Deployment of new COVID pill is prevented by deficiency while omicron rages

Two brand new COVID-19 pills that were supposed to be an important weapon against the pandemic in the US are in short supply and have played only a small role in the fight against the omicron wave of infections.

The problem is that production is not yet full strength and that the pill, which is considered far superior, Pfizers, takes six to eight months to manufacture.

While supply is expected to improve dramatically in the coming months, doctors are shouting for the pills now, not only because omicron is causing an explosion of cases, but because two antibody drugs that were once the main treatments are not working so well against the variant.

“This should be a really happy time because we now have very effective antiviral pills,” said Erin McCreary, a pharmacist and administrator at the University of Pittsburgh Medical Center. “Instead, this feels like the hardest and most chaotic stretch of the pandemic.”

The pills – and other COVID-19 drugs for that matter – are carefully rationed, reserved for patients at greatest risk.

“January is going to be a terrible month with a million cases a day,” said virologist Dr. Myron Cohen of the University of North Carolina. “Most people will do well, but we have to pick the people who do not want to and give them the drugs we have available.”

The Food and Drug Administration approved the two pills from Pfizer and Merck late last month based on studies showing that they reduce the risk of serious illness and death when given shortly after symptoms appear. These are the first COVID-19 treatments that patients can take at home, and they can thus reduce the burden on hospitals.

The United States did not make the kind of mass procurement in advance that it did with vaccines.

Due to the time it takes to manufacture Pfizer’s pill, Paxlovid, the company says it can only deliver around 250,000 treatments by the end of this month.

The United States has ordered enough Paxlovid to process 20 million people, but the first 10 million orders will not be delivered until June.

White House Covid-19 coordinator Jeff Zients said this week that the government was working with Pfizer to help accelerate the development of the pill by several months, and that officials are continuing to work with the company to lead for ways to increase production.

Pfizer said it is adding capacity: “We expect to use our strong production capacity and our extensive supplier network to continue to improve production rapidly.”

Merck’s pill, molnupiravir, is easier to manufacture and available in large quantities.

However, the final test showed that it was far less effective than Pfizer’s pill and carried significant risks, including the potential for birth defects when pregnant women take it. As a result, it is considered a last resort under federal guidelines.

Merck said it has delivered 900,000 courses of the drug and is on track to ship all 3 million ordered by the U.S. by the end of the month.

Since last month, the government has sent states enough Pfizer pills to treat 164,000 people, broken down by population. That approach comes under fire from some states with heavier caseloads.

The amount allocated to New York – enough to treat about 20,000 people – is just not enough, said Health Commissioner Dr. Mary Bassett.

“We need more of these drugs to make them change the course of the pandemic and reduce hospitalization,” she said.

State guidelines generally recommend that physicians prioritize the drugs for those at the highest risk, including cancer patients, transplant recipients, and people who have lung disease or are pregnant. New York guidelines also recommend prioritizing certain racial and ethnic minorities because of their higher incidence of serious illness and death.

States distribute the pills differently.

In Michigan, all initial shipments went to 10 pharmacies in the hardest hit areas. Pennsylvania, Maryland, Texas and many other states have distributed the pills more widely so that at least one pharmacy in each county carries the drug.

Despite the strict prescribing guidelines, some patients have been able to get the pills through luck and persistence.

Craige Campbell, a website manager from Desert Hot Springs, California, began leaving messages for his doctor immediately after testing positive for COVID-19 and developing a 101-degree fever. Despite having no underlying health condition, he was soon able to get a prescription.

The only pharmacy that dispensed the drug was more than an hour’s drive away, so Campbell had a friend pick it up for him.

“I felt a little privileged in a way,” he said. “The odds that it would land on my plate at the right time were pretty extraordinary.”

At the same time there is one lack of antibody medication, the infused or injected medicine that can prevent death and hospitalization. Only one of them, from GlaxoSmithKline, seems to be effective against omicron and it is also being rationed.

Federal officials limit shipments of it to about 50,000 doses a week. This week, the government announced that it is buying 600,000 more doses, on top of 400,000 purchased in November.

At the UPMC hospital system in Pennsylvania, staff can treat fewer than 1,000 patients a week with antibodies, down from as many as 4,000 earlier in the pandemic.

Doctors and nurses around the United States have developed complex methods to decide who should receive the sparse medication, based on patients’ symptoms, their underlying medical risks, where they live, and whether they are healthy enough to travel to get one. infusion.

“What do we have on hand?” is the first question, said the University of Maryland Medical Centers Dr. Greg Schrank. “Among these therapies, what is the most effective, and how can we address it to the people we know are most at risk?”

The increasingly complicated picture of treatment comes as exhausted, frustrated hospital workers try to cope with increasing hospitalizations.

As of Sunday, nearly 128,000 Americans were in the hospital with COVID-19, surpassing the highest level of about 125,000 in January last year. While fewer COVID-19 patients now require intensive care, the increase is pushing hospitals to the breaking point.

Given that threat, Pfizer’s pill arrived just in time, Schrank said.

“It’s not going to reverse the trend in the total number of cases, but it can really help dampen the impact on hospitals,” he said.

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