Freedom of Information request on the total number of ADR reports of COVID-19 vaccines for people with psychotic disorders taking penfluridolt (FOI 21-610)
Published 13 August 2021
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30th June 2021 FOI 21/610
Dear
Thank you for your recent correspondence dated on 2nd June 2021, where you asked for information on the following:
“Total numbers of reported adverse effect of covid-19 vaccines (any type) for people with psychotic disorders taking penfluridol”
There are currently three COVID-19 vaccines, Pfizer/BioNTech, Oxford University/AstraZeneca and Moderna, being used in the UK. All have been authorised for supply by the Medicines and Healthcare products Regulatory Agency (MHRA) following a thorough review of safety, quality and efficacy information from clinical trials. All vaccines and medicines have some side effects, these side effects need to be continuously balanced against the expected benefits in preventing illness.
Further to your request I can confirm to date that the MHRA has received no Adverse Drug Reactions (ADR) reports in association with any of the Covid-19 vaccines used in patients being treated with penfluridol for any indication. It should be noted that penfluridol is not currently licenced for use in the UK.
The MHRA’s role is also to continually monitor safety during widespread use of a vaccine. Any member of the public or health professional can submit suspected side effects through the Yellow Card scheme. The nature of Yellow Card reporting means that reported events are not always proven side effects. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are being vaccinated, including the most elderly people and people who have underlying illness. A weekly report of the adverse reactions reported for the approved Covid-19 vaccines is available at: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions.
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