The drug company Pfizer said Monday that early results from its coronavirus vaccine suggest the shots may be a surprising 90 percent effective at preventing covid-19, putting the company on track to apply later this month for emergency-use approval from the Food and Drug Administration (FDA).
“We’re in a position potentially to be able to offer some hope,” said Bill Gruber, Pfizer’s senior vice president of clinical development. “We’re very encouraged.”
Anthony Fauci, the U.S. government’s top-infectious disease expert, said the results suggesting 90 percent effectiveness are “just extraordinary,” adding: “Not very many people expected it would be as high as that.”
“It’s going to have a major impact on everything we do with respect to covid,” Fauci said as Pfizer appeared to take the lead in the all-out global race by drug companies and various countries to develop a well-tested vaccine against the virus.
Bruce Aylward, the World Health Organization’s senior adviser, said that the vaccine could “fundamentally change the direction of this crisis” by March, when the U.N. agency hopes to start vaccinating high-risk groups.
Still, Monday’s announcement doesn’t mean for certain that a vaccine will be available soon: This interim analysis, from an independent data monitoring board, looked at 94 infections recorded so far in a study that has enrolled nearly 44,000 people in the United States and five other countries. Some participants got the vaccine, while others got dummy shots.
Pfizer cautioned that the protection rate might change by the time the study ends. Even revealing such early data is highly unusual.
Jesse Goodman of Georgetown University, former chief of the FDA’s vaccine division, called the partial results “extremely promising” but ticked off many questions still to be answered, including how long the vaccine’s effects last and whether it protects older people as well as younger ones.
Also, whenever a vaccine does arrive, initial supplies will be scarce and reserved for certain groups of people, with priority likely to be given to health care workers and others on the front lines. Pfizer has estimated that 50 million doses of its two-shot vaccine could be available globally by the end of 2020.
Confirmed infections in the United States rose above 10 million on Monday, the highest in the world. Cases in the United States are running at all-time highs of more than 100,000 new ones per day.
The shots, made by Pfizer and its German partner BioNTech, are among 10 possible vaccine candidates in late-stage testing around the world — four of them so far in huge studies in the United States.