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WASHINGTON — Monday’s announcement that pharmaceutical giant Merck and a partner, Ridgeback Biotherapeutics, have submitted an application to the Food and Drug Administration for a drug called molnupiravir means that the world could finally soon see the widespread distribution of an easy-to-administer pill that is effective in treating COVID-19.
“It will make living with COVID a much less dangerous activity,” Andy Slavitt, who recently stepped down as a top adviser on the pandemic to President Biden, told Yahoo News.
Initial results from Merck showed that the new drug cut both deaths and hospitalizations by half in clinical trials. Federal regulators will not scrutinize the results of those trials closely before granting approval for distribution. That approval will be initially made on an emergency-use basis, as it was for the coronavirus vaccines.
“Given what we have seen of the data, the hype is justified,” George Mason University economist Alex Tabarrok, who has been hailed for his pandemic-related observations, wrote to Yahoo News in a text message. “I am hoping that Molnupiravir gets a quick FDA emergency approval and then a rollout with it being used first in cases with the most co-morbidities (e.g. the unvaccinated elderly or those with other health issues.)”
The search for a simple, widely available treatment for the coronavirus began as soon as the potential severity of the disease it causes became apparent in early 2020.
Although the wave fueled by the highly transmissible Delta variant of the coronavirus appears to be subsiding, the return to indoor activities and widespread travel over the holiday season may lead to a spike in cases, as it did last year.
With that in mind, Monday’s news was widely hailed as another sign that, as Tabarrok put it, “the tide has really turned” in a battle that has now lasted for nearly two years. More than 700,000 people in the United States have died since the pandemic began.
A treatment from Regeneron is also available, but it is a monoclonal antibody that requires injection. Such an injection is done by a medical professional, much like a COVID-19 vaccine. “That creates barriers,” Slavitt said.
Molnupiravir is a small-molecule antiviral that can be taken by mouth, in pill form.
“A pill is much better and can be scaled up much quicker both for production and for administration,” Tabarrok said. “The monoclonal antibodies will never be rolled out on a large scale in the developing world.
“Molnupiravir could be,” he added, “and as they lag in vaccinations that will be important.”
The federal government has already invested $1.2 billion in purchasing 1.7 million doses of the new drug, an outlay that Slavitt says is both reasonable and strategic, signaling as it does to Merck that it should devote significant capacity to producing molnupiravir.
Slavitt could not predict when the FDA would grant approval of the new treatment, though he saw no reason such approval should be withheld for a prolonged period of time.
“There’s reason to be enthusiastic based on everything we know,” Slavitt told Yahoo News. The agency, which is without a Senate-confirmed head, has been criticized for the pace of the approval process. It recently vacillated on the need for booster shots and is currently considering childhood inoculations.
“Approval of the Merck pill would be a huge deal,” said Dr. Lucy McBride, a Washington, D.C., physician who writes about the pandemic. “It would save lives and reduce hospitalizations. Pairing rapid tests with a ready-to-go oral treatment for mild to moderate COVID would really help tame this COVID beast.”
Yet the new drug, McBride cautioned, “is not a substitute for vaccination but offers great hope for the future.”
Vaccine skeptics have frequently looked for such substitutes, either in the deworming drug ivermectin or other, more sound treatments. During the Delta surge, Gov. Ron DeSantis of Florida — where the surge was the worst in the country — downplayed vaccinations even as he flew around the state opening Regeneron monoclonal antibody injection sites.
A repeat of that would worry public health experts. “Prevention is always better than treatment,” Slavitt said.
Vaccine mandates issued by the Biden administration last month could blunt any complacency fostered by the advent of a new treatment.
Other recent developments point to a 2022 that may resemble a pre-pandemic normal.
“Having oral, outpatient treatment for COVID-19 is one of the three things that I believe will turn this pandemic around (the other two are vaccines for younger children and widespread rapid testing),” said Dr. Leana Wen, the former Baltimore health commissioner.
None of which takes away from the news that a pill to treat COVID-19 could be just weeks away from reaching the marketplace. While professing no special knowledge of the approval timeline, Slavitt said that molnupiravir could see approval before the end of the year.
Dr. Eric Topol, a molecular medicine expert and the founder and director of the Scripps Research Translational Institute, put Monday’s news of Merck’s application to the FDA in context.
“A very big deal,” he wrote in an email to Yahoo News.
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