Freedom of Information request on COVID 19 Vaccine Information (FOI-21-002)
Published 24 March 2021
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Thank you for your email.
There is a lot of information published about the vaccines that have been authorised to date. This includes Information for Healthcare Practitioners, Information for Recipients of the Vaccine and Public Assessment Reports (PARs), which can be accessed for each vaccine via the links 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
The PARs consist of the non-confidential parts of the MHRA’s assessment of the data submitted for each vaccine, including the efficacy/safety data upon which the Information for Healthcare Practitioners and Information for Recipients of the Vaccine is based, and demographic data concerning the recipients of the vaccines in the trials (including any illnesses and concomitant medication).
In addition, the study results from the Pfizer/BioNTech vaccine are available in a peer-reviewed journal, the New England Journal of Medicine. This includes the efficacy/safety data collected during the clinical trial and demographic data concerning the recipients of the vaccines in the trials (including any illnesses and concomitant medication). A link to this is provided below:
https://www.nejm.org/doi/full/10.1056/NEJMoa2034577?query=featured_home
Section 4.2 of the Information for Healthcare Practitioners states for the Pfizer/BioNTech vaccine that the “COVID-19 mRNA Vaccine BNT162b2 is administered intramuscularly after dilution as a series of two doses (0.3 mL each) at least 21 days apart.”
Section 4.2 of the Information for Healthcare Practitioners states that the Oxford/AstraZeneca vaccine course “consists of two separate doses of 0.5 ml each. The second dose should be administered between 4 and 12 weeks after the first dose.”
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
If you have a query about the information provided, please reply to this email.
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Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
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