Freedom of Information request on the safety of vaccine excipients (FOI 21-710)
Published 29 December 2021
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-16-july-2021/freedom-of-information-request-on-the-safety-of-vaccine-excipients-foi-21-710
16th July 2021
FOI 21/710
Dear
Thank you for your information request, dated 23rd June.
I can confirm that the MHRA does hold some of the information that you have requested. However, we have also determined that the information is exempt under Section 12 of the Freedom of Information Act and we cannot process your request any further.
Section 12 of the Act allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information.
We consider that this request would take longer than 24 working hours to complete.
We advise that you narrow your request by, for example, by reducing the number of queries asked and timeframe of these queries.
Please note that substantially similar requests made within 60 working days of an original request can be aggregated into one for the purposes of calculating a cost limit, meaning that section 12 could still apply.
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 would 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.
Information on the safety of vaccine excipients is available in the public domain in the form of published literature. The Vaccine Knowledge Project website also contains information on vaccine ingredients
Further information on the use of human/animal products in vaccines is available below:
Guide to the use of human and animal products in vaccines
In addition the Public Assessment Reports (PARs) are available for vaccines that have been granted in the UK or the EU since October 2005, from either the MHRA website or the European Medicines Agency (EMA) website. The PARs include MHRA’s safety assessment of each authorised vaccine and its ingredients. These can be found at the following links:
Medicines European Medicines Agency
Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000