After weeks of mounting coronavirus cases and hospitalizations, the country received a bolt of good news on Monday morning: An interim analysis found Pfizer’s vaccine candidate was more than 90 percent effective in preventing COVID-19.
“Today is a great day for science and humanity,” said Pfizer CEO Albert Bourla.
Here are five things to know about the breakthrough:
The results are better than expected
Experts had been girding the public that many vaccines are not close to 100 percent effective. The Food and Drug Administration (FDA) had set a minimum of 50 percent effectiveness for a coronavirus vaccine to be approved.
These results would far exceed that bar. Multiple experts said they were pleasantly surprised.
“It’s an incredibly high number for most vaccines,” said Bob Wachter, chairman of the department of medicine at the University of California-San Francisco. “Most people were expecting 50 to 70 percent.”
There are still some unknowns and the full data from the clinical trial has not yet been published. Among the outstanding questions is how long the protection from the vaccine will last. It is possible people will have to return every year to get a shot again, for example. There is also not yet data on how well the vaccine works in subgroups, like the elderly, who are particularly vulnerable to COVID-19.
It won’t be available right away
Despite the encouraging data, the vaccine will not be an immediate game-changer in the fight against the coronavirus.
The company needs to wait until the third week of November to finish gathering the two months of safety data required by the FDA, and then plans to apply for emergency authorization. No serious safety concerns have been observed so far, the company said.
Even after authorization, the number of initial doses will be limited and will go first to high-risk groups like health care workers or the elderly. Many experts expect the first doses could be given before the end of the year, but that much of the general public will not be vaccinated until sometime several months into 2021.
Alejandro Cané, a vaccine official at Pfizer, told The Hill on Monday the company plans to have 100 million doses of vaccine available in the U.S. from December through March, under a previously announced deal where the U.S. government purchased those doses for $1.95 billion.
Because each person needs to get two doses of the vaccine, though, that translates to enough initial doses for 50 million people, which will be free of charge to the patient.
“My personal hope is to see people vaccinated in the U.S. before the end of the year,” Cané said. “Definitely that is our hope and we are working so, so hard to have the information that the FDA required in order to fulfill their requirements and to have the safe and efficacious vaccine available.”
It’s still important to take precautions
Because the vaccine will not be available to the general public for some number of months, it is crucial that people take precautions like wearing a mask, maintaining distance from others and washing their hands.
The U.S. is now reporting more than 100,000 coronavirus cases a day, and hospitalizations are on pace to soon set a new record as well. As winter arrives and more activity moves indoors, it will be even more important for people to take precautions.
“We all need to keep two seemingly contradictory facts in mind,” Ashish Jha, dean of the Brown University School of Public Health, tweeted Monday. “1. We are entering the hardest days of the pandemic. The next two months will see a lot of infections and deaths. 2. There is a light at the end of the tunnel. Today, that light got a bit brighter.”
There’s political maneuvering over the credit
Republicans were quick to credit the Trump administration’s Operation Warp Speed effort for helping speed the vaccine along.
“HUGE NEWS: Thanks to the public-private partnership forged by President @realDonaldTrump, @pfizer announced its Coronavirus Vaccine trial is EFFECTIVE, preventing infection in 90% of its volunteers,” Vice President Pence tweeted Monday.
The picture is complicated, though, by the fact that Pfizer and its partner, the German firm BioNTech, did not receive U.S. government funding for research and development, unlike some other pharmaceutical companies working on coronavirus vaccines. However, Pfizer did receive $1.95 billion from the government to purchase the doses of its vaccine.
“Trump shouldn't take the credit for the Pfizer/BioNTech progress, but it's not fair to suggest that this was simply a ‘private sector’ effort,” tweeted Sen. Chris MurphyChristopher (Chris) Scott MurphySenators slow Biden with holds at Pentagon, State Tell our troops: 'Your sacrifice wasn't in vain' Sunday shows preview: Bombing in Kabul delivers blow to evacuation effort; US orders strikes on ISIS-K MORE (D-Conn.). “They got purchase/distribution contracts from the U.S., EU, and Japan, and BioNTech got $445M in funding from the German government.”
President-elect Joe BidenJoe BidenUkraine's president compares UN to 'a retired superhero' Biden touts 'progress' during 'candid' meetings on .5T plan Biden to tap law professor who wants to 'end banking as we know it' as OCC chief: reports MORE, meanwhile, took a high-level view in a statement that did not mention President TrumpDonald TrumpUkraine's president compares UN to 'a retired superhero' Collins to endorse LePage in Maine governor comeback bid Heller won't say if Biden won election MORE. He called the vaccine progress “excellent news,” but cautioned that “the end of the battle against COVID-19 is still months away.”
Distribution is still a challenge
Even once the vaccine itself is authorized by the FDA, there is still the daunting undertaking of getting shots into the arms of hundreds of millions of Americans.
The Pfizer vaccine has the added complication that it must be stored at extremely cold temperatures, beyond what a normal freezer provides.
State health officials, who are largely responsible for the vaccination effort, warned Congress last month that they need $8.4 billion for vaccine distribution efforts that they do not currently have. A coronavirus response package has been stalled for months, which would be a vehicle for providing those funds.
“This is a pretty major undertaking,” said Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officials. “It’s not just the scale but also the need for speed. We've got to be able to scale up the system further in order to do that.”
The group says much of the funding is needed to build up the health care workforce, as well for costs like storage and transportation of the vaccine.
“It’s still a really hard problem,” said Wachter, the University of California doctor. “People should not take it as trivial that you have a vaccine coming out of a vat and it’s a straight shot to get it into my shoulder.”