Pfizer and BioNTech announced that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2) against COVID-19, according to a press release.
This is the first emergency use authorization following a worldwide Phase 3 trial of a vaccine, the companies said.
Pfizer and BioNTech said they expect the first doses of the COVID-19 vaccine to arrive in the United Kingdom “in the coming days, with complete delivery fulfilment expected in 2021.”
The companies also recently filed for a similar emergency use authorization with the U.S. Food and Drug Administration (FDA).
“As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic,” said Albert Bourla, Chairman and Chief Executive Officer of Pfizer.
The MHRA’s decision is based on a rolling submission, including data from the Phase 3 clinical study, which demonstrated a vaccine efficacy rate of 95 percent in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose, Pfizer said.
In July 2020, Pfizer and BioNTech announced an agreement with the United Kingdom to supply 30 million doses of the BNT162b2 mRNA-based vaccine, once authorized for emergency use. That agreement was increased to 40 million doses in early October. The delivery of the 40 million doses will occur throughout 2020 and 2021, in stages, to ensure an equitable allocation of vaccines across the geographies with executed contracts.
To assure product quality, the companies have developed specially designed, temperature-controlled shippers for the BNT162b2 vaccine candidate, which can maintain recommended storage conditions (-70°C ±10°C) for extended periods of time without any additional equipment but dry ice. The shipper can maintain temperature for 10 days unopened, which allows 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 (-70°C ±10°C) up to 30 days with re-icing every five days in accordance with the handling instructions.
