MHRA update on COVID-19

Dear colleague,

This email updates you on details of recently published guidance for industry on the coronavirus (COVID-19) pandemic and, where relevant, how we are working closely with our healthcare partners.

Please share this email with your members.

Moderna COVID-19 vaccine approval

The COVID-19 vaccine developed by Moderna has today been given regulatory approval for supply by the MHRA. This follows a thorough and rigorous assessment by the MHRA, including advice from the independent Commission on Human Medicines (CHM). The CHM reviewed in depth all the data to ensure this vaccine meets the required standards of safety, quality and effectiveness.

This is the third COVID-19 vaccine to be approved for use by the MHRA and is the second mRNA vaccine (the Pfizer/BioNTech vaccine approved in December 2020 is also an mRNA vaccine).

For more information, see our press release and Decision page on GOV.UK, which includes information for healthcare professionals and the public about the vaccine.

Oxford University/AstraZeneca COVID-19 vaccine approval - update

We have updated the Decision page on our website to provide more details about the COVID-19 vaccine. We have now published the public assessment report (PAR). This is a scientific report, written by the MHRA, that explains how this product was assessed and its authorisation recommended, as well as its conditions of use.

Guidance and regulatory flexibilities

Please see our regulatory flexibilities page for guidance for industry on flexible approaches to regulation we are taking during COVID-19.

New or updated guidance published on our general guidance page for industry since the last edition of this email:

Updated guidance:
Medical devices given exceptional use authorisations during the COVID-19 pandemic

Details of update:
We updated the list of medical devices given exceptional use authorisations and the list of devices no longer covered.

Subscribing to updates on GOV.UK

You can sign up for email updates about the MHRA’s work – you will then receive an email every time the MHRA publishes a new page or makes a significant edit to an existing page.

Contacting the MHRA

Most of our workforce is working from home, although National Institute for Biological Standards and Control (NIBSC) is continuing essential laboratory activities on site. If you need to get in touch with the MHRA during this period, please email info@mhra.gov.uk or phone 0203 080 6000.

For more information please visit mhra.gov.uk.

We welcome your feedback on what other information you would find useful – please email.

Kind regards,

Patient, Public and Stakeholder Engagement team
Communications division

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 0203 080 6000
Email: engagement@mhra.gov.uk
gov.uk/mhra

Read our guidance on coronavirus (COVID-19)

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