Pfizer-BioNTech COVID-19 Vaccine Gets UK Approval For Emergency Use

Pfizer Inc PFE and its German partner BioNTech SE BNTX said Wednesday they have received regulatory approval in the United Kingdom for their COVID-19 vaccine.

What Happened: The go-ahead from the Medicines and Healthcare Products Regulatory Agency (MHRA) means the U.K. has become the first country to approve a COVID-19 vaccine on an emergency basis ahead of the United States and the European Union.

Pfizer CEO Albert Bourla described the authorization as a “historic moment in the fight against COVID-19.”

This authorization is a goal we have been working toward since we first declared that science will win,” said Bourla.

“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,” said Ugur Sahin, CEO of BioNTech.

MHRA’s decision to approve the vaccine was based on a “rolling submission” including data from Phase 3 clinical trials, which demonstrated a vaccine efficacy rate of 95%, according to Pfizer.

Why It Matters: Pfizer and BioNTech have an agreement with the U.K. government to supply 40 million doses of their mRNA-based vaccine. The delivery of the vaccine would be made throughout 2020 and 2021, as per Pfizer.

It was reported Monday that the approval from U.K. authorities for the Pfizer vaccine was imminent and the country also secured two million additional doses from Moderna Inc MRNA this week.

Pfizer and Moderna said they have filed for an emergency use authorization for the vaccine with the United States Food and Drug Administration and filed a final Conditional Marketing Authorization Application with the European Medicines Agency.

An FDA panel is set to meet on Dec. 10 to discuss the vaccine, Bloomberg reported. The vaccine will be available in the United Kingdom beginning next week.

Price Action: Pfizer shares closed nearly 2.9% higher at $39.41 on Tuesday and gained 0.66% in the after-hours session. On the same day, BioNTech shares closed almost 8.2% lower at $114.01 and gained 2.27% higher in the after-hours session.