Pfizer, BioNTech Vaccine for COVID-19 Receives UK Authorization

December 2, 2020
Gabrielle Ientile, Assistant Editor

The first doses of the mRNA COVID-19 vaccine will be delivered in the UK in the next few days, Pfizer announced.

The United Kingdom Medicines & Healthcare Products Regulatory Agency (MHRA) has authorized the Pfizer/BioNTech coronavirus disease 2019 (COVID-19) vaccine, making the UK the first western country in the world to OK a vaccine to combat the pandemic.

BNT162b2, which uses messenger RNA (mRNA) to fight off severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), will likely be distributed first to health care workers, older individuals, and residents and workers in long-term care facilities. These populations were determined by the Joint Committee on Vaccination and Immunization (JCVI) prior to authorization.

Related: Pfizer, BioNTech to Submit EUA Request to FDA Today for COVID-19 Vaccine 

In October, Pfizer and BioNTech revised an earlier agreement with the UK to increase distribution to 40 million doses of the vaccine once it receives authorization. The first doses will be delivered in the UK in the coming days, with a total of 40 million doses to be delivered in December 2020 and the upcoming year. Pfizer and BioNTech also expect authorization in the United States in December, according to the news release.

The UK agency’s authorization was based on a phase 3 clinical study that reported a 95% efficacy rate in participants without prior SARS-CoV-2 infection, as well as participants with and without prior SARS-CoV-2 infection.

Pfizer and BioNTech have also developed temperature-controlled shippers for the mRNA vaccine that have the ability to maintain storage conditions (-70 degrees °C ±10 degrees °C), or about -94 degrees °F, for 10 days unopened, effectively allowing for global distribution of the vaccine. Once the shippers are opened, pharmacies and other health care centers administering the vaccine are able to use them for storage for up to 30 days, as long as ice is replaced every 5 days. Vaccine vials can also be stored for up to 5 days at refrigerated (2-8 degrees °C) conditions.

“Today’s Emergency Use Authorization in the UK marks a historic moment in the fight against COVID-19,” said Albert Bourla, chairman and chief executive officer, Pfizer.

“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 UK,” said Bourla.

“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,” Bourla added.

Reference:

  1. Pfizer and BioNTech Achieve First Authorization in the World For a Vaccine to Combat COVID-19. News Release. Pfizer; December 2, 2020. Accessed December 2, 2020. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-achieve-first-authorization-world.