According to Pfizer, a key clinical trial found that Paxlovid prevents severe disease and may also be effective against the highly mutated species Omicron. If approved by the US Food and Drug Administration, patients in the United States may be able to receive the treatment by the end of the year. Although supply will be limited at first, public health experts hope that the pill, regardless of the species, can prevent the worst consequences of the disease.
According to Pfizer, their antiviral pills reduce the risk of hospitalization and death by 88 percent when given to unvaccinated people at high risk of developing Quid during the first five days of symptoms. The company also says that laboratory tests have shown that the drug attacks a key protein in the omicron species.
Omicron species are on the rise in South Africa and Europe and are expected to become dominant in the United States in the coming weeks. “This is a very surprising and potentially transformative achievement,” said Sarah Chery, a virologist at Perlman School of Medicine at the University of Pennsylvania who did not participate in the study. “If we can keep people out of hospitals, it will have a significant impact on health care.”
Pfizer’s promising study was good news on a day when the Centers for Disease Control and Prevention warned that a wave of infections from both Omicron and Delta could hit next month, just as the flu and other winter respiratory infections peak.
Some US states are now experiencing unprecedented hospitalization due to the delta outbreak, mostly among unvaccinated individuals. Researchers warn that omicron may spread faster and appear to be escaping some of the immune defenses from past vaccines or infections.
In a study published on Tuesday, South African researchers found that the protection that two doses of the Pfizer / Bivantec vaccine provide against omicron-induced infection is less than the protection it provides against other species. Although the vaccine continues to provide strong protection against severe illness and hospitalization, high rates of omicron transmission may cause a wave of severe infections, especially in unvaccinated individuals. Very sick people may be under a lot of pressure from hospitals in the coming months. According to Dr. Chery, highly effective antiviral loans such as Pfizer pills can be vital in reducing this trend.
Paxlovid tablets (Covid treatment made by Pfizer) in a laboratory in Germany. Experts hope Paxlovid can cure the worst cases of the disease, regardless of the species.
Last month, Pfizer asked the Food and Drug Administration to confirm Paxlovid treatment for high-risk adults based on a set of preliminary data. The new results will undoubtedly strengthen the company’s request for approval. The new drug is to be prescribed after a positive virus test and taken at home.
The new results, based on data analysis of more than 2,200 unvaccinated volunteers at high risk of severe disease, are largely consistent with a smaller initial analysis released last month. In the final analysis, 0.7 of the patients who received Paxlovid were admitted within 28 days of entering the trial, and none died. In contrast, 5.6% of patients who received placebo were hospitalized or died.
Pfizer also released preliminary data from a separate trial of people at lower risk. These volunteers included vaccinated people with a risk factor for severe disease and unvaccinated people without risk factors. In this group of 662 volunteers, Paxlovid reduced the risk of hospitalization and death by 70%.
Several public health experts have said that the Food and Drug Administration is unlikely to approve Paxlovid based on preliminary results for people at standard risk of developing severe Quid disease, although the agency may eventually do so. Sima Lakdavala, a virologist at the University of Pittsburgh, said it may be a medicine your doctor will prescribe if you have a severe underlying disease.
Dr. Lakdavala said that if the benefits of the drug outweigh the potential risks, regulatory agencies may authorize wider use of the drug. Paxloid, for example, may shorten the time it takes for infected people to shed the corona virus, which in turn reduces the amount of time people have to be in quarantine. The pill may even reduce the chance of transmitting the virus from infected people to others.
Dr. Lakdavala warned that these possibilities must first be confirmed in trials. Pfizer is conducting a trial to see how Paxlovid is performing in controlling the transmission of the virus in the family environment, and its results are expected in the first half of 2022.
After months of overseeing the drug-making process and testing it in animals and humans, Michael Dolesten, Pfizer’s senior scientific director, was pleased to see the results. When the drug was in development, Dr. Dolatsen hoped it would be 60 percent effective, but its true power surprised him.
In both trials, most of the volunteers were carriers of the delta species. But in laboratory tests, Pfizer said on Tuesday that Paxlovide also performed well against the highly mutated species Omicron. According to the company, the drug binds to micron species proteases just as efficiently as it binds to proteases of other species. Dr. Chery said Pfizer’s test was a good initial acceptance of the Omicron treatment test. But he and other scientists are receiving omicron viruses from other labs this week and can test Paxloid directly to see how it works to stop the virus from invading cells.
Pfizer treatment is to be taken in the form of 30 tablets in five days. Patients take three pills at a time: two new Pfizer pills and one low-dose ritonavir (an HIV drug). Ritonavir helps Pfizer stay active in the body for longer.
Ritonavir can interact with certain medications, including those commonly used for cholesterol and cardiovascular problems, and can cause serious side effects. But doctors are usually only concerned about these side effects when HIV patients have been taking the drug for years.
Regarding five-day Pfizer treatment, doctors may recommend that patients stop taking medications such as statins for a few days. But for other drugs, such as blood thinners and immunosuppressive drugs that cannot be stopped easily, patients may need to adjust the dose or be monitored while receiving Pfizer treatment. “The risk will be very different depending on the drugs we’re talking about,” says Conan McDougall, an infectious disease pharmacist at the University of California, San Francisco.
Health officials have been waiting for a convenient option like Paxlovid since the beginning of the world. They rely on pills that are much more accessible to people than the painstaking monoclonal antibody treatments that are usually offered in a hospital or clinic. Some existing antibiotic therapies may not work well for the omicron species.
However, there are logistical barriers that can limit the promise of Pfizer treatment. To receive the pills, patients are expected to have a positive coronavirus test and a prescription from a doctor, all of which must be done within the first five days of developing symptoms. These challenges can become especially apparent among those who are most vulnerable to severe Covid disease.
Receiving monoclonal antibodies in Anchorage, USA. Authorities have been keen to get a pill to treat Covid 19 because monoclonal antibody therapies are cumbersome and may not work well for the Omicron species.
Pfizer ‘s good news came as his rival, Merck, awaited the Food and Drug Administration’ s decision on its Covid antiviral pill, called Mulnopiravir. In October, Merck and his partner Rybek Biotropiotics announced that preliminary data showed that molnopiravir reduced the risk of hospitalization and death from Covid 19 by 50 percent if taken within 5 days of the onset of symptoms. But when the company did the final analysis on all its data, the effectiveness of molnopiravir was reduced to 30%. The Food and Drug Administration has not yet announced whether it will finally approve the drug.
France, meanwhile, has rejected Merck’s request, citing its ineffectiveness and safety concerns. Britain approved Molnopiravir last month. “If Pfizer pills are found to be as effective as the data show and there is enough supply, I do not think Merck pills will last long in the United States,” said Dr. Waleed Glad, director of the Center for Drugs and Prescribing at the University of Pittsburgh.
Pfizer prepares to make a lot of money from Paxlovid. According to SVB Leerink Investment Bank, the drug will generate $ 24 billion in global revenue in 2022 and $ 33 billion in 2023. As such, Paxloid will be one of the highest-selling medical products in history. To date, only one other product has gained more sales, and that is the Covid Pfizer vaccine.
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