Freedom of Information request on COVID19 Vaccine Information – ingredients, risk assessment, vaccine development information (FOI 21-109)
Published 24 March 2021
Thank you for your email.
We note that the original request was not addressed to us but in the interests of being helpful please see below.
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 (including the demographics of the participants) 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 the Information for Healthcare Professionals and Information for Recipients of the Vaccine, and Public Assessment Reports [PARs] for each vaccine) are available on the MHRA website. The PARs contain details of the demographics of the participants in the clinical trials, including illnesses and concomitant medication. 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
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.
Further information concerning the JCVI’s recommendations is provided below: https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAttachment.aspx?Attachment_id=103741
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.
Regarding your specific questions:
1.Please provide a breakdown of the contents of the vaccine that has been prepared for the Covid 19 virus in 2020 naming all ingredients. The contents of each vaccine are available in Section 2 (Quantitative and Qualitative Composition) and Section 6.1 (List of Excipients) of the Information for Healthcare Professionals for that vaccine, links to these are provided above.
2.Please provide a Risk Assessment of the side effects of this vaccine on a person. Short and long term up to 40 years. An assessment of the safety of each vaccine is available in the PARs, which are linked above. Additionally, a list of side effects observed with each vaccine is available in Section 4.8 (Undesirable effects) of the Information for Healthcare Professionals for that vaccine. Again, these are linked above.
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
3.Please provide the names and qualifications of the professionals who developed this vaccine. MHRA does not hold this information.
4.Please provide the date this vaccine started it’s development journey. MHRA does not hold this information.
5.Please provide the name, address and location of the laboratory that the vaccine was created in. MHRA does not hold this information.
6.Please provide a guarantee and proof that the vaccine will cause no harm to any person. No vaccine is completely safe. We have specified the side effects that can be experienced with each vaccine in the Information for Healthcare Professionals, which is linked above. We have also provided the MHRA’s assessment of the safety and benefit/risk of the Pfizer/BioNTech vaccine and Oxford/AstraZeneca vaccine in the PARs for these vaccines.
7.Please provide proof that there will be no form of micro chip in the vaccine as rumours are saying. We have provided a list of ingredients in the Information for Healthcare Professionals for each vaccine. In none of these ingredients do we specify “microchips” or any components/materials that could be constituents of a microchip.
Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000