UK regulator begins assessing Pfizer-BioNTech vaccine data
Since the UK continues to be a member of the EU until the end of the Brexit transition period on December 31, Covid-19 vaccine candidates can be licensed via the Amsterdam-based European Medicines Agency and that authorisation will automatically be valid in the UK.
The UK regulator of medicines said on Monday that it has begun assessing the data received from the Pfizer-BioNTech vaccine candidate trial that showed nearly 95% efficacy, adding that public safety “will always come first”.
The Medicines and Healthcare products Regulatory Agency (MHRA) said since the UK continues to be a member of the EU until the end of the Brexit transition period on December 31, Covid-19 vaccine candidates can be licensed via the Amsterdam-based European Medicines Agency and that authorisation will automatically be valid in the UK.
However, if a suitable 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 public health need.
Based on the speed of MHRA’s assessment and approval, the Pfizer vaccine may be rolled out from December.
MHRA chief executive 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”, she added.
The MHRA said it 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 will not need to go through a European marketing authorisation for use in the UK; it will be assessed directly by the MHRA.
