imageCredit…Pfizer, via Getty Images
A highly anticipated study of Pfizer’s Covid pill confirmed that it helps ward off serious illnesses, the company said on Tuesday.
Pfizer also said its antiviral pill had worked in laboratory studies against the variant of Omicron, which is on the rise in South Africa and Europe and is expected to dominate US cases in the coming weeks.
“We are confident that this potential treatment, if approved or approved, could be a critical tool in containing the pandemic,” Pfizer CEO Albert Bourla said in a statement.
Last month Pfizer asked the Food and Drug Administration to approve the pill known as paxlovid based on preliminary data collection. The new results will no doubt bolster the company’s motion, which could mean Americans infected with the virus have access to the pill within weeks.
In Tuesday’s announcement, Pfizer said that paxlovid, when given within three days of symptoms appearing, reduced the risk of hospitalization and death by 89 percent. When given within five days, the risk was reduced to almost 88 percent.
The results, based on an analysis of 2,246 unvaccinated volunteers at high risk for serious illness, are largely in line with the company’s first, smaller analysis of the clinical study, published last month.
Pfizer said that 0.7 percent of patients who received paxlovid were hospitalized within 28 days of entering the study, and none 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 that looked at people at lower risk. These volunteers included vaccinated people who had a risk factor for serious illness and unvaccinated people who had 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 in abundance of the results after overseeing the drug’s development with more than 200 company scientists, who manufactured the molecule and then tested it on animals and humans, since spring 2020.
While developing the drug, Dr. Dolsten to a 60 percent effectiveness. His true potency left him stunned. “We really have reached the top,” he said in an interview.
In both studies, most of the subjects were infected with the Delta variant. However, Pfizer said Tuesday that paxlovid had also performed well against the highly mutated Omicron variant in laboratory experiments. The drug builds up in one of Omicron’s key proteins – a so-called protease – just as effectively as in other variants, Pfizer found.
The good news from Pfizer came as its rival Merck awaited approval of its own antiviral pill known as molnupiravir. In October, Merck and its 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 symptoms appear.
But after the companies had finally analyzed all of their data, the effectiveness dropped to 30 percent. At an FDA advisory committee meeting last month, a number of experts reacted coolly to this modest effectiveness, especially given some 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. Meanwhile, France has rejected Merck’s application on the grounds of its modest effectiveness and safety concerns. The UK approved molnupiravir last month.
Dr. Dolsten said that if Paxlovid were approved soon, Pfizer would have 180,000 courses of treatment available, and the company planned to have 80 million courses available worldwide by 2022.
Pfizer will make a lot of money from the drug. Investment bank SVB Leerink estimates that Paxlovid would raise $ 24 billion worldwide in 2022 and $ 33 billion in 2023. This would make Paxlovid one of the highest annual sales of any medical device in history.
So far, only one other product has brought more: Pfizer’s Covid vaccine.
Carl Zimmer and