Covid-19 Updates: Vaccines, Omicron and Mandate News
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A long-awaited study of Pfizer’s Covid pill has confirmed that it helps prevent serious illness, the company said on Tuesday.
Pfizer also said its antiviral pill was working in lab studies against the Omicron variant, which is booming in South Africa and Europe and is expected to dominate cases in the United States in the coming weeks.
“We are convinced that, if authorized or approved, this potential treatment could be an essential tool to help quell the pandemic,” Albert Bourla, chief executive of Pfizer, said in a statement.
Last month, Pfizer asked the Food and Drug Administration to clear the pill, known as Paxlovid, based on a first batch of data. The new findings will no doubt bolster the company’s app, which could mean Americans infected with the virus could have access to the pill within weeks.
In Tuesday’s announcement, Pfizer said that if given within three days of symptom onset, Paxlovid reduced the risk of hospitalization and death by 89%. 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 for serious illness, largely match the smaller initial analysis from the company’s clinical trial, published last month.
Pfizer said 0.7 percent of patients who received Paxlovid were hospitalized within 28 days of entering the trial, and none died. In contrast, 6.5 percent of patients who received placebo were hospitalized or died.
Pfizer has also released preliminary data from a separate trial involving people at low risk. These volunteers included vaccinated people who had a risk factor for serious illness, as well as unvaccinated patients without a risk factor.
Among that group of 662 volunteers, Paxlovid reduced the risk of hospitalization and death by 70%, the company said.
Mikael Dolsten, Pfizer’s chief scientific officer, was rambunctious about the results after overseeing the drug’s development since the spring of 2020, with more than 200 company scientists making the molecule and then testing it in animals and humans.
While the drug was in development, Dr Dolsten hoped it could be 60% effective. His true power left him stunned. “We have really reached 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 lab experiments, Paxlovid also performed well against the highly mutated Omicron variant. The drug hangs in one of Omicron’s key proteins – called a protease – just as effectively as it does with other variants, Pfizer found.
The good news from Pfizer came as rival Merck awaited approval for 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% if taken within five days of symptom onset.
But once companies did a final analysis of all their data, the efficiency dropped to 30%. At an FDA advisory committee meeting last month, a number of experts reacted coldly to this modest efficacy, especially given some concerns about the safety of the pill.
The committee narrowly voted in favor of authorizing molnupiravir. But now, two weeks later, the FDA has yet to announce whether it will. In the meantime, France rejected Merck’s request, citing its modest efficiency and security concerns. Britain cleared molnupiravir last month.
Dr Dolsten said Pfizer will have 180,000 treatment courses ready if Paxlovid is licensed soon and the company plans to make 80 million courses available globally by 2022.
Pfizer is going to make a huge amount of money from the drug. Investment bank SVB Leerink estimated that Paxlovid would generate $ 24 billion in global revenue in 2022 and $ 33 billion in 2023. This would give Paxlovid one of the highest annual sales of any medical product in the world. story.
To date, only one other product has reported more: Pfizer’s Covid vaccine.
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