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Pfizer announced on Tuesday The Covid pill was found to fend off serious diseases in a major clinical trial and work against a highly mutated Omicron variant of the virus. The results underscore the promise of health officials and doctors to ease the burden on hospitals as the United States prepares for the fourth wave of the pandemic.

If the Food and Drug Administration allows the drug, which can happen within days, patients can start taking the drug by the end of the year. While supply will be limited at first, public health experts are hopeful that the pills, whatever the variant, could ward off the worst consequences of the disease.

Pfizer said the antiviral pill reduced the risk of hospitalization and death by 88 percent when given to unvaccinated people at high risk of severe Covid-19 within five days of the onset of symptoms. The company also said that laboratory experiments have shown that the drug will attack an important protein. Omicron variantIt is expected to dominate US cases in the coming weeks, rising in South Africa and Europe.

“It’s pretty surprising and potentially transformative,” said Sara Cherry, a virologist at the University of Pennsylvania Perelman School of Medicine who was not involved in the study. “If we could keep people out of hospitals, that would have a huge impact on healthcare.”

The promising Pfizer study was good news on a day when the Centers for Disease Control and Prevention warned that a tidal wave of infections from both the Omicron and Delta variants could arrive as soon as next month, just like the flu and other winter respiratory infections. peak.

“Initial signals say waves are coming,” said Scott Becker, president of the Association of Public Health Laboratories, who called when the CDC sounded the alarm during a briefing.

Some US states are seeing record hospitalizations from Delta variant spread, mostly among the unvaccinated. The researchers warn that Omicron could spread even faster and appear to evade some of the immune defenses provided by vaccines or previous infection.

In Research Published Tuesday, South African researchers found that two doses of the Pfizer-BioNTech vaccine provided much less protection against Omicron infection than other variants.

Although vaccines still provide strong protection against severe illness and hospitalizations, the severe contagion rate of Omicron is likely to result in an increase in serious infections, especially in unvaccinated individuals. These seriously ill people could suffocate hospitals in the next few months. Dr. Cherry said a highly effective antiviral pill like Pfizer’s could be crucial to easing this surge.

Last month, Pfizer she asked The Food and Drug Administration to allow the treatment known as Paxlovid for high-risk adults, based on a preliminary set of data. The new results will undoubtedly strengthen the company’s application for the drug, which must be prescribed by a healthcare provider and taken at home after a positive virus test.

The results, based on an analysis of more than 2,200 unvaccinated volunteers at high risk of serious illness, largely match those of the company. first, smaller analysis Results of the clinical trial published last month.

In its latest analysis, Pfizer said 0.7 percent of patients who took Paxlovid were hospitalized within 28 days of entering the trial, and none of them died. In contrast, 6.5 percent of patients who took a placebo were hospitalized or died.

Pfizer also released preliminary data from a separate trial that looked at people at lower risk. These volunteers included vaccinated people with a risk factor for serious illness and unvaccinated patients without risk factors.

Among this group of 662 volunteers, the company said Paxlovid reduced the risk of hospitalization and death by 70 percent.

Several public health experts said they thought it unlikely that the FDA would immediately authorize Paxlovid for people at risk of becoming seriously ill from the standard Covid, based on preliminary results, but the agency might eventually do so.

“Maybe it’s something your doctor would consider if you had serious underlying conditions,” said Seema Lakdawala, a virologist at the University of Pittsburgh.

Dr. Lakdawala said regulators may consider expanding the use of the drug if the benefits outweigh any potential risks. Paxlovid, for example, can shorten the amount of time people spread the coronavirus, which could reduce how long people have to spend in quarantine. It can even reduce the chances of infected people passing the virus to others. “All this will be very useful,” he said.

Dr. Lakdawala cautioned that these possibilities must first be confirmed in trials. Pfizer is conducting a trial to see how well Paxlovid can prevent transmission in homes and expects results to be in the first half of 2022.

After Pfizer chief science officer Mikael Dolsten oversaw the drug’s development since spring 2020, more than 200 companies were enthusiastic about the results as scientists made the molecule and then tested it on animals and humans.

While the drug was in development, Dr. Dolsten hoped it could be 60 percent effective. His true strength astonished him. “We’ve really reached the top of the board,” he said in an interview.

In both trials, most of the volunteers carried the Delta variant. But Pfizer said on Tuesday it also performed well against the highly mutated Omicron variant of Paxlovid in lab tests. Pfizer found that the drug stuck to one of Omicron’s key proteins, called a protease, as effectively as it did with other variants.

Dr. Cherry said the Pfizer trial was a good first pass in testing treatment against Omicron. But he and other scientists will this week receive Omicron viruses from the labs currently in cultivation, and then be able to directly test Paxlovid to see how well it stops the viruses from invading cells. Dr. “We hope to begin these experiments this week,” Cherry said.

Pfizer therapy is intended to be taken as 30 pills for five days. Patients will take three pills at a time: two of Pfizer’s newer pills and one of the low-dose HIV medication known as ritonavir, which helps the Pfizer drug stay active in the body longer.

ritonavir can interfere With certain medications that cause potentially serious side effects, including those common for cholesterol and cardiovascular issues. But doctors usually only worry about these interactions when HIV patients have been using the drug for years. With Pfizer’s five-day treatment, doctors may recommend that patients stop taking certain medications, such as statins, for a few days. However, with other drugs whose treatment cannot be easily interrupted, such as anticoagulants and immunosuppressive drugs, patients may need to be dosed or monitored during Pfizer treatment.

“The risk will vary a lot depending on the drug we’re talking about,” said Conan MacDougall, an infectious disease pharmacist at the University of California San Francisco.

Health authorities have been waiting for a viable option like Paxlovid since the start of the pandemic. They rely on pills to reach far more people than the cumbersome monoclonal antibody treatments typically given in a hospital or clinic. Several brands of antibody therapy may not work as well against Omicron.

Still, experts cautioned that there are logistical hurdles that could limit the promise of the Pfizer treatment. To take the pills, patients are expected to need a positive coronavirus test and a prescription from a healthcare provider within five days of symptoms developing. These difficulties can be particularly pronounced among those most vulnerable to becoming seriously ill from Covid.

The federal government has ordered enough Pfizer pills to cover 10 million people at a cost of about $530 per patient. Pfizer will have approximately 180,000 treatment courses when it receives its expected authorization this month, although some of these will likely go to countries outside the United States. The company is expected to deliver enough of its pills to cover 300,000 Americans before the end of February and then sharply increase the pace of their deliveries.

“There is probably some moderate expectation that is needed because that doesn’t exist today. It won’t be available for the average person a month from now. An infectious disease specialist at the University of Minnesota, Dr. “It’s going to be something that spreads slowly,” said David Boulware.

Pfizer’s good news came as it awaited news of rival Merck’s authorization of its own antiviral pill for Covid, known as molnupiravir. In October, Merck and partner Ridgeback Biotherapeutics announced These preliminary data showed 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.

However, after companies have performed a final analysis on all their data, the effectiveness of molnupiravir fell to 30 percent. At an FDA advisory committee meeting last month, a number of experts reacted calmly to this modest event, especially given some concerns. safety of the pill.

Committee narrowly voted in favor authorization of molnupiravir. But now, two weeks later, the FDA has yet to announce whether it will do so. Meanwhile, France turned down Merck’s application, citing its modest effectiveness and safety concerns. Britain official molnupiravir last month.

Managing the Pharmacy Center, Dr. “If the Pfizer pill works as well as the data suggest and there is adequate supply, I don’t think Merck pills have a long lifespan in the United States,” said Walid Gellad. Policy and Prescribing at the University of Pittsburgh.

Pfizer aims to make a large amount of money from Paxlovid. Investment bank SVB Leerink estimates that the drug will generate global revenues of $24 billion in 2022 and $33 billion in 2023. This would give Paxlovid one of the highest single-year sales of any medicinal product in history.

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