Freedom of Information request (FOI 22/905)
Published 17 January 2024
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FOI 22/905
13th September 2022
Dear
Thank you for your email dated 15th August 2022, where you asked about the COVID-19 vaccination reports in association with Amyotrophic Lateral Sclerosis (ALS):
- I was wondering whether you had any data on whether these patients recovered and why these are listed as non-fatal when the prognosis is 2- 3 years max life expectancy from diagnosis?
As you will know, the Medicines and Healthcare products Regulatory Agency (MHRA), have been publishing all data relating to reported adverse events regarding the COVID-19 vaccinations on a monthly basis: (Coronavirus vaccine - summary of Yellow Card reporting – https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting.
I can confirm that as of the 24th August 2022 we have received a total of 5 UK suspected spontaneous reports in association with ALS and either the COVID-19 mRNA Pfizer/BioNTech vaccination or the COVID-19 Oxford University/AstraZeneca vaccination all of which were reported as non-fatal cases. All reports received are captured on our database with the information provided by the reporter at the time the report is submitted. Should we receive any further information from the reporter, such as the outcome of a suspected adverse reaction, then the report will be updated to reflect this as will the information within the Vaccine Analysis Prints (VAPs).
It is important to note that a reported reaction does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a vaccine or medicine and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by it. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.
As with any serious suspected adverse reactions such as ALS, these remain under continual review, including through analysis of expected rates in the absence of vaccination. There are currently no indications of specific patterns or rates of reporting that would suggest an association between any of the COVID-19 vaccines and ALS.
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