FOI release

Freedom of Information request on the temporary authorisation of the COVID-19 vaccines (FOI 21/969)

Published 20 January 2022

2nd September 2021

FOI 21/969

Dear

Thank you for your email.

The temporary authorisations of the Pfizer/BioNTech, Oxford/AstraZeneca and Moderna vaccines was done through an expedited rolling review. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis. The temporary authorisation under Regulation 174 permits the supply of identified vaccine batches, based on the safety, quality and efficacy data submitted to MHRA. These authorisations do not constitute a marketing authorisation.

All vaccines are tested through three phases of clinical trials to ensure they meet the gold standard. Phase 1 trials are with a small group of people to make sure there are no safety concerns and determines the appropriate dosage for the best immune response. Phase 2 trials are conducted on a larger group of people to check the vaccine works consistently and that the immune response is sufficient. Phase 3 trials test the vaccines on thousands of people for scientists to assess if the vaccine is producing immunity that will prevent disease. Usually, these phases are run in sequence, but in an effort to find a safe and effective Covid-19 vaccine as quickly as possible, once safety has been ascertained through Phase 1, Phases 2 and 3 are being run in parallel. Extensive checks and balances are required at every stage of the development of a vaccine, and this is no different for a Covid-19 vaccine. No stages in the vaccine development processes were bypassed.

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, Moderna 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

A marketing authorisation has been granted for the Janssen Covid-19 vaccine on 28 May 2021. Further information is available via the below link:

https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-janssen

In addition, a marketing authorisation was granted for the Oxford/AstraZeneca vaccine on 24 June 2021 following an EC Reliance Procedure (PLGB 17901/0355). 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-astrazeneca https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca

As with any vaccine or medicine, COVID-19 vaccines require continuous safety monitoring and that the benefits in protecting people against COVID-19 outweigh any side effects or potential risks. This is a process known as safety monitoring (pharmacovigilance). This ensures that any potential medium and long term safety issues are promptly and adequately evaluated. As part of our signal detection processes, all adverse reaction reports received are individually assessed and cumulative information reviewed at regular intervals. Be reassured that the MHRA is working in collaboration with partners in the health system to rapidly assess all available safety data in real time and communicate any emerging issues, as necessary.

In response to your specific questions:

1) Is graphene oxide present in any form in any of the vaccines

There is no graphene oxide in any of the authorised vaccines, a list of excipients in each vaccine is available in the Information for Healthcare Professionals for that vaccine. These documents can be found at the following link:

Regulatory approval of Pfizer/BioNTech vaccine for COVID-19 - GOV.UK (www.gov.uk)

Regulatory approval of Vaxzevria (previously COVID-19 Vaccine AstraZeneca) - GOV.UK (www.gov.uk)

Regulatory approval of COVID-19 Vaccine Moderna - GOV.UK (www.gov.uk)

2) What are the dangers of graphene oxide to the human body

As no medicinal products approved by MHRA contain graphene oxide, we hold no information on the effects of graphene oxide on the body.

3) We know the world health organisation downgraded sars covid on the 13-03-20 due to the low morality rate and we know that the vaccines are experimental and only authorised for emergency use if there is a recorded proven high consequence infectious disease present in the UK - currently there are no known high consequence infectious diseases present in the UK. So why are you authorising the vaccine against the laws laid down?

Please note that the authorised vaccines are now no longer authorised under Regulation 174 and have full marketing authorisations. The authorisation of the vaccines follows assessment by MHRA that shows these vaccines have a positive benefit/risk in the prevention of Covid-19 infection.

4) Has your organisation ever received financial incentives or funding from any other organisation business or person other than the UK government

The MHRA is an executive agency of the Department of Health and Social Care. Our Annual report (link below) contains information on page 11 regarding our funding.

MHRA_Annual_Report_and_Accounts_2020-21.pdf (publishing.service.gov.uk)

The MHRA does receive funding from other sources outside government. This funding mainly supports work to strengthen regulatory systems across the world as well as conducting valuable research into regulatory science.

The majority of MHRA income comes from the pharmaceutical industry through fees. For example, all Marketing Authorisation applicants have to pay a fee. The licensing of medicines is an independent, scientific process which is overseen by the Commission on Human Medicines (CHM).

The CHM is an independent body which advises on applications for marketing authorisations. This includes considering further representation against our provisional advice in respect of national applications; advises on the need for, and content of, risk management plans for new medicines; advises on the impact of new safety issues on the balance of risks and benefits of licensed medicines – e.g. adding warnings, restricting or suspending use of a medicine and advises the licensing authority on changes to legal status of marketing authorisations.

For more information on MHRA income please refer to the financial statements (page 79 onwards) in the Annual report.

1. Was the sars covid virus isolated in a British laboratory so the prc tests could be calibrated against a live sample

MHRA holds no information on the isolation of the Covid-19 virus. We suggest that you consult the Scientific Advisory Group for Emergencies (SAGE) website that we have provided below.

https://www.gov.uk/government/organisations/scientific-advisory-group-for-emergencies which includes information supporting the governments’ decision making on the Covid-19 pandemic, including information on the isolation of the Covid-19 virus.

Please note that information on the isolation of the Covid-19 virus is also available in the public domain through scientific papers.

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

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 you receive this response and addressed to: info@mhra.gov.uk

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Best regards,

MHRA Customer Service Centre