Promising COVID-19 antiviral pill, Paxlovid, in scarce supply, as doctors, patients compete for access
Dr. Albert Lam, a geriatrician who works with nursing home patients in Palo Alto, California, was excited to be among the first to prescribe the new antiviral pill Paxlovid after one of his patients tested positive for COVID-19.
Hailed as a "game-changer" in the pandemic, Paxlovid is a drug made by Pfizer that if taken within five days of being diagnosed reduces the chance of hospitalization and death by 88% for people who are at high risk of severe illness.
The treatment has proved so promising that President Joe Biden included it in a Jan. 4 televised speech on the omicron variant, announcing that the first batch had shipped on Christmas Eve. While production would take "months," Biden said it was in "full swing" and promised the drugs were on their way.
"The United States has more pills than any other country in the world, and our supply is going to ramp up over the coming months as more of these pills are manufactured," Biden said.
Lam's patient, a woman in her 80s with a history of cancer, got the drug within 24 hours and responded well.
Since then, however, the doctor hasn't been so lucky.
Whereas nursing homes were first in line to get COVID vaccines last year, Lam now regularly scours a publicly available federal database to see if a Paxlovid prescription pops up near his location. This week, his home state of California got 9,560 doses -- about 24 prescriptions for every 100,000 people.
Five weeks after federal regulators approved Paxlovid and began distributing it to states, few people can find it -- omicron's aggressive rise has quickly outstripped supplies.
According to an ABC News analysis of federal data on Paxlovid in more than 3,100 U.S. counties, three-quarters didn't have any of the drug on hand as of Jan. 27, and about three-fifths had no access to a provider offering Paxlovid.
States are given amounts based on population, but some face more demand than others. Among the states that have the lowest rates of Paxlovid treatment on hand are Alabama, California, Florida, Idaho, New Jersey, New Mexico and Texas, according to data released by the Department of Health and Human Services.
Race also seems to be a factor in access, at least for now: Urban counties with majority nonwhite population have the lowest average of doses on hand, whereas counties with less than 10% of its population being nonwhite have the highest average of treatments on hand.
Scarcity isn't the only problem. Doctors and pharmacists told ABC News the process of obtaining the drug is opaque, even arbitrary.
In Nevada, for example, Paxlovid primarily goes to long-term care facilities like nursing homes. But in neighboring California, state officials use a complex formula that factors in rising case numbers with other risk factors. In the District of Columbia, a few Safeway grocery stores are the primary distributors, although city health officials have asked doctors to give priority to high-risk individuals.
Dr. Christian Ramers of the Family Health Centers of San Diego, a network of clinics for low-income patients, said his clinic was able to secure its first shipment of 100 treatments of Paxlovid two weeks ago as part of a Biden program aimed at improving health equity.
But the staff also had to set up a system, using federal guidelines, to decide who gets the drugs first because there just weren't enough. Often, that's meant prioritizing people who initially refused a vaccination and now are at much greater risk of dying.
"The volume has been just mind-blowing for the last three to four weeks -- just absolutely insane," he said. That spike "to us means hundreds to thousands of people vying for about ... 40 to 50 treatment slots per day."
For now, he said, the reality is "if you're vaccinated and you're under age 65 and you don't have a medical condition, you're not going to get Paxlovid."
Adding to the confusion is that many doctors are nervous about prescribing the drug for many high-risk patients because of potentially dangerous interactions with other commonly used medications, including cholesterol-lowering drugs and certain anti-depressants. Advocates say more data should be collected on people in their 80s and 90s.
But there aren't a lot of other options.
"It is a little disappointing, and it makes me wonder: Could we do more?" said Erin Karara, a pharmacy consultant who works with nursing homes and long-term care facilities. "I mean, we're seeing entire wings of nursing homes or facilities converted to COVID units. ... It's a lot of people affected by it."
For its part, both the White House and Pfizer said the drug was never expected to roll out in large numbers right away, in part because of the time it takes to secure raw materials and to scale up manufacturing.
The current plan calls for 265,000 courses of treatment in January, gradually ramping up to 10 million by the end of June and 20 million by the end of September.
This week, Pfizer told ABC News it plans to increase its production of Paxlovid overall to 120 million courses of treatment globally -- some 3.6 billion pills total.
Pfizer CEO Albert Bourla said producing the drug can't be compared to its COVID vaccine.
"It is very different, the situation," Bourla said at anindustry conference. "Any decent manufacturer of medicines can make it. But the chemistry, it is complicated, and it takes time to synthesize the active substance."
Some conservatives still have been quick to criticize Biden's handling of the rollout, with The Wall Street Journal's editorial board deriding it as "Biden's Operation Snail Speed," writing, "Why didn't it order more treatments sooner?"
According to one senior administration official, the White House did everything it could, including promising to Pfizer last July it would spend at least $1 billion on the drugs if it worked. This informal "handshake agreement" was intended to be a powerful incentive for the company, which doesn't use government money to develop new products, the official said, speaking on condition of anonymity.
By then, Pfizer had already spent months preparing its supply chain and developing the drug. It agreed to allow the U.S. to receive the world's first shipments.
A company official declined to confirm details of private discussions with the White House before the drug became available.
"Thanks to this at-risk preparation -- drawing on our deep expertise -- we have already shipped hundreds of thousands of Paxlovid courses in the U.S.," a spokesperson told ABC. "We continue to work quickly to ship courses in accordance with our agreed delivery schedule."
Two years into the pandemic, doctors still have few ways to treat COVID-19 with vaccines as the most effective option. Treatment options dwindled further this week when federal regulators pulled authorization of two types of monoclonal antibodies that had been widely used in the pandemic, including the kind given to then-President Donald Trump.
The antibody cocktails, made by Eli Lilly and Regeneron, were found to be useless against omicron, now 99.9% of all U.S. cases.
Two remaining drugs, Remdesivir and Sotrovimab, have to be administered intravenously at a medical facility. Molnupiravir, the new antiviral pill from Merck and Ridgeback Biotherapeutics, found to be 30% effective at preventing hospitalization and death, is authorized only for high-risk patients who can't access other treatments.
That leaves Paxlovid -- if a person can find it and take it early enough, and if the medication doesn't put them at risk because of other drugs they are taking.
This week, the Southern Nevada Health District in Las Vegas announced it received 120 prescriptions last week and was willing to offer the medication to anyone older than 12 who is at high risk of COVID and tests positive through their clinic.
"If we can identify and treat people early in the course of their illness who otherwise may have ended up in the emergency department or hospital ... we can potentially reduce the impact on our hospital system," said Dr. Cort Lohff, chief medical officer of the public health agency.
Lam, the doctor in northern California, said he's hopeful access will improve, particularly for nursing homes and long-term care residents.
"Frankly," he added, "I think that if we were able to target those advanced therapeutics for the most at-risk populations, I think we would really make a bigger difference in terms of our death rate."
