Pfizer says COVID vaccine 95% effective, will seek FDA’s okay “within days”
Pfizer said Wednesday that a final assessment of trial data on the COVID-19 vaccine it developed in conjunction with German company BioNTech showed it was 95% effective, and that it would apply for emergency use authorization with the U.S. Food and Drug Administration “within days.” It was the latest hopeful news for a world desperate to turn the tide on the coronavirus pandemic that has killed more than 1.3 million people globally, and almost 250,000 in the U.S. alone.
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In a statement released early Wednesday, Pfizer said the efficacy of its vaccine was consistent “across age, gender, race and ethnicity demographics,” and that trial data after two months had met the criteria laid out by the FDA to demonstrate both the safety and function of the vaccine.
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“Pfizer and BioNTech plan to submit a request within days to the FDA for an EUA [Emergency Use Authorization] based on the totality of safety and efficacy data collected to date,” the U.S. pharmaceuticals giant said.
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Pfizer became the first vaccine maker to claim an extremely high efficacy for its formula last week, saying preliminary data showed it to be more than 90% effective at preventing new coronavirus infections. Wednesday’s announcement cemented those results with final data, and made them even more optimistic by matching preliminary efficacy data reported by Moderna, another American vaccine maker that hopes to seek EUA in the U.S.
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Pfizer said the Phase 3 human trials, which involved more than 43,000 people, showed the vaccine “was well tolerated across all populations,” with “no serious safety concerns observed.” The only notable side effects, according to Pfizer, were fatigue in 3.8% of vaccine recipients and headaches in about 2%.
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If approved for use by the FDA, the Pfizer vaccine will require patients to get two shots, the second one coming 21 days after the first.
Both Pfizer and, in theory, Moderna could get emergency approval from the FDA in short order, but only after the drugmakers manage to ship millions of doses around the world can widespread vaccination efforts begin in earnest. And with the Pfizer vaccine in particular, that poses significant challenges.
Pfizer’s vaccine must be kept at almost 100 degrees below zero Fahrenheit to remain effective. That’s about 20 degrees colder than extreme winter temperatures at the South Pole. Early on, experts warned that the U.S. lacked the necessary ultra-cold storage trucks and cargo planes needed to ship hundreds of millions of doses at sub-sub-zero temperatures.
To get around that, Pfizer has developed specially built deep-freeze “suitcases” that can be tightly sealed and shipped even in non-refrigerated trucks. But while Pfizer may have solved the problem of how to ship the frozen vaccine, these highly engineered shipping containers create other problems, particularly for the hospitals, pharmacies and outpatient clinics that will have to administer the vaccinations to hundreds of millions of Americans.
“The reality is there has never been been a drug that required storage at this temperature,” said Soumi Saha, a pharmacist and director of advocacy at Premier, which acts as a purchasing agent for hospitals across the country. “The administration and distribution effort will require an all hands on deck.”
Game change. This is a great day for patients as Pfizer (where I serve on the BoD) announces final top line results from the phase 3 trial with its Covid-19 vaccine. We should now have two vaccines that could effectively end the U.S. epidemic next year if everything goes right.
Despite those challenges, the latest news from Pfizer was likely to be welcomed by the medical and scientific community. Former FDA administrator Scott Gottlieb called the result a “game change” in a tweet early Wednesday.
“We should now have two vaccines that could effectively end the U.S. epidemic next year if everything goes right,” Gottlieb, who serves on Pfizer’s board of directors, said, referring to both Pfizer’s and Moderna’s positive results.
While the U.S. government has poured billions of taxpayer dollars into helping develop a number of “candidate” vaccines still in undergoing trials around the world, Pfizer’s management decided not to accept any government funding to develop it’s drug.
CEO Albert Bourla said he “wanted to liberate our scientists from any bureaucracy… When you get money from someone, that always comes with strings.”
Pfizer did strike a large-scale production and delivery deal with the U.S. government, however, worth up to $1.95 billion, to secure an initial 100 million doses of the vaccine once its approved, with the option to purchase 500 million more, according to the Department of Health and Human Services.
CBS News’ Haley Ott in London contributed to this report.
