World

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.

For more coronavirus news, visit our dedicated page.

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.

For the latest headlines, follow our Google News channel online or via the app.

UK authorizes Merck coronavirus antiviral pill, first shown to treat COVID

Pfizer says its antiviral pill cuts risk of severe COVID-19 by 89 percent

World

Putin, Xi pledge friendship but talks yield no Ukraine breakthrough

Xi Jinping and Vladimir Putin emerged from two days of talks on Tuesday with warm words of friendship between China and Russia and joint criticism of the West but no sign of a diplomatic breakthrough over Ukraine.

Xi's visit to Moscow – long touted by the Kremlin as a show of support from its most powerful friend – featured plenty of demonstrative bonhomie. The two leaders referred to each other as dear friends, promised economic cooperation and described their countries' relations as the best they have ever been.

A joint statement included familiar accusations against the West – that Washington was undermining global stability and NATO barging into the Asia-Pacific region.

On Ukraine, Putin praised Xi for a peace plan he proposed last month, and blamed Kyiv and the West for rejecting it.

“We believe that many of the provisions of the peace plan put forward by China are consonant with Russian approaches and can be taken as the basis for a peaceful settlement when they are ready for that in the West and in Kyiv. However, so far we see no such readiness from their side,” Putin said.

But Xi barely mentioned the conflict at all, saying that China had an “impartial position” on it.

The summit, Putin's biggest display of diplomacy since he ordered his invasion of Ukraine a year ago, was partly upstaged in Kyiv, where Japan's Prime Minister Fumio Kishida made a surprise visit and met President Volodymyr Zelenskyy.

The latest world leader to make the gruelling overland journey to show solidarity with Ukraine, Kishida toured Bucha on the capital's outskirts, left littered with dead last year by fleeing Russian troops. He lay a wreath by a church before observing a moment of silence and bowing.

“The world was astonished to see innocent civilians in Bucha killed one year ago. I really feel great anger at the atrocity upon visiting that very place here,” Kishida said. “Japan will keep aiding Ukraine with the greatest effort to regain peace.”

Diplomatic cover

Washington denounced the timing of Xi's visit to Moscow, just three days after the International Criminal Court in the Hague issued a warrant for Putin's arrest on war crime charges of illegally deporting Ukrainian children.

US Secretary of State Antony Blinken said visiting at such a time amounted to giving Putin “diplomatic cover” for atrocities. Moscow denies illegally deporting children, saying it has taken in orphans to protect them, and has opened its own criminal case into the ICC prosecutor and judges.

Putin and Xi signed a “no limits” partnership agreement last year just weeks before Russia invaded Ukraine. Beijing has since declined to blame Moscow for the war and criticised the West for imposing sanctions on Russia, even as China has profited by securing a deep discount for purchases of oil and gas that Russia can no longer export to Europe.

The West has largely dismissed Xi's peace plan for Ukraine as at best too vague to make a difference, and at worst a ploy to buy time for Putin to rebuild his forces and tighten his grip on occupied land.

But Kyiv, perhaps hoping to keep China neutral, has been more circumspect, cautiously welcoming the plan when China unveiled it last month. Zelenskyy has repeatedly called on Xi to speak to him.

Ukrainian officials hinted that a phone call could be in the works: “We are waiting for confirmation,” Ukraine's Deputy Prime Minister Iryna Vereshchuk told Italian newspaper Corriere della Sera. “That would be an important move. They have things to say to each other.”

Kyiv says firmly there can be no peace talks with Russia unless it withdraws its troops. Moscow says Kyiv must accept territorial “realities” – a reference to its claim to have annexed nearly a fifth of Ukraine.

Washington has said over the past month that it is worried that Beijing could arm Russia, which China denies.

Explosion in Crimea

On the ground, Ukraine's Defence Ministry said an explosion in Dzhankoi city in Crimea overnight destroyed Russian Kalibr-KN cruise missiles as they were being transported by rail for use by Russia's Black Sea Fleet to attack Ukraine.

Russian-installed officials in Crimea, controlled by Moscow since 2014, said the blast was caused by drones laced with shrapnel and explosives, and targeted civilian sites. One person was injured, they said.

Kyiv never discusses responsibility for attacks in Crimea. Dzhankoi is Crimea's main railway hub, linking routes to Russia proper with naval bases on the peninsula and Russian-occupied territory in mainland Ukraine.

Mick Ryan, a retired Australian major general and military analyst, said Ukraine apparently being able to hit the cargo “forces the Russians to rethink their force posture and defensive deployments in Crimea and beyond”.

“Strikes like this are not war winning silver bullets. But, their impact is cumulative on the degradation of Russian morale and war fighting capability,” he tweeted.

Kyiv recaptured swathes of territory in the second half of 2022, but its forces have largely kept to the defensive in recent months. Moscow, meanwhile, has launched a massive winter offensive using hundreds of thousands of freshly called-up reservists and convicts recruited as mercenaries from jail.

Despite the bloodiest fighting of the war, which both sides describe as a meatgrinder, the front line has barely moved for four months.

The one exception has been around the small eastern city of Bakhmut, where Russian forces made gains in January and February. Kyiv has decided this month not to pull its forces out of the city.

In the town of Chasiv Yar, just west of Bakhmut, bursts of incoming and outgoing artillery fire could be heard. Between apartment blocks, mainly elderly residents queued for water and food delivered by a team from the State Emergency Service.

Oleksii Stepanov said he had been in Bakhmut until five days ago but was evacuated when his house was destroyed by a missile.

“We were in the kitchen and the missile came through the roof. The kitchen was all that was left standing,” said the 54-year-old.

For the latest headlines, follow our Google News channel online or via the app.

Russia's reliance on China rises amid Ukraine sanctions

Putin says Russia-China ties have ‘unlimited possibilities’

World

US ‘extremely troubled’ by Israeli parliament vote to legitimize settlements

The United States said Tuesday it was “extremely troubled” by the Israeli parliament's vote legitimizing some settlements, calling the move "provocative" and in violation of promises to ally Washington.

“The United States is extremely troubled that the Israeli Knesset has passed legislation rescinding important parts of the 2005 disengagement law,” State Department spokesman Vedant Patel told reporters.

Iran protest abuses could be ‘crimes against humanity’: UN expert

Iran’s protest anthem ‘Baraye’ played at White House celebration

World

End of truce: Colombia kills two cartel members, captures one

The Colombian army said Tuesday it had killed two members of the infamous Gulf Clan drug cartel and captured one of its bosses as operations resumed after the government called off a ceasefire.

On New Year’s Eve, the government of new President Gustavo Petro had declared a bilateral ceasefire with armed groups including the Clan, National Liberation Army (ELN) rebels and dissidents of the disarmed former Revolutionary Armed Forces of Colombia (FARC) guerrilla group.

For the latest headlines, follow our Google News channel online or via the app.

It was a first step in leftist Petro’s “total peace” plan to end decades of armed conflict through negotiation.

But on Sunday, Petro suspended the truce with the Gulf Clan, accusing it of being behind attacks on civilians.

The government said the group had been supporting attacks by illegal gold miners since March 2 in the country’s northwestern Antioquia department.

Workers in illegal mines have been protesting the government’s destruction of the heavy machinery they use to dredge up soil to find gold.

Miners have shut down roads, and attacked a town hall and a bank in the Caucasia district.

On Monday, the army said, it had captured the alleged “coordinator of the hired killers… of this illegal group,” a man known as “Andres,” in the Antioquia region.

According to Defense Minister Ivan Velasquez, some 10,000 policemen and soldiers were deployed to the area.

And in a video sent to the media, the military said a “confrontation” in the neighboring Bolivar department “caused the deaths of two members of the Clan.”

The troops will “continue military operations,” added Colonel Luis Cifuentes, in charge of operations against the Clan.

Criminal groups in Colombia make almost as much money from illegal mining as they do from trafficking cocaine, authorities say.

According to official estimates, the Gulf Clan – Colombia’s biggest cartel – is behind between 30 and 60 percent of the drugs exported from Colombia, the world’s largest cocaine producer.