around the world.  So, for now we should make sure that the doses of vaccines that exist are used as strategically as possible – and giving them to children is unlikely to be the priority, at least for now.

Prof Russell Viner

Decisions about vaccinating children and teenagers will need to balance the risks and benefits for both children and for broader society, while recognising a range of ethical and operational issues.

Benefits for children/teenagers are two-fold:

a. direct clinical benefit through reduced risk of rare serious COVID disease, the Paediatric Multisystem Inflammatory Syndrome(PIMS) and also post-COVID syndromes.  There is a rights-based argument that children and teenagers should have the same access to protection against COVID as adults.  However serious COVID-19 disease and PIMS are very rare in children.  Very few children and teenagers ended up in intensive care with COVID-19 disease, and almost all of these were the same children we know are vulnerable to winter viruses every year.  We don’t know how common post-COVID syndromes are in children.  There are undoubtedly a very small group of teenagers who are clinically extremely vulnerable and would benefit more from vaccination.  However for healthy children and teenagers and the great majority of children with chronic conditions or disabilities, it is difficult to argue for vaccination on the basis of direct benefit to them given our current knowledge.

b. indirect benefits in terms of greater freedom within society.  There are dangers that being unvaccinated may mean that children/young people are excluded from aspects of society that require proof of vaccination (e.g. travel; events).  It’s also possible that societies will give children more freedom in schools (no distancing, no masks) if they are vaccinated.  Given that many have argued that requiring proof of vaccination is unethical for adults, these arguments cannot ethically be used to support vaccination of children.

Benefits for broader society:

These largely relate to reduction in transmission which we are now confident that come with vaccination of adults.  Children and teenagers do play a role in transmission, and if they remain unvaccinated they are likely to act as a reservoir of infection.  We don’t currently have any evidence that vaccination will reduce transmission from children to vulnerable adults, although it is reasonable to believe that the same reductions in transmission will occur as for adult vaccination.

Risks for children and young people:

The key one is safety.  The signals thus far are that the Pfizer vaccine appear very safe in teenagers although data have only been reported and not yet formally published.  Regulators in Canada and the USA have given the Pfizer vaccine emergency approval for 12-16 year olds.  However we must remember that safety data on this vaccine – and the future data from children’s trials – number only in the thousands.  Children’s immune systems differ to those of adults, and they respond differently to certain drugs and vaccines.  Given that all medicines and vaccines have some side effects, no matter how rare, we can assume that there will undoubtedly be very rare vaccine side effects in children and teenagers.

Risks for broader society:

The key risk for broader society is the diversion of vaccines to those at low risk whilst there is a desperate need for vaccines for vulnerable adults in many countries.

The question of whether we should vaccinate our children and teenagers is a complex one.  We currently don’t have any safety data on children under 12 years and the data on teenagers are only on small numbers, although the Pfizer data are very promising.  The argument for vaccinating children and teenagers to reduce transmission to adults has strengthened with recent data showing vaccination reduces transmission.  However this means that we are vaccinating children and teenagers to benefit adults, which requires very careful ethical consideration.  We do vaccinate children to protect others against other diseases (influenza, rubella for example) however we do this with full knowledge about the risks of vaccination for children.  We do not have this information about COVID-19 vaccines.

We currently do not have the data to consider vaccinating children.  The balance for and against vaccinating teenagers is much more finely balanced.  We need current data to be publicly available, data on larger numbers and to have ethicists and young people themselves involved in discussions and decisions about whether to vaccinate teenagers later this year.

Q&A

No items found.