Freedom of Information request on the regulatory approval of the COVID-19 vaccinations (FOI 22/398)
Published 31 May 2022
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-14-february-2022/freedom-of-information-request-on-the-regulatory-approval-of-the-covid-19-vaccinations-foi-22398
FOI 22/398
14th February 2022
Dear
Thank you for your email.
Please find below answers to the questions your raise below.
1) The drugs approval document for all 3 covid-19 vaccinations for human use in the UK: Moderna vaccine, Oxford/AstraZeneca vaccine, Pfizer/BioNTech vaccine.
The Information for Healthcare Professionals/Information for Vaccine Recipients and Summary of Product Characteristics/Patient Information Leaflet provide detail of each vaccine’s approval under Regulation 174 and as marketing authorisations, respectively. Links to these documents 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
2) FOI request for all documents claiming that all 3 vaccinations are safe for human use, the effectiveness of all 3 vaccinations as to prevent a covid-19 infection.
The Public Assessment Reports (PARs) published by MHRA and the European Medicines Agency (EMA) detail the assessments by these regulatory agencies to show that the authorised vaccines are safe and efficacious. The PARs published by MHRA are available via the above links. The PARs published by the EMA are provided below:
https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty
https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-moderna
https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca
The use of the vaccine as a third-dose booster was evaluated through the COV-Boost trial, further information on this trial is provided below.
Home - COV-Boost (covboost.org.uk)
3) I request an up to date report on all adverse reactions to the vaccines.
For Q3 please refer them to the weekly publication:
https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions
4) Copies of the full drugs information accompanying for all 3 covid-19 vaccines used in the UK for human use.
and for Q4, the product information can be found here:
https://coronavirus-yellowcard.mhra.gov.uk/productinformation
5) All Information concerning why all 3 vaccinations are subject to a regular booster dose within a 12 months period.
Please see the response to Q2 and the links to the information from MHRA, the EMA and the COVBOOST trial.
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.
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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:
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Yours sincerely
MHRA Customer Experience Centre