UK approves Pfizer, BioNTech COVID-19 vaccine, ‘likely’ signaling FDA nod
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The United Kingdom on Wednesday became the first country to approve the COVID-19 vaccine developed by Pfizer and BioNTech, which will soon be reviewed for use in the United States.
“This is very welcome news and is likely a good harbinger of what the FDA’s decision will be in the weeks to come,” Amesh A. Adalja, MD, FIDSA, FACP, FACEP, senior scholar in the Johns Hopkins Center for Health Security, told Healio. “The rapidity of the decision also reflects the benefits of the U.K.’s ‘rolling review’ policy that basically allowed a real-time decision to be issued. Now the distribution challenge will need to be tackled.”
The U.K. Medicines and Healthcare products Regulatory Agency’s “rolling review” process is used to quickly assess promising medicines or vaccines during a public health emergency.
“We have carried out a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness,” June Raine, CBE, MSc, who heads the agency, said in a statement. “The public’s safety has always been at the forefront of our minds — safety is our watchword.”
The messenger RNA (mRNA)-based vaccine, currently referred to as BNT162b2, was 95% efficacious in a phase 3 trial beginning 28 days after the first of two doses, according to a final analysis of the data released by Pfizer and BioNTech.
“I’m really pleased to say that the U.K. is now one step closer to providing a safe and effective vaccine to help in the fight against COVID-19 — a virus that has affected each and every one of us in some way — and in helping to save lives,” Raine said.
The vaccine must be stored at nearly –100°F and will be moved through specially designed, temperature-controlled shipping containers equipped to maintain extremely cold temperatures, according to Pfizer and BioNTech. Following delivery, the vaccine can be stored at normal refrigerator temperatures for up to 5 days.
The companies submitted a request for an emergency use authorization (EUA) to the FDA about 2 weeks ago. The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) for Dec. 10 to discuss the request. Pfizer and BioNTech said the vaccine will be available for distribution “within hours” of an FDA authorization.
They said there will be up to 50 million doses available globally by the end of the year, with enough to vaccinate up to 25 million individuals. By the end of 2021, there could potentially be up to 1.3 billion doses available, the companies said.
The VRBPAC will also meet on Dec. 17 to discuss an EUA for another mRNA-based COVID-19 vaccine candidate developed by Moderna Inc. and the NIH, which was also shown to be around 95% efficacious.
On Tuesday, the CDC’s Advisory Committee on Immunization Practices voted 13-1 to recommend that health care personnel and residents of long-term care facilities be prioritized to receive a COVID-19 vaccine in the U.S. upon availability.
The ACIP’s recommendation is solely for adults, but Pfizer has received FDA approval to enroll children aged 12 years or older in the trial for its vaccine. The ACIP said it would consider children in its recommendations for prioritization upon authorization for a pediatric vaccine.