August 26, 2021

expert reaction to study looking at side effects of the Pfizer vaccine in a group of children 12-15 who are at high risk from COVID-19

A study published in Archives of Disease in Childhood looks at the side effects of vaccination with the Pfizer-BioNTech COVID-19 vaccine in 12-15 year olds at high risk of COVID-19 complications.

Dr David Elliman, Consultant Paediatrician, Great Ormond Street Hospital, said:

“This is a small study, as the authors point out, and it is not explained how these patients were chosen to be included. It is useful to know the nature of the reactions to the vaccine, not all of which were minor, but because of the size of the study it would be unwise to assume that this picture could be generalised to a larger group of similar children.

“The authors rightly say that children and young people with similar long term conditions are more likely to have severe COVID-19 disease than children and young people without. However, what we need to know is what is the chance of someone with one of these conditions getting severe COVID-19, balanced against the risks of the vaccine. This study cannot help us with that.

“As regards rolling out COVID-19 vaccine to all 12-15 year olds, this study provides no further evidence. To address that issue we need to compare the possible risks of the vaccine with its benefits. This information will come from countries who are using the vaccine in young people in this age group.”

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

“The Pfizer COVID-19 vaccine has been available for some time in the UK for a small group of teenagers with severe neurodisability and more recently available to a broader group of 12-15 year olds who are more clinically vulnerable. This paper provides data on reported side-effects after vaccination (2 doses) in 27 teenagers with severe neurodisability, one-third of them needing home oxygen and over half needing tube feeding.

“These data are generally reassuring that the Pfizer COVID-19 vaccine produces few side-effects in a group with severe disability and very high medical needs, although one child had severe fatigue and discomfort and another had a brief change in seizure type. This

should reassure parents and doctors that there are no special precautions or issues with this vaccine in this small group of children.

“However these data can tell us very little about rare side effects or about vaccinating healthy teenagers or those with common conditions such as asthma and diabetes. For that we must await further data in the order of millions of doses.

“There were no cases of myocarditis reported, however US reports suggest this occurs in around 1 in 15,000 second vaccine doses in young men, so these data on 27 cases can’t be informative about myocarditis. Furthermore, nearly 40% of the teenagers had cardiac impairment and this may have obscured any issues.”

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:

“We all know that it is not unusual to experience symptoms for a few days following vaccination – a sore arm, perhaps a fever or a headache. These adverse events are monitored and quantified in vaccine trials.

“This paper reports a small, independent study, undertaken by paediatricians caring for children aged 12-15 years with conditions making them particularly vulnerable to Covid-19 disease (and for whom vaccination has now been recommended). It supports what was already known about the frequency of common side-effects; but the number of patients included in the study is too small for us to draw any wider conclusions.”

‘Initial Experience of the Safety and Tolerability of the BNT162b2 (Pfizer-Bio-NTech) vaccine in extremely vulnerable children aged 12-15 years’ was published in Archives of Disease in Childhood at 23:30 UK Time on Thursday 26 August 2021.

doi 10.1136/archdischild-2021-322655

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

www.sciencemediacentre.org/tag/covid-19

Declared interests

Prof Russell Viner: “No COI”

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, 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.”

None others received.