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Merck plans to submit data on the antiviral pill and apply for emergency use authorization.
An antiviral pill from Merck has proven effective at preventing hospitalization and death from COVID-19.
According to a news release, a planned interim analysis of a Phase 3 MOVe-OUT trial in 775 at risk, non-hospitalized adult patients with mild to moderate COVID-19 found that the antiviral, molnupravir, reduced the risk of hospitalization or death by 50 percent. No patients who received the pill died after 29 days compared to eight who died after receiving a placebo.
On the recommendation of an independent data monitoring committee in consultation with the Food and Drug Administration (FDA), Merck has chosen to end recruitment in the study. The company plans to submit the data in an application for emergency use authorization (EUA) from the agency as soon as possible, the release says.
“More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families, and societies and strain health care systems all around the world,” Robert M. Davis, CEO and president of Merck, says in the release. “With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most. Consistent with Merck’s unwavering commitment to save and improve lives, we will continue to work with regulatory agencies on our applications and do everything we can to bring molnupiravir to patients as quickly as possible.”
The company plans to produce 10 million courses of treatment by the end of the year and previously entered into an agreement with the federal government to supply about 1.7 million courses of molnupiravir upon receiving an EUA or approval from the FDA. Merck has struck similar deals with other countries, according to the release.
Vaccination on the rise
A Kaiser Family Foundation survey found that 72 percent of adults in the U.S. have received at least one dose of a COVID-19 vaccine up from 67 percent in late July. Of those receiving doses since June 1, 39 percent cited the increase in COVID-19 cases tied to the Delta variant, 38 percent cited reports of local hospitals filling up, and 36 percent said they got the shot because someone they knew became seriously ill or died. More modest portions of the newly vaccinated cited a desire to participate in vaccine-required events, employer mandate, and full Food and Drug Administration approval of the Pfizer vaccine (35 percent, 19 percent, and 15 percent respectively.)
Hispanic adults saw the largest increase in vaccinations increasing 12 percent to 73 percent in September. Young adults aged 18 to 29 also saw an increase of 11 percent to 68 percent.
This month 2 percent of adults said they plan to get vaccinated “as soon as possible” while an additional 7 percent say that want to “wait and see.” While 4 percent say they’ll be vaccinated if required by work, school, or other activities, only 12 percent now say they will “definitely not” get vaccinated.
Politics is the largest remaining gap in vaccination, with 90 percent of Democrats having received at least one dose compared to only 58 percent of Republicans. Meanwhile 68 percent of independents say they’re at least partially vaccinated.