A long-awaited study of Pfizer’s Covid pill confirmed that it helps prevent serious illness, the company announced on Tuesday.
Pfizer also said that the antiviral pill worked in laboratory studies against the Omicron variant, which is increasing in South Africa and Europe and is expected to dominate US cases in the coming weeks.
“We are confident that, if authorized or approved, this potential treatment can be a critical tool in curbing the pandemic,” said Albert Bourla, Pfizer’s CEO, in a statement.
Last month, the Pfizer Food and Drug Administration asked for approval of the pill, known as Paxlovid, based on a preliminary group of data. The new results will undoubtedly strengthen the company’s application, which may mean that Americans infected with the virus can access the pill within weeks.
In Tuesday’s announcement, Pfizer said that if Paxlovid was given within three days of symptom onset, Paxlovid reduced the risk of hospitalization and death by 89 percent. If given within five days, the risk was reduced almost as much, to 88 percent.
The results, based on an analysis of 2246 unvaccinated volunteers with a high risk of serious illness, are largely consistent with the company’s initial, minor analysis of the clinical study, published last month.
Pfizer said that 0.7 percent of the patients who received Paxlovid were hospitalized within 28 days of entering the study, and no one died. On the other hand, 6.5 per cent of the patients who received placebo were hospitalized or died.
Pfizer has also released preliminary data from a separate study looking at people at lower risk. These volunteers included vaccinated individuals who had a risk factor for serious illness, as well as unvaccinated patients without risk factors.
Among this group of 662 volunteers, Paxlovid reduced the risk of hospitalization and death by 70 percent, the company said.
Mikael Dolsten, CEO of Pfizer, was overwhelmed by the results after monitoring the development of the drug since the spring of 2020, with more than 200 business researchers who made the molecule and then tested it on animals and humans.
While the drug was under development, Dr. Dolsten held out hope that it could be 60 percent effective. Its true strength paralyzed him. “We really hit the top of the board,” he said in an interview.
In both trials, most of the volunteers were infected with the Delta variant. But Pfizer said on Tuesday that in laboratory experiments, Paxlovid also performed well against the highly mutated Omicron variant. The drug attaches itself to one of Omicron’s key proteins – called a protease – as effectively as it does to other variants, Pfizer found.
Pfizer’s good news came when competitor Merck was waiting to be notified of the approval of its own antiviral pill, known as molnupiravir. In October, Merck and 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 symptom onset.
However, when the companies made a final analysis of all their data, the efficiency 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 safety of the pill.
The committee barely voted in favor of approving molnupiravir. But now, two weeks later, the FDA has not yet announced whether it will do so. Meanwhile, France has rejected Merck’s application, citing its modest efficiency and safety concerns. The UK approved molnupiravir last month.
Dr. Dolsten said that Pfizer would have 180,000 treatment courses ready if Paxlovid was soon authorized, and that the company planned to make 80 million courses available worldwide by 2022.
Pfizer stands to make a huge amount of money on the drug. Investment bank SVB Leerink estimated that Paxlovid would bring in $ 24 billion in global revenue in 2022 and $ 33 billion in 2023. This would give Paxlovid one of the highest one-year sales of any medical product in history.
To date, only one other product has brought in more: Pfizer’s Covid vaccine.