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A Food and Drug Administration (FDA) advisory panel have recommended allowing children aged 5 to 11 to receive the Pfizer-BioNTech COVID-19 vaccine.
Dr Michael Absoud, Honorary Reader, Department of Women & Children’s Health, King’s College London, said:
“The UK Medicines & Healthcare products Regulatory Agency (MHRA) has not yet completed its review for the Pfizer Covid vaccine for 5-11 year olds. The dosage represents a third of the dose given to 12-17 year olds and adults. A vaccination programme for children however, should not be based on reducing transmission. After MHRA approval, the JCVI will make an expert evidence based assessment and issue advice based on the balance of direct benefits to children themselves against potential harms. It is of note that the essential routine childhood vaccination programme has fallen behind pre-pandemic levels.”
Prof Penny Ward, Independent Pharmaceutical Physician, Visiting Professor in Pharmaceutical Medicine at King’s College London, said:
“The vaccine advisory board voted almost unanimously yesterday in favour of extending approval for the PfizerBioNTech vaccine to children 5-11 years of age. The approval was based on the immunogenicity results from a study in ~1500 children, demonstrating that a two shot course of 10ug mRNA vaccine given with a 3 week interdose interval resulted in good immune responses and was >90% effective in preventing symptomatic COVID infection in recipients. The dose was selected after a prior Phase I dose ranging study demonstrated that this dose had similar immune responses to those noted in older teenagers/young adults receiving the full 30ug dose and was better tolerated than higher doses. This is expected given that younger children generally have a prompt and efficient priming response to vaccination at doses lower than those needed in adults. The vaccine was well tolerated with side effects limited to ‘reactogenic’ effects including fever, headache, muscle pains and fatigue as well as pain at the injection site. No cases of myocarditis were observed, but this could have occurred by chance, as the sample size was relatively small given the rate of this complication (approx 17:100,000 second doses administered) in teenagers aged >16. The company presented updated safety information from observation studies following ongoing vaccination of 12-15 year olds in Israel which demonstrated a lower incidence of myocarditis in this age group compared to older teenagers and young adults (approx 1 vs 17 per 100,000 second doses given). This information suggests that there may be many fewer such cases in younger children than were seen in young adults. It was concern about this effect which caused the JCVI concern when considering extending vaccination to teenagers in the UK although subsequent information has been reassuring, particularly when compared to the greater frequency and greater severity of myocarditis in the same age groups following COVID infection and illness. As the current outbreak is continuing among younger children and considerably disrupting schooling, with all this implies for long term impact on their health and wellbeing, these data support extension of vaccination against COVID to younger children.”
Prof Russell Viner, Professor of Child and Adolescent Health, UCL, said:
“It is essential not to confuse making a vaccine available for small groups of children 5-11 years who are highly vulnerable to COVID-19 and vaccinating all otherwise healthy children. It’s also important to remember that licensing a vaccine merely makes it available for use in this age group – and that decisions about who and when to vaccinate are entirely separate.
“I believe that it is important that the small numbers of children 5-11 years who are highly vulnerable to COVID-19 have access to vaccination as teenagers and adults do, and this is a useful step in that direction.
“However very few children of this age are in fact highly vulnerable to COVID-19. The data from the UK’s first pandemic year showed that COVID-19 caused extremely few deaths and serious illnesses in this age group, with almost all of these in small groups of children who are at higher risk due to other medical conditions.
“While any death of a child is one too many, we will need to extremely carefully weigh the risks and benefits of vaccinating younger children and not rush to a decision or blindly follow other countries. As for younger teenagers, the balance of risks and benefits for vaccinating healthy children is likely to be complex and involve a range of social and ethical as well as medical issues. Risk balances for the UK will be different to the USA, as we have better and comprehensive data and a health system that protects the most vulnerable.”
Video of the VRBPAC meeting which took place yesterday with the vote at the end is available here: https://twitter.com/US_FDA/status/1452975809174585345?s=20
All our previous output on this subject can be seen at this weblink:
www.sciencemediacentre.org/tag/covid-19
Declared interests
Prof Penny Ward: “I am semi-retired, but I am owner/Director of PWG Consulting (Biopharma) Ltd a consulting firm advising companies on drug and device development. Between December 2016 and July 2019 I served as Chief Medical Officer of Virion Biotherapeutics Ltd, a company developing antiviral treatments for respiratory viral diseases. Previous employee of Roche, makers of tocilizumab (anti IL6 antibody) and CMO of Novimmune, makers of empalumab (anti IFN gamma antibody).”
Prof Russell Viner: “No COI declared.”
None others received.