FOI release

Freedom of Information request on authorisation of COVID-19 vaccines (FOI 21-223)

Published 28 May 2021

6th April 2021 FOI 21/223

Dear,

Thank you for your email.

The authorisation of the Pfizer/BioNTech and the Oxford/AstraZeneca 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.

Information on the study conducted using the Pfizer/BioNTech vaccine and its results are available in a peer-reviewed journal, the New England Journal of Medicine. This includes demographic data on the recipients included in the study, including any concomitant illnesses. A link to this is provided below: https://www.nejm.org/doi/full/10.1056/NEJMoa2034577?query=featured_home

The approval for use of the Pfizer/BioNTech and Oxford/AstraZeneca 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

Further to the above, the Moderna vaccine has also recently been authorised for use. Further information on this is provided below: https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna

MHRA will be collecting data concerning any adverse reactions observed to vaccine treatment through our Yellow Card Scheme. The MHRA will be publishing Yellow Card data associated with COVID-19 vaccinations. Yellow Card data for drugs is routinely published on the Yellow Card website, with vaccine data available on request. However, for COVID-19 vaccinations we will be proactively publishing details of adverse drug reactions received, including MHRA assessment of the data to provide context. https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

Throughout this global pandemic, we have always been guided by the latest scientific advice. Having studied evidence on both the Pfizer/BioNTech and Oxford/AstraZeneca vaccines, the Joint Committee on Vaccination and Immunisation (JCVI) has advised that we should prioritise giving as many people in at-risk groups their first dose, rather than providing two doses in as short a time as possible.

The four UK Chief Medical Officers agree with JCVI that at this stage of the pandemic prioritising the first doses of vaccine for as many people as possible on the priority list will protect the greatest number of at risk people overall in the shortest possible time and will have the greatest impact on reducing mortality, severe disease and hospitalisations and in protecting the NHS and equivalent health services.

This is because the evidence shows that one dose of either vaccine provides a high level of protection from Covid-19.

For both vaccines, data provided to MHRA demonstrate that whilst efficacy is optimised when a second dose is administered both offer considerable protection after a single dose, at least in the short term. For both vaccines the second dose completes the course and is likely to be important for longer term protection.

The NHS across the UK will prioritise giving the first dose of the vaccine to those in the most high-risk groups. Everyone will still receive their second dose and this will be within 12 weeks of their first. The second dose completes the course and is important for longer-term protection.

The JCVI’s independent advice is that this approach will maximise the benefits of both vaccines allowing the NHS to help the greatest number of people in the shortest possible time. It will ensure that more at-risk people are able to get meaningful protection from a vaccine in the coming weeks and months, reducing deaths and starting to ease pressure on our NHS.

For further information on prioritising the first COVID-19 vaccine dose see the statement from the Joint Committee on Vaccination and Immunisation (JCVI). This information includes the rationale and evidence for prioritising the first dose.

Regarding your specific questions: • Proof of the Genetic sequence of isolation to the covid 19 virus? The isolation of the Covid-19 virus, including its genetic sequence, is available in the public domain. Please see below the link to the SAGE website, which includes information on the identification/isolation of the virus and the data supporting the government’s response to this pandemic https://www.gov.uk/government/organisations/scientific-advisory-group-for-emergencies

• Conformation of what ingredients is in the AstraZeneca and Pfizer vaccines? A list of ingredients in the Oxford/Astrazeneca and Pfizer vaccines is provided in Section 2 and Section 6.1 of the Information for Healthcare Professionals.

• Are the vaccines a genetic re-modification of the human genes? The Oxford/AstraZeneca vaccine contains ChAdOx1-S, which is a recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS CoV 2 Spike (S) glycoprotein. It is produced in genetically modified human embryonic kidney (HEK) 293 cells.

• Are these vaccines described as gene therapy and do they provide immunity again covid 19 disease? These vaccines are not gene therapy. These vaccines do provide immunity against the Covid-19 virus.

• The total deaths in uk in all areas of types in 2018, 2019 and 2020? If you want information on deaths following COVID-19 infection we do not hold this information and suggest you contact the Office of National Statistics (ONS) for advice and please find below contact details.

https://www.ons.gov.uk/aboutus/contactus/generalandstatisticalenquiries

Email: info@ons.gov.uk

Telephone: 0845 601 3034

• The effects of our health on wearing masks long term? This does not fall within the MHRA’s area of work. Please see https://www.gov.uk/government/publications/nervtagemg-duration-of-wearing-of-face-coverings-15-september-2020

• Conformation that the CPR test carried out to detect infectious diseases cannot be used as to detect infectious diseases stated by PCR inventor kery mullis? Kary Mullis was a Nobel prize winning biochemist who invented the polymerase chain reaction (PCR) method. He did not invent an RT-PCR test for SARs-CoV-2. Kary Mullis died on 07 August 2019 before the first case of SARs-CoV-2 was identified. The current generation of RT-PCR tests used in the detection of many diseases and disease states are good demonstrations of the application of the polymerase chain reaction technique.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

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

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000