A Tuesday report from Bloomberg stated that the U.S. Food and Drug Administration could authorize use of COVID-19 pills by Pfizer and Merck as early as this week.
Bloomberg spoke with individuals familiar with the topic and reported, “[a]n announcement may come as early as Wednesday, according to three of the people. They asked not to be identified ahead of the authorization and cautioned that the plan could change.”
“Pfizer and Merck pared earlier declines on the news. Merck was trading down 0.7% at 10:43 a.m. in New York, while Pfizer was off 5.1%,” the outlet noted.
It added, “FDA’s authorizations may include limitations for populations in which they could be used, one of the people familiar with the matter said.”
Reuters further reported:
The U.S. Food and Drug Administration is set to authorize COVID-19 treatment pills from both [Pfizer] and [Merck] as early as Wednesday, Bloomberg News reported on Tuesday, citing people familiar with the matter.
The U.S. has put in orders of 10 million rounds of Pfizer’s pill and around 3 million of the Merck pill, which is reported to have hazards associated with it.
As The Daily Wire reported last month, an advisory panel for the U.S. Food and Drug Administration (FDA) recommended Merck’s antiviral COVID-19 pill for use in adults who are at a high risk of contracting the virus, although the panel did not all agree on the decision.
As reported by The New York Times:
The drug, known as molnupiravir, has been shown to modestly reduce the risk of hospitalization and death, predominantly from the Delta, Mu and Gamma variants. The expert panel recommended it for Covid patients who are older or have medical conditions that make them vulnerable to severe illness. The pill could be authorized in the United States within days, and available by year’s end.
CNBC noted, “The FDA’s Antimicrobial Drugs Advisory Committee voted 13 to 10 to recommend emergency authorization of molnupiravir,” adding that it is an 800-milligram pill intended to be “taken every 12 hours for five days after symptom onset.”
“Merck originally said the drug was more than 50% effective in preventing hospitalizations and death, but a more full set of data presented to the FDA on Tuesday noted the drug is just 30% effective,” the outlet added.
Members who did not vote in favor of endorsing the treatment said the aid of the pill was “modest,” and also cited worries about safety due to the experiments. “The treatment works by inserting errors into the virus’s genes. Some scientists say there is a theoretical risk that it could trigger mutations in cells as well, potentially causing reproductive harm or a long-term risk of cancer,” the Times reported.
“I was not convinced that the potential benefit outweighed risk,” Dr. Peter Weina, the director of the Office of Research Protections at the Defense Health Agency, said, per the Times.
Merck and the FDA noted that women who are pregnant should not get the pill. Kids and pregnant women were not included in the treatment’s clinical trials.
CNBC added, “Molnupiravir was found to be lethal to embryos in pregnant rats, also causing birth defects and reducing fetal body weight. It also caused other defects that interfered with bone growth in young pups, along with other abnormalities, the data shows.”
Concern over the drug potentially prompting COVID to mutate in less treatable ways was present.
While the advisory panel is not the final say in approval, the FDA typically goes in favor of their recommendations. The U.S. Centers for Disease Control and Prevention would also need to approve the pill.
Last month, Pfizer also submitted its COVID-19 pill treatment to the FDA for authorization to be used for certain people.
Pfizer announced that “it is seeking Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, PAXLOVID™ […] for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death.”
“If authorized or approved, PAXLOVID would be the first oral antiviral of its kind … that could be prescribed as an at-home treatment to high-risk patients at the first sign of infection, potentially helping patients avoid severe illness which can lead to hospitalization and death,” the announcement noted.
As previously reported by The Daily Wire, Pfizer announced results from an interim analysis reportedly showing its new pill designed to treat COVID-19 minimized the risk of death or hospitalization by 89%.
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Source: Dailywire
