Pfizer Vaccine Cleared in U.S., a Landmark in Covid-19 Fight
Pfizer-BioNTech Covid-19 vaccine will be the first shot that will be deployed to Americans amid soaring virus-related deaths.
(Bloomberg) -- 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.
Gen. Gustave F. Perna, the chief operating officer for the government vaccine program Operation Warp Speed, said at a news briefing Saturday that vaccines are being packaged and will arrive at the first administration sites on Monday. Among the first to be inoculated will be health-care workers and seniors living in long-term care facilities.
The shot is a landmark achievement, 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.
“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. On Saturday, Hahn defended the agency’s thoroughness and transparency.
“We worked quickly because of the urgency of this pandemic, not because of any external pressure,” Hahn said Saturday on a call with reporters.
The FDA’s career scientists “conducted a fast but incredibly thorough review,” he said, adding they worked “around the clock including holidays, weekends and nights.” The agency is in the process of reviewing its response to Covid-19, including how it handles emergency authorization requests, Hahn said.
Trump called the clearance “one of the greatest scientific accomplishments in history” in a video on Twitter, saying it will save millions of lives and end the pandemic.
Distribution Begins
The first doses will begin shipping throughout the country immediately, Pfizer Chief Executive Officer Albert Bourla said. Trucks will head out from manufacturing sites in Wisconsin and Michigan, packed with the shots, which must be stored at ultracold temperatures. Pfizer has developed special dry-ice containers to make it easier to store for facilities that don’t have the needed equipment.
“We’re pretty convinced that we can make this happen here,” Marks said regarding maintaining cold storage. “We’re hopeful that this is going to work out.”
The vaccine is expected to be given first to health-care workers and residents of long-term care facilities. Later on Saturday, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will make its own recommendation on the vaccine, likely clearing the way for doctors to begin administering it.
Health systems around the U.S. are preparing to begin immunizing people in the coming days. Sanford Health, based in the Upper Midwest, said that it had received notice from Pfizer that its order had been received and that it would be notified when its doses ship.
“We could receive the vaccine in our hospitals in North Dakota and South Dakota as early as Sunday, and be putting shots in arms as soon as Monday,” said spokeswoman Angela Dejene.
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 news release, without elaborating. “The vaccine option will be voluntary and will be implemented in alignment with the regulatory authorities where the trial is conducted.”
Allergy Issues
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. The CDC, which is helping states with the vaccine rollout, will ensure each site has medication on hand to treat any allergic reactions, FDA’s Marks said Saturday.
While serious allergic reactions were not seen in Pfizer’s clinical trials and Marks said the FDA is “comfortable” giving the vaccine to Americans, he added: “We’ll be monitoring very closely for them. I think we still need to learn more.”
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.
Stopping Spread
It isn’t clear whether the vaccine is effective at preventing Covid-19’s spread. It is 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.
The FDA expects more data on the shot’s effect on Covid-19 transmission in a “few months,” Marks said Saturday.
The vaccine showed some protection from symptomatic Covid-19 after one shot, but the FDA is recommending people take both doses to achieve the full 95% effectiveness of the vaccine, particularly given that Pfizer studied a two-dose regimen so it’s not known how long the reduced protection from one shot would last.
Pfizer didn’t study the vaccine in pregnant or lactating women, though the FDA is leaving it up to those women as to whether they will receive the vaccine. The company also did not have much data on the shot’s use in 16 and 17 year olds but Marks said they’re comfortable with the safety profile for the age group.
Global Demand
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.
Countries around the world are clamoring for more doses of the vaccine, 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.
©2020 Bloomberg L.P.