Freedom of Information request the risks of having the COVID-19 vaccination by age group which was used to make the public statement ‘the benefits of preventing COVID-19 far outweigh the risks of having the jab (FOI 21/1229)
Published 31 May 2022
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FOI 21/1229
was used to make the public statement ‘the benefits of preventing COVID-19 far outweigh the risks of having the jab’.
14th December 2021
Dear,
Thank you for your email dated 15th November 2021, where you requested the MHRA to provide data that shows the risks of having the COVID-19 vaccination by age group and the risks of COVID-19 by age group which was used to make the public statement ‘the benefits of preventing COVID-19 far outweigh the risks of having the jab’.
Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19. The temporary authorisations for use of the COVID-19 vaccines in the UK followed a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine, and also considered the conditions for its safe supply and distribution. The decision was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. Regarding the MHRA approval of the Pfizer/BioNTech and the Oxford/AstraZeneca COVID-19 vaccines, further information (including information for physicians and recipients of the vaccine, and Public Assessment Reports [PARs] for each vaccine) are available on the MHRA website. Links to these are provided below:
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna
Please note that a marketing authorisation was granted for the Pfizer/BioNTech vaccine (Comirnaty) following a European Commission (EC) decision on 21 December 2020 (PLGB 53632/0002). Further information is available on the European Medicines Agency (EMA) website, a link to this is provided below:
https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty
Please also note that a marketing authorisation was granted for the Moderna vaccine on 31 March 2021 following an EC Reliance Procedure (PLGB 53720/0002). Further information is available on the MHRA website and the EMA website, links to these are provided below:
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna
https://www.ema.europa.eu/en/medicines/human/EPAR/spikevax
In addition, the European Commission, following recommendations from the European Medicines Agency (EMA), have granted a marketing authorisation for the Oxford/AstraZeneca vaccine. Further information is provided below:
https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca
The product information for the COVID-19 vaccines details the recognised possible side effects of receiving the vaccination. You can find the product information for each of the COVID-19 vaccines here; https://coronavirus-yellowcard.mhra.gov.uk/productinformation.
As with any vaccine, COVID-19 vaccines will cause side effects in some people. The total number and the nature of the majority of Yellow Cards received so far is not unusual for a new vaccine for which members of the public and healthcare professionals are encouraged to report any suspected adverse reaction.
For all COVID-19 vaccines, detailed review of all Adverse Drug Reaction (ADR) reports has found that the overwhelming majority relate to injection site reactions (sore arm for example) and generalised symptoms such as a ‘flu-like’ illness, headache, chills, fatigue (tiredness), nausea (feeling sick), fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illness. These types of reaction reflect the acute immune response triggered by the body to the vaccines, are typically seen with most types of vaccine and tend to resolve within a day or two. The nature of reported suspected ADRs across all ages is broadly similar, although, as seen in the clinical trials and usually seen with other vaccines, they may be reported more frequently in younger adults.
The MHRA also publish a weekly summary of Yellow Card reporting concerning the COVID-19 vaccines which can be found here. The summary includes data analysis on reported suspected adverse reactions from the COVID-19 vaccines, including a breakdown by age in relation to specific safety topics. It is important to note that the safety topics discussed in the weekly summary are not all confirmed risks. For a list of the recognised possible side effects to each vaccine you should refer to the information contained within the links above.
I hope the information provided is helpful, but 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 the date of this response; and can be addressed to this email address.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division