FOI release

Freedom of Information request on risk management plans for COVID-19 vaccinations (FOI 21-577)

Published 13 August 2021

18th June 2021 FOI 21/577

Dear

Thank you for your information request, dated 27th May 2021, where you asked for:

1) What risk management plans are in place for the Pfizer, Astra Zeneca and Moderna Covid 19 vaccines? Please provide the documents to support this.

2) What parameters / checks and balances are in place for advising on the impact of safety issues / balance of risks and benefits for emergency approval specific to covid 19 vaccines? Meaning how many deaths and/or percentage of deaths or injuries do there have to be to create a red flag / signal?

3) What parameters / checks and balances are in place for advising on the impact of safety issues / balance of risks and benefits for emergency approval vaccines, not specific to covid 19 ? Meaning how many deaths and/or percentage of deaths or injuries do there have to be to create a red flag / signal?

4.1) What parameters / checks and balances are in place for advising on the impact of safety issues / balance of risks and benefits for vaccines outside of emergency approval (meaning fully licensed and approved vaccines) which is obviously not specific to covid 19 vaccines? Meaning how many deaths and/or percentage of deaths or injuries do there have to be to create a red flag / signal?

4.2) Please provide any documentation on the marketing authorisation for the Pfizer, Astra Zeneca and Moderna C19 vaccines.

5) Please provide Standard Operating Procedures for the process used to monitor the flags mentioned in points 2,3 and 4.

I am pleased to provide you with the information requested, see below.

Question 1

The Risk Management Plans for Pfizer/BioNTech, COVID-19 Vaccine AstraZeneca or COVID-19 Vaccine Moderna are available on the European Medicines Agency (EMA) website at the following links:

Pfizer/BioNTech COVID-19 vaccine (known by the EMA under the brand name Comimaty): https://www.ema.europa.eu/en/documents/rmp-summary/comirnaty-epar-risk-management-plan_en.pdf

COVID-19 vaccine AstraZeneca (now known by the EMA as Vaxzevria): https://www.ema.europa.eu/en/documents/rmp-summary/vaxzevria-previously-covid-19-vaccine-astrazeneca-epar-risk-management-plan_en.pdf

Moderna COVID-19 vaccine: https://www.ema.europa.eu/en/documents/rmp-summary/covid-19-vaccine-moderna-epar-risk-management-plan_en.pdf

Questions 2, 3, 4.1 & 5

Vaccines are the most effective way to prevent infectious diseases and they save millions of lives worldwide. Like all medicines, vaccines can cause side effects. Most of these are mild and short-term, and not everyone gets them. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for continuously monitoring the safety of all medicines and vaccines once they are approved for use.

The safety monitoring processes used by the MHRA do not differ according to whether the vaccine is for emergency use or under normal approval, although for COVID-19 vaccines we have outlined a specific surveillance strategy in light of the large numbers of people being vaccinated over a short space of time, the COVID-19 Vaccine Surveillance Strategy. We also regularly publish a report summarising information received via the Yellow Card scheme which includes safety investigations carried out by the MHRA.

There is currently no defined threshold at which a signal is raised as many factors are considered. Yellow Card reports of suspected adverse drug reactions are evaluated, together with additional sources of evidence, by a team of safety experts to identify any new safety issues or side effects. We apply statistical techniques that can tell us if we are seeing more events than we would expect to see, based on what is known about background rates of illness in the absence of vaccination. This aims to account for factors such as coincidental illness. We also look at the clinical characteristics to see if new patterns of illness are emerging that could indicate a new safety concern. In particular, all reports of events with a fatal outcome are carefully reviewed to distinguish possible side effects from illness that would have occurred irrespective of vaccination. These reports are reports are also followed up for further information. In addition, part of our continuous analysis includes an evaluation of natural death rates over time, to determine if any specific trends or patterns are occurring that might indicate a vaccine safety concern.

We supplement this form of safety monitoring with other epidemiology studies including analysis of data on national vaccine usage, anonymised GP-based electronic healthcare records and other healthcare data to proactively monitor safety. These combined safety data enables the MHRA to detect side effects or safety issues associated with COVID-19 vaccines.

We also work closely with our public health partners in reviewing the effectiveness and impact that the vaccines are having to ensure benefits continue to outweigh any possible side effects. In addition, and as mentioned, we work with our international counterparts to gather information on the safety of vaccines in other countries. We now have very clear evidence from Public Health England (PHE) that both vaccines are highly effective and are contributing to an 80% reduction in hospitalisations.

All vaccines and medicines remain under continual review by the MHRA. The MHRA uses all available sources of evidence in pharmacovigilance, including regular review of suspected adverse reactions submitted through the Yellow Card Scheme, data from clinical and epidemiological studies, the medical literature and information from pharmaceutical companies and other worldwide regulatory authorities. The MHRA’s processes and data analysis systems are regularly evaluated to ensure optimal performance in monitoring the safety of vaccines and medicines.

Information about on MHRA processes for monitoring the safety of medicines is available at Yellow Card Scheme - MHRA.

Guidance on pharmacovigilance procedures operated by the MHRA in accordance with current Regulations is available at Guidance on pharmacovigilance procedures - GOV.UK (www.gov.uk).

Question 4.2

The temporary authorisations for use of the COVID-19 vaccines in the UK followed a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine, and also considered the conditions for its safe supply and distribution. The decision was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. Regarding the MHRA approval of the Pfizer/BioNTech and the Oxford/AstraZeneca COVID-19 vaccines, further information (including information for physicians and recipients of the vaccine, and Public Assessment Reports [PARs] for each vaccine) are available on the MHRA website. Links to these are provided below:

https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19 https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna

Please note that a marketing authorisation was granted for the Pfizer/BioNTech vaccine (Comirnaty) following a European Commission (EC) decision on 21 December 2020 (PLGB 53632/0002). Further information is available on the European Medicines Agency (EMA) website, a link to this is provided below: https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty

Please also note that a marketing authorisation was granted for the Moderna vaccine on 31 March 2021 following an EC Reliance Procedure (PLGB 53720/0002). Further information is available on the MHRA website and the EMA website, links to these are provided below: https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-moderna

In addition, the European Commission, following recommendations from the European Medicines Agency (EMA), have granted a marketing authorisation for the Oxford/AstraZeneca vaccine.

Further information is provided below: https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca

If you have a query about the information provided, please reply to this email.

Yours sincerely,

FOI Team, Vigilance and Risk Management of Medicines Division