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Dear Colleague,
This email updates you on details of recently published MHRA guidance on the coronavirus (COVID-19) pandemic aimed at supporting healthcare partners.
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.
Medical devices given exceptional use authorisations during the COVID-19 pandemic
We have updated the list of medical devices given exceptional use authorisations and the list of devices no longer covered.
Letter from the UK Chief Medical Officers regarding the UK COVID-19 vaccination programmes
The Chief Medical Officer issued a letter that sets out the scientific and public health rationale for the dosing schedule for the AstraZeneca vaccine and the change to the dosing schedule for the second dose of the Pfizer vaccine.
The Joint Committee on Vaccination and Immunisation (JCVI) also put forward a prioritisation scheme, as included in the Green Book Chapter 14a (tables 2 and 3) which is included.
The JCVI have also issued a short statement 'Optimising the COVID-19 vaccination programme for maximum short-term impact' which is also included.
Please see further information on the Central Alerting System website.
Guidance for industry
We continue to update our guidance page for industry on GOV.UK as our response to COVID-19 evolves.
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 engagement@mhra.gov.uk.
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
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Read our guidance on coronavirus (COVID-19)
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