November 25, 2021

expert reaction to announcement from the EMA that they are recommending approval of use of the Pfizer-BioNTech vaccine for use in children aged 5 to 11 years old

The European Medicines Agency (EMA) have recommended the approval of the use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5-11.

Dr Peter English, Retired Consultant in Communicable Disease Control, Former Editor of Vaccines in Practice, Immediate past Chair of the BMA Public Health Medicine Committee, said:

“This is excellent news, although it emphasises how far behind we are in the UK.

“There is now ample evidence – from phase three trials, and also from the vaccine’s use in a number of countries (my nine-year-old nephew got his first “shot” on 5 November – he lives in the USA) that the vaccine is both safe and effective in children.

“The dosage used in a vaccine is usually based on the dose used in trials; and this will be decided based on the outcome of early phase 1 and 2 trial. It is not necessarily the optimum dose. (Indeed, the best dose can also vary with the route of administration: vaccines given into the most superficial layer of the skin (the dermis), where there are many more immune cells, require lower doses than vaccines given into muscles.^2-8)

“In this case, early studies in children looked at the effect of different doses, and found that a third of the adult dose worked just as effectively. It is possible that further studies would show that lower doses would work as well, or almost as well, in adults: you need enough antigen to stimulate the immune system to respond; but extra antigen does not necessarily enhance the response.

“Children age 5 and upward will benefit from vaccination directly.⁹ All children exposed to Covid-19 infection in schools through pressure to attend and a failure to implement mitigations. A much smaller proportion of children this age will get ill than older people do; but a small proportion of a very large number is still a large number! The number of deaths in children – while tragic, especially as it didn’t need to be so high – is not enormous (although it will lead to a large effect in terms of years of life lost at population level); but many children have been ill enough to require hospital treatment.¹⁰ Many more children – it’s not yet clear how many, or for how long – will suffer “Long Covid”; and some will suffer damage to their organs (the virus attacks organs including lungs, liver, kidneys, brain…) which might impair them for the rest of their lives, or cause problems later in life. They will also benefit indirectly from not infecting their families or their teachers, and from avoiding educational disruption due to outbreaks.

“The risks of vaccinating in this age group would not be expected to be as high as vaccinating adolescents on theoretical grounds; and so far the safety data from the trials and from post-implementation surveillance bears this out.

“I would expect all European countries to start to roll out vaccination for this age group, where they haven’t already started to do so (as Austria has, for example).

“Whether the UK will follow is another matter. The JCVI failed to recommend vaccination of older children despite clear evidence that they – and society – would benefit, so it may do the same with younger children.¹¹ The UK equivalent of the EMA, the Medicines and Healthcare products Regulatory Agency (MHRA), is not obliged to follow eg the US’ Food and Drugs Administration (FDA) or the European Medicines Agency (EMA) EMA. (There was no obligation to leave the EMA as part of Brexit, but the UK government decided to do so, losing many experts in the process) The MHRA has recently been subject to cuts to its budget which may delay a decision.

“I hope that the UK’s MHRA and JCVI will rapidly catch up with much of the rest of the world, and approve, recommend, and get on with vaccinating children from the age of five.”

References

1. European Medicines Agency. Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11. EMA Statement 2021; Updated 25 Nov 2021; Accessed: 2021 (25 Nov): (https://www.ema.europa.eu/en/news/comirnaty-covid-19-vaccine-ema-recommends-approval-children-aged-5-11).
2. Kenney RT, Frech SA, Muenz LR, Villar CP, Glenn GM. Dose sparing with intradermal injection of influenza vaccine. The New England journal of medicine 2004;351(22):2295-301  PMID: 15525714. (http://content.nejm.org/cgi/content/full/352/10/1044).
3. Friede M. Dose-sparing by intradermal immunization. 2006; Updated 5 Dec 2006; Accessed: 2010 (8 February): (http://www.who.int/vaccine_research/diseases/influenza/160207_Friede_Weniger.pdf).
4. Auewarakul P, Kositanont U, Sornsathapornkul P, Tothong P, Kanyok R, Thongcharoen P. Antibody responses after dose-sparing intradermal influenza vaccination. Vaccine 2007;25(4):659-63  PMID: 17011678.
5. Young F, Marra F. A systematic review of intradermal influenza vaccines. Vaccine 2011;1:1  PMID: 21968444. (http://www.sciencedirect.com/science/article/pii/S0264410X11014964).
6. Hung IF, Levin Y, To KK, Chan KH, Zhang AJ, Li P, et al. Dose sparing intradermal trivalent influenza (2010/2011) vaccination overcomes reduced immunogenicity of the 2009 H1N1 strain. Vaccine 2012;30(45):6427-35  PMID: 22910287. (http://www.sciencedirect.com/science/article/pii/S0264410X12011930).
7. Van Damme P, Oosterhuis-Kafeja F, Van der Wielen M, Almagor Y, Sharon O, Levin Y. Safety and efficacy of a novel microneedle device for dose sparing intradermal influenza vaccination in healthy adults. Vaccine 2009;27(3):454-9  PMID: 19022318. (http://www.sciencedirect.com/science/article/pii/S0264410X08014515).
8. Bryan JP, Sjogren MH, Perine PL, Legters LJ. Low-dose intradermal and intramuscular vaccination against hepatitis B. Clin Infect Dis 1992;14(3):697-707  PMID: 1532914.
9. Wise J. Headlines play down the gravity of covid-19 in children. BMJ 2021;375:n2826. (https://www.bmj.com/content/375/bmj.n2826).
10. Office for National Statistics (ONS). Coronavirus (COVID-19) latest insights: Hospitals. Office for National Statistics (ONS) 2021; Updated 23 Nov 2021; Accessed: 2021 (25 Nov): (https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/articles/coronaviruscovid19latestinsights/hospitals#hospital-admissions-by-age).
11. Mahase E. Covid-19: Release of JCVI minutes prompts more questions over committee’s decisions. BMJ 2021;375:n2718. (https://www.bmj.com/content/375/bmj.n2718.short).

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

“This is welcome news as it provides the option for children 5-11 years to be vaccinated against COVID-19 in the European Union. Following the FDA decision in the USA and now the EMA, I suspect it would be unlikely for our MHRA not to provide a similar license in the UK.

“A license to use a vaccine in this age-group in the UK, should it eventuate, does not necessarily mean we should vaccinate all primary-school children. But it would mean that children with serious other medical conditions, who are at much higher risk from COVID-19, would have access to the protection from the virus that they don’t currently have.

“There were no serious side-effects identified in the trial, which is excellent news and reassuring that the vaccine appears to work much as it does in teenagers and adults despite the reduced dose. However we will only be reassured about rare side effects once we have data on millions having had the vaccine.

“It is important to recognise the very early stage of our knowledge on vaccination of children against COVID-19. In the normal course of things, we would rarely approve widespread use of a drug in potentially many millions of children based upon data on only a few thousand. Yet the pandemic has challenged our business as usual. We will have decisions ahead about vaccinating children with other medical conditions and healthy children. Decisions on the first group will be easier. The second set of decisions around vaccinating healthy children will need to balance the risks and benefits to the child and consider the ethical issues of vaccinating children to benefit broader society. The challenge will be to take a considered view which puts the rights of the child first, within a rapid time-scale. We will soon have data on over a million children vaccinated in the USA to help in our deliberations.”

https://www.ema.europa.eu/en/news/comirnaty-covid-19-vaccine-ema-recommends-approval-children-aged-5-11

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

www.sciencemediacentre.org/tag/covid-19

Declared interests

Dr Peter English: “Dr English is on the editorial board of Vaccines Today: an unpaid, voluntary, position. While he is also a member of the BMA’s Public Health Medicine Committee (and its chair until Oct 2020), this comment is made in a personal capacity. Dr English sometimes receives honoraria for acting as a consultant to various vaccine manufacturers, most recently to Seqirus.”

Prof Russell Viner: “No conflicts of interest.”