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COVID-19 pill rollout hampered by shortages as Omicron rages

COVID-19 pill rollout hampered by shortages as Omicron rages

Two brand new COVID-19 pills with high expectations have played little role in the fight against the Omicron wave of infections because they are scarce.

Production is still ramping up and it could take five to eight months for the pills to be produced.

While the supply is expected to improve dramatically in the coming months, doctors are now clamoring for the drugs, not only because Omicron is pushing the number of cases up, but also because two antibody drugs that were once the best treatments don’t work so well against the now dominant variant.

“This should be a very joyous 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 part of the pandemic.”

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

“January is going to be a terrible month with a million cases a day,” he said dr. Myron Cohen, a virologist at the University of North Carolina. “Most people will be fine, but we have to select the people who don’t 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. They are the first COVID-19 treatments that patients can receive at home and can thus reduce the burden on hospitals.

The US hasn’t made the kind of massive purchases in advance that they did with vaccines.

Pfizer’s Pill, Paxlovíd, is considered much better than Merck’s, but because of the six to eight months it takes to manufacture, the company says it can only deliver about 250,000 courses of treatment by the end of the month.

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

White House Covid-19 coordinator Jeff Zients said this week the government was working with Pfizer to accelerate development of the pill by several months, and officials will continue to work with the company to find ways to boost production.

pfizer said: it adds capacity: “We expect to use our strong manufacturing capabilities and our extensive supplier network to continue to rapidly improve output.”

Merck’s pill, molnupiravir, was pre-produced in larger quantities. It takes six months to produce, although the company says it can be compressed to five months if needed.

But the latest tests showed that the drug was much less effective than Pfizer’s Pill and carried significant risks, including the risk of birth defects when used by pregnant women. As a result, it is considered the last choice 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 states enough Pfizer pills to treat 164,000 people across the population. That approach is coming under fire from some states with heavier caseloads.

The amount allocated to New York — enough to treat about 20,000 people — is insufficient, said health commissioner Dr. Mary Bassett.

“We need more of these drugs to ensure they change the course of the pandemic and reduce hospitalizations,” she said.

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

States distribute the pills differently.

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

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

Craige Campbell, a website administrator from Desert Hot Springs, California, immediately began messaging his doctor after he tested positive for COVID-19 and developed a 101-degree fever. Despite having no underlying health issues, he was soon able to get a prescription.

The only pharmacy that dispensed the drug was over an hour away, so Campbell had a friend pick it up for him.

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

At the same time, there is a shortage of antibody drugs, the infused or injected drugs that can prevent death and hospitalization. Only one of them, from GlaxoSmithKline, seems to be effective against Omicron, and that too is being rationed.

Federal officials limit shipments to about 50,000 doses per week. This week, the government announced it will buy an additional 600,000 doses, on top of the 400,000 purchased in November.

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

Doctors and nurses in the US have developed complex tools for deciding who should receive the scarce drugs, based on the patient’s symptoms, their underlying medical risks, where they live, and whether they are healthy enough to travel for an IV.

“What do we have on hand?” is the first question, said Dr. Greg Schrank of the University of Maryland Medical Center. “Of those therapies, which is most effective and how can we refer it to the people we know are most at risk?”

The increasingly complex treatment picture comes as: exhausted, frustrated hospital workers trying to manage rising withdrawals.

On Sunday, nearly 128,000 Americans were hospitalized with COVID-19, surpassing the record of about 125,000 last January. While fewer COVID-19 patients now require intensive care, the wave is pushing hospitals to breaking point.

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

“It won’t turn the tide on the overall number of cases, but it could really help mitigate the impact on hospitals,” he said.

Associated Press writers Bobby Calvan in New York and David Eggert in Lansing, Michigan contributed to this report.