Pfizer/BioNTech COVID-19 vaccine: MHRA statement (update)

MHRA Chief Executive Dr June Raine said:

We are pleased to have received further data for the Pfizer/BioNTech COVID-19 vaccine candidate.

It is our job now to rigorously assess these data and the evidence submitted on the vaccine’s safety, quality and effectiveness.

As we have received this data through a rolling review, we have already started our analysis and will aim to make a decision in the shortest time possible, without compromising the thoroughness of our review.

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.

The safety of the public will always come first. Our job is to work to the highest standards and safety is our watchword.

Approval process for a potential COVID-19 vaccine

• Until the end of December, and as part of the transition period, COVID-19 vaccine candidates can be licensed (authorised) via the European Medicines Agency (EMA) and that authorisation will automatically be valid in the UK.  
• However, if a suitable COVID-19 vaccine candidate, with strong supporting evidence of safety, quality and effectiveness from clinical trials becomes available before the end of the transition period, EU legislation allows for temporary authorisation of supply in the UK, based on the public health need.
• The MHRA will evaluate the data rigorously for quality, safety and effectiveness to reach an independent, scientifically robust opinion. The data must include results from lab and clinical trials in humans; manufacturing and quality controls, product sampling, and testing of the final product. 
• Any COVID-19 vaccine candidate submitted after the transition period ends in January 2021 will not need to go through a European marketing authorisation for use in Great Britain and will instead be assessed directly by the MHRA. The MHRA is globally recognised for requiring the highest standards of safety, quality and effectiveness for any vaccine.