CORONAVIRUS

COVID-19 pill rollout stymied by shortages as omicron rages

Jan 13, 2022, 9:35 AM | Updated: Jun 13, 2022, 3:41 pm
Pfizer hopes it can eventually offer the pills, under the name Paxlovid, for people to take at home...
Pfizer hopes it can eventually offer the pills, under the name Paxlovid, for people to take at home before they get sick enough to go to the hospital. (Pfizer)
(Pfizer)

WASHINGTON (AP) — Two brand-new COVID-19 pills that were supposed to be an important weapon against the pandemic in the U.S. 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 that the pill considered to be far superior, Pfizer’s, takes six to eight months to manufacture.

While the supply is expected to improve dramatically in the coming months, doctors are clamoring for the pills now, not just because omicron is causing an explosion of cases but because two antibody drugs that were once the go-to treatments don’t work as well against the variant.

“This should be a really joyous time because we now have highly 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 being carefully rationed, reserved for the highest-risk patients.

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

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

The U.S. didn’t make the kind of mass purchases in advance that it did with vaccines.

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

The U.S. 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 that the government collaborated with Pfizer to help speed up development of the pill by several months, and that officials continue to work with the company to look for ways to boost production.

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

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

But final testing showed it was far less effective than Pfizer’s pill and carried significant risks, including the potential for birth defects when taken 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 U.S. by the end of the month.

Since last month, the government has sent states enough Pfizer pills to treat 164,000 people, allocating them by 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 just not enough, said Health Commissioner Dr. Mary Bassett.

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

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

States are distributing 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 with his doctor immediately after testing positive for COVID-19 and developing a 101-degree fever. Despite having no underlying health conditions, he was soon able to get a prescription.

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

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

At the same time, there is a shortage of antibody medications, the infused or injected drugs that can head off death and hospitalization. Only one of them, from GlaxoSmithKline, appears effective against omicron, and it, too, is being rationed.

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

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

Doctors and nurses around the U.S. have developed complex means of deciding who should get the scarce medications, based on patients’ symptoms, their underlying medical risks, where they live and whether they are healthy enough to travel for an infusion.

“What do we have on hand?” is the first question, said University of Maryland Medical Center’s Dr. Greg Schrank. “Among those therapies, what’s the most effective and how can we direct it to the people that we know are of greatest risk?”

The increasingly complicated treatment picture comes as exhausted, frustrated hospital workers try to manage rising admissions.

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

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

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

___

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

___

Follow Matthew Perrone on Twitter: @AP_FDAwriter

___

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

KSL 5 TV Live

Top Stories

Coronavirus

RSV and flu...
Deidre McPhillips, CNN

Flu season intensifies, holiday gatherings could make it worse

Americans gathered for Thanksgiving last week amid a flu season that's worse than any has been in more than a decade, and experts continue to urge caution as multiple respiratory viruses circulate at high levels nationwide.
2 days ago
Protesters hold up blank papers and chant slogans as they march in protest in Beijing, Sunday, Nov....
Jessie Yeung and CNN's Beijing bureau

Rare protests are spreading across China. Here’s what you need to know

From Shanghai to Beijing, protests have erupted across China in a rare show of dissent against the ruling Communist Party.
2 days ago
Police officers block Shanghai's Urumqi Road on Sunday. (Hector Retamal/AFP/Getty Images)...
CNN's Beijing bureau and Nectar Gan

Protests erupt across China in unprecedented challenge to Xi Jinping’s zero-Covid policy

Protests erupted across China throughout the weekend, including at universities and in Shanghai where hundreds chanted "Step down, Xi Jinping! Step down, Communist Party!"
3 days ago
Salt Lake City Police at the University of Utah Hospital due to a possible bomb threat. (Salt Lake ...
Michael Houck

Police: Unattended bag led to bomb squad response at U of U Hospital

Salt Lake City Police responded to a possible bomb threat at the University of Utah hospital Tuesday afternoon.
15 days ago
Evusheld...
Elizabeth Cohen and Naomi Thomas, CNN

COVID-19 medicine for immunocompromised patients is losing effectiveness

Judy Salins considers herself a smart, empowered patient, but until this week, she had no idea that the medicine she takes to defend herself against Covid-19 isn't protecting her as well as it used to.
19 days ago
Paxlovid, the antiviral pill that reduces the risk of hospitalization and death from Covid-19, also...
Jamie Gumbrecht, CNN

Paxlovid reduces risk of long Covid, Veterans Affairs study finds

Paxlovid, the antiviral pill that reduces the risk of hospitalization and death from Covid-19, also reduces the risk of long Covid, according to a new study by the US Department of Veterans Affairs.
24 days ago

Sponsored Articles

house with for rent sign posted...
Chase Harrington, president and COO of Entrata

Top 5 reasons you may want to consider apartment life over owning a home

There are many benefits of renting that can be overshadowed by the allure of buying a home. Here are five reasons why renting might be right for you.
Festive kitchen in Christmas decorations. Christmas dining room....
Lighting Design

6 Holiday Decor Trends to Try in 2022

We've rounded out the top 6 holiday decor trends for 2022 so you can be ahead of the game before you start shopping. 
Happy diverse college or university students are having fun on their graduation day...
BYU MBA at the Marriott School of Business

How to choose what MBA program is right for you: Take this quiz before you apply!

Wondering what MBA program is right for you? Take this quiz before you apply to see if it will help you meet your goals.
Diverse Group of Energetic Professionals Team Meeting in Modern Office: Brainstorming IT Programmer...
Les Olson

Don’t let a ransomware attack get you down | Protect your workplace today with cyber insurance

Business owners and operators should be on guard to protect their workplace. Cyber insurance can protect you from online attacks.
Hand turning a thermostat knob to increase savings by decreasing energy consumption. Composite imag...
Lighting Design

5 Lighting Tips to Save Energy and Money in Your Home

Advances in lighting technology make it easier to use smart features to cut costs. Read for tips to save energy by using different lighting strategies in your home.
Portrait of smiling practitioner with multi-ethnic senior people...
Summit Vista

How retirement communities help with healthy aging

There are many benefits that retirement communities contribute to healthy aging. Learn more about how it can enhance your life, or the life of your loved ones.
COVID-19 pill rollout stymied by shortages as omicron rages