FOI release

Freedom of Information request about COVID-19 vaccine approval (FOI-21-146)

Published 7 May 2021

8th March 2021

FOI 21/146

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. 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.

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:

1) Please provide scientific evidence that SARS COV2 has been isolated. 2) Please provide scientific evidence that SARS COV2 has mutated. 3) Please provide scientific proof of “COVID-19” or SARS COV 2 being highly contagious. The Government website clearly states it is not considered a HCID. MHRA holds no information on this. The scientific basis supporting the government’s response to the SARS-Cov-2 virus is available on the SAGE website, including information on the identification/isolation of the virus and any variants, a link to the website is provided below: https://www.gov.uk/government/organisations/scientific-advisory-group-for-emergencies

4) Please provide a document that shows and provides scientific evidence that the testing procedure being used in the UK 100% positively identifies COVID-19 otherwise known as SARS COV2, NOT any other type of virus, bacteria or debris left by previous colds, flu etc; beyond any reasonable doubt.

The PCR swab tests being used by NHS laboratories are not 100% accurate in the detection SARs-CoV-2. Meta-analysis suggests that they are likely to be in the region of 90% sensitive, missing around 1 in 10 positive samples, although this differs from test to test. However, the overall specificity of the tests is generally very good, close to 100%. See Diagnostic Performance of CT and Reverse Transcriptase Polymerase Chain Reaction for Coronavirus Disease 2019: A Meta-Analysis - PubMed (nih.gov)

5) Please provide evidence that you can guarantee 100% and prove that the tests being used to justify these “guidelines” will not give a false positive result. Please see above answer to question 4.

6) Please make it clear why the PCR test is being used, the inventor Kary Mullis states clearly that the test was never designed for the detection of infectious diseases. 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.

7) Provide evidence that these “guidelines” are law (under what section).

Please refer to https://www.gov.uk/guidance/national-lockdown-stay-at-home?priority-taxon=774cee22-d896-44c1-a611-e3109cce8eae - Cabinet Office is the author of this page: publiccorrespondence@cabinetoffice.gov.uk

8) Please clearly define what you mean by a “public health threat”. Please see our response to question 1, 2, & 3, this information is available through the SAGE website.

9) Please provide medical/scientific evidence of the current medical threat to a normal healthy individual (under 75 yrs) The death rates by age are provided by Public Health England, a link to these is below: https://www.gov.uk/government/publications/covid-19-reported-sars-cov-2-deaths-in-england/covid-19-confirmed-deaths-in-england-report

It should be noted that, although the death rate is lower in younger, healthier individuals, it is not guaranteed that because an individual is younger or more healthy that they will get mild symptoms. It should also be noted that individuals who are asymptomatic or with mild symptoms are still contagious, and can still pass COVID-19 infection to others who may be elderly or in poorer health, i.e. others in whom it can be serious and result in death.

10) Please confirm the following so I can make an informed decision:

A) How many critically ill people without any underlying conditions are in Hospital/ICU in the UK with SARS COV 2 ONLY.

B) Please confirm the number of deaths to date in the UK from SARS COV 2 ONLY, please exclude people with underlying health conditions. MHRA does not hold this information. We suggest that you contact Public Health England (PHE) for further information concerning hospitalisations and deaths from COVID-19 infection.

11) Please provide evidence that these guidelines have been through a risk assessment and will protect me from any/all health issues. 12) In the event of a risk assessment having been done, please provide a copy of it. 13) Please present me with the full “guidelines” in plain English, not legalese, and the supporting medical/scientific evidence. The guidelines you refer to are not decided by MHRA. We hold no data on these. We suggest you refer you refer to the PHE and SAGE websites, which contain data supporting the government guidelines.

14) Please explain to me what law I am breaking by not adhering to these guidelines. MHRA is the UK medicines regulatory authority. We assess and licence new medicines, including vaccines, depending on the benefit/risk. Further information on our role and how we licence medicines is provided below: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency/about

The information requested is not held by MHRA.

15) Please provide scientific evidence that social distancing is effective. 16) Please provide scientific evidence that wearing a face covering/mask prevents the spread of any virus and supporting evidence that face coverings/mask protect people who wear them. The information requested is held by SAGE and PHE, and is published on their website, including the changes in death/hospitalisation rates from COVID-19 infection observed with changes in social behaviour.

17) How many people have been injected with the pfizer/biontech vaccine since Dec; 2020? The numbers of people who have received the Pfizer/BioNTech vaccine up to 24 December 2020 is provided below. Any request for numbers since this date should be referred to the Department of Health and Social Care (DHSC). https://www.gov.uk/government/news/over-600000-people-get-first-dose-of-pfizerbiontech-vaccine

18) How many people have… A) Suffered adverse reactions after receiving this vaccine?

We can confirm that we have published the data and this is available to view at the following links of our website page below, please note this information will be published weekly moving forward:

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting

B) Have died after receiving this vaccine?

We advise that you contact the Public Health England for advice.

Email: enquiries@phe.gov.uk

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