A long-awaited study of Pfizer’s Covid pill confirmed that it helps prevent serious illness, the company announced on Tuesday.
Pfizer also said its antiviral pill worked in lab studies against the Omicron variant, which is on the rise in South Africa and Europe and is expected to dominate US cases in the coming weeks.
“We believe that, if authorized or approved, this potential treatment could be a critical tool to help contain the pandemic,” Albert Bourla, CEO of Pfizer, said in a statement.
Last month, Pfizer asked the Food and Drug Administration to approve the pill, known as Paxlovid, based on a preliminary set of data. The new results will no doubt bolster the company’s application, which could mean Americans infected with the virus will have access to the Pill within weeks.
In Tuesday’s announcement, Pfizer said that when administered within three days of the onset of symptoms, Paxlovid reduced the risk of hospitalization and death by 89 percent. When given within five days, the risk was reduced almost as much, to 88 percent.
The results, based on an analysis of 2,246 unvaccinated volunteers at high risk for serious disease, are broadly consistent with the company’s first, smaller analysis of the clinical trial, released last month.
Pfizer said 0.7 percent of patients who received Paxlovid were hospitalized within 28 days of participating in the study, and no one died. In contrast, 6.5 percent of patients who received a placebo were hospitalized or died.
Pfizer also released preliminary data from a separate study of people at lower risk. These volunteers included vaccinated people with a risk factor for serious disease, as well as unvaccinated patients with no risk factors.
Among this group of 662 volunteers, Paxlovid reduced the risk of hospitalization and death by 70 percent, the company said.
Mikael Dolsten, Pfizer’s Chief Scientific Officer, was elated by the results after overseeing development of the drug since spring 2020, with more than 200 business scientists creating the molecule and then testing it on animals and humans.
While the drug was in development, Dr. Dolsten hoped it would be 60 percent effective. His true strength amazed him. “We’ve really reached the top of the board,” he said in an interview.
In both studies, most of the volunteers were infected with the Delta variant. But Pfizer said on Tuesday that Paxlovid also performed well against the highly mutated Omicron variant in lab experiments. The drug blocks one of Omicron’s key proteins — called a protease — just as effectively as it does with other variants, Pfizer found.
Pfizer’s good news came as its rival, Merck, waited for approval for its own antiviral pill known as molnupiravir. In October, Merck and his partner Ridgeback Biotherapeutics announced that the pill reduced the risk of hospitalization and death from Covid-19 by 50 percent if taken within five days of the onset of symptoms.
The coronavirus pandemic: important things to know
US approaches 800,000 Covid deaths. The United States is on the cusp of surpassing 800,000 deaths from the virus, and no group has suffered more than older Americans. Seventy-five percent of people who have died in the US are 65 years of age or older. One in 100 older Americans has died from the virus.
But when the companies did a final analysis of all their data, the effectiveness dropped to 30 percent. At a meeting of the FDA advisory committee last month, a number of experts coolly commented on this modest effectiveness, especially given concerns about the pill’s safety.
The committee narrowly voted to approve molnupiravir. But now, two weeks later, the FDA has yet to announce whether it will do so. In the meantime, France has rejected Merck’s application, citing its modest effectiveness and safety concerns. Britain approved molnupiravir last month.
dr. Dolsten said Pfizer would have 180,000 courses ready if Paxlovid was approved soon, and the company plans to make 80 million courses available worldwide by 2022.
Pfizer is about to make a huge amount of money from the drug. The investment bank SVB Leerink estimated that Paxlovid would generate worldwide turnover of $24 billion in 2022 and $33 billion in 2023. That would give Paxlovid one of the highest annual sales of any medical product in history.
To date, only one other product has delivered more: Pfizer’s Covid vaccine.