Pfizer Says Its Covid Pill, Paxlovid, Will Protect Against Severe Disease

The company said the treatment, Paxlovid, taken in pill form, reduced the risk of hospitalization and death by 89 percent if given within three days of the onset of symptoms.,

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Pfizer says its oral Covid treatment will protect against severe disease, even from Omicron.

Pfizer’s oral Covid treatment, Paxlovid, being produced in a laboratory in Freiburg, Germany. It includes a new pill, nirmatrelvir, as well as an existing medicine, ritonavir, that helps it remain in the body longer.Credit…Pfizer, via Getty Images

Dec. 14, 2021Updated 4:17 p.m. ET

A highly anticipated study of Pfizer‘s oral Covid treatment confirmed that it helps stave off severe disease, the company announced on Tuesday.

Pfizer also said its antiviral treatment, taken in pill form, worked in laboratory studies against the Omicron variant, which is surging in South Africa and Europe and is expected to dominate U.S. cases in the weeks ahead.

“We are confident that, if authorized or approved, this potential treatment could be a critical tool to help quell the pandemic,” Albert Bourla, Pfizer’s chief executive, said in a statement.

Last month, Pfizer asked the Food and Drug Administration to authorize the treatment, known as Paxlovid, based on a preliminary batch of data. The new results will undoubtedly strengthen the company’s application, which could mean that Americans infected with the virus may have access to the treatment within weeks.

In Tuesday’s announcement, Pfizer said that if given within three days of the onset of symptoms, 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 2,246 unvaccinated volunteers at high risk of severe disease, largely match the company’s initial, smaller analysis of the clinical trial, released last month.

Pfizer said that 0.7 percent of patients who received Paxlovid were hospitalized within 28 days of entering the trial, and none died. By contrast, 6.5 percent of patients who received a placebo were hospitalized or died.

Pfizer also released preliminary data from a separate trial looking at people with a lower risk. These volunteers including vaccinated people who carried a risk factor for severe 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, the chief scientific officer of Pfizer, was exuberant about the results after having overseen the development of the treatment since the spring of 2020, with more than 200 company scientists crafting the new molecule and then testing it in animals and people.

While the treatment was in development, Dr. Dolsten held out hope that it might be 60 percent effective. Its true potency left him stunned. “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 treatment jams into 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, awaited word on authorization 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 the onset of symptoms.

The Coronavirus Pandemic: Key Things to Know

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Pfizer’s Covid pill. A study of Pfizer’s oral Covid treatment confirmed that it helps stave off severe disease, even from the Omicron variant, the company announced. Pfizer said the treatment reduced the risk of hospitalization and death by 89 percent if given within three days of the onset of symptoms.

The Omicron variant. The latest Covid-19 variant, which has been detected in dozens of countries, seems to dull the power of the Pfizer vaccine, but the company said its boosters offer significant protection. Omicron appears to spread rapidly, though it may be less severe than other forms of the virus.

U.S. nears 800,000 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 U.S. have been 65 or older. One in 100 older Americans has died from the virus.

U.S. mandates. The Supreme Court refused to block New York State’s vaccine requirement for health care workers which allows medical, but not religious, exemptions. Meanwhile, a new mask mandate went into effect in New York, and California announced it would reinstate its mask mandate.

A new wave in Europe. Prime Minister Boris Johnson of Britain said that the country’s vaccine booster program would be accelerated to counter a “tidal wave of Omicron,” while authorities in Denmark and Norway predicted the new variant will dominate both countries in a matter of days.

But once the companies carried out a final analysis on all their data, the effectiveness dropped to 30 percent. At an F.D.A. 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 narrowly voted in favor of molnupiravir’s authorization. But now, two weeks later, the F.D.A. has yet to announce whether it will do so. In the meantime, France has turned down Merck’s application, citing its modest effectiveness and concerns about safety. Britain authorized molnupiravir last month.

Dr. Dolsten said that Pfizer would have 180,000 courses of treatment ready if Paxlovid was authorized soon and that the company planned to make 80 million courses available worldwide in 2022.

Pfizer stands to make a huge amount of money from the drug. The investment bank SVB Leerink estimated that Paxlovid would bring in $24 billion in global revenue in 2022 and $33 billion in 2023. That would give Paxlovid one of the highest single-year sales of any medical product in history.

To date, only one other product has brought in more: Pfizer’s Covid vaccine.

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