Pfizer / BioNTech COVID-19 vaccine: MHRA statement

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MHRA CEO Dr June Raine said:

The results reported by Pfizer today are very encouraging and add to their announcement from last week.

We look forward to receiving the full results of the trials as soon as possible, after which we will rigorously assess the evidence of safety and effectiveness of the vaccine.

Approval process for a potential COVID-19 vaccine

  • There are two routes to obtain a COVID-19 vaccine approval: through a full marketing authorisation or through a temporary authorisation route known as regulation 174.
  • As regulation 174 is a public health-related measure, manufacturers cannot apply for this authorisation, it is the Government that requests the MHRA approval for specific products as part of a public health response.
  • The MHRA will apply the key criteria of safety, quality and efficacy before authorising the use of a vaccine under either route.
  • This means that, for both routes, once the data is submitted our scientists and clinicians will carefully and scientifically review the safety, quality and effectiveness data – how it protects people from COVID-19 and the level of protection it provides. The data must include results from the lab and clinical trials in humans; manufacturing and quality controls; product sampling; and testing of the final product.
  • The safety of the public will always come first. A COVID-19 vaccine will only be approved for use via either route once it has met robust standards on safety, effectiveness and quality through clinical trials.
  • For both routes, we will rigorously assess the data in the shortest time possible, without compromising the thoroughness of our review.
  • Once we have thoroughly reviewed the data via either route, we will seek advice from the Government’s independent advisory body, the Commission on Human Medicines. The Commission will critically assess the data too before advising the UK government on the safety, quality and effectiveness of any potential vaccine.
  • While a vaccine is approved by us, the Joint Committee on Vaccination and Immunisation will advise the government about the use of the vaccine.
  • The MHRA is globally recognised for requiring the highest standards of safety, quality and effectiveness for any vaccine.

Published 18 November 2020

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