The Medicines and Healthcare products Regulatory Agency (MHRA) approval came after a “rolling review” in which assessment takes place as the packages of data become available from ongoing studies on a staggered basis. The idea is to evaluate a promising medicine or vaccine as quickly as possible during public health emergencies, with MHRA scientists and clinicians reviewing everything from clinical trials to manufacturing and quality controls to supply chain and distribution conditions.
“We are globally recognized for requiring high standards of safety, quality and effectiveness for any vaccine. Our expert scientists and clinicians worked tirelessly, around the clock, carefully, scientifically, robustly and rigorously poring over hundreds of pages and tables of data, methodically reviewing the data,” said MHRA chief executive Dr. June Raine.
“Vaccines are the most effective way to prevent infectious diseases. They save millions of lives worldwide,” Raine said in a news release.
The U.K. approval comes more than a week before FDA’s Vaccines and Related Biological Products Advisory Committee will consider whether to recommend U.S. approval of the Pfizer/BioNTech vaccine. An emergency use authorization is expected to quickly follow, with the government quickly shipping an initial 6.4 million doses of the vaccine to states and other local jurisdictions.
Pfizer currently specifies that its vaccine candidate should be stored at a super-cold –70° C., so the earlier U.K. approval should give U.S. officials a chance to evaluate how well the company’s dry ice storage containers work as the British distribute the vaccine.
In the U.K., distribution will be prioritized by guidance from the country’s Joint Committee on Vaccination and Immunization (JCVI).
Pfizer and BioNTech announced an agreement with the U.K. in July that it would distribute 30 million doses of the vaccine in the country once it was authorized for emergency use, and was later increased to 40 million doses in October. Through the agreement, 40 million doses will occur throughout the rest of this year and into 2021 in stages to allocate vaccines to more vulnerable demographics.
Complete delivery fulfillment is expected in 2021.
Senior editor Danielle Kirsh contributed to this report.