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Food and Drug Administration on Wednesday official It is the first Covid-19 pill to offer a highly effective defense against serious illness that will emerge as the country endures another wave of great pandemics.

Developed by Pfizer and known as Paxlovid, the drug is authorized for Covid patients aged 12 years and older who are vulnerable to becoming seriously ill because of their age or medical conditions such as obesity or diabetes. Tens of millions of Americans, including both vaccinated and unvaccinated people, will be eligible if they become infected. Treatment may be available within a few days.

Pfizer’s lab studies Omicron variantrapidly becoming the dominant form of new cases in the United States.

A clinical trial showed that Paxlovid was highly effective when taken soon after people started getting sick. In one final analysis According to a major study conducted while the delta variant was elevated, the Pfizer drug reduced the risk of hospitalization or death by 88 percent when given to high-risk unvaccinated adults within five days of the onset of their symptoms.

Paxlovid appears to be significantly more effective than Merck’s similar antiviral pill, known as molnupiravir, which is pending FDA approval.

Until now, monoclonal antibody drugs, typically infused into the bloodstream in a hospital or clinic, were the only treatment allowed for Covid patients who were not hospitalized but were at higher risk of developing serious illness. But antibodies went to fewer people than the pills expected to reach, and most of the nation’s supply of antibody therapy unlikely to work against Omicron.

The federal government has ordered enough Pfizer pills to cover 10 million people at a cost of about $530 per patient, but supply will be limited at first.

Within a week, Pfizer is expected to deliver enough of its pills to the United States to cover 65,000 Americans. hour current infection ratesIf given to half the people in the United States who tested positive for the virus, that would be enough for less than a day.

Pfizer is expected to deliver 200,000 treatment courses to the United States in January, followed by another 150,000 treatment courses in February. After that, the speed of deliveries is expected to increase sharply.

coronavirus cases increasing Since early November, it has been driven primarily by the Delta variant and now mostly Omicron, especially in the Midwest and Northeast.

The federal government has stated that it plans to allocate antiviral pills to the states and then distribute them as they see fit to health departments, pharmacies and community health centers, as with Covid vaccines.

Director of the Center for Emerging Infectious Diseases Policy and Research at Boston University, Dr. “The hard thing for governments to understand is who is going to make it available because there are very few people to get started with,” said Nahid Bhadelia. “You want to make sure it’s at least given to the people most likely to benefit from it.”

He said it would be important for state and local governments to prioritize taking the pills for medically vulnerable people, particularly in nursing homes and clinics in severely affected communities.

The FDA said that to take Pfizer pills, patients would need to test positive for the virus and get a prescription from a healthcare provider, all within five days of the onset of symptoms. These requirements pose serious difficulties.

While the agency did not specify which type of test will be needed, over-the-counter rapid antigen tests with results within 15 minutes are expected to be widely used. President Biden announced on Tuesday The administration has purchased 500 million quick tests to distribute them free to the public, but it is unclear whether this will be enough to meet the expected very high demand.

There’s also the risk that the Americans who most need the pills refuse them, just as they refuse vaccines. About half of unvaccinated adults A poll by Morning Consult said they wouldn’t take FDA-approved antiviral pills if they got sick with Covid.

Pfizer expects to produce 120 million courses of Paxlovid by 2022. The company already has deals to sell its pills to a number of wealthy countries, and says it is in talks with dozens of governments around the world about additional supply deals. It also agreed to allow other manufacturers to manufacture the pills cheaply and sell them to poorer countries.

European Medicines Agency last week suggested Paxlovid is paving the way for European countries to start using it soon by treating adults at risk of serious illness with Covid.

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

FDA, Paxlovid’s should not be taken With certain medications, including a commonly used statin, because ritonavir can interact with them, causing potentially serious side effects. With certain drugs, healthcare providers may need to recommend that patients stop taking their usual medications for a few days or adjust their doses.

Pfizer already record-breaking Covid vaccine, will get another surprise from its new pill, which emerged in a company lab during the SARS epidemic nearly two decades ago.

Pfizer executives told analysts last week He said Paxlovid could reach up to 155 million people in richer countries and 95 million in poorer countries by 2022. Governments and commercial buyers have said they expect the market to last long as they may be interested in stocking the pills in the US. in the years to come.

Analysts at investment bank SVB Leerink estimate that Paxlovid will generate global revenues of $24 billion in 2022 and $33 billion in 2023.

Merck’s treatment is also expected to receive approval this week. Within weeks, some patients may choose between the Pfizer treatment and the Merck treatment. Pfizer’s option may be safer as well as work better to fend off the severe Covid.

Merck’s pill adds errors to the virus’s genes to stop the virus from reproducing. While Merck said their work has found the treatment to be safe, some scientists have expressed concern that it could result in death. dangerous unintended consequences.

Paxlovid does not cause mutations, so it did not raise the same concerns as molnupiravir. But for the first few months, Merck’s treatment is expected to be much more plentiful. Merck is expected to provide the federal government with enough pills for 3.1 million Americans by the end of January. The first 378,000 treatment courses are expected approximately two weeks after authorization.

Director of the Center for Pharmacy Policy and Prescribing at the University of Pittsburgh, Dr. “Obviously if people have a choice, they will choose the Pfizer product,” said Walid Gellad. “There is no doubt that the data supports better efficacy and fewer safety concerns. The question is, how easily will the Pfizer product be available?”