Pfizer and German partner BioNTech’s application to distribute their vaccine comes days after their final trial results showed it is 95% effective in preventing COVID-19 with no major safety concerns.
If the Food and Drug Administration grants the emergency approval, the first doses could be shipped in a few weeks.
“Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” says Pfizer Chairman and CEO Dr. Albert Bourla.
The companies expect to produce up to 50 million doses by the end of the year and up to 1.3 billion by the end of next year.
"This is the light at the end of the tunnel that we have been waiting for, especially after what we went through in New York City in spring," says Dr. Eric Wei, senior vice president of NYC Health and Hospitals.
In September, the Cuomo administration laid out the broad parameters of who should get the vaccine first.
The plan gives priority to vulnerable New Yorkers as well as essential front-line workers, followed by first responders and teachers, individuals over 65, other essential workers, and then healthy adults and children.
Dr. David Buchin at North Shore University Hospital says once the FDA grants full approval, it could still be several months to work through the priority list. The Pfizer vaccine requires two doses. New York State alone will need 39 million doses.
“This is going to take some time to get everyone in the country vaccinated. So we are getting there, but we need to be patient, “ says Dr. Buchin.
Distributing Pfizer’s vaccine could be difficult. It must be stored at -70 degrees Celsius. Pfizer says it will ship the vaccine in special containers that can be used as temporary storage for up to 15 days.
The state will be responsible for distributing the vaccine. Governor Andrew Cuomo has said the state is ready to start accepting vaccines, but he has criticized the lack of federal funding for the program.
He also says there needs to be special efforts to reach communities of color, which have been hit especially hard by the pandemic and often lack adequate healthcare.
But there is no guarantee everyone will be willing to get vaccinated right away.
Meanwhile, another pharmaceutical company, Moderna, whose vaccine shows similar results to Pfizer’s, plans to apply for FDA approval later this month.