Pfizer Inc. (PFE) - Get Report, as well as its German partner BioNTech (BNTX) - Get Report, received the first formal approval for any globally-available coronavirus vaccine Wednesday following a nod from health officials in Britain.
The U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) agreed to the emergency use of the pair's messenger-RNA based vaccine less than a month after data from late-stage trials were published in November and an order of 40 million doses from the Boris Johnson-lead government.
Vaccinations could start as early as next week, Health Secretary Matt Hancock said, with healthcare workers and those most at-risk to the respiratory virus expected to be inoculated first.
“Today’s Emergency Use Authorization in the U.K. marks 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, 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.,” said CEO Pfizer Albert 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," he added. "With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic.”
Pfizer shares were marked 3.7% higher in pre-market trading Wednesday to indicate an opening bell price of $40.89 each. BioNTech BNTX U.S.-listed shares on the Nasdaq Composite, meanwhile, were marked 7.4% higher at $122.40 each.
The U.S. Food & Drug Administration will assess Pfizer's Emergency Use Authorization request on December 10, with EU officials are set to make a decision on December 29.
Pfizer said last month that the vaccine, known as BNT162b2, reached a 95% efficacy rate across all age and race demographics and based on a total case cohort of 170 and reiterated their aim of having 1.3 billion doses available next year and 50 million doses before the end of the year.
Pfizer also said it would be ready to distribute the vaccine 'within hours' of approval by the FDA, with the Centers for Disease Control taking the final decision on allocation at both a state and national level.
Moderna, which reported a 100% efficacy rate against severe forms of COVID-19 from late-stage trials of its mRNA-based vaccine on Monday, will likely get a decision from the European Medicines Agency (EMA) on January 12, officials indicated.