FOI release

Freedom of Information request on the adverse reactions reported following the COVID-19 vaccinations (FOI 22/433))

Published 21 December 2023

FOI 22/433

15th July 202

Dear

FOI adverse reactions 15-year-old boy Pfizer vaccine

Thank you for your email dated 3 February 2022 regarding your son’s experience following vaccination and for your request surrounding whether other children have had similar reactions. I would firstly like to offer my sincere apologies for the delay in replying to your questions. I am also very sorry to hear of the symptoms your son experienced, and I hope that his condition has improved.

We are unfortunately unable to comment on individual cases as this is beyond the role of the Agency, and we would recommend that you continue to seek advice from healthcare professionals that are involved in your son’s investigations and treatments should his symptoms not have fully recovered. It is a key role of the MHRA to provide doctors with advice on the safe use of medicines and vaccines; however, the final responsibility for the clinical care of the patient remains with the doctor given their clinical expertise and knowledge of your child’s medical history.

You may already be aware that the product information for the COVID-19 vaccines, which includes information relating to known side effects, is available on the Yellow Card Coronavirus website (https://coronavirus-yellowcard.mhra.gov.uk/productinformation).

I would like to reassure you that the MHRA is closely monitoring the safety of the COVID- 19 vaccines in recipients under 18 years of age, and our analysis has shown that adverse events are reported less than half the frequently in this age group compared to adults. Generally, the types of reactions reported in children and adolescents are similar to that reported in older age group, and there have been no new safety concerns identified following use in these age groups.

Following a search of our database up to and including 2nd February 2022, I can confirm that the MHRA had received 1253 spontaneous suspected Adverse Drug Reaction (ADR) reports associated with COVID-19 Vaccine Pfizer/BioNTech in male patients aged between 12-17 years. Up to and including the 2nd February the majority of the events reported were transient and recovered a short period of time after vaccination, and there were no fatal events reported.

Further to your request, please find enclosed a Vaccine Analysis Prints (VAP) listing the ADRs reported within these 1253 reports. A VAP guidance sheet is also enclosed which provides you with further information on how to interpret the print.

When considering the spontaneous ADR data, it is important to be aware of the following points:

• A reported reaction does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have. Each year, millions of doses of routine vaccines are given in the UK alone, and when any vaccine is administered to very large numbers of people, some recipients will inevitably experience illness following vaccination. The fact that symptoms or events occur after use of a vaccine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by the vaccine. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.

• It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions. Therefore, Yellow Card data cannot be used to determine the incidence of a reaction or to compare the side effect profiles of different medicines or vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug or vaccine and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.

You may also be interested to see the weekly summary of Yellow Card reporting (Coronavirus (COVID-19) vaccines adverse reactions - GOV.UK (www.gov.uk)). Here you can find a summary of all the Yellow Card reports submitted for each of the COVID-19 vaccines as well as comments on specific reactions and events. Within this report there is a section on suspected side effects reported in individuals under 18 years old.

For all COVID-19 vaccines, the overwhelming majority of reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as ‘flu-like’ illness, headache, fever and tiredness. Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illness.

Vaccination and surveillance of large populations also means that, by chance, some people will experience and report a new illness or events in the days and weeks after vaccination. It is therefore important that we carefully review Yellow Card reports to distinguish possible side effects from illness that would have occurred irrespective of vaccination.

Finally, I would like to thank you for your contribution to the Yellow Card Scheme. Support like yours is invaluable in helping us to continuously monitor the safety of medicines and published information about known side-effects which allows patients and healthcare professionals to make informed decisions.

I hope this information is of use to you. Should you have any additional questions, please contact: pharmacovigilanceservice@mhra.gov.uk. If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of this response’s date and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division