Pfizer says COVID-19 vaccine is more than 90% effective. What are the next steps?
Drugmaker Pfizer announced Monday that early data show its COVID-19 vaccine candidate is exceedingly effective at preventing the virus — and outlined the next steps toward making it available to the public.
Pfizer’s first “interim analysis” of its phase three study found the vaccine candidate was “more than 90% effective” among participants who were not known to have previously been infected with the coronavirus, the company wrote in a news release.
That level of effectiveness would put the vaccine “on par” with highly effective vaccines such as the measles shot, according to The New York Times.
“Ninety percent is a game changer,” Dr. Albert Bourla, Pfizer chairman and CEO, told CNN on Monday.
But how long the vaccine’s protection could last remains unknown, Bourla told CNN.
No “serious safety concerns” were found in the study, according to the release from Pfizer, which says it will continue collecting safety and efficacy data.
The phase three trials began in late July with 43,538 participants, 42% of whom had “diverse backgrounds” and 38,955 of whom had received a second dose of the vaccine as of Sunday, the release says. Pfizer says it’s continuing to enroll participants in the study and plans to “evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure.”
“With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis,” Bourla said in the release.
What are the next steps?
Pfizer says it plans to submit a request for Emergency Use Authorization with the U.S. Food and Drug Administration soon after a “required safety milestone is achieved” — which could be in the third week of November.
An Emergency Use Authorization from the FDA allows “unapproved medical products” to be used to “diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met,” according to the FDA.
Pfizer and its partner BioNTech say they are preparing to send data to the FDA to “demonstrate the safety and quality of the vaccine product produced.”
“Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021,” the news release says.
Fifty million doses would be enough to vaccinate roughly 15% of the population of the United States.
General Gus Perna — chief operating officer of Operation Warp Speed, the U.S. government’s program to get vaccine doses to Americans — told “60 Minutes” on Sunday that the operation is stockpiling needles, syringes and alcohol swabs to administer the shot, and that once a vaccine is ready, it’s “a simple command of, ‘Execute.’”
“We know it’s a two-dose vaccine,” he told “60 Minutes” of the Pfizer candidate. “So we want to ensure that we can manage the delivery of the first dose and ensure the delivery of the second dose while we simultaneously integrate new rounds of doses being delivered to the American people.”
The second dose of the vaccine would need to be given 21 days after the first, CBS News reports.
Bourla told CNN’s chief medical correspondent Sanjay Gupta that the vaccine will be free of cost.
Health experts have previously said most people in the United States likely won’t be able to get a COVID-19 vaccine until well into 2021, CNBC reports.
“This is likely to be a very staged market entry,” Dr. Scott Gottlieb, former FDA commissioner and member of Pfizer’s board of directors told “Face the Nation” in September. “I think that’s what people should expect. But for most people, they will not have access to a vaccine until 2021. I think maybe the first quarter of 2021, probably the first half of 2021. And that’s assuming that these vaccines are demonstrated to be safe and effective in these large trials.”
Biden and Trump react
President-elect Joe Biden released a statement Monday applauding Pfizer’s announcement but cautioning that it will be “many more months” before vaccination is widespread. He added that wearing a mask is still a “more potent weapon” against the virus.
“Today’s news does not change this urgent reality,” he said in the statement, according to NBC News. “Americans will have to rely on masking, distancing, contact tracing, hand washing and other measures to keep themselves safe well into next year.”
President Donald Trump tweeted about the news Monday morning.
“STOCK MARKET UP BIG, VACCINE COMING SOON,” he tweeted. “REPORT 90% EFFECTIVE. SUCH GREAT NEWS!”
This story was originally published November 9, 2020 at 8:28 AM with the headline "Pfizer says COVID-19 vaccine is more than 90% effective. What are the next steps?."
