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Pfizer, Merck Pills Hinge on Biden Plan to Expand Covid Testing

Dec. 29, 2021, 10:30 AM

Covid-19 testing expansion could be critical to the success of Merck & Co. and Pfizer Inc.’s newly authorized treatment pills, which require an early diagnosis and administration to effectively reduce the risk of severe cases.

Food and Drug Administration clearance of the first two at-home therapies for Covid-19 addresses some criticisms that the Biden administration’s pandemic response has leaned too heavily on vaccines. But without adequate access to testing, those at higher risk of hospitalization may not be able to obtain the medication in time for it to have a meaningful impact, public health experts say.

“If you can actually get in there early enough with medication to prevent people from ever getting hospitalized, getting pneumonia, having a life-threatening illness, that would completely change the course of the pandemic,” Lynn Goldman, dean of the George Washington University’s Milken Institute School of Public Health, said.

“To make that work, you have to have more testing than we have now,” she said.

Pfizer’s Paxlovid and Merck’s molnupiravir offer treatment options for higher-risk people who test positive for the virus. Early clinical trial data show that Paxlovid led to an 88% reduction in hospitalization within five days of symptoms starting. Molnupiravir reduced the relative risk of hospitalization or death among adults with mild to moderate disease by 30% when taken within five days.

But availability of testing to detect the virus hasn’t kept up with heavy demand, especially during the holiday weekend with many people waiting hours in line to get tested.

President Joe Biden said this week that there aren’t enough at-home tests and that his administration will continue using the Defense Production Act to produce “as many tests as possible.” His strategy to curb the omicron variant includes buying 500 million at-home Covid-19 tests to ship free to Americans starting in January.

‘Test-and-Treat’

Early research on omicron indicates the variant may be less severe than previous strains, especially for the vaccinated. But the recent surge in case numbers amid the busy holiday season is fueling worries that hospitals could soon be overwhelmed with Covid-19 patients.

Ensuring easy and early access to treatments like Pfizer’s and Merck’s will be critical to turning the tide of the pandemic nearly two years in, policy researchers say. And early access hinges on a better testing strategy, they add.

“The U.S. needs to quickly develop a test-and-treat strategy that encourages people to get tested regularly and at first signs of symptoms and then to quickly connect to care,” said Brook Baker, a professor at Northeastern University School of Law and a senior policy analyst at Health GAP, an advocacy group focusing on equity in access to HIV medications.

Treatments are “most effective” when started within five days of a person’s first sign of symptoms, he said.

Access to testing required to receive a Covid-19 treatment, however, may be “a barrier for a lot of people,” Goldman said.

“It’s hard to get testing, and most people, their insurance doesn’t cover the testing, unless it’s ordered by a physician,” she said. “Without the diagnosis, you’re not going to get the treatment.”

Goldman added that the pace of testing across the U.S. “has just been a place where our country has lagged behind since day one.”

Treatment Access

The FDA authorizations follow ongoing demands from Americans for more Covid-19 treatment options, especially for those in older age groups or with underlying health conditions that put them at greater risk. They come as U.S. vaccination numbers stall around 60% and the new omicron variant—which accounted for 58.6% of Covid-19 cases in the week ending Dec. 25—drives up nationwide infections.

While health experts widely agree that vaccination is critical, some say it’s time for the administration to redirect its focus to additional tools to curb the pandemic fallout. Merck and Pfizer’s pills, they say, are a major step in that direction.

“We have to turn our attention to providing compassionate and competent care for those unvaccinated with the use of these two oral antiviral medications,” Monica Gandhi, an infectious disease doctor and professor at the University of California, San Francisco, said.

The pills provide an easier-to-get alternative to monoclonal antibodies, laboratory-made proteins infused into a person’s body that help fight against Covid-19 and reduce the risk of hospitalization. Those treatments are limited in supply and can only be administered by authorized health-care providers to those at most risk of severe infection.

“Many people live in places where we really don’t have the ability, haven’t really been delivering the monoclonals and other IV medications,” Goldman said.

And given that “many people are far more accepting of an oral medication than an IV,” Covid treatment pills “open up access to treatment for many more people,” she added.

Yet some think the focus should mostly remain on vaccinations.

“Prevention is always preferred to treatment, so emphasizing vaccination should be the primary focus of any strategy to combat Covid-19,” said Andrew Pekosz, vice chair of Johns Hopkins University’s W. Harry Feinstone Department of Molecular Microbiology & Immunology.

The Pfizer and Merck drugs are likely to be most effective when used “in combination with increased efforts to get vaccines into the U.S. population,” he said.

‘Immediate Need’

In addition to testing, researchers say the government should place a greater focus on masking and other health precautions.

“An immediate need is increased access to testing and institution of better social distancing and other public health interventions to reduce omicron’s spread,” Pekosz said. He added that more N95 or KN95 masks may be needed in place of other types of facial coverings “because omicron is so much more effective at transmission than any other variant seen to date.”

Biden addressed the testing concerns this week, telling governors in a conference call from the White House that the administration would be expanding pop-up sites and the availability of at-home test kits.

“Seeing how tough it was for some folks to get a test this weekend shows that we have more work to do and we’re doing it,” Biden said. “We have to do better. And we will.”

To contact the reporters on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com; Ian Lopez in Washington at ilopez@bloomberglaw.com

To contact the editors responsible for this story: Alexis Kramer at akramer@bloomberglaw.com; Karl Hardy at khardy@bloomberglaw.com