The U.K.’s Medicines & Healthcare Products Regulatory Agency (MHRA) today granted Pfizer and BioNTech a temporary emergency use authorization of their COVID-19 messenger RNA (mRNA)-based BNT162b2—giving the companies the world’s first authorization for a vaccine designed to protect against the virus.
“Today’s Emergency Use Authorization in the U.K. marks a historic moment in the fight against COVID-19,” declared Pfizer Chairman and CEO Albert Bourla, DVM, PhD, in a statement. “This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the U.K.”
BNT162b2 is a nucleoside modified mRNA (modRNA) candidate that encodes an optimized SARS-CoV-2 full-length spike glycoprotein antigen. The vaccine is among 20 “Front Runner” candidates among the more than 300 COVID-19 therapeutics under study in GEN’s “COVID-19 Drug & Vaccine Candidate Tracker.”
BNT162b2 has received the FDA’s Fast Track designation, as has the other advanced construct under study, BNT162b1, another nucleoside modRNA candidate which encodes an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen.
Pfizer and BioNTech have applied to the FDA for emergency use authorization (EUA) of BNT162b2. That application is being supported in part with final efficacy data showing BNT162b2 to be 95% effective in a nearly 44,000-patient Phase III trial (NCT04368728) of the vaccine in participants without prior SARS-CoV-2 infection, as well as positive safety data.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is set to discuss and issue a recommendation on BNT162b2 on December 10.
Just yesterday, Pfizer and BioNTech applied in Europe for conditional marketing authorisation (CMA) for BNT162b2, with an advisory committee hearing set for December 11.
“We think this [U.K. temporary] authorization bodes well for the FDA and EU authorization coming up in December, and expect this vaccine to be granted emergency authorization shortly after the respective advisory committee meetings,” Geoffrey C. Porges, MBBS, director of therapeutics research and a senior research analyst with SVB Leerink, wrote today in a research note.
800,000 doses expected
In the U.K., the first doses are being shipped for arrival in coming days, with a reported 800,000 doses expected. Those first doses will be distributed to senior citizens in nursing homes, staffers of those homes, and healthcare workers, the BBC reported.
“We believe that the roll-out of the vaccination program in the U.K. will reduce the number of people in the high-risk population being hospitalized,” BioNTech CEO and Co-Founder Ugur Sahin, MD, stated. “Our aim is to bring a safe and effective vaccine upon approval to the people who need it.”
The vaccine is expected to be administered first in NHS hospitals, since they have the ultra-low temperature freezers required for BNT162b2, which requires shipping and storage at -70º C (-94º F).
The companies have developed temperature-controlled thermal shippers for BNT162b2 that they say are designed to maintain ultra-low temperatures for extended periods of time without any additional equipment but dry ice by maintaining temperatures for 10 days unopened, long enough to allow for transportation to markets globally.
Once open, a vaccination center may use the specially designed shippers as a temporary storage solution to maintain the recommended storage conditions (between -70º C and +10º C) up to 30 days with re-icing every five days in accordance with the handling instructions. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment 24 hours a day, seven days a week. Once thawed, the vaccine vial can be stored for up to five days at refrigerated temperatures of (2–8° C.
Pfizer said its established infrastructure for supplying the vaccine worldwide includes distribution hubs that can store vaccine doses for up to six months. The company says its distribution is built on a flexible just-in-time system that can ship the frozen vials quickly to designated points of vaccination at time of need, minimizing the need for long term storage anywhere.
“We do not expect that the product will need to be stored at any location for more than 30 days,” Pfizer added.
Up to 1.3B doses in 2021
BioNTech and Pfizer have agreed to supply 40 million doses of BNT162b2 to the U.K. by next year, up from the initial 30 million agreed to in July. The companies today restated earlier projections that their combined manufacturing network could supply up to 50 million vaccine doses globally through December 31, and up to 1.3 billion doses by the end of 2021—subject to manufacturing capacity and regulatory approval or authorization.
Pfizer says its manufacturing site in Puurs, Belgium, one of the company’s largest sterile injectable sites, will be critical to distribution in the U.K. The Puurs site is being used primarily for European supply but will also serve as back up supply to Kalamazoo, Michigan, for the U.S. market.
BioNTech produced the vaccine candidate doses for the clinical trials, and can produce mRNA for commercial supply through its existing mRNA production sites in Mainz and Idar-Oberstein, Germany. In 2021, BioNTech said, it will be able to increase its manufacturing capacity once a third site in Germany begins operation.
Pfizer and BioNTech have studied BNT162b2, BNT162b1, and two other constructs of BNT162: a uridine containing mRNA (uRNA) candidate; and a candidate using self-amplifying mRNA (saRNA).