The pandemic may not be over, but the beginning of the end has arrived with the Food and Drug Administration’s issuance of an emergency use authorization (EUA) to Pfizer-BioNTech for a COVID-19 vaccine.
Data analyzed by FDA showed that the Pfizer-BioNTech COVID-19 vaccine has a 95% effective rate, and the two companies said that they have the ability to manufacture 50 million doses this year and 1.3 billion doses next year. Meanwhile, many of the nation’s leading pharmacy retailers participating in the federal government's Operation Warp Speed program are ready to begin administering vaccines, based on priority protocols.
In a statement, Deerfield, Illinois-based Walgreens said that it's preparing to immediately bring vaccines to high-priority populations, such as long-term care facilities and health care workers, as determined by the Centers for Disease Control (CDC) and federal and state governments. Walgreens is working with nearly 35,000 skilled nursing and assisted-living facilities nationwide that have selected the company as their vaccine provider.
“Our purpose – to champion the health and well-being of every community in America – has never been more clear or critical,” said John Standley, Walgreens' president. “Walgreens pharmacists have been supporting communities every step of the way throughout the COVID-19 pandemic and will play an important role in the administration of vaccines to high-priority groups, as well as the general public, once available.”
The day prior to FDA's announcement, Dr. Tom Van Gilder, chief medical officer of Bentonville, Arkansas-based Walmart, said, "our pharmacists give millions of shots a year, and they are trained under strict, up-to-date guidelines to be able to administer vaccines.”
Van Gilder added that the company had prepared its more than 5,000 Walmart and Sam’s Club pharmacies to receive vaccine doses, including making sure that there are freezers in all pharmacies, as well as dry ice to handle any requirements for storing the vaccine. He said that the company has also put in place processes to inform people of when to receive the first and second doses.
New York-based Pfizer said in a statement that it would use manufacturing sites in Saint Louis; Andover, Massachusetts; Kalamazoo, Michigan; Pleasant Prairie, Wisconsin; and Puurs, Belgium, to manufacture the vaccine. Pfizer and Geman biotechnology company BioNTech also noted that their global supply-chain infrastructure and cold-chain compliance abilities would enable efficient distribution to administration sites, which will eventually include many of the nation’s pharmacy retailers.
“The tireless work to develop a new vaccine to prevent this novel, serious and life-threatening disease in an expedited time frame after its emergence is a true testament to scientific innovation and public-private collaboration worldwide,” FDA Commissioner Stephen Hahn, M.D., said on Dec. 11.
An EUA is not the same as an FDA new drug approval, but given the circumstances, regulators said that the vaccine’s known and potential benefits clearly outweighed its known and potential risks.
"Pfizer's purpose is breakthroughs that change patients’ lives, and in our 171-year history, there has never been a more urgent need for a breakthrough than today, with hundreds of thousands of people continuing to suffer from COVID-19,” Pfizer chairman and CEO Albert Bourla said in a statement. “As a U.S. company, today's news brings great pride and tremendous joy that Pfizer has risen to the challenge to develop a vaccine that has the potential to help bring an end to this devastating pandemic.”
An accelerated return to normality is how BioNTech CEO and co-founder Ugu Sahin characterized FDA’s authorization to begin using the vaccine.
“We founded BioNTech to develop new technologies and medicines that utilize the full potential of the immune system to fight serious diseases,” Sahin said, adding that distribution of the a vaccine shown in clinical trial data to be effective and safe “will help to save lives across the United States and could accelerate a return to normality.”
That normality will depend on getting the vaccine to people willing to take it as the available supply increases throughout 2021. According to Walgreens, it plans to work closely with Operation Warp Speed, as well as the CDC, Health and Human Services (HHS), and federal and state governments to ensure the administration of COVID-19 vaccines at its 9,000 stores across the nation as soon as possible.