WASHINGTON — There is new hope for fighting the pandemic in pill form beyond vaccines. Several drug companies have rolled out antivirals before the Food and Drug Administration (FDA) for approval -- including Merck’s new COVID-19 pill.
Initial studies showed it was highly effective but new FDA studies showed that effectiveness dropped off significantly.
Could it still be approved?
The FDA’s standard to give the vaccines emergency use authorization was 50%. Studies show Merck’s antiviral fell short of that. We wanted to find out if the FDA has an effectiveness threshold for COVID-19 treatments.
Is there a threshold of effectiveness for COVID-19 medications?
No, there is no effectiveness threshold for COVID-19 treatments.
WHAT WE FOUND:
This month, an FDA panel took a look at Merck’s newest tool to fight the pandemic: An anti-viral in pill form.
“The Merck pill interferes with the replication of the coronavirus,” Dr. Sharfstein said.
As to how the pill works, Dr. Sharfstein explained a patient takes the pill after they get infected with COVID-19.
“The medication basically inserts itself into that process,” he said. “So that the new viruses that are being made by your cells don't work anymore.
But according to the most recent data from Merck, it only reduces the likelihood of death and hospitalization by 30%.
Which is not nearly as effective as any of the FDA authorized vaccines. We asked our experts, is that a problem?
“There's no kind of threshold that the FDA has set, kind of for anti-viral efficacy,” Dr. Moss said.
“Now there is such a number that FDA put out there as a guidance for vaccines,” Dr. Sharfstein concurred. “But they did not do that for medications.
Which then begs the question: How does a treatment with a lower effectiveness help?
“We’re continuing to have about 1,000 deaths a day,” Dr. Moss summed it up. “Even a 30% reduction in hospitalizations or deaths would be, would have a major impact.”
The FDA review panel did recommend authorization of the pill despite the low effectiveness.
But ultimately, the decision to authorize the Merck pill as a treatment is left up to the FDA. That decision could come in the next few days or weeks.