FOI release

Freedom of Information request on COVID-19 vaccination ingredients and RNA (FOI 21-529)

Published 13 August 2021

14th June 2021 FOI 21/529

Dear

Thank you for your email.

Please find below answers to the questions you have raised in blue below:

Q1. Please could you clarify the exact quantities of the following “other excipients” -

This information is exempt under Section 41 and Section 43 of the Freedom of Information (FOI) Act.

Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.

Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in providing the quantities of the excipients in an authorised medicinal product, which can be used by competitors to aid the product development of their own rival products. Examples of public interest arguments would be a major public health risk or a major procedural failure or irregularity.

Q2. Regarding the same injections, please could you confirm or deny if they contain any of the following ingredients, along with specific quantities of each ingredient

The ingredients present in the vaccine are those listed in the leaflet you were given. None of the ingredients you have listed in your question are present in the Oxford/AstraZeneca vaccine.

Q3. What specifically is the chimpanzee adenovirus used for? (in laymans terms).

The active substance of the Oxford/AstraZeneca vaccine is a single recombinant, replication-deficient chimpanzee adenovirus (ChAdOx1) vector that codes for the S glycoprotein of SARS-CoV-2 (ChAdOx1-S [recombinant]). Following vaccine administration, this vector enters into the cells of the body and produces the S glycoprotein of SARS-CoV-2 which is then expressed on the surface of the cells. Expression of the spike protein induces neutralising antibodies and T-cells to be raised against it. Should the body then become infected with SARS-CoV-2, the immune system will recognise the SARS-CoV-2 virus and attack it.

Q4. Please could you clarify if the RNA being used in the Pfizer and Moderna injections has been inserted into the recombinant chimpanzee adenovirus - therefore making AstraZeneca a DNA ‘vaccine’ containing the RNA strand, without the “RNA Vaccine” label.

The Pfizer and the Moderna vaccines are not inserted into recombinant chimpanzee adenovirus.

Q5. Please explain the details of how the HEK cells have been genetically modified.

This information is exempt under Section 41 and Section 43 of the Freedom of Information (FOI) Act.

Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.

Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in providing technical knowhow about an authorised medicinal product, which can be used by competitors to aid the product development of their own rival products. Examples of public interest arguments would be a major public health risk or a major procedural failure or irregularity.

Q6. Are the HEK cells MRC-5 or WI-38 cells?

The HEK cells are neither MRC-5 nor WI-38 cells.

Q7. Please could you provide full and specific details regarding the donor of the human embryonic kidney cells.

MHRA does not hold any information on the donor of the HEK cells. Information about the origin of the HEK 293 cell line is available in the public domain, e.g. How fetal cells from the 1970s power medical innovation today (medicalxpress.com)

Q8. Regarding the SARS-CoV-2 Spike glycoprotein - please could you supply all information on record regarding the full isolation and purification of SARS-CoV-2, and its full sequencing (not computer generated).

MHRA does not hold this information. This information should be available in the public domain, through peer-reviewed papers and also through the data on the SAGE website, which includes information that supports the advice from SAGE during the pandemic, including the isolation of the SARS-CoV-2 virus. The original Oxford University data are in the public domain: About the Oxford COVID-19 vaccine | Research | University of Oxford

If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: 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.

After that, if you remain dissatisfied, you may write to the Information Commissioner at; The Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF

They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.

Yours sincerely

MHRA Customer Service Centre

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