FOI release

Freedom of Information request on the staff employed for the purpose of COVID-19 vaccine adverse reactions (FOI 22/606)

Published 27 March 2023

FOI 22/606

10th May 2022

Dear

Thank you for your request under FOI Act. We have included our replies beneath the questions asked, see below.

I am requesting three questions to be answered immediately.

1)Does the MHRA know how many staff were imployed [SIC] in February 2021 by Pfizer to handle the anticipated adverse reactions to the covid 19 vaccines ?

Please see links below referring to court documents and information supplied to the FDA

https://www.redvoicemedia.com/2022/04/pfizer-document-bombshell-hid-concealed-redacted-hired-1000s-to-process-adverse-events-increase-videos/?utm_source=daily-email&utm_medium=email

https://rumble.com/vzuqgd-bombshell-pfizer-saw-so-many-adverse-events-they-had-to-hire-2400-new-emplo.html

A.Under Section 1(1) of the Freedom of Information Act (FOIA) part a), we confirm that we do not hold this information. However, an increase in staff numbers to process and assess reports of adverse reactions would be an expected occurrence, in the context of a large scale of vaccination programme / the number of doses of COVID-19 vaccine Pfizer administered.

2)How many new staff members has the MHRA employed just before or after the covid 19 vaccines to deal with the adverse reactions ?

A.In May 2020, the Commission on Human Medicines established an Expert Working Group (EWG) to advise the Medicines and Healthcare products Regulatory Agency (MHRA) on its safety monitoring strategy for COVID-19 vaccine(s).

The EWG held four meetings from May to October 2020, during which it considered proposals and methodologies for MHRA-led vigilance activities. Based on this advice, the MHRA has developed, and now has in place, a four-stranded approach to vigilance.

The MHRA prepared for a COVID-19 mass immunisation programme, taking into account that many millions of doses of one or more novel vaccines would be administered across the UK over a relatively short time period, at a scale that had not been used previously. Several vaccination campaigns such as the human papillomavirus (HPV) and swine flu pandemic were considered to estimate the likely adverse drug reaction volumes at the start of the COVID-19 vaccination campaign. Although these earlier vaccination campaigns were used as models to estimate volumes of reports, there are key differences such as the much wider patient population who received the vaccine, greater awareness of how to report from patient leaflets given to vaccine recipients and the influence on reporting from social media.

In the first four months of the COVID-19 vaccine programme, December 2020 – March 2021, the MHRA received an approximate 5 reports per 1000 doses of a COVID-19 vaccine administered. This has declined as the programme has continued and, for the same period in 2021-2022, we received 2 reports per 1000 doses administered. This reporting rate remains higher than for other vaccines administered as part of the UK routine vaccination schedule but aligns more closely with our prior experience of new vaccines, for example the human papillomavirus (HPV) vaccine for which we received 1 report per 1000 doses administered in the first year it was used (2008/9). Overall reporting rates, for all medicines and vaccines, have increased over time as an awareness to report has also increased substantially over this time period.

The plan was underpinned by a combination of technology enhancement, and increasing human resources to ensure rapid provision of all data for signal detection. Between Summer 2020 and December 2020 an additional 6 posts were added to the vigilance team. Between January 2020 and April 2022 (in line with peaks of the vaccination campaign) a further 10 posts have been utilised.

3)Has the MHRA received the Pfizer Documents released by order of a Federal Court and if so why has the MHRA not put a pause or halt to the covid 19 vaccines ?

A.The MHRA has in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines.

Part of our monitoring role is to regularly review safety information from the COVID-19 vaccine manufacturers and safety data from other regulators around the world. This information, alongside UK data, is considered in our assessments to ensure that the benefits of the COVID-19 vaccines continue to outweigh the risks.

The “Pfizer document” you refer to contains global safety data in relation to Pfizer’s COVID-19 vaccine, including post marketing reports of suspected ADRs from the UK. The MHRA is aware of this document and has all the UK reports mentioned in the document on our safety database, plus all the serious reports from other countries, either because these were reported directly to the MHRA, or because they were reported directly to Pfizer, who informed the MHRA of the reports. A summary of all the Yellow Card reports submitted for each of the COVID-19 vaccines as well as an evaluation of trends in reporting of suspected adverse reactions associated with the Pfizer vaccine is included in our weekly update on COVID-19 vaccines.

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 140 million COVID-19 vaccines have been given in the UK alone to date), including elderly people and people who have underlying illness.

Following continual review of the safety of Pfizer/BioNTech COVID-19 vaccine since December 2020, it is considered that the benefits of the vaccine continue to outweigh the risks for most people.

If you have a query about this email, please do not hesitate to contact us at info@mhra.gov.uk

If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: info@mhra.gov.uk

After that, if you remain dissatisfied, you may write to the Information Commissioner at;

The Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.

Yours sincerely

MHRA Customer Experience Centre