FOI release

Freedom of Information request on MHRA/DHSC staff correspondence – 18/11/20 to 02/12/20 (FOI 20-501)

Published 24 March 2021

Thank you for your information request, dated 2nd December, where you requested the following information under the Freedom of Information Act:

“Please provide a copy of all emails between Department of Health and Social Care staff and MHRA staff delivered between the 18th November and the 2nd December regarding the BioNtech-Pfizer covid-19 vaccine?”

We have looked closely at this and can confirm that the MHRA does hold the information that you have requested. However, there is a significant amount of information, and to respond to your request in its entirety, would bring the cost in excess of £600 (which itself is estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information). We are therefore applying Section 12 of the Freedom of Information Act allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit.

Over 500 email chains were located in response to requests across the Agency for information. A significant number of these are identical or continuation of an existing chain but each must be reviewed to confirm this. This is based on work that has already been undertaken in relation to this request, with approximately 25 chains being retrieved per hour. This equates to approximately 22 hours of work. Additional time relating to colleagues locating the information and extraction of relevant information within the scope of the request leads us to estimate that the limit has already been exceeded but the task in relation to your initial request is not yet completed.

We could provide relevant information if you were able to narrow your request. Some possibilities for you to consider are: • By use of a narrower date range if there is a particular point of interest, e.g. a significantly shorter date range rather than the whole period specified. For example, the immediate surrounding period when the Pfizer vaccine was authorised (1st-2nd December), or the immediate surrounding period when it was announced that data had been received (22nd-23rd November) • The majority of the email chains are in relation to Communications surrounding decisions (for example, briefing stakeholders or preparing for press releases). Narrowing the request to exclude this would significantly reduce the time taken. • A particular search term explored exclusively in relation to the Pfizer-BioNTech vaccine (as opposed to any emails that also reference the Pfizer vaccine, for example, more general communications about the regulation of the range of vaccines being developed, which then “name-checks” the list of vaccines being developed)

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 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. The review would be carried out by a senior member of the Agency who was not involved with the original decision.

Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk .

Please remember to quote the reference number above in any future communications. Please note, 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.

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 020 3080 6000