US authorizes second pill against COVID-19, now from Merck

US health authorities have authorized a second pill against COVID-19, a medicine from the pharmaceutical company Merck that can be taken at home, which offers another easy-to-use medicine to combat the growing wave of infections by the omicron variant.

Authorization from the Food and Drug Administration (FDA) to the antiviral drug molnupiravir from Merck It comes a day after the same agency approved a pill from rival Pfizer.

Pfizer’s pill, Paxlovid, is likely to become the first-line treatment for the virus, thanks to its greater benefits and milder side effects.

As a result, Merck’s pill is expected to play a lesser role against the pandemic than was predicted just a few weeks ago. Its ability to prevent the severe effects of COVID-19 is much less than initially announced, and the drug’s label will warn of serious safety risks, including the potential for birth defects.

Both treatments will be free to patients in the United States after they are purchased by the federal government.

The FDA licensed the Merck drug for adults with early COVID-19 symptoms who face the highest risks of hospitalization, including older adults and those with conditions such as obesity and heart disease. The UK was the first government to authorize the pill, in early November.

The medicine of Merck will carry a warning against use during pregnancy. Women of childbearing potential should use birth control during treatment and for a few days afterward, while men should use birth control for at least three months after their final dose, the FDA said.

The federal agency added that molnupiravir should not be used in patients under 18 years of age since it can affect bone and cartilage growth.

The doctor Nick Kartsonis, Senior Vice President of Clinical Studies, Merckreported that company scientists continue to study the drug and hope that it will eventually be approved for use in children.

The restrictions were expected after an FDA advisory panel barely endorsed the drug last month, warning that the use of molnupiravir would have to be tailored strictly for patients who may benefit the most.

Kartsonis said that scientists from Merck they feel “very comfortable”Regarding the safety profile of the drug and noted that molnupiravir has been studied in more than 1,000 people.

He said the scientists detected side effects such as diarrhea and nausea in only a small percentage of patients. “The drug has in fact been very well tolerated“, He said.

The Pfizer pill works differently than Merck’s and does not carry the same risks. In addition, the drug of Pfizer it was about three times more effective in tests, reducing hospitalizations and deaths by about 90% among high-risk patients, compared with 30% for the Merck drug.

Some experts question whether the pill Merck it will have a relevant role in the United States.

“Since there is a plentiful supply of the Pfizer pill, I think it will not be used“Said Mayo Clinic physician Gregory Poland, referring to the Merck pill. “There would be no reason, because it is less effective and has higher risks of side effects”.

For now, the decision of the FDA offers another potential option to fight the virus, which has killed more than 800,000 Americans, as health authorities prepare for a new record wave of cases, hospitalizations and deaths fueled by the omicron variant.

Antiviral pills, including antiviral pills, are expected to Merck, are effective against the omicron variant, since they do not attack the spicule protein where most of the worrying mutations of the variant occur.

The FDA made its decision based on results showing that about 7% of patients taking the drug end up in hospital and that one died after 30 days. Those data are compared with 10% of hospitalized patients who received a placebo and with nine deaths.

The federal government has agreed to buy enough medicine to serve 3.1 million people.