Pfizer’s Covid Pill works well and the company confirms in a final analysis

Pfizer Announced on Tuesday The Covid pill has been shown to stop serious illness in critical clinical trials, indicating that it is likely to be effective against highly mutated Omicron variants of the virus. The results underscore the treatment promises that health authorities and physicians are expecting to ease the burden on hospitals as the United States prepares for the rise of the fourth wave of the pandemic.

If the Food and Drug Administration approves the drug (which can occur within a few days), the patient may start taking the drug by the end of the year. Although supply is initially limited, public health experts hope that pills, regardless of variety, may reduce the worst consequences of the disease.

Pfizer said the antiviral drug was found to reduce the risk of hospitalization and death by 88% when given to unvaccinated people at high risk of severe Covid within 5 days of the onset of symptoms. I did.The company also said that laboratory experiments have shown that the drug attacks major proteins. Omicron variant, This is skyrocketing in South Africa and Europe and is expected to dominate US cases in the coming weeks.

“This is very surprising and can potentially revolutionize,” said Sara Cherry, a virologist at the University of Pennsylvania’s Perelman School of Medicine, who was not involved in the study. “If we can keep people away from the hospital, it will have a big impact on medical care.”

A promising Pfizer study shows that the Centers for Disease Control and Prevention could receive a tsunami of infections from both Omicron and Delta variants soon next month, similar to influenza and other winter respiratory infections. It was good news on the day I warned that there was. peak.

“Early cues say a wave will come,” said Scott Becker, CEO of the Public Health Institute Association, who was answering the phone when the CDC issued a warning during the briefing. Said.

Record hospitalizations for delta mutations are already widespread in some US states, mostly among unvaccinated people. Researchers warn that Omicron could spread even more rapidly, apparently evading some of the immune defenses provided by vaccines and previous infections.

and study A South African researcher, published Tuesday, found that two doses of the Pfizer-BioNTech vaccine were far less protective against Omicron infections than other variants.

Although Shot still provides strong protection against severe illness and hospitalization, the dramatic transmission rate of Omicron can cause a surge in severe infections, especially in unvaccinated people. These seriously ill people could hit the hospital in the coming months. Very effective antivirals like Pfizer could be important in mitigating the surge, Dr. Cherry said.

Last month, Pfizer Asked The Food and Drug Administration approves a treatment known as Paxlovid for high-risk adults based on a preliminary batch of data. The new results will undoubtedly enhance the company’s drug application, which means it will be prescribed by the healthcare provider and taken home after a positive virus test.

Results based on an analysis of more than 2,200 unvaccinated volunteers at high risk of severe illness are in close agreement with company results. Early small analysis Of the clinical trials released last month

In a final analysis, Pfizer said that 0.7% of patients who received Paxrovid were hospitalized within 28 days of the start of the study and none died. In contrast, 6.5% of patients receiving placebo were hospitalized or died.

Pfizer also released preliminary data from another trial of low-risk people. These volunteers included vaccinated people with risk factors for serious illness and unvaccinated patients without risk factors.

Within this group of 662 volunteers, Pax Rovid reduced the risk of hospitalization and death by 70 percent, the company said.

Some public health experts say Paxlovid soon for people at standard risk that the FDA will get seriously ill from Covid, based on preliminary results, although the FDA may eventually do so. He said he thought it was unlikely to approve.

Seema Lakdawala, a virologist at the University of Pittsburgh, said:

Dr. Rakdawara said regulators may consider expanding drug use if profits outweigh potential risks. Paxlovid, for example, has the potential to reduce the amount of time people shed the coronavirus. This can reduce the amount of time people spend on quarantine. It may even be possible to reduce the chances of an infected person transmitting the virus to others. “All of them would be very beneficial,” she said.

These possibilities would have to be confirmed in the trial first, Dr. Rakdawara warned. Pfizer is conducting tests to see how well Paxrovid can stop infections at home and expects results in the first half of 2022.

Pfizer’s Chief Scientific Officer Michael Dorsten has overseen the development of the drug since the spring of 2020, after more than 200 corporate scientists have created the molecule and tested it on animals and people. I was enthusiastic about it.

While the drug was being developed, Dr. Dorsten had the hope that it might be 60 percent effective. Its true potency surprised him. “We really were at the top of the board,” he said in an interview.

In both trials, most volunteers had a delta type. But Pfizer said in a laboratory experiment on Tuesday that Paxrovid also worked well against highly mutated Omicron variants. Pfizer found that the drug was packed into one of Omicron’s key proteins, called proteases, as effectively as any other mutant.

Dr. Cherry said the experiments Pfizer performed were a good first path to test treatment for Omicron. But she and other scientists will receive the Omicron virus this week from a lab that is currently growing. You can then test PaxRovid directly to see how well it prevents the virus from invading the cells. “We want to start these experiments this week,” said Dr. Cherry.

Pfizer’s treatment is intended to be taken as 30 tablets in 5 days. The patient takes 3 tablets at a time. Two new Pfizer pills and one of the low-dose HIV drugs known as ritonavir that helps Pfizer’s drug stay active in the body longer.

Ritonavir May interfere Certain medications, including common ones for cholesterol and cardiovascular problems, can cause potentially serious side effects. However, doctors are usually worried about these interactions only if HIV patients have been taking the drug for years. With Pfizer’s five-day treatment, doctors may recommend that patients stop taking certain medications, such as statins, for several days. However, with other drugs that cannot be easily discontinued, such as anticoagulants and immunosuppressive drugs, patients should adjust or monitor their dose during Pfizer’s treatment.

Conan MacDougall, an infectious disease pharmacist at the University of California, San Francisco, said:

Since the beginning of the pandemic, health authorities have been waiting for useful options like the Paxlovid. They rely on pills to reach far more people than the nasty monoclonal antibody therapies that are usually done in hospitals and clinics.Several brands of antibody treatment May not work Against Omicron.

Still, experts warned that there were logistical obstacles that could limit Pfizer’s treatment promises. To receive the pills, patients are expected to need a positive coronavirus test and a prescription from their healthcare provider within 5 days of the onset of symptoms. These challenges can be particularly pronounced among those most vulnerable to Covid’s aggravation.

The federal government has ordered enough Pfizer pills to cover 10 million people at a cost of about $ 530 per patient. Pfizer plans to have about 180,000 treatment courses by the time this month’s approval is expected, some of which are likely to go to countries other than the United States. The company is expected to deliver enough pills to cover 300,000 Americans by the end of February, after which it will significantly increase the pace of delivery.

“This isn’t available today, so there’s probably some mitigated expectations needed. The average person won’t be available for the next month. Dr. David Boulware, an infectious disease specialist at the University of Minnesota, said: It states as follows.

The good news for Pfizer is that rival Merck has been waiting for an announcement regarding the approval of a unique antiviral drug for Covid known as molnupiravir. October, Merck and its partner Ridgeback Biotherapeutics announcement The preliminary data showed that pills reduce the risk of hospitalization and death from Covid-19 by 50% when taken within 5 days of the onset of symptoms.

However, after the company has made a final analysis of all the data, the effectiveness of molnupiravir drop To 30 percent. At a meeting of the FDA Advisory Board last month, many experts responded calmly to this modest effect. Pill safety..

Committee Narrowly voted in favor Approved by Molnupiravir. But now, two weeks later, the FDA has not yet announced whether to do so.Meanwhile, France refused Merck’s application cites its modest effectiveness and safety concerns.UK approved Molnupiravir last month.

“If Pfizer tablets work as the data suggest and have sufficient supply, I don’t think Merck tablets have a long life in the United States,” said Dr. Walid Gerad, who heads the drug center. Policy and prescription at the University of Pittsburgh.

Pfizer is in a position to make huge amounts of money from Pax Rovid. Investment bank SVB Leerink estimates that the drug will generate $ 24 billion in 2022 and $ 33 billion in 2023. This makes Paxlovid one of the highest single-year sales ever.

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