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Pfizer Says Its Antiviral Pill Is Highly Effective in Treating Covid

Pfizer Says Its Antiviral Pill Is Highly Effective in Treating Covid

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The Pfizer pill appears to be more effective than a similar offering from Merck, which is awaiting federal authorization.
Credit…Bebeto Matthews/Associated Press

Pfizer announced on Friday that its pill to treat Covid-19 had been found in a key clinical trial to be highly effective at preventing severe illness among at-risk people who received the drug soon after they exhibited symptoms.

The antiviral pill is the second of its kind to demonstrate efficacy against Covid. It appears to be more effective than a similar offering from Merck, which is awaiting federal authorization.

Pfizer’s pill, which will be sold under the brand name Paxlovid, cut the risk of hospitalization or death by 89 percent when given within three days of the start of symptoms.

Pfizer said an independent board of experts monitoring its clinical trial had recommended that the study be stopped early because the drug’s benefit to patients had proved so convincing. The company said that it planned to submit the data as soon as possible to the Food and Drug Administration to seek authorization for the pill to be used in the United States.

“The results are really beyond our wildest dreams,” said Annaliesa Anderson, a Pfizer executive who led the drug’s development. She expressed hope that Paxlovid “can have a big impact on helping all our lives go back to normal again and seeing the end of the pandemic.”

The treatment could become available in the next few months, though supplies are likely to be limited at first. The Pfizer and Merck pills are both geared toward patients regarded as high-risk, such as those above the age of 60 or with conditions like obesity that make them more susceptible to severe consequences from Covid.

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Credit…Altaf Qadri/Associated Press

When a devastating second wave of coronavirus infections hit India in the spring, hospitals were overwhelmed with sick patients and crematories struggled to bury the dead as the bodies piled up.

Now India is celebrating one its most important holidays — Diwali, the festival of lights — and many fear another wave of infections as millions gather for the celebrations.

“We let our guard down on this Diwali,” said Dr. Thekkekara Jacob John, a former head of clinical virology at Christian Medical College in the southern Indian state of Tamil Nadu. “Despite government and health experts’ warnings, people think the virus is gone — it is not.”

The holiday began on Thursday, and there is no data yet on what impact the festivities might be having on the country’s battle to curb the spread of the virus. But epidemiologists said that they already had concerns.

People have been thronging markets with little social distancing, and hundreds of thousands traveled around the country this week to celebrate the holiday with their family members.

“For this Diwali, people almost forgot the virus is still here and killing people,” said Dr. Prakash Singh, a virologist in New Delhi, India’s capital.

Last year’s festival was observed without the usual fanfare of group prayers and fireworks. Then, the authorities deployed police officers in residential areas to restrict large gatherings. Hundreds of people in New Delhi were fined for breaching coronavirus restrictions.

Before this year’s gatherings, health officials in India had already been warning of a possible third wave of infections, even though the second wave has at best only leveled off. A relaxed attitude — combined with the holiday festivities — could hamper the country’s fight against the virus, they said.

During the second wave in the spring, the country experienced one of the world’s worst coronavirus surges, reaching a tragic peak in early May of more than 400,000 cases reported per day, with 4,500 daily deaths.

But as vaccinations picked up after a slow and chaotic initial rollout, India saw cases plummet. More than three out of four adults have now received at least one vaccine shot, according to government data. And Prime Minister Narendra Modi’s government recently lifted an eight-month ban on vaccine exports.

More than 680,000 people flew from airports across the country on Monday in the lead-up to the festival, government officials said.

The surge in travel was an apparent sign of confidence in the country’s inoculation campaign, with 54 percent of the population having received at least one shot and 25 percent having been fully inoculated, according to the Our World in Data project at the University of Oxford.

During a strict lockdown from late March to late May last year, most of India’s Covid-19 cases were concentrated in urban areas. But as restrictions on interstate travel were eased, many people started moving from the cities to rural areas, bringing the virus with them. That is what experts fear might happen this time.

On Friday, a throat-burning cloud settled over New Delhi, swallowing national monuments, as the air quality deteriorated to the “severe” category a day after Diwali. Despite a government ban, people had celebrated the holiday by setting off fireworks.

Amit Tandon, a businessman in the northern Indian city of Chandigarh whose wife died during the second wave of infections in April, said that he was pained by the scenes of people celebrating the holiday while ignoring health restrictions.

“When I saw people mixing together without masks and bursting firecrackers, my blood boiled,” he said. “Only those who lost their loved ones know how this disease can destroy families and lives.”

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Credit…Saul Loeb/Agence France-Presse — Getty Images

The U.S. federal government has canceled its contract with a troubled Covid-19 vaccine manufacturer that ruined millions of doses and had to halt production for months after regulators raised serious quality concerns.

The decision marks a stark reversal of fortune for the politically connected contractor, Maryland-based Emergent BioSolutions, and an abandonment by the government of a deal that was supposed to be a centerpiece of Operation Warp Speed.

Early in the pandemic, the government decided to bank on the company to be the sole domestic manufacturer of the Johnson & Johnson and AstraZeneca vaccines. But this March, testing found that a batch of the Johnson & Johnson vaccine had been contaminated, and Emergent agreed to pause manufacturing after an inspection uncovered a host of problems at its facility in the Bayview area of Baltimore.

The termination of the contract, disclosed on Thursday by Emergent executives during a call with investors, was the result of negotiations that began after the government this year stopped making payments under the deal, which was awarded in May 2020 and was worth more than $600 million. Emergent will now forgo roughly $180 million of that amount, according to company disclosures.

The company said that it would continue working with Johnson & Johnson to produce its vaccine in Baltimore because the arrangement with that company, while endorsed by the government, was not financed under the $600 million deal. While the site has not yet won regulators’ approval, it has resumed operations, and the Food and Drug Administration has allowed roughly 100 million doses to be released for potential use.

The contract cancellation also brings an abrupt end to a nearly decade-old effort by the government that was intended to better prepare for a pandemic. In 2012, the Department of Health and Human Services gave Emergent a $163 million contract to expand the Baltimore site and make it ready to rapidly produce vaccines in response to a novel virus.

The cancellation will likely have no impact on the availability of coronavirus vaccines in the United States. The contract only involved production of AstraZeneca’s vaccine, which is not authorized for distribution in the United States.

But the manufacturing problems at the Bayview site have affected immunization efforts outside the United States, delaying the distribution of vaccines in Canada, the European Union and South Africa.

Sharon LaFraniere and Sheryl Gay Stolberg contributed reporting.

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As new coronavirus cases surge to record levels in Latvia, Parliament on Thursday passed a law giving employers permission to fire workers who refuse to be vaccinated or to work remotely when possible, a spokesman for the legislative body said.

Officials in the Baltic country of 1.9 million people also declared a three-month state of emergency starting on Nov. 8 as new coronavirus cases soar to levels not seen there before.

As of Nov. 1, Latvia had the second-worst rate of per capita infection in the European Union, after neighboring Estonia. Only slightly more than 60 percent of Latvian adults have been fully vaccinated, significantly below the European average of 75 percent, according to the European Centre for Disease Prevention and Control.

“Today, Latvia is at the epicenter of the Covid-19 crisis, because we have lacked solidarity and a clear direction towards this common goal for society as a whole,” Daniels Pavluts, the health minister, told members of the Saeima, the Latvian Parliament, on Thursday during the debate on the law.

On Nov. 3, the country reported 2,718 new cases in the preceding 24 hours, according to the Johns Hopkins University global Covid tracker, and a total of 3,357 have died since the beginning of the pandemic.

Mr. Pavluts blamed a polarized political environment and rampant disinformation about vaccines, some of which had been repeated by politicians, for the resistance to vaccination in the country. “As a result, we started the autumn wave as an under-vaccinated society and today we have a medical system that works practically in wartime conditions,” he said.

The president, Egils Levits, still has to sign the new law for it to come into force. The legislation says that people without proof of vaccination or recovery from Covid, or a valid medical exemption, can be internally transferred when possible, or suspended for up to three months without pay, after which they can be fired.

Mandatory vaccines are contentious in Latvia. An estimated 5,000 people protested in Riga, the capital, in mid-August when the idea of empowering employers to fire workers for refusal was first floated. According to Latvia’s public broadcaster, 52 members of the Saeima voted in favor of the mandatory vaccination legislation, while 27 opposed it, and two abstained.

Latvia was among the first in Eastern Europe to reimpose a lockdown this autumn, which began on Oct. 19 and will last until at least Nov. 15. At the time, Prime Minister Krisjanis Karins sought assistance from other E.U. members in building field hospitals to cope with the growing number of Covid patients in need of urgent care.

The new rules for employers are set to take effect when the lockdown ends on Nov. 15, according to Reuters, and the law provides exceptions for those who have a medical reason not to vaccinate or have recently recovered from the virus.

Previously, vaccines were mandatory only for the health and education sectors, as well as for social workers.

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Credit…James Estrin/The New York Times

Parents of schoolchildren in New York City — and hopefully some students themselves — got some exciting news on Thursday when Mayor Bill de Blasio announced that a $100 vaccine incentive it had been offering to New Yorkers to get a first vaccine dose would also apply to them.

Rather than getting handed a crisp $100 bill, guardians of children who get vaccinated at a city-run site or at their schools will receive an email telling them how to retrieve the incentive, which comes in the form of a $100 prepaid debit card.

Families can also choose other incentives, such as tickets to the Statue of Liberty or to a Brooklyn Cyclones baseball game. Unfortunately, children getting their vaccines at pharmacies or private hospitals do not qualify.

While many appointments were being snapped up on Thursday, parents and children can also just walk into city vaccination sites. And thousands of children are expected to be inoculated at their place of learning starting on Monday as the city rolls out a vaccine clinic program to its 1,070 schools that serve children of elementary school age.

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Credit…Sarahbeth Maney/The New York Times

WASHINGTON — A White House aide who traveled with President Biden to Scotland tested positive for the coronavirus this week and remains in quarantine abroad, according to an administration official who spoke on the condition of anonymity to describe a medical issue.

The aide tested positive on Tuesday after taking a lateral flow test, which was a daily requirement to attend the United Nations climate summit held in Glasgow, but has not shown any symptoms of Covid-19. President Biden was not in close contact with the aide, the official said.

The aide has taken subsequent tests, but those came back inconclusive, the official said. The aide remains in quarantine in Scotland, and is waiting on the results of a P.C.R. test.

Mr. Biden tested negative for the virus on Tuesday, the official said. The president, who is 78, received a booster shot in September.

Aides who had close contact with the person who tested positive traveled separately from the president from Scotland to the United States, the official said, and have tested negative since. The positive case was first reported by Bloomberg.

On Sunday, Jen Psaki, the White House press secretary who stayed behind from the trip at the last minute because of a family emergency, said that she had tested positive for the coronavirus.

“Thanks to the vaccine, I have only experienced mild symptoms, which has enabled me to continue working from home,” Ms. Psaki said on Sunday.

Karine Jean-Pierre, the White House principal deputy press secretary, traveled on the trip while Ms. Psaki stayed home and went into quarantine, and has been holding press briefings at the White House this week.

Mr. Biden traveled abroad with a large delegation that included his national security adviser, Jake Sullivan, and the secretary of state, Antony Blinken. The president’s entourage also included several press officials who interacted both with other White House officials and with numerous journalists covering the trip.

In July, after a White House staff member tested positive for the virus, Ms. Psaki warned that there would be more breakthrough cases and said that precautions were in place to protect the president.

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Credit…Kim Kyung-Hoon/Reuters

Japanese officials said on Friday that they would reduce the length of quarantine for vaccinated business travelers from 10 days to three, reflecting the incredible turnaround in the country’s control over the coronavirus.

Travelers with vaccination documents recognized by Japanese health officials “will be allowed to go out for their necessary businesses or training, or use public transportation” after quarantining for three days with a negative test for the virus, Seiji Kihara, Japan’s deputy chief cabinet secretary, said.

He added: “We will examine the situation if we can allow group tourists to visit again, aiming at by the end of the year.”

Japan has virtually closed its borders since the start of the pandemic, and the easing of rules comes as cases decline significantly. While new daily cases rarely went below 10,000 a day in August, peaking at 25,851 on Aug. 20, they have steadily declined to below 310 in the past week, according to data provided by the Health Ministry.

The change, which will take effect on Monday, will be part of a broader easing of travel rules in Japan, the world’s third-largest economy. Japan will also start letting in international students and issue long-term visas to business travelers, Mr. Kihara said.

But Japan’s border restrictions remain some of the strictest in the region despite about 73 percent of the country’s population having been fully vaccinated, according to data from the University of Oxford.

So far, only visitors with visas have been able to enter, and they needed to quarantine for 14 days. The authorities shortened that period to 10 days in October for those with full doses of Pfizer, Moderna or AstraZeneca vaccines. Recipients of Sinovac and Johnson & Johnson vaccines, and unvaccinated travelers, have been stuck with the 14 days.

Source: https://www.nytimes.com/live/2021/11/05/world/covid-delta-variant-vaccine