MHRA estimate of Covid vaccine ADR Yellow Card reporting rate

The request was partially successful.

Dear Medicines and Healthcare products Regulatory Agency,

This FOI request is filed on behalf of TranspariMED.

Your webpage titled "Coronavirus vaccine - weekly summary of Yellow Card reporting
Updated 18 February 2021 - Updated 18 February 2021" was accessed at 18:30 on 19 February 2021:
https://www.gov.uk/government/publicatio...

Permanent link:
https://web.archive.org/web/202102182107...

The website stated that:
"For both vaccines the overall reporting rate is around 3 to 4 Yellow Cards per 1,000 doses administered."

It also noted that the most frequently reported adverse reactions in preceding clinical trials of each of these vaccines were each reported in more than 1 in 10 people.

Yellow Card reporting rates of adverse reactions per 1000 doses are thus far lower than adverse reactions recorded during clinical trials, presumably because not every adverse reaction is reported using the Yellow Card system.

The website further states that "Based on current experience, the expected benefits of both COVID-19 vaccines in preventing COVID-19 and its serious complications far outweigh any known side effects. As with all vaccines and medicines, the safety of COVID-19 vaccines is being continuously monitored."

Please briefly answer the following questions:

Q1: For the purposes of informing its continuous monitoring of Covid vaccine safety, what percentage of adverse reactions actually experienced by people being vaccinated does the MHRA assume/estimate is being recorded via the Yellow Card system specifically for Covid vaccinations?

Q2: On what evidence is the MHRA's assumption/estimate based?

Yours faithfully,

Till Bruckner

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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References

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1. https://www.gov.uk/government/collection...

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/196

Dear Till Bruckner,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 22 February 2021.

I confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Kind Regards,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

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Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Dear Till Bruckner,

Please find attached the response to your FOI request.

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

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