FOI release

Freedom of Information request on the authorisation of the COVID-19 vaccinations for children ages 5-11 (FOI 22/778)

Published 21 December 2023

FOI 22/778

22nd July 2022

Dear

Thank you for your email.

Please find below answers to the questions you have raised below:

7.COVID-19 vaccination: A guide for parents of children aged 5 to 11. How many cases of inflammation of the heart have been reported after COVID-19 vaccines, across all age groups, per 100,000 people, since January 2020?

Reporting rates for UK adverse drug reaction (ADR) reports of suspected myocarditis and pericarditis (inflammation of the heart) associated with COVID-19 Vaccines, by patient age and dose, up to and including 15 June 2022 can be found in table 8 of the coronavirus vaccine - summary of Yellow Card reporting here: Coronavirus vaccine - summary of Yellow Card reporting - GOV.UK (www.gov.uk)

11.Please supply a full statistical analysis of reports of deaths and side effects of all COVID-19 vaccines to the Yellow Card scheme to date.

Since the launch of the COVID-19 immunisation campaign we have been proactively monitoring the safety of all approved COVID-19 vaccines for near real-time safety monitoring at population level for all reports including those with a fatal outcome. It is important to note that as with any serious suspected ADR, reports with a fatal outcome are fully evaluated by the MHRA to consider whether the medicine or vaccine may have caused the event or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness. To ensure the comprehensive assessment of fatal reports, we follow-up all fatalities where permission has been provided to do so for further information. Please be assured that any additional information received via follow up information or post-mortem reports, relating to the date of death are included for full assessment.

Yellow Card reports of suspected ADRs are evaluated, together with additional sources of evidence, by a team of safety experts to identify any new safety issues or side effects. We apply statistical techniques that can tell us if we are seeing more events than we would expect to see, based on what is known about background rates of illness in the absence of vaccination. This aims to account for factors such as coincidental illness. We also look at the clinical characteristics to see if new patterns of illness are emerging that could indicate a new safety concern.

We supplement this form of safety monitoring with other epidemiology studies including analysis of data on national vaccine usage, anonymised GP-based electronic healthcare records and other healthcare data to proactively monitor safety. We also take into account the international experience based on data from other countries using the same vaccines. These combined safety data enables the MHRA to detect side effects or safety issues associated with COVID-19 vaccines. As well as confirming new risks, an equally important objective of monitoring is to quickly rule out risks – in other words to confirm that the vaccine is not responsible for a suspected side effect and to provide reassurance on its safety.

With regards to your specific request for information on the analysis of reports of death and side effects to COVID-19 vaccines, please  may I also direct you to our Vaccine Analysis Prints and weekly summary of Yellow Card reporting which contains a section on specific analysis of groups of Adverse Drug Reaction (ADR) reports and details any MHRA investigations.

When considering the spontaneous ADR data contained within Vaccine Analysis Prints, it is important to be aware of the following points:

• A reported reaction does not necessarily mean it has been caused by the medicine/vaccine, only that the reporter had a suspicion it may have. The fact that symptoms or events occur after use of a medicine, and are reported via the Yellow Card Scheme, does not in itself mean that they are proven to have been caused by the medicine.

• 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 and therefore cannot be used to determine the incidence of a reaction. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, and may be stimulated by promotion and publicity about a drug.

• It may be difficult to tell the difference between something that has occurred naturally and a suspected adverse reaction. Sometimes these events can be part of the condition being treated rather than being caused by the vaccine.

• Many factors have to be considered when assessing whether the vaccine has caused a reported adverse reaction. When monitoring the safety of vaccines and medicines, MHRA staff carry out careful analysis of these factors.

12.Is there a figure for the maximum number of deaths of children aged 5 to 11 from the COVID-19 vaccine that would cause the NHS to cease to offer it?
13.What is the maximum number of deaths of children aged 5 to 11 from the COVID-19 vaccine that would cause the NHS to cease to offer it?

MHRA does not make recommendations on vaccination policy. However, the MHRA proactively monitors the safety of the COVID-19 vaccines and reviews all reports of fatalities received through the Yellow Card scheme. Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or events in the days and weeks after vaccination. However it is important to note that a fatal report does not mean that death was caused by the vaccine. There is no specific number of deaths following vaccination which would cause the MHRA to withdraw the authorisation of a medicinal product. Products remain authorised on the basis of a favourable balance of benefits and risks. The benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects. As with all vaccines and medicines, the safety of COVID-19 vaccines is continuously monitored and benefits and possible risks remain under review.

16.How many children aged 5 to 11, in the United Kingdom, have taken part in clinical trials of the COVID-19 vaccine?

17.Does the COVID-19 vaccine for children aged 5 to 11 have an unconditional marketing authorisation?

18.The UK government information on the Pfizer vaccine states “COVID-19 mRNA Vaccine BNT162b2 is not recommended for children under 12 years.” Is this the vaccine that is being administered to children aged 5 to 11 in the quantity of a third of a dose that is given to adults?”

Further information on Comirnaty 10 micrograms/dose concentrate for dispersion for injection (PLGB 53632/0006), which is authorised for children aged 5-11 years of age, is available through the SmPC and PIL for this product that are available on the MHRA website, and the information available through the European Medicines Agency (EMA). This information includes the Public Assessment Report (PAR) published by the EMA, which contains information about the conditions of the marketing authorisation and the clinical studies submitted for the authorisation of this vaccine. Links to these are provided below:

https://products.mhra.gov.uk/search/?search=PLGB+53632%2F0006&page=1

https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty

If you have a query about the information provided, please reply to this email.

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely

MHRA Customer Experience Centre