Freedom of Information request on the authorisation of the COVID-19 vaccines (FOI 21/992)
Published 25 February 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-20-september-2021/freedom-of-information-request-on-the-authorisation-of-the-covid-19-vaccines-foi-21992
24th September 2021
FOI 21/992
Dear
Thank you for your email.
1) Do you know what all the ingredients are in each of the authorised Covid-19 vaccines?
A list of the excipients can be found in the Information for Healthcare Professionals at the following links:
Regulatory approval of Pfizer/BioNTech vaccine for COVID-19 - GOV.UK (www.gov.uk)
Regulatory approval of Vaxzevria (previously COVID-19 Vaccine AstraZeneca) - GOV.UK (www.gov.uk)
Regulatory approval of COVID-19 Vaccine Moderna - GOV.UK (www.gov.uk)
2) For each manufacturer, do the ingredients of these vaccines vary between batches or is each batch identical in composition? (I understand the different manufacturers produce different products; my question refers to differences between batches of the same product.) As the vaccines are still in a clinical trial and are experimental, is it the case that the manufacturers are experimenting with different ingredients / proportions in the vaccines given to people in the UK?
Each batch of vaccine is identical in composition and no one who has been administered the vaccine as part of the vaccine rollout has been given a placebo.
With reference to your query surrounding magnetism, we would refer you to the following link where we responded to a similar FOI:
3) Are any of the vaccine batches given to people in the UK placebos?
All COVID-19 vaccines given to people in the UK population as part of the Government’s mass vaccination policy for COVID-19 contain vaccine constituents as described in the product information for those vaccines. The clinical trials conducted to investigate efficacy, safety and quality of the COVID-19 vaccines now deployed in the UK (Pfizer/BioNTech, COVID-19 Vaccine AstraZeneca and COVID-19 Vaccine Moderna) involved placebo groups which acted as comparators for groups receiving the vaccine – this is a standard design for clinical trials of this nature and all details of the trial protocols were reviewed and approved by regulatory and ethics bodies prior to trial commencement.
4) What explanation do you give for the widespread evidence of magnetism in some individuals at the injection site (and elsewhere on the body in some cases) post-injection? For example, the study of 30 vaccinated people in Luxembourg of whom 29 were magnetic (Study on the Electromagnetism of Vaccinated Persons in Luxembourg, European Forum for Vaccine Vigilance, Goudjil, 2021). Are the MHRA investigating this phenomenon in the UK?
As of 08/09/2021 the MHRA has not received any Yellow Card (UK spontaneous Adverse Drug Reaction [ADR]) reports relating to magnetic effects, either of the vaccine or the injection site. This search included Yellow Card reports for the 3 COVID-19 vaccines currently being used in the UK (Pfizer/BioNTech, COVID-19 Vaccine AstraZeneca and COVID-19 Vaccine Moderna) as well as reports where the vaccine details were not specified.
The MHRA continuously monitors the safety of medicines and vaccines through a variety of pharmacovigilance processes including the Yellow Card scheme. As part of our signal detection processes all adverse reaction reports received by the Yellow Card scheme are individually assessed and cumulative information reviewed at regular intervals. Any emerging evidence relating to possible risks associated with vaccines and medicines, is carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed.
The MHRA publishes interactive listings of all suspected ADRs reported by healthcare professionals and members of the public for a particular drug substance, including the 3 COVID-19 vaccines currently being used in the UK (Pfizer/BioNTech, COVID-19 Vaccine AstraZeneca and COVID-19 Vaccine Moderna) as well as reports where the vaccine details were not specified. These are known as Interactive Drug Analysis Profiles (iDAPs) and they are available here: www.yellowcard.mhra.gov.uk/iDAP.
The information described as ‘Study on the electromagnetism of vaccinated persons in Luxembourg’ does not appear to have been published in a recognized scientific journal or subjected to peer review. In addition the article does not state which vaccines were given so little can be derived from this information.
MHRA is continuing to conduct signal detection on Yellow Card reports and other relevant data sources for the COVID-19 vaccines deployed in the UK. To date our analyses have not raised a safety concern related to injection site magnetism.
5) I have evidence of someone displaying magnetism at the site of an injection (given in preparation for travel abroad) at a Boots pharmacy in the East of England prior to January 2021. How can this be accounted for? Are the MHRA aware of any other reports of cases of post-injection magnetism prior to the rollout of the Covid-19 vaccines?
During clinical trials for the vaccines currently deployed in the UK, no adverse events that match the magnetic phenomenon described were reported. The ‘Information for UK Recipients’ [Pfizer BioNTech/AstraZeneca vaccines] and ’Patient Information Leaflet’ [Moderna vaccine] provide a list of ingredients for each vaccine. None of these ingredients are considered to cause “magnetism” when administered to a vaccine recipient.
Information for UK recipients on Pfizer/BioNTech COVID-19 vaccine - GOV.UK (www.gov.uk)
Information for UK recipients on COVID 19 Vaccine AstraZeneca - GOV.UK (www.gov.uk)
Patient Information Leaflet for COVID-19 Vaccine Moderna - GOV.UK (www.gov.uk)
We 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.
Kind regards,
FOI Team
Vigilance and Risk Management of Medicines Division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU