The Food and Drug Administration approved the COVID-19 vaccine from BioNTech and Pfizer Inc. on Friday evening. This makes it the first vaccine to reach Americans during the coronavirus pandemic.
"The FDA's emergency approval to use the first COVID-19 vaccine marks a major milestone in the fight against this devastating pandemic that is affecting so many families in the US and around the world," said FDA Commissioner Dr . Stephen Hahn in a statement. "Today's action follows an open and transparent review process that included input from independent science and public health experts and a thorough evaluation by the agency's career scientists to ensure this vaccine meets the FDA's rigorous scientific standards for safety, efficacy and manufacturing quality that are required to support emergency approval. "
The vaccine developed by German BioNTech BNTX and marketed by American pharmaceutical giant Pfizer
– is the first COVID-19 vaccine to receive emergency approval in the United States and the first mRNA product to ever receive regulatory approval.
Since the first efficacy data was made public, the expectation of the potent vaccine has generated gains in the stock markets, where vaccination is seen as the beginning of the end of the COVID-19 crisis. According to federal health officials, administration of the vaccine could begin within days of approval.
It is also the first vaccine to be given to Americans during the pandemic outside of the thousands of volunteers currently participating in Phase 3 clinical trials for at least four vaccine candidates currently ongoing in the US. Pfizer BioNTech's BNT162b2 vaccine had already received emergency approval in Bahrain, Canada and the UK.
An emergency permit is a less stringent type of government permit that can be used during a public health emergency. It's not a full FDA approval; However, it has become a useful tool for regulators trying to speed up the use of COVID-19 therapies, and now vaccines, during the pandemic.
"While this is not an FDA approval, today's emergency approval for the Pfizer-BioNTech COVID-19 vaccine promises to change the course of this pandemic in the United States," said Peter Marks, director of the FDA Center for Biologics Evaluation and Research, in an explanation.
The two-dose vaccine, which showed 95% effectiveness in a late-stage clinical trial, requires patients to return 21 days after a first vaccination to receive a second vaccination. It was tested on around 44,000 people in six countries.
An advisory body (AdCom) convened by the FDA on Thursday voted 17: 4: 1 for regulatory approval of the vaccine. The benefits outweighed the risks in those aged 16 and over. (A second AdCom meeting for Moderna Inc.
The mRNA-based COVID-19 vaccine is scheduled to take place on December 17th. Approval for this vaccine candidate is also expected.)
The FDA label states that the Pfizer BioNtech vaccine can be used for those who are 16 or older, although the first doses of the vaccine are expected to go to health care workers and nursing home residents, two groups with the highest risk according to the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.
Pfizer and BioNTech first partnered in 2018 to develop mRNA or messenger ribonucleic acid vaccines to prevent seasonal flu infections. BioNTech and Pfizer announced plans in mid-March to jointly develop a COVID-19 vaccine. This means that in less than 10 months, companies developed, tested, and approved a vaccine. (Your partnership excludes the Chinese market.)
This is the fastest time a vaccine has ever been developed.
"For an R&D freak like me, this is just the Holy Grail," said John LaMattina, a longtime pharmaceutical executive who led Pfizer's research and development business for 30 years. "Are you kidding me? It's unprecedented to do something like this."
Wall Street analysts expect the vaccine to generate billions of dollars in sales within a year. Mizuho Securities' Vamil Divan predicts the vaccine will have sales of more than $ 8 billion by the end of 2021, which could make it Pfizer's best-selling drug next year, he said. In 2019, Prevnar 13, a pneumococcal vaccine with sales of $ 5.8 billion, was Pfizer's top performing drug.
Beyond the direct impact on sales, analysts see Pfizer's rapid development of the vaccine as an indicator that it is evolving from a slow-moving pharmaceutical giant to a nimble biopharmaceutical company that is what drives investors most.
“The speed at which Pfizer has developed this vaccine candidate is also encouraging to us, and suggests that Pfizer may be able to achieve its stated goal of being a faster, more nimble biopharmaceutical company that we believe will be further multiple expansion would enable over time, "wrote Divan on December 6th.
Unlike some other drug companies developing COVID-19 vaccines, BioNTech and Pfizer have not received federal funding under what is known as Project Warp Speed to support the candidate's development. Instead, they brokered a deal this summer in which the U.S. government would purchase 100 million cans for $ 1.95 billion, with the option to purchase an additional 500 million cans, with the deal priced at $ 1.95 billion Geoffrey Porges of SVB Leerink reflects about $ 20 per dose in the US.
The shares of both companies have rallied since the beginning of the year. BioNTech's shares rose 269.3% and Pfizer's shares rose 12.7%. The S&P 500
has increased by 13.7%.