Following a historically rapid development program, the FDA on Friday issued the United States' first emergency use authorization (EUA) for a COVID-19 vaccine to Pfizer Inc. and Biontech SE for their jointly-developed mRNA vaccine BNT-162b2. The eagerly anticipated move, made under intense political pressure, arrived little more than a week after the U.K.'s MHRA granted a world-first EUA for the product, followed by similar authorizations in Bahrain, Canada, Saudi Arabia and Mexico.

“The totality of the available data provides clear evidence that Pfizer-Biontech COVID-19 vaccine may be effective in preventing COVID-19,” the FDA said in issuing the EUA. The approval covers people ages 16 and older.

“Today, we can begin to turn millions of American’s hopes into reality,” said Pfizer chairman and CEO Albert Bourla in a video statement released Friday night.

The first doses of the vaccine, which requires ultralow temperatures to retain stability, will begin shipping throughout the country immediately, he said. By the end of 2021, Pfizer expects to deliver “hundreds of millions” of doses to Americans he said.

Health care workers and residents of long-term living facilities will be first in line to receive the product. In a Friday evening statement, Walgreens Boots Alliance Inc. said that “as states finalize their distribution plans, we believe we can begin administration in some long-term care facilities on the date of activation approved by the CDC to help ensure those most vulnerable are among the first to be protected against the virus.

“We are prepared to expand access to the general population through our more than 9,000 stores once COVID-19 vaccines become available more broadly in 2021,” the retail pharmacy giant said.

To meet demand for the vaccine, of which the U.S. federal government alone has contracted to receive 100 million doses and has an option to acquire up to 500 million additional doses, Pfizer is putting into motion a substantial manufacturing operation. It’s leaning on sites in St. Louis, Miss., Andover Mass., and Kalamazoo, Mich.

U.S. pricing for the vaccine wasn’t immediately disclosed, though Pfizer told BioWorld it was “committed to equitable and affordable access for COVID-19 vaccines for all people.”

“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen Hahn.

“Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization,” he said.

The FDA authorization was based on data from multiple studies, including a phase III trial that found BNT-162b2 to be 95% effective in preventing people from contracting the infection for seven days following the second injection. Crucially, in light of data showing the virus has hit people of some demographics much harder than others, investigators have reported seeing consistent efficacy across age, gender, race and ethnicity demographics among those enrolled in clinical trials testing it. No serious safety concerns were observed in any trial participants.

The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain and fever.

The FDA's vaccine advisory committee voted on 17-4 on Thursday, with one abstention, to recommend the agency grant the vaccine EUA, though with some panelists expressed concern about the paucity of data around the vaccine's effect in 16- and 17-year-olds.

The lipid nanoparticle mRNA vaccine, which received FDA fast track status in July 2020, encodes an optimized SARS-CoV-2 full length spike glycoprotein, which is the target of virus neutralizing antibodies. It is administered as a series of two doses, three weeks apart.

Pfizer and Biontech will continue with a hefty clinical program as they expand the populations being studied and do long-term follow-up to gather the data needed to turn the EUA into a biologic license application, which the FDA is expecting to be submitted in the next three or four months.

Shares of Mainz, Germany-based Biontech (NASDAQ:BNTX) closed at $127.30 on Friday, down $2.24. New York-based Pfizer's shares (NYSE:PFE) ended the day at $41.12, down 61 cents, while shares of Cambridge, Mass.-based Moderna rose $1.24 to $156.93.

Good for Moderna

Success for the Pfizer-Biontech vaccine has raised expectations that both the FDA and the EMA may also soon approve Moderna Inc.’s mRNA-1273 COVID-19 vaccine. Moderna well along with its candidate, submitting its own EUA filing to the FDA on Nov. 30 after phase III data confirmed it to be 94.1% effective in preventing symptomatic cases of the disease and 100% effective in preventing severe cases. An agency advisory meeting to discuss the application is set for Dec. 17.

On Dec. 10, the company gained a new partner in its efforts to advance the program, Roche Holding AG, which will supply its Elecsys anti-SARS-CoV-2 S antibody test for use in Moderna’s trials.

A dynamic day

The FDA's EUA approval for BNT-162b2 arrived amid a tumultuous day, both politically and scientifically, though not drastically different from others in the journey to the milestone.

Friday morning, President Donald Trump ramped up his ongoing criticism of the FDA and Hahn, via Twitter, calling on him to "get the dam vaccines out NOW" and suggesting the regulator was "a big, old, slow turtle." Despite a recent decline in the proportion of first launches, the FDA remains the global leader in first launches for new molecular entities, according to Clarivate's Centre for Medicines Research. (BioWorld is owned by Clarivate.)

At other times, the Trump administration has reveled in progress on the vaccine. The president recently called it a “gold-standard” vaccine developed in less than nine months – a miracle that he said would end the pandemic.

Appearing keen to make its efforts more visible following the Dec. 10 vaccines advisory committee meeting, Hahn issued a statement saying the agency had “informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.”

Despite the EUA in the U.S. and emergency authorizations elsewhere in the world, it will take time for the Pfizer-Biontech vaccine and others approved for emergency use elsewhere to slow the spread of the virus. According to the Johns Hopkins Center for Health Security, the U.S. daily COVID-19 incidence continues to set records, with 231,396 new cases reported Thursday. The nation is averaging more than 207,000 new cases per day, or more than 1 million cases every five days, the center noted in a recent update.

Canada's chief public health officer, Theresa Tam, also sees a bleak near-term picture, despite Health Canada’s recent EUA for the vaccine. In a Friday presentation, she shared that overall, Canada’s number of reported cases remains on a “rapid trajectory.”

Furthermore, the development of other vaccines, something which may be important to expanding the overall number of people able to be vaccinated near-term, has not always been smooth. Data from a phase I/II interim study of a vaccine under development by Glaxosmithkline plc and Sanofi SA, for instance, showed an insufficient response in patients age 50 and over, causing them to delay the program, pushing its expected availability to sometime in the second half of the coming year. That scuttled what was expected to be an AUD$1 billion deal between CSL and the Australia’s federal government.

On Dec. 10, the University of Queensland and CSL Ltd. said they would abandon their trials of an Australian COVID-19 vaccine, UQ-CSL v451, after recipients generated HIV antibodies during phase I trials.