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One company appears to lead the pack for getting a green light for its COVID-19 vaccine - Pfizer. The company's CEO has hinted that preliminary results from its vaccine trial could be available as soon as the end of this month. NPR's Joe Palca looks at how the Pfizer vaccine made it to the front of the line.
JOE PALCA, BYLINE: The race to find a vaccine for COVID-19 started in mid-January. That's when Chinese scientists published the genetic sequence of the coronavirus causing the disease. At the time, no one even knew if it was possible to make a vaccine against this new viral invader. When I spoke to Pfizer's chief scientific officer for viral vaccines at the start of May this year, he was sounding confident.
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PHILIP DORMITZER: I think there's a very good chance we'll have a vaccine.
PALCA: Phil Dormitzer says Pfizer's advantage came from a strategic partnership it made with the German biotech company BioNTech. The two companies had been working on a flu vaccine using a new kind of technology based on the virus's genes. Dormitzer says BioNTech was able to quickly refocus its research from flu to the coronavirus.
DORMITZER: It's literally a matter of swapping out influenza genes and swapping in a SARS coronavirus spike gene.
PALCA: The SARS coronavirus spike gene is the key to making a COVID-19 vaccine. Dormitzer says BioNTech quickly came up with vaccine candidates.
DORMITZER: And then what requires a much greater research and infrastructure, we can come in and really start to pitch in there.
PALCA: Pfizer organized initial safety testing of several different versions of the vaccine in May.
KIRSTEN LYKE: We started with four different agents at three different doses each.
PALCA: Kirsten Lyke is one of the scientists who tested the Pfizer vaccine candidates. She's at the University of Maryland Center for Vaccine Development. She says normally, testing all those different versions and all those different doses would have taken years. But for the COVID vaccine, they did it in four months.
LYKE: So we're just moving very quickly.
PALCA: Part of the reason they were able to finish so fast was a new technique for measuring how well a volunteer's immune system responded to the vaccine. Pei-Yong Shi at the University of Texas Medical Branch at Galveston developed the technique. He found a way to tag genes in the virus so they light up when they infected cells in the lab.
PEI-YONG SHI: You don't have to wait for four, five days. And the computer calculates the data you wish. It's just, like, very rapid.
PALCA: By the end of July, Pfizer was ready to start large-scale testing in humans. The company has now enrolled some 44,000 volunteers in a trial to show that the vaccine can prevent disease in someone exposed to the coronavirus and isn't likely to cause any rare health problems. It's a huge logistical undertaking, but one Edward Walsh from the University of Rochester says Pfizer is quite capable of.
EDWARD WALSH: They've got a well-oiled system for testing vaccines at various stages of their development.
PALCA: Even though other companies started large efficacy studies around the same time, University of Maryland's Kirsten Lyke says it's not surprising Pfizer may get results first.
LYKE: Pfizer's incredibly organized and is always, like, a couple steps ahead, planning where they want to go.
PALCA: Developing a vaccine during a pandemic is tough, and Lyke says it's impossible to ignore the politics that have been swirling around the effort. President Trump has accused regulators of trying to slow down the approval process to thwart his reelection bid. But Lyke says politics hasn't invaded the actual research.
LYKE: From boots on the ground getting these studies done, it's 100% science, and that's been super rewarding.
PALCA: It's possible that Pfizer may have enough evidence that their vaccine works before the end of the month, at which point the company could go to the FDA and ask for permission to distribute it to the public. FDA has said its review could take weeks. But for his part, Pfizer's Phil Dormitzer says that's time well spent. Having an external review of the data Pfizer has collected is essential for the public to be convinced that the vaccine is safe and actually works.
DORMITZER: I work for a pharmaceutical company, but I'm also a consumer. So I'm thinking of myself on the other end. I would want someone else to verify that as well.
PALCA: And just to provide a little perspective, everything about developing a vaccine for COVID-19 is moving faster than usual, from creating the vaccine candidates to testing them to getting them ready for FDA's regulatory review, a review that will also likely go much faster than usual. It still may not seem fast enough to some, but for the people used to working in this field, it's been nothing short of remarkable.
Joe Palca, NPR News. Transcript provided by NPR, Copyright NPR.
