By Benjamin
RyanNBC News
Abby Robinson panted as she drove to a Long Beach, California, emergency room on January 19, terrified that her cystic fibrosis and what she assumed was COVID-19 were a fatal combination.
After a nurse flagged her as a high-risk patient and a rapid coronavirus test came back positive, a doctor offered the 24-year-old graduate student one hope: a prescription for Paxlovid, Pfizer's new antiviral cocktail.
[Police, soldiers, and parents sign on as substitute teachers to keep schools open in multiple states]
Sick as she was, the responsibility of finding a supply of the drug fell on Robinson.
Paxlovid, a five-day oral coronavirus treatment that can significantly reduce the risk of hospitalization and death, has been in critical supply since its emergency authorization on December 22.
When Robinson received the prescription, California was in the midst of a record increase in cases of the omicron variant.
She was competing with dozens of other newly diagnosed people for a share of the federal government's latest two-week allotment of just 9,560 doses of the pills.
Robinson made a series of calls to about two dozen local pharmacies before finding a nearly depleted supply of Paxlovid at an Orange County CVS.
The pharmacy would have been 30 minutes away if he hadn't driven "fast lane" to make sure he got there before the drug disappeared.
[“I was born free, I will die free”: a man rejects a kidney transplant for not being vaccinated against COVID-19]
“It was really humiliating, for someone who desperately needed this drug, how hard it was to get it and how my timing had to be so perfect,” he lamented of his ultimately successful search for Paxlovid.
She is feeling much better now, thanks to the medication, but she is still not herself.
Which people are more likely to suffer sequelae from COVID-19?
An expert answers
Feb. 3, 202202:17
This shortage has put health care providers in a bind, as the winter surge caused by the omicron variant has fueled a desperate need for treatments to keep infected people out of hospital.
The situation has worsened because states do not prioritize those most at risk of severe illness or death: immunocompromised and unvaccinated people with underlying illnesses.
[Anti-Vaccine Demonstrators Demonstrate in Washington DC Against Immunization Mandates]
The only monoclonal antibody treatment still approved by the Food and Drug Administration (FDA) to treat omicron, GlaxoSmithKline and Vir Biotechnology's sotrovimab, was not available at any hospital near Long Beach, according to the report. an emergency doctor confirmed to Robinson.
Time is critical once someone is diagnosed as being at high risk for severe coronavirus symptoms.
The pills must be started within five days of the onset of symptoms, which increases anxiety when filling a prescription.
Restriction of antiviral prescriptions
Robinson's frantic medical odysseys reflect the extraordinary efforts that many Americans have been forced to make to obtain this scarce life-saving antiviral drug.
The Biden administration has purchased 20 million lots of Paxlovid, half of which Pfizer says it expects to deliver by the end of June and the rest by September 30.
A consolidated supply of the treatment is not expected until April.
A Pfizer employee checks boxes containing Paxlovid at a distribution facility in Memphis, Tennessee. Pfizer via Reuters
So far, the federal government has only been able to deliver 265,000 lots of Paxlovid to state health departments, even though the United States has recorded some 20 million coronavirus cases and 55,000 related deaths in January alone.
Although omicron cases are declining across the country, there are still more than 140,000 hospitalizations and thousands of people dying daily from COVID-19.
The federal government allocates the supply of Paxlovid to state health departments, which in turn distribute their share to local pharmacies, health systems, and long-term care facilities as they see fit.
[Colorado Woman Denied Transplant Because She Wasn't Vaccinated]
“Unlike the entire response to COVID-19, the federal government has not wanted to give more than guidance,” explained Richard Freeman, regional clinical chief for Loyola Medicine in Chicago.
“Then it depends on the states, so you have 50 different versions.
I don't think that's helpful,” he added.
Little did Robinson know, but the California health department has not tried to restrict Paxlovid's availability to only those at highest risk of hospitalization and mortality.
According to a survey by our sister network NBC News of state health departments, only a few -- including those in Michigan, Minnesota and New Mexico -- have established systems that limit access.
These states mandate that physicians only prescribe Paxlovid to the highest-risk patients.
Or health departments collaborate with pharmacies or health systems to which the state ships Paxlovid to help ensure they adhere to such restrictions.
[Omicron infections in the US drop by almost 14% in the last two weeks]
"Our primary goal, with an eye toward equity, is to protect the most vulnerable among us and prevent the greatest number of serious outcomes," said Dr. Natasha Bagdasarian, chief medical officer for the Michigan Department of Health and Human Services.
On video: This mother had to wait a month to meet her baby after falling ill with COVID-19
Feb. 2, 202200:43
In Michigan, the state health department regularly publishes and updates a guidance document telling doctors that a Paxlovid candidate is at higher risk levels for severe coronavirus.
And then pharmacists at the Meijer chain store, which is the state's largest supplier of Paxlovid, confirm eligibility documentation before filling the prescription.
Other states - such as Indiana, Maryland, North Carolina, Pennsylvania, West Virginia and Wisconsin - take a more relaxed approach, issuing notices to health care providers that only advise, but do not require, that they prescribe the therapy to people who are most they can benefit from it.
[The White House questions the role of the government's health secretary, according to reports]
Providers are often urged to follow the National Institutes of Health COVID-19 treatment prioritization guidelines.
Some states, such as Tennessee, have not sent physicians any guidance on prioritizing access to antivirals.
Dr. William Parker, a medical ethicist, argues that the available supply of coronavirus treatment should be dispensed more strictly based on strict criteria.
“Restricting access to only the highest-risk patients is justified to reduce pressure on the health care system and maximize lives saved,” said Parker, a health services researcher at the University of Chicago.
[Airlines and tourist companies demand that COVID tests be eliminated from vaccinated passengers]
Dr. Jeffrey Klausner, an infectious disease specialist at the University of Southern California Keck School of Medicine, was critical of California's approach to managing coronavirus treatments.
A worker unpacks boxes of Pfizer's antiviral drug Paxlovid at a warehouse in Shoham, Israel, on January 18, 2022. Kobi Wolf/Bloomberg via Getty Images
“I have not received any communication from the state or local health department regarding Paxlovid or any other therapy,” Klausner said.
“I've had to search on my own, often getting contradictory or outdated information,” she lamented.
Many hospital systems across the country, such as the Zuckerberg Trauma Center and General Hospital in San Francisco, have placed internal restrictions on access to Paxlovid.
However, experts note that this does not prevent people on the lower end of the high-risk spectrum from finding an independent doctor willing to write a prescription.
A better distribution system?
States often distribute Paxlovid through pharmacy chains, forcing residents to run, sometimes over considerable distances, to obtain a prescription.
Some health systems have already used a lottery method to dispense other COVID-19 therapies when supplies were tight.
In 2020, the University of Pittsburgh Medical Center system, made up of 40 hospitals, ran a lottery, which slightly favored frontline workers and people from disadvantaged communities, to assign Gilead Sciences' remdesivir to eligible hospitalized patients.
[Five things to know about free home COVID tests]
Even when states restrict Paxlovid to the highest-risk levels, the allocation system still invites feverish competition for the resource and favors people with the financial means and ability to obtain the drugs, said Dr. Douglas White, a medical specialist in medical ethics and critical care from the University of Pittsburgh.
"It's become a pitched battle," White said.
"First come, first served is a terrible way to both do the greatest good with a scarce resource and make sure that resource is distributed fairly."
Who should receive antivirals first?
According to the NIH, the people most at risk of severe Covid - those at the highest priority level - are
Immunocompromised people.
Unvaccinated people over 75 years of age.
Unvaccinated people who are 65 years of age or older and have additional risk factors, such as diabetes, cancer, obesity, or heart, kidney, liver, or lung disease.
The next level of risk includes all unvaccinated people age 65 and older, as well as all unvaccinated people with risk factors.
It is not clear if Paxlovid benefits vaccinated people.
The study submitted to the FDA only included high-risk unvaccinated people, although the agency's authorization applies to people at "high risk of progression to severe COVID-19" regardless of vaccination status.
"If you take the FDA at face value, you're giving Paxlovid to a lot of people who won't benefit," said Dr. John Hick, an emergency room physician at Hennepin County Medical Center in Minneapolis.
[How many times can N95 masks be reused? This is what the experts say]
Despite her terrifying shortness of breath after developing coronavirus, Abby Robinson is only in the fourth, and last, level of NIH high-risk individuals, considering that she has received a booster of the vaccine and is under 65 years.
Having cystic fibrosis is the only factor that puts you in the general high-risk category, according to the Centers for Disease Control and Prevention (CDC).
The CDC recommends not traveling to Mexico due to COVID-19 and many fear that it will affect tourism
Feb. 1, 202201:39
For people on the lower end of the high-risk spectrum, several medical ethicists said society shouldn't hold them to account for ordering Paxlovid, as long as they comply with FDA authorization terms and state regulations that regulate access.
"People behave rationally in an irrational environment," said JP Leider, a researcher at the University of Minnesota School of Public Health, who helped develop Minnesota's COVID-19 therapy prioritization guide.
"You have to put barriers in the system to make sure it's going to save as many people as possible and keep trying to promote equity," he said.
[Misinformation about COVID-19 and its effect on an indigenous community in California: “We did not believe, until it took our loved ones”]
For patients who cannot access Paxlovid, there are other FDA-approved antivirals to treat early-stage coronavirus cases.
Merck's oral antiviral molnupiravir has gone on sale with four times the supply of Paxlovid.
However, the drug is only 30% effective against hospitalization and death, and has raised safety concerns.
Consequently, the FDA specifies that molnupiravir should only be used when other treatments "are not accessible or clinically appropriate."
However, health professionals may continue to turn to this drug in the hope of reaping even its modest potential benefit, said Bagdasarian, of Michigan.
Another antiviral, remdesivir, recently got expanded FDA approval to prevent high-risk patients from needing to be hospitalized.
But because remdesivir requires three days of intravenous infusions to treat milder coronavirus cases, its use will remain limited.
That said, Bagdasarian suggested that remdesivir may be feasible for high-risk people with mild or moderate COVID-19 who are in a long-term care facility, psychiatric hospital or prison, or hospitalized for an unrelated reason. with the coronavirus and are diagnosed with an early case of infection.
["We didn't know COVID-19 existed": This remote village discovers the pandemic when health workers come to vaccinate them]
"It is important to note that Paxlovid is not our only therapy and we are trying to match our available tools with the right candidate," Bagdasarian explained.