Freedom of Information request on all emails sent or received by the head of the MHRA's Biologicals Unit since the start of the COVID-19 pandemic for Novavax , Novavax, NVX-CoV2373 and Nuvaxovid (FOI 21/1243)
Published 31 May 2022
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FOI 21/1243
6th December 2021
Dear
Thank you for your emails which have been combined for one FOI response.
Your first request asked:
“Please can you provide me with copies of all e-mails sent or received by the head of the MHRA’s Biologicals Unit since the start of the COVID-19 pandemic which contain at least one of the following words (spelled with any combination of upper- and lower-case letters):
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Novavax
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Covovax
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NVX-CoV2373
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Nuvaxovid”
Regarding your request for emails related to the terms Novavax, Covovax, NVX-CoV2373 and Nuvaxovid, which are not currently authorised for use, MHRA neither confirms nor denies that it holds information falling within the description specified in your request. The duty in Section 1(1)(a) of the Freedom of Information (FOI) Act 2000 does not apply, by virtue of Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of that Act. This should not be taken as an indication that the information you requested is or is not held by the department.
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 alerting competitors to whether a rival product is trying to come onto the market or not. Examples of public interest arguments would be a major public health risk or a major procedural failure or irregularity.
Your second request asked:
“Please can you provide me with copies of all e-mails sent or received by the head of the MHRA’s Biologicals Unit since the start of the COVID-19 pandemic which contain at least one of the following words (spelled with any combination of upper- and lower-case letters):
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Pfizer
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BioNTech
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BNT162b2
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Tozinameran
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Comirnaty”
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.
In order to process your request, we would need to: identify all emails received which referenced the requested words in addition to identifying any emails where these may have been misspelt. We consider that this would take longer than 24 working hours to complete.
We advise that you narrow your request by, for example, reducing your request to a single product and a single issue/point of interest about that product.
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 disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.
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
Please remember to quote the reference number above in any future communications.
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
Kind regards,
MHRA Customer Service Centre