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US FDA panel backs first-of-a-kind COVID-19 pill from Merck

A panel of US health advisers on Tuesday narrowly backed the benefits of a closely watched COVID-19 pill from Merck, setting the stage for a likely authorization of the first drug that Americans could take at home to treat the virus.

A Food and Drug Administration panel voted 13-10 that the drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy.

The group’s recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. Experts backing the treatment stressed that it should not be used by anyone who is pregnant and called on FDA to recommend extra precautions before the drug is prescribed, including pregnancy tests for women of child-bearing age.

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The vote specifically backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including older people and those with conditions like obesity and asthma. Most experts also said the drug shouldn't be used in vaccinated patients, who weren't part of the study and haven't been shown to benefit from the medication.

The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision before year’s end.

The drug, molnupiravir, could provide a much-needed weapon against the virus as colder weather pushes case counts higher and US officials brace for the arrival of the new omicron variant. It is already authorized for emergency use.

Merck hasn’t specifically tested its drug against the new variant but said it should have some potency based on its effectiveness against other strains of coronavirus.

But that uncertainty frustrated many panelists as they grappled with whether to back the treatment for millions of Americans.

“With no data saying it works with new variants I really think we need to be careful about saying that this is the way to go,” said Dr. David Hardy of Charles Drew University School of Medicine and Science, who ultimately voted to back the drug.

The panel’s narrow-but-positive recommendation came despite new data from Merck that paint a less compelling picture of the drug’s effectiveness than just a few weeks earlier.

Last week, Merck said final study results showed molnupiravir reduced hospitalization and death by 30% among adults infected with the coronavirus, when compared with adults taking a placebo. That effect was significantly less than the 50 percent reduction it first announced based on incomplete results.

That smaller-than-expected benefit amplified experts' concerns about the drug's toxicity for human fetuses.

FDA scientists told the panelists earlier Tuesday that company studies in rats showed the drug caused toxicity and birth defects when given at very high doses. Taken together, FDA staffers concluded the data “suggest that molnupiravir may cause fetal harm when administered to pregnant individuals.”

FDA is weighing a blanket restriction against any use in pregnant women or allowing it in rare cases. Some panelists said the option should be left open for pregnant mothers who have high-risk COVID-19 and may have few other treatment options.

Dr. Janet Cragan, who backed the drug, said that even with tight restrictions some pregnant women would inevitably take the drug.

“I don’t think you can ethically tell a woman with COVID-19 that she can’t have the drug if she’s decided that’s what she needs,” a panel member and staffer with the Centers for Disease Control and Prevention. “I think the final decision has to come down to the individual woman and her provider.”

Merck's drug uses a novel approach to fight COVID-19: It inserts tiny errors into the coronavirus’ genetic code to stop it from reproducing. That genetic effect has raised concerns that the drug could spur more virulent strains of the virus. But FDA regulators said Tuesday that risk is theoretical and seems unlikely.

While Merck and its partner Ridgeback Biotherapeutics were the first to submit their COVID-19 pill to the FDA, rival drugmaker Pfizer is close behind with its own pill under review.

Pfizer’s drug is part of a decades-old family of antiviral pills known as protease inhibitors, a standard treatment for HIV and hepatitis C. They work differently than Merck’s pill and haven’t been linked to the kind of mutation concerns raised with Merck’s drug.

Pfizer said this week that its drug shouldn’t be affected by the omicron variant’s mutations.

The US government has agreed to purchase 10 million treatment courses of Pfizer’s drug, if it’s authorized. That’s more than three times the government’s purchase agreement with Merck for 3.1 million courses of molnupiravir.

Both drugs require patients to take multiple pills, twice a day for five days.

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US: Bodies of two of three missing kids found in Minnesota lake

The bodies of two young children have been recovered from a Minnesota lake, and searchers are still looking for a third they fear may have been intentionally drowned.

Meanwhile, the father of the children died at a different location hours earlier, and their mother is missing. Names have not been released.

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The chain of events began Friday morning when the father was found dead at a mobile home park in the town of Maplewood, near Minneapolis. Police determined that the woman had left with the children, and a search began.

Maplewood Police Lt. Joe Steiner said the woman’s car was found near Vadnais Lake around 4 p.m. Friday. The shoes of the children were found on the shore.

A search of the lake found one child’s body Friday evening. A second body was found overnight. Searchers from several organizations were busy Saturday looking for the third, as well as the mother.

Authorities believe all three children were under the age of 5.

“There’s nothing more tragic than the loss of young children,” Ramsey County Sheriff Bob Fletcher said at a news conference on Friday. He called the deaths a “likely triple homicide.”

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Foreign firefighters arrive in Greece for summer wildfire season

Several dozen Romanian and Bulgarian firefighters took up their posts in Greece on Saturday, the first members of a European force being deployed to the country to provide backup in case of major wildfires during the summer.

More than 200 firefighters and equipment from Bulgaria, France, Germany, Romania, Norway and Finland will be on standby during the hottest months of July and August in Greece, where a spate of wildfires caused devastation last summer.

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A group of 28 Romanian firefighters with eight vehicles, and 16 firefighters from Bulgaria with four vehicles, were the first to arrive for the two-month mission, financed and coordinated under the European Union’s civil protection mechanism.

“We thank you very much for coming to help us during a difficult summer for our country, and for proving that European solidarity is not just theoretical, it’s real,” Greek Civil Protection Minister Christos Stylianides said on Saturday as he welcomed the members of the Romanian mission in Athens.

“When things get tough, you will be side by side with our Greek firefighters so we can save lives and property.”

The Bulgarian firefighters have been stationed in Larissa, in central Greece.

Last summer’s wildfires ravaged about 300,000 acres (121,000 hectares) of forest and bushland in different parts of Greece as the country experienced its worst heatwave in 30 years.

Following sharp criticism of its response to the fires, the Greek government set up a new civil protection ministry and promised to boost firefighting capacities.

In Greece’s worst wildfire disaster, 102 people were killed when a blaze tore through the seaside town of Mati and nearby areas close to Athens during the summer of 2018.

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One killed, six injured in shootout between migrant groups in Serbia

One migrant was killed and at least six others, including a teenage girl, were injured Saturday in a shootout between migrant groups in Serbia near the Hungarian border, the state-run RTS television reported.

The 16-year-old girl sustained life threatening injuries in the incident that occurred in a forest in the outskirts of Subotica, some 160 kilometers (100 miles) north of Belgrade, where the injured were hospitalized, RTS reported.

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Police, who made no immediate comment, blocked access to the forest where the incident took place, only around a kilometer from the Hungarian border.

Interior Minister Aleksandar Vulin rushed to the scene.

The injured, aged between 20 and 30, have no documents, Subotica mayor Stevan Bakic told local media.

It is not known what triggered the incident, he added.

Local media reported that the shootout occurred between Afghan and Pakistani migrants most likely over human trafficking from the area to European Union member Hungary.

Serbia lies on the so-called Balkans route used by migrants heading towards Western Europe as they flee war and poverty in the Middle East, Asia and Africa.

Although the route is nowhere as busy as it was during Europe’s migrant crisis in 2015, tens of thousands of illegal migrants still cross the region annually.

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