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________________________________________ From: [Name Removed]
<[FOI #817463 email]> Sent: Saturday, December 18,
2021 5:46:59 PM To: MHRA Customer Services Subject: Freedom of Information
request - Date of receipt of Cumulative Analysis of Post-Authorization
Adverse Event Reports of PF-07302048 (BNT162B2) received through 28
February 2021” Dear Medicines and Healthcare Products Regulatory Agency,
please provide the date you received the Pfizer document referenced in
this Doctor Daniel Nagase video
https://eur01.safelinks.protection.outlo...
such document titled: “Cumulative Analysis of Post-Authorization Adverse
Event Reports of PF-07302048 (BNT162B2) received through 28 February 2021”
which can also be downloaded here:
https://eur01.safelinks.protection.outlo...
. Yours faithfully, [Name Removed]
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #817463 email] Is [MHRA request email] the wrong
address for Freedom of Information requests to Medicines and Healthcare
Products Regulatory Agency? If so, please contact us using this form:
https://eur01.safelinks.protection.outlo...
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Dear Enquirer,

Thank you for your email.

The Medicines and Healthcare products Regulatory Agency’s (MHRA’s) role is to continually monitor safety during widespread use of a vaccine. We have in place a proactive strategy to do this. We also work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects.

Part of our monitoring role includes reviewing reports of suspected side effects. 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 vaccinated (over 130 million COVID-19 vaccines have been given in the UK alone to date), including elderly people and people who have underlying illness.

The document you refer to has not been submitted to the MHRA. However, we regularly review safety information from the COVID-19 vaccine manufacturers and are in regular contact with other regulators across the world to exchange safety data on the COVID-19 vaccines. This is considered in our assessments alongside the UK data.

Information about our analysis of safety data regarding COVID-19 vaccines is published in our weekly summary of COVID-19 vaccine Yellow Card reports which is available at: https://eur01.safelinks.protection.outlo....

Please be assured that the MHRA continues to closely monitor the safety of the COVID-19 vaccines used in the UK.

Please note this has not been handled as a Freedom of Information request but under our usual correspondence procedures.

Regards

MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000
gov.uk/mhra
Stay connected

For information on how the Agency uses your personal data and your data protection rights, please see our three centres’ Privacy Notices: MHRA, CPRD and NIBSC.

show quoted sections