Pfizer said on Tuesday that its Covid pill was found to stave off severe disease in a key clinical trial and that it is likely to work against the Omicron variant of the virus. As the United States braces for a fourth wave of the Pandemic, the results underscore the promise of the treatment, which health officials and doctors are counting on to ease the burden on hospitals.
If the FDA approves the drug within a few days, patients could receive it by the end of the year. Public health experts are hopeful that the pills will curb the worst outcomes from the disease, no matter the variant.
Pfizer said that its pill reduced the risk of hospitalization and death by 88 percent when given to people at high risk of severe Covid. The company said that laboratory experiments indicated that the drug will attack a keyprotein in the Omicron variant, which is surging in South Africa and Europe, and is expected to dominate U.S. cases in the weeks ahead.
Sara Cherry, a virologist at the Perelman School of Medicine at the University of Pennsylvania, was not involved in the study. It would have a huge impact on health care if we could keep people out of hospitals.
The Delta variant is spreading and some U.S. states are seeing record high hospitalizations. Researchers warn that Omicron may spread even more rapidly and that it may evade some of the immune defenses provided by vaccines.
Two doses of the Pfizer-BioNTech vaccine provide less protection against Omicron than against other versions, according to a study released on Tuesday.
It is possible that Omicron will cause a surge of severe infections in unvaccinated people. Hospitals could be overwhelmed in the next few months. A highly effective pill like Pfizer's could be crucial to easing the surge.
Pfizer asked the FDA to approve Paxlovid for high-risk adults based on preliminary data. The new results will help strengthen the company's application for the drug, which is meant to be prescribed by a health care provider after a positive virus test and taken at home.
The company released a smaller analysis of the clinical trial last month, but the results of an analysis of more than 2,200 unvaccinated volunteers at high risk of severe disease largely match that.
In its analysis, Pfizer found that 0.7 percent of patients who received Paxlovid were hospitalized within 28 days of entering the trial. The placebo patients were more likely to be hospitalized or dead.
The data from the trial looked at people with a lower risk. These volunteers included people who were notvaccinated, as well as people who had a risk factor for severe disease.
Paxlovid reduced the risk of hospitalization and death by 70% among this group of volunteers.
The F.D.A. might authorize Paxlovid for people at risk of becoming severely ill from Covid based on the preliminary results, according to several public health experts.
If you had a lot of underlying conditions, your doctor might think about it.
If the benefits outweigh any potential risks, regulators might consider expanding the drug's use. Paxlovid could shorten the amount of time that people have to stay in isolation. It could cut down on the chances of people passing on the virus. She said that all of those would be beneficial.
The possibilities would have to be confirmed in trials. Pfizer expects Paxlovid to block transmission in households in the first half of the century.
The chief scientific officer of Pfizer was excited about the results after overseeing the development of the drug since the spring of 2020, with more than 200 company scientists crafting the molecule and then testing it in animals and people.
The drug was in development and Dr. Dolsten hoped it would be 60 percent effective. He was stunned by its true power. He said in an interview that they hit the top of the board.
Most of the volunteers carried the Delta variant. Paxlovid performed well against the Omicron variant in laboratory experiments, according to Pfizer. Pfizer found that the drug jams into one of Omicron's crucial proteins just as effectively as it does with other versions.
Pfizer ran an experiment that was a good first step in testing the treatment against Omicron. She and other scientists will be receiving Omicron viruses this week from labs where it is being grown, and they will be able to test Paxlovid to see how well it stops the viruses from invading cells. Dr. Cherry said they hope to start those experiments this week.
Pfizer is supposed to take 30 pills over five days. Two of Pfizer's new pills and a low-dose H.I.V. drug called ritonavir will be taken by patients at a time.
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Pfizer has a pill. Pfizer announced that a study showed that its oral Covid treatment helps stave off severe disease even from the Omicron variant. If the treatment was given within three days of the start of symptoms, it reduced the risk of hospitalization and death by 89 percent.
The US has around 800,000 deaths. The United States is on the verge of killing more people than any other country from the virus. Most of the people who have died in the US have been 65 or older. One in 100 older Americans have died from the disease.
U.S. mandates. New York State has a vaccine requirement for health care workers which the Supreme Court refused to block. New York has a new mask mandate, and California decided to restore it.
It's possible that ritonvir can interfere with certain medications, which could cause serious side effects. When H.I.V. patients take the drug for a long time, doctors usually don't worry about those interactions. Doctors might recommend that patients stop taking certain drugs for a few days if Pfizer's five-day treatment is used. Patients on Pfizer's treatment may need to adjust their dosage or be monitored if other drugs like blood thinners and immunosuppressive medications can't be easily interrupted.
The risk of contracting a disease will vary by drug, according to a University of California San Francisco infectious disease pharmacist.
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The person is in Alaska. The officials were eager for a pill option to treat Covid-19 as the treatments are cumbersome and might not work against the Omicron variant.
Since the start of the Pandemic, health officials have been waiting for Paxlovid. They are counting on the pills to reach more people than the treatments given at a hospital or clinic. Several brands of treatments may not work against Omicron.
Logistical obstacles could limit the Pfizer treatment's promise. Patients will need a positive coronaviruses test and a prescription from a health care provider within five days of developing symptoms to receive the pills. The people most vulnerable to becoming severely ill from Covid have those challenges in mind.
The federal government has ordered enough Pfizer's pills to cover 10 million people at a cost of $530 per patient. Pfizer will have about 180,000 treatment courses ready by the time it gets authorization this month, but some of them will most likely go to countries other than the United States. The company is expected to deliver only enough of its pills to cover 300,000 Americans before the end of February, and then increase the pace of its deliveries.
There are some expectations that need to be met because this is not available today. It will not be available for the average person in a month. Dr. David Boulware, an infectious disease specialist at the University of Minnesota, said that it was going to be something that slowly gets rolled out.
Pfizer received good news as it awaits word on authorization of its own pill for Covid. The pill reduced the risk of hospitalization and death by 50 percent if taken within five days of the start of symptoms, according to preliminary data.
molnupiravir's effectiveness dropped to 30 percent after the companies analyzed all their data. 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. The F.D.A. hasn't said whether it will do so. France turned down the application because of its modest effectiveness and safety concerns. molnupiravir was authorized by Britain last month.
If the Pfizer pill works as well as the data suggests, there is enough supply for the United States, according to Dr. Walid Gellad, who directs the Center for Pharmaceutical Policy and Prescribing.
Pfizer will make a lot of money from Paxlovid. The drug would bring in $24 billion in global revenue in 2022, according to the investment bank. Paxlovid would be one of the highest single-year sales of any medical product in history.
Pfizer's Covid vaccine has brought in more than any other product to date.
