Pfizer Inc. gained emergency U.S. authorization for its Covid-19 vaccine on Friday, completing an unprecedented scientific sprint that could eventually help bring an end to a pandemic that has killed nearly 300,000 Americans.
The Food and Drug Administration’s decision to authorize use of Pfizer and partner BioNTech SE’s vaccine will now set in motion a complicated immunization drive that will launch across the country in coming days. Among the first to be inoculated will be health-care workers and seniors living in long-term care facilities.
“With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech Covid-19 vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks,” Peter Marks, the head of the FDA’s office that oversees vaccines, said in a statement.
The approval also caps a fraught political struggle that has seen President Donald Trump push drug regulators to swiftly clear a vaccine. In the final hours of the review Friday, White House Chief of Staff Mark Meadows suggested to FDA Commissioner Stephen Hahn that failure to clear the vaccine for use soon could cost him his job. https://www.bloomberg.com/graphics/2020-coronavirus-dash/
The Pfizer-BioNTech shot is a landmark scientific achievement, a vaccine built from a breakthrough technology in a matter of months, in the face of a pandemic that has sickened millions worldwide. It has already been cleared by regulators in the U.K., Canada and other countries.
“We have worked tirelessly to make the impossible possible, steadfast in our belief that science will win,” Pfizer Chief Executive Officer 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.”
The first doses will begin shipping throughout the country immediately, Bourla said in a video message released following the emergency-use authorization.
Trump called it “one of the greatest scientific accomplishments in history” in a video on Twitter, saying the vaccine will save millions of lives and end the pandemic.
A shot similar to Pfizer and BioNTech’s made by Moderna Inc. is expected to gain U.S. clearance next week, providing the country with a potent combination for beating back the pathogen. More vaccines are also expected to be brought to market next year, expanding the arsenal doctors will have to rein in Covid-19.
Pfizer’s vaccine, like Moderna’s, uses a new technology called messenger RNA that turns the body’s own cells into vaccine-producing factories to fight the coronavirus. In a trial of almost 44,000 people, it was 95% effective at preventing symptomatic cases of Covid-19, protecting people of all ages and ethnicities. Crucially, it was able to prevent the most severe infections.
Pfizer and BioNTech plan to provide clinical trial participants who received the placebo the authorized shot “at scheduled timepoints in the study,” the companies said in a joint-release, without elaborating on when those timepoints would be. “The vaccine option will be voluntary and will be implemented in alignment with the regulatory authorities where the trial is conducted.”
Following a Thursday vote by an advisory panel of outside experts backing the vaccine for use in people 16 and older, the FDA was weighing how to address reports of serious allergic reactions in the U.K., where the vaccine was approved earlier this month. Officials there have since told people with a history of significant allergic reactions not to get the vaccine.
In a fact sheet for patients, the FDA said “there is a remote chance” the vaccine could cause a severe allergic reaction and told doctors in a similar document they should have medical interventions on hand to help treat such a side effect.
Many Americans have expressed skepticism about the vaccines being developed to fight the coronavirus. A wider campaign to convince the hesitant to get inoculated is expected in the weeks and months ahead.
“As a physician, I have no hesitation recommending that my parents and my patients’ families receive the vaccine, and I encourage all Americans to get vaccinated in the order recommended by the CDC,” said Richard Besser, the president and CEO of the Robert Wood Johnson Foundation and former acting director of the CDC. “When my group is called, I will gladly roll up my sleeve.”
Side effects in Pfizer’s clinical trial were mild and developed more frequently in younger participants in the study, specifically those aged 55 and younger, with no signs of serious safety concerns, according to an FDA staff report on the vaccine’s safety and efficacy.
After the second injection, fatigue and headache were the most common systemic reactions, occurring in 59% and 52% of the younger participants, compared with 51% and 39% in those over age 56. Pfizer said patients in the trial did not experience serious allergic reactions.
It’s unclear whether the vaccine is effective at preventing Covid-19’s spread. It’s possible the shot didn’t work as well at preventing cases where people didn’t have symptoms, meaning there will likely be a continued need for basic public-health measures such as wearing masks and social distancing.
Among the vaccine front-runners, the Pfizer-BioNTech shot is the only one that didn’t take funding from the White House-led Operation Warp Speed program to accelerate development, manufacturing and distribution of Covid-19 shots. However, the two companies have secured a $2 billion deal to supply 100 million doses to the U.S., with an option for 500 million more.
The shot requires special freezers to be kept extra cold temperatures until a few days before use, making distribution more complicated. Pfizer has developed special dry-ice containers to make it easier to store for facilities that don’t have the needed equipment.
With initial supply very limited, the vaccine is expected to be given first to health-care workers and residents of long-term care facilities. Countries are clamoring for more doses, said Sean Marett, BioNTech’s chief business and commercial officer, in an interview.
“Everybody wants all their doses on January 2nd of next year, but that’s not practical,” he said in an interview. “This is a new technology, there does not exist a manufacturing network. We are building it.”
To help increase the number of shots on hand, the U.S. agreed to buy 100 million more doses of Moderna’s vaccine on Friday, doubling its initial order. The government has an option to buy another 300 million doses of the shot.