U.S. FDA set to authorize Pfizer, Merck COVID-19 pills this week – Bloomberg News

(Reuters) -The U.S. Food and Drug Administration is set to authorize COVID-19 treatment pills from both Pfizer Inc and Merck as early as Wednesday, Bloomberg News reported on Tuesday, citing people familiar with the matter.

The two drugs, especially Pfizer’s pill Paxlovid, are seen as promising new oral treatments that can be taken upon onset of symptoms at home to help prevent COVID-19 hospitalizations and deaths.

Merck’s drug, molnupiravir, developed with Ridgeback Biotherapeutics, was shown to reduce hospitalizations and deaths by around 30% in a clinical trial of high-risk individuals early in the course of the illness.

Molnupiravir gained a narrow vote in favor of authorization by a panel of advisers to the FDA on Nov. 30.

Meanwhile, Pfizer’s Paxlovid showed near 90% efficacy in preventing hospitalizations and deaths in high-risk patients.

The FDA did not immediately respond to a request for comment.

Britain in November became the first country in the world to approve Merck’s antiviral drug for use in people with mild to moderate COVID-19 and for those who have at least one risk factor for developing severe illness.

The United States has a contract to buy as many as 5 million courses of Merck’s drug, and 10 million courses of Pfizer’s treatment.

(Reporting by Manas Mishra in Bengaluru; editing by Uttaresh.V)

Russia fires cruise missile from Sea of Japan in test exercise -media

MOSCOW (Reuters) – A submerged Russian submarine has successfully launched a Kalibr cruise missile from the Sea of Japan at a target more than 1,000 kilometers (621 miles) away, located at a Russian training ground onshore, the RIA news agency said on Tuesday.

The drill also involved covert movement and support from military ships, aircraft and drones, it quoted Russia’s Pacific Navy as saying.

Japan lays claim to the Russian-held southern Kuril islands in the nearby Sea of Okhotsk, which Tokyo refers to as the Northern Territories in a territorial row dating from the end of World War Two, when Soviet troops seized them from Japan.

The dispute has prevented the two countries from signing a formal peace treaty.

(Reporting by Maxim Rodionov; Writing by Olzhas Auyezov)

Biden to deliver free tests, military doctors to battle surging Omicron

By Jarrett Renshaw and Ahmed Aboulenein

WASHINGTON (Reuters) – The Biden administration will open federal COVID-19 testing sites in New York City this week and buy 500 million at-home rapid tests that Americans can order online for free starting in January as it tries to tackle the Omicron variant sweeping the country.

Striking a more dire tone about the risks to the one in four American adults who remain unvaccinated, President Joe Biden will lay out the initiatives in a speech on Tuesday warning of the risks from the fast-spreading variant, a senior administration official said.

The measures include activating some 1,000 military medical personnel to support hospitals that are already being overwhelmed in some areas.

“We will also note that if you are unvaccinated, you are at high risk of getting sick. This variant is highly transmissible and the unvaccinated are eight times more likely to be hospitalized and 14 times more likely to die from COVID,” the official said.

With the holiday travel season already begun, new COVID-19 cases are surging in the United States, prompting local and federal officials to again confront just how far to go to combat the virus. Federal officials said that Omicron now accounts for 73% of all new cases, up from less than 1% at the beginning of the month.

The U.S. is mulling reducing the recommended 10-day quarantine time for people who catch COVID, to help asymptomatic people return to work or school, White House medical adviser Anthony Fauci said on Tuesday.

Health officials in Texas said on Monday the state recorded what ABC News reported is believed to be the first known U.S. death related to Omicron.

The highly contagious variant was first detected last month in southern Africa and Hong Kong, and has raced around the globe and been reported in 89 countries, the World Health Organization said on Saturday.

In New York, Washington and other U.S. cities over the weekend, lines for COVID-19 tests wrapped around the block as people clamored to find out if they were infected before celebrating the holidays with family.

Facing criticism that testing resources are inadequate, Biden will announce on Tuesday that the federal government will buy 500 million at-home rapid tests and make them available to all Americans in January.

Americans can access a new website to have them delivered, but officials are still working on how many tests a household can request.

The administration will also open multiple federal testing centers starting in New York City ahead of Christmas, a senior administration official said.

More federal sites will be opened across the country in areas of high need and when requested by local and state officials, the official said.

BREAKTHROUGH INFECTIONS RISE

Biden’s COVID-19 response has been criticized for focusing on vaccines at the detriment of testing and masking, and for underestimating the impact of the politically motivated anti-vaccine movement in the U.S.

The free tests are in addition to a plan to have health insurers provide free tests for Americans with coverage that is also expected to begin in January.

Biden will note that the Omicron variant is so contagious that it will infect vaccinated Americans but that they will be far less likely to get seriously sick.

So-called breakthrough infections are rising among the 61% of the country’s fully vaccinated population, including the 30% who have gotten booster shots.

Still, Biden will tell Americans that those who are vaccinated and follow guidance around using masks, especially while traveling, should feel comfortable celebrating the holidays as planned.

New COVID-19 cases rose 9% in the United States in the past week but are up 57% since the start of December, according to a Reuters tally.

The number of hospitalized COVID-19 patients has increased 26% this month, with hospitals in some areas already strained by the Delta variant that emerged earlier this year.

There have been almost 51 million infections and 809,268 coronavirus-related deaths reported in the country since the pandemic began, the most of any country.

(Reporting by Jarrett Renshaw and Ahmed Aboulenein; Editing by Peter Cooney and Chizu Nomiyama)

Magnitude 6.2 earthquake strikes offshore Northern California

By Sharon Bernstein

SACRAMENTO, Calif. (Reuters) -A 6.2 magnitude earthquake struck offshore in the Cape Mendocino area of Northern California, the United States Geological Service said on Monday.

The quake struck at a depth of 9 km (5.6 miles) in the Pacific Ocean about 24 miles (39 km) west of the tiny community of Petrolia along the rocky wilderness of California’s Lost Coast region in Humboldt County.

The quake did not trigger a tsunami warning because of the nature of the fault system from which it came, seismologist Lucy Jones posted on Twitter.

No injuries were immediately reported after the quake struck at 12:10 p.m. local time, Humboldt County Sheriff’s Department spokeswoman Samantha Karges, said in an email to Reuters, and no evacuations have been ordered in the sparsely populated region.

Workers and crews were deployed to check for damage to roadways, and two roads were closed due to rockslides caused by the shaking, Karges said.

A scientist in San Francisco had felt the shaking about 200 miles (320 km) away, the California Geological Survey posted on Twitter.

“Moderate to strong shaking was recorded by the seismic network along the coast,” a posting on the agency’s Twitter feed said. “The earthquake was felt in San Francisco by this CGS geologist!”

In 1992, the same region was rattled by a series of earthquakes that damaged more than 1,100 homes and businesses, destroying about 200 structures, the Los Angeles Times reported later that year.

The largest of the 1992 quakes measured 7.2, about 10 times the magnitude of Monday’s quake. A small tsunami about 2 feet (0.61 m) high was also recorded.

The Humboldt County Fire Department did not immediately respond to a request for information on whether there had been injuries or damage.

(Reporting by Sharon Bernstein in Sacramento, California, and Maria Ponnezhath in Bengaluru; Editing by Sonya Hepinstall, Matthew Lewis and Jonathan Oatis)

U.S. EPA finalizes tougher new vehicle emissions requirements

By David Shepardson

WASHINGTON (Reuters) – The Environmental Protection Agency (EPA) on Monday finalized new vehicle emissions requirements through 2026 that reverse former President Donald Trump’s rollback of car pollution cuts and will speed a U.S. shift to more electric vehicles.

EPA Administrator Michael Regan called the tough standards “doable” even as he vowed to quickly move ahead with the next round of requirements. “We are setting robust and rigorous standards that will aggressively reduce the pollution that is harming people and our planet,” Regan said.

In August, President Joe Biden’s administration proposed undoing the Trump-era action easing requirements imposed during the presidency of Barack Obama. The new rule finalized Monday is tougher than EPA’s August proposal or requirements issued by Obama.

If expressed in miles per gallon (mpg) requirements, the EPA rules would result in a fleetwide real-world average of about 40 mpg in 2026, versus 38 mpg under the August proposal and 32 mpg under the Trump rules.

Officials said the EPA as soon as next year could propose still tougher requirements through 2030 or beyond for vehicles.

“We urge the agency to get moving on the strongest possible long-term standards that rapidly accelerate the transition to zero-emission vehicles,” said Sierra Club President Ramon Cruz.

The Democratic administrations of Biden and Obama have pushed for stricter fuel efficiency standards to reduce greenhouse gas emissions and fight climate change. The new rules will result in 3.1 billion tons of avoided CO2 emissions through 2050 and come after many states and environmental groups urged the administration to impose stricter rules.

Biden wants 50% of all new vehicles sold in 2030 to be EV or plug-in hybrid models but has not endorsed California’s plan to phase out new gas-powered light-duty vehicles by 2035.

In March 2020, Trump’s Republican administration rolled back Obama’s standards to require only 1.5% annual increases in efficiency through 2026. Obama had required 5% annual increases.

The new rules take effect in the 2023 model year and require a 28.3% reduction in vehicle emissions through 2026.

The rules will be challenging for automakers to meet, especially for Detroit’s Big Three automakers. General Motors, Ford Motor Co and Chrysler-parent Stellantis NV appeared at an event Monday with Regan announcing the rules.

The Biden administration’s EV plans suffered a setback Sunday when key Democratic Senator Joe Manchin said he would not support a $1.75 trillion domestic investment bill that includes new EV tax credits that would favor Detroit’s Big Three automakers and the United Auto Workers (UAW) union.

UAW President Ray Curry said in an interview he is hopeful that the EV tax credits will ultimately be approved.

A major auto trade association, the Alliance for Automotive Innovation, said the new rules will require a substantial increase in electric vehicle sales and government incentives for consumers to buy those cars.

EPA estimates the vehicle emissions reduction benefits will exceed costs by up to $190 billion and drivers will save between $210 billion and $420 billion through 2050.

EPA estimates the savings from the new rules will outweigh the increase in vehicle costs by about $1,000 over the life of the vehicle.

EPA estimates the final rule will result in 17% of new U.S. vehicles by 2026 as EVs or plug-in hybrids.

The transportation sector is the largest U.S. source of greenhouse emissions.

(Reporting by David Shepardson; Editing by Lisa Shumaker)

Rise of Omicron dashes New York’s Christmas cheer as COVID surges

By Maria Caspani and Gabriella Borter

NEW YORK (Reuters) -COVID-19 cases surged in New York City and around the United States over the weekend, dashing hopes for a more normal holiday season, resurrecting restrictions and stretching the country’s testing infrastructure ahead of holiday travel and gatherings.

The spike is alarming public health officials, who see the Omicron variant of the coronavirus fast becoming dominant in the United States and fear an explosion of infections after the Christmas and New Year’s holidays.

With the new variant in circulation, COVID-19 cases are now doubling in one and a half to three days in areas with community transmission, the World Health Organization said on Saturday.

Lines for COVID-19 tests wrapped around the block in New York, Washington, D.C., and other U.S. cities over the weekend as people clamored to find out if they were infected before celebrating the holidays with family.

“I just want to make sure before seeing my wife’s 70-year-old mom that I’m negative,” said David Jochnowitz while waiting for a test in Washington.

With a rapid rise in infections, Washington Mayor Muriel Bowser on Monday reinstated an indoor mask mandate until the end of January and required government workers to get vaccinated, including a booster shot.

“I think we’re all tired of it,” Bowser told reporters. “I’m tired of it too, but we have to respond to what’s happening in our city and what’s happening in our nation.”

In New York City, COVID-19 cases rose 60% in the week that ended on Sunday as the Omicron variant spread rapidly around the U.S. northeast. New York has set records for the most new cases reported in a single day since the pandemic started for three consecutive days.

“It is a predictor of what the rest of the country will see soon, and the minimum – since NYC is highly vaccinated – of what other parts of the country will experience in under-vaccinated cities and states,” said Georges Benjamin, executive director for American Public Health Association.

Many Broadway productions canceled performances as cast and crew have become infected. The popular “Hamilton” production on Monday extended cancellations until after Christmas due to breakthrough COVID-19 infections.

Breakthrough infections are rising among the 61% of the country’s fully vaccinated population, including the 30% who have gotten booster shots.

Omicron appears to be causing milder symptoms in vaccinated populations, and health experts remain optimistic this wave might not cause the same spikes in hospitalizations and deaths as previous surges.

‘JUST STAY HOME’

New York City Health Commissioner Dr. Dave Chokshi on Monday said that while new COVID-19 cases have “increased sharply,” hospitalizations have not jumped at the same rate. He credited vaccinations and booster shots, which help prevent severe illness, and urged that more were needed to build a “sea wall” against the variant.

The rise of Omicron prompted Duke University in Durham, North Carolina, on Monday to require all students, faculty and staff to get a COVID-19 booster shot for the upcoming spring semester.

On Monday, Maryland Governor Larry Hogan announced he tested positive for COVID-19. U.S. Senators Cory Booker and Elizabeth Warren said the same on Sunday. All three said they had been vaccinated and boosted.

Nationally, cases rose 9% in the past week but are up 57% since the start of December, according to a Reuters tally. Hospitalized COVID-19 patients have increased 26% this month, with hospitals in some areas already strained by the Delta variant.

While cases climbed in the U.S. Northeast, Midwest hospitals are still dealing with a surge in patients from a Delta wave this fall. Michigan, Indiana and Ohio have the nation’s most hospitalized COVID patients per 100,000 residents, a Reuters tally found.

In New York City, the daily test rate reached an average of 130,000 per day, Mayor Bill de Blasio told reporters on Monday, more than double three weeks ago.

With demand for tests exceeding capacity, de Blasio said the city was working with the White House and private sector to help increase testing availability.

New York Governor Kathy Hochul said on Monday she was ramping up the state’s testing program, with 1 million kits arriving this week and the same amount in each of the next two weeks.

“More and more people are going to be testing positive from this,” she said. For those who do, she advised: “Just stay home, do not go out. Don’t go to work. Don’t go see your family.”

Omicron’s arrival is a headwind for an economic revival in New York that already lags the rest of the country, especially where employment is concerned.

The pandemic delivered an even larger body blow to the city than the country because of the outsized role played by tourism, leisure and hospitality, which suffered the worst under lockdowns and travel restrictions. New York’s jobless rate topped out at 20% in the spring of 2020 – more than 5 percentage points above the U.S. average, and is still 9%, more than twice the national rate.

(Reporting by Maria Caspani in New York, Lisa Shumaker in Chicago; Additional reporting and writing by Gabriella Borter in Washington and Peter Szekely in New York; Additional reporting by Carl O’Donnell in New York and and Greg Savoy in Washington; Editing by Bill Berkrot)

Russia presses for urgent U.S. response on security guarantees

By Tom Balmforth

MOSCOW (Reuters) – Russia said on Monday it urgently needed a response from the United States on its sweeping security demands and again warned of a possible Russian military response unless it saw political action to assuage its concerns.

Moscow, which has unnerved the West with a troop buildup near Ukraine, last week unveiled a wish list of security proposals it wants to negotiate, including a promise NATO would give up any military activity in Eastern Europe and Ukraine.

Washington has said some of Russia’s proposals are obviously unacceptable, but that the United States will respond some time this week with more concrete proposals on the format of any talks.

Emily Horne, spokesperson for the White House National Security Council, said Biden’s national security adviser Jake Sullivan spoke by phone with his Russian counterpart, Yuriy Ushakov, to stress the United States is prepared to communicate through multiple channels including bilateral engagement.

Sullivan “made clear that any dialogue must be based on reciprocity and address our concerns about Russia’s actions, and take place in full coordination with our European allies and partners. He also noted that substantive progress can only occur in an environment of de-escalation rather than escalation,” she said.

Konstantin Gavrilov, a Russian diplomat in Vienna, said that relations between Moscow and NATO had reached a “moment of truth”.

“The conversation needs to be serious and everyone in NATO understands perfectly well despite their strength and power that concrete political action needs to be taken, otherwise the alternative is a military-technical and military response from Russia,” he was quoted as saying by RIA news agency.

The U.S. response is likely to shape Moscow’s calculus over Ukraine, which has become the main flashpoint in East-West relations.

The United States and Ukraine say Russia may be preparing an invasion of its ex-Soviet neighbor. Russia denies that and says it is Ukraine’s growing relationship with NATO that has caused the standoff to escalate. It has compared it to the 1962 Cuban missile crisis, when the world came to the brink of nuclear war.

Deputy Foreign Minister Sergei Ryabkov said that Moscow had so far received no response from the United States.

“I think they’ll try to turn this into a slow-moving process, but we need it to be urgent, because the situation is very difficult, it is acute, it tends to become more complicated,” he was quoted by RIA as saying.

The Kremlin said it was still too early to assess the West’s response, but that information from “various sources” about a readiness to discuss the ideas was positive.

Asked separately about a Belarusian proposal to host Russian nuclear weapons in the event of similar deployments in its vicinity by the West, Kremlin spokesman Dmitry Peskov said Moscow had numerous options.

“It’s no secret the deployment of different types of armaments near our borders that could pose a danger would require corresponding steps to be taken to balance the situation. There are all sorts of options here,” he said.

(Reporting by Tom Balmforth, Maria Kiselyova and Dmitry Antonov; additional reporting by Steve Holland in Washington; editing by Mark Trevelyan, William Maclean)

WHO sounds warning over fast-spreading Omicron

By Stephanie Nebehay and Emma Farge

GENEVA (Reuters) -The Omicron variant of the coronavirus is spreading faster than the Delta variant and is causing infections in people already vaccinated or who have recovered from the COVID-19 disease, the head of the World Health Organization (WHO) said on Monday.

WHO chief scientist Soumya Swaminathan added it would be “unwise” to conclude from early evidence that Omicron was a milder variant that previous ones.

“… with the numbers going up, all health systems are going to be under strain,” Soumya Swaminathan told Geneva-based journalists.

The variant is successfully evading some immune responses, she said, meaning that the booster programs being rolled out in many countries ought to be targeted towards people with weaker immune systems.

“There is now consistent evidence that Omicron is spreading significantly faster than the Delta variant,” WHO director-general Tedros Adhanom Ghebreyesus told the briefing.

“And it is more likely people vaccinated or recovered from COVID-19 could be infected or re-infected,” Tedros said.

Their comments echoed the finding of study by Imperial College London, which said last week the risk of reinfection was more than five times higher and it has shown no sign of being milder than Delta.

WHO officials said however that other forms of immunity vaccinations may prevent infection and disease.

While the antibody defenses from some actions have been undermined, there has been hope that T-cells, the second pillar of an immune response, can prevent severe disease by attacking infected human cells.

WHO expert Abdi Mahamud added: “Although we are seeing a reduction in the neutralization antibodies, almost all preliminary analysis shows T-cell mediated immunity remains intact, that is what we really require.”

However, highlighting how little is known about how to handle the new variant that was only detected last month, Swaminathan also said: “Of course there is a challenge, many of the monoclonals will not work with Omicron.”

She gave no details as she referred to the treatments that mimic natural antibodies in fighting off infections. Some drug makers have suggested the same.

ENDING THE PANDEMIC

In the short term, Tedros said that holiday festivities would in many places lead to “increased cases, overwhelmed health systems and more deaths” and urged people to postpone gatherings.

“An event cancelled is better than a life cancelled,” he said.

But the WHO team also offered some hope to a weary world facing the new wave that 2022 would be the year that the pandemic, which already killed more than 5.6 million people worldwide, would end.

It pointed towards the development of second and third generation vaccines, and the further development of antimicrobial treatments and other innovations.

“(We) hope to consign this disease to a relatively mild disease that is easily prevented, that is easily treated,” Mike Ryan, the WHO’s top emergency expert, told the briefing.

“If we can keep virus transmission to minimum, then we can bring the pandemic to an end.”

However Tedros also said China, where the SARS-CoV-2 coronavirus was first detected at the end of 2019, must be forthcoming with data and information related to its origin to help the response going forward.

“We need to continue until we know the origins, we need to push harder because we should learn from what happened this time in order to (do) better in the future,” Tedros said.

(Reporting by Stephanie Nebehay and Emma Farge; Editing by Alison Williams)

Saudi-led coalition hits Yemen’s Sanaa airport – state media

(Reuters) -The Saudi-led coalition fighting in Yemen on Monday carried out air strikes on the international airport of the Houthi-controlled Yemeni capital Sanaa after asking civilians to immediately evacuate, state media reported.

The coalition called on the workers of international and humanitarian organizations in the airport to immediately evacuate as it had taken “legal measures to deal with the threat operationally,” state media said.

The coalition said it lifted the protection off specific sites in the airport and carried out strikes on “legitimate military targets” in it.

“The operation comes in response to threats and the use of the airport’s facilities to launch cross-border attacks,” it said.

During the seven-year-old conflict, forces of the Iran-aligned Houthi movement have sent drones and fired missiles into Saudi Arabia, and the Saudi-led coalition has retaliated with air strikes inside Yemen.

On Sunday, the coalition said it had destroyed a drone launched from the airport and aimed at civilians at Saudi Arabia’s King Abdullah airport in Jizan, near the border with Yemen.

The coalition also said on Sunday it conducted a military operation in Sanaa to destroy workshops and warehouses for drones and other weapons, urging civilians to avoid the area.

The coalition intervened in Yemen in 2015 after the Houthis ousted the internationally recognized government from Sanaa.

(Reporting by Nayera Abdallah, Omar Fahmy, and Moataz Mohamed; Editing by Chris Reese, Jonathan Oatis, William Maclean)

Indonesia’s Semeru volcano erupts, people warned to stay away

JAKARTA (Reuters) – Indonesia’s Semeru volcano on Java island erupted early on Sunday spewing a two km (1.24 miles) high ash column, prompting authorities to warn people to stay away from the eruption range.

Earlier this month, the eruption of Semeru, Java’s tallest mountain, ejected ash clouds and pyroclastic flows that killed at least 46 people and left several missing, while thousands were displaced.

On Sunday, the early morning eruption resulted in dense white and grey ash clouds, according to Indonesia’s Center for Volcanology and Geological Hazard Mitigation (PVMBG).

The agency warned nearby residents not to conduct any activities within a five km (three miles) radius of the eruption center and to keep a 500 meter (1,500 feet) distance from riversides due to risks of lava flow.

PVMBG also told people to not conduct any activities within 13 km (eight miles) southeast of the eruption center.

With 142 volcanoes, Indonesia has the largest population globally living in close range to a volcano, including 8.6 million within 10km (six miles).

(Reporting by Bernadette Christina Munthe; Writing by Fransiska Nangoy; Editing by Michael Perry)