COVID-19 pill rollout stymied by shortages as omicron rages

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Two brand new COVID-19 pills, which were considered a vital weapon against the pandemic in the US, are in short supply and have played little role in the fight against the Omicron wave of infections.

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WASHINGTON – Two brand new COVID-19 pills, considered a key weapon against the pandemic in the US, are in short supply and have played little role in the fight against the omicron wave of infections.

The problem is that production is not yet at full strength and Pfizer’s pill takes six to eight months to make.

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While supplies are expected to improve dramatically in the coming months, doctors are now scrambling for pills, not only because Omicron is exploding cases, but because the two antibody drugs that once used to treat , they don’t work either. against variants.

“It should be a really joyous time because we now have highly effective antiviral pills,” said Erin McCreery, a pharmacist and administrator at the University of Pittsburgh Medical Center. “Instead, it feels like the toughest and most chaotic stretch of the pandemic.”

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

“January is going to be a terrible month, with a million cases a day,” said Dr. Myron Cohen, a virologist at the University of North Carolina. “Most people will do perfectly well, but we have to select those who won’t give the drugs we have available.”

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

America hasn’t already done mass buying like it did with vaccines.

Because of the time it takes to manufacture Pfizer’s pill, Paxlovid, the company says it can supply about 250,000 courses of treatment by the end of this month.

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

White House COVID-19 coordinator Jeff Ziants said this week that the government collaborated with Pfizer to help speed development of the pill for several months, and that officials continue to work with the company to help speed up production. To find ways to promote

Pfizer said it is adding capacity: “We look forward to using our strong manufacturing capabilities and our extensive supplier network to continue to rapidly improve production.”

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

But final trials showed it was far less effective than Pfizer’s pill and carried significant risks, including the possibility of birth defects, when taken by pregnant women. As a result, it is considered the last option 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 US by the end of the month.

Since last month, the government has sent enough Pfizer pills to states to treat 164,000 people, allocating them based on population. This approach is coming under fire with heavy caseloads from some states.

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

“We need more of these drugs so that they can reverse the course of the epidemic and reduce hospitalizations,” she said.

State guidelines generally advise doctors to prioritize the drugs for those at highest risk, including cancer patients, transplant recipients and those with lung disease or who are pregnant. New York’s guidelines also recommend prioritizing certain racial and ethnic minorities, given their high rates of serious illness and death.

States are distributing bullets in different ways.

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

Despite strict prescribing guidelines, some patients have found the pills through luck and perseverance.

Craig Campbell, a website manager in Desert Hot Springs, Calif., began leaving messages with his doctor shortly 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 dispensing the drug was more than an hour’s drive away, so a friend of Campbell’s took it in for himself.

“I felt kind of a little privileged,” he said. “The prospect of it landing on my plate at the right time was pretty extraordinary.”

Also, there is a lack of antibody drugs, infused or injected drugs that can avoid death and hospitalization. Only one of them, from GlaxoSmithKline, appears to be effective against Omicron, and is being rationed as well.

Federal officials are limiting its shipments to about 50,000 doses per week. This week, the government announced it was buying 600,000 more doses, on top of the 400,000 it bought in November.

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

Doctors and nurses across America have developed complex means of deciding which rare drugs to take based on patients’ symptoms, their underlying medical risks, where they live and whether they are healthy enough to travel for an infusion. should receive.

“what do we have?” The first is the question, said Dr. Greg Schrank of the University of Maryland Medical Center. “Among those treatments, what is most effective and how can we direct it to the people we know are at greatest risk?”

As increasingly complex treatment comes to the picture, frustrated hospital staff try to manage the rising admissions.

As of Sunday, nearly 128,000 Americans were in hospital with COVID-19, surpassing the all-time high of nearly 125,000 last January. While fewer COVID-19 patients now require intensive care, the surge is pushing hospitals to breaking point.

With that threat in mind, Pfizer’s shot arrived in time, Schrank said.

“It’s not going to turn the tide of total cases, but it can really help reduce the impact on hospitals,” he said.

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Writers Bobby Calvan in New York and David Eggert in Lansing, Michigan contributed to this story.

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Follow Matthew Perron on Twitter: @—FDAwriter

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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. is solely responsible for all content.

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