Freedom of Information request on the vaccine for Brain Tumours from Northwest Biotherapeutics (FOI 22/780)
Published 21 December 2023
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FOI 22/780
5th July 2022
Dear
Thank you for your email of 15 June 2022 where you asked the following question:
“I was wondering if there is any news about approval of the vaccine for brain tumor from Northwest Biotherapeutics?
It seems as it is a long time since submitted and it’s so important to get out to the public for use”
We are sorry to hear that you, or someone you know maybe affected by a brain tumour. We appreciate that this particular condition is time sensitive, and so we would like to highlight that we seek to approve applications for medicines as soon as the data and evidence demonstrate that it is safe to do so i.e. when the benefit-risk balance is favourable.
The Medicines and Healthcare Products Regulatory Agency is the agency responsible for licensing medicines and ensuring that medical devices work and are acceptably safe.
Regarding whether any application has been received by MHRA for a vaccine for brain tumor from Northwest Biotherapeutics, we refuse to confirm or deny we hold any information under Section 41 (S41) and Section 43 (S43) of the FOI Act (FOIA). S41 is an absolute exemption and no consideration of the public interest is required, except to state that we would consider the release of this information to be an actionable breach of confidence. S43 is a conditional exemption and requires a consideration of the public interest. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in alerting competitors to whether a competitor is close to obtaining a marketing authorisation or not. You may wish to contact the company directly, as they may be willing to provide an update on their regulatory position / plans, see contact us page: Northwest Biotherapeutics Contact Us - Northwest Biotherapeutics (nwbio.com).
There are Clinical Trial databases available where records of clinical trials that are currently in progress as well as completed trials can be searched:
https://www.clinicaltrialsregister.eu/ctr-search/search
There is also a page for this product on the NICE website that might be of interest to you: Project information - DCVax-L for treating newly diagnosed glioblastoma multiforme [ID836] - Guidance - NICE
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. 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.
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 Experience Centre