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Sanofi Says Its Vaccine Results Show 100% Efficacy Against Severe Disease

Sanofi Says Its Vaccine Results Show 100% Efficacy Against Severe Disease

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A coronavirus vaccine, made by the European-based pharmaceutical companies Sanofi and GSK, was among the candidates that received billions of dollars for development from Operation Warp Speed, the Trump administration’s program to accelerate vaccines.
Credit…Eric Piermont/Agence France-Presse — Getty Images

Two doses of a new Covid vaccine that is based on a conventional approach achieved 100 percent efficacy against severe disease and hospitalizations, and it could be an effective booster after other Covid shots, the vaccine’s manufacturers announced on Wednesday.

The vaccine, made by the Europe-based pharmaceutical companies Sanofi and GSK, is one of four candidates that received billions of dollars for development from Operation Warp Speed, the Trump administration’s program to accelerate vaccines.

The new vaccine had an efficacy of 75 percent against moderate-to-severe disease. It showed 58 percent efficacy against symptomatic disease in its Phase 3 clinical trial. Although that number is lower than was observed for the mRNA vaccines made by Pfizer-BioNTech and Moderna in their initial trials, it is “in line with expected vaccine effectiveness in today’s environment dominated by variants of concern,” Sanofi and GSK said in a statement. The number of infections observed in the trial was small, however, and the efficacy may have been lower in a bigger trial.

Used as a booster dose after one of the other available coronavirus vaccines, the Sanofi-GSK shot increased antibody levels by 18- to 30-fold. The companies intend to submit the vaccine for authorization to regulatory authorities in the United States and Europe, they said on Wednesday.

Sanofi and GSK were expected to seek authorization for their vaccine last year, but shelved those plans after clinical trials showed disappointing results in older adults. They then developed a stronger version of the vaccine and tested it in new trials.

In laboratory studies, two doses of the Sanofi-GSK vaccine stimulated the production of more neutralizing antibodies than an approved mRNA vaccine, according to the companies. The data have not yet been published. The vaccine was safe and well-tolerated by adults of all ages, the companies said.

The best target for Covid vaccines is a protein called spike that covers the surface of the virus like a crown. While the mRNA vaccines contain the genetic instructions for making the protein, the Sanofi-GSK vaccine uses a slightly modified version of the protein itself to stimulate an immune response.

This is a commonly used approach for vaccines, and so may convince some people who have been hesitant to adopt the newer mRNA technology. Protein-based vaccines are also relatively inexpensive to manufacture and may not require the ultracold storage needed for the mRNA vaccines. Those features make them more likely candidates for rollout in African nations where vaccine coverage is still very low.

The pharmaceutical company Novavax last month applied to the Food and Drug Administration for authorization of a similar protein-based vaccine.

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Credit…Ahn Young-Joon/Associated Press

South Korea on Wednesday approved the Pfizer-BioNTech’s coronavirus vaccine for 5- to 11-year-olds, as case counts shatter even the most pessimistic government projections issued earlier in the Omicron wave.

The country, which had been a pandemic success from the start, is now grappling with one of the world’s worst outbreaks. South Korea recorded 171,452 new cases on Tuesday — a jump of nearly 72,000 from the day before — its highest figure by far since early 2020.

Omicron became the nation’s dominant variant in late January, and experts originally predicted that daily case counts would reach 30,000 in February. Their projections have risen several times, including last week, when they said daily case counts could reach 170,000. Now, the government is expecting 270,000 cases a day by March.

South Korea has seen a 214 percent increase in daily cases over the past two weeks to a daily average of 110,904, according to Our World in Data. Several other places in Asia have had similar surges over the same period, including Malaysia, with a 234 percent increase, and Hong Kong, with a 3,168 percent increase.

South Korea, a nation of about 50 million people, is now reporting more cases each day than the United States, a once unimaginable development.

Confronting the more contagious but less virulent Omicron variant, South Korea has moved away from its rigorous contact tracing system and has expanded its immunization campaign.

7–day average

110,904

Source: Center for Systems Science and Engineering (CSSE) at Johns Hopkins University. The daily average is calculated with data that was reported in the last seven days.

The Ministry of Food and Drug Safety announced on Wednesday that it was expanding access to the Pfizer vaccine to children ages 5 to 11 — the first vaccine approved for this age range in the country. In a statement, the ministry said that the shot would be 90.7 percent effective against the virus.

South Korea is also shifting its focus toward testing and treating high-risk groups and severe cases.

“Considering the characteristics of Omicron,” Park Hyang, a senior health official, said at a news briefing on Tuesday, “it is more important to stably manage the medical system’s capacity and minimize severe cases and deaths rather than the number of confirmed cases.”

The country has averaged about 57 deaths per day from Covid over the past week.

Trying to “live with Covid,” the government has shortened quarantine periods to seven days. Vaccine passes are no longer required at malls and major shopping centers, and businesses are now allowed to operate until 10 p.m., an hour later than before.

“If we can overcome this surge, this will be a good opportunity to go back to normal,” Lee Ki-il, a senior health official, said at a news briefing on Friday.

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WELLINGTON, New Zealand — The antigovernment protests that jolted Canada have been quashed. But nearly 9,000 miles away, in the capital of another Western democracy largely unaccustomed to violent tears in the social fabric, an occupation on the grounds of Parliament has entrenched itself and turned increasingly ominous.

Hundreds of demonstrators opposed to New Zealand’s coronavirus vaccine mandate are in their third week of encampment in Wellington, building tents, illegally parking vehicles and establishing communal kitchens and toilets in a deliberate echo of the Canadian siege.

Initially, the New Zealand occupation had a carnival-like atmosphere, with a popcorn stand, a doughnut truck and a number of children brought in by their parents. New Zealanders joked that it was the country’s only Omicron-era music festival: Officials blared Barry Manilow and James Blunt to try to drive out the protesters, who responded with some Twisted Sister.

In recent days, however, after the police moved to evict some protesters, the demonstration has grown more violent. On Monday, protesters threw feces at the police. On Tuesday, a driver tried to ram a car into a large group of officers, and three other members of the force required medical attention after protesters sprayed them with what a police statement called a “stinging substance.”

Pete McKenzie

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Credit…Karsten Moran for The New York Times

With federal in-flight and airport mask mandates scheduled to expire next month, a flight attendants’ union is pushing the Biden administration to extend the mask requirement until more people are vaccinated against the coronavirus.

In a statement, the Association of Flight Attendants-C.W.A. said that allowing the mask requirement to lapse on March 18 would endanger medically vulnerable travelers as well as passengers under 5, who are not yet eligible for a vaccine in the United States.

“The layered approach to safety and security includes masks,” the union,which represents 50,000 flight attendants at 20 airlines, said in a statement on Tuesday.

The Biden administration imposed the mask rule for flights a year ago, during a brutal rise in coronavirus cases across the country before vaccines were widely available. People who did not comply were subject to fines. Officials extended the mandate twice as deadly new waves of infection washed over the nation.

As the most recent wave, driven by the highly contagious Omicron variant, has dwindled in recent weeks, states and local authorities across the United States have been relaxing mask requirements, and so have some major employers. But many forms of public transportation, including air travel, are regulated by the federal Transportation Security Administration, whose mask requirements for passengers and crew has not been lifted.

Patricia Mancha, a spokeswoman for the T.S.A., said on Tuesday night that the requirement was still on track to expire on March 18. “If there is a change to halt or extend the mask requirement, we will make an announcement,” she said in an email. “As of now, nothing new to share.”

Many flight crews are anxious about the prospect.

Disagreements over masks and the refusal of some passengers to wear them often led to shouting matches, fights and other problems with unruly passengers during the pandemic. From Jan. 1 to Feb. 15, the Federal Aviation Administration received nearly 400 reports of unruly passengers, including 255 reports of passengers refusing to comply with the federal mask mandate.

Last month, a man on a Delta Air Lines flight from Dublin to New York who refused to wear a mask pulled down his pants and exposed his buttocks, and an American Airlines flight to London from Miami turned around about an hour into its journey because of a passenger who refused to wear a mask.

Cases like those are why airline executives and the Association of Professional Flight Attendants have been urging the federal authorities to create a federal no-fly list for unruly passengers.

Many flight attendants support extending the mask requirement as well. “It’s also critical that we maintain passenger confidence in the safety of air travel,” the union said in its statement.

The federal mask mandate for air travel has faced court challenges — the Republican attorney general of Texas filed such a suit last week — but so far, the courts have sustained it.

Some airline executives have questioned the efficacy of masks on planes. At a Senate hearing in December, Gary Kelly, the chief executive of Southwest Airlines, said, “The case is very strong that masks don’t add much, if anything, in the air cabin environment.”

But Dr. Anthony S. Fauci, the nation’s top infectious disease expert, urged travelers to wear face masks at airports and during flights. “Even though you have a good filtration system, I still believe that masks are a prudent thing to do, and we should be doing it,” he said a few days after the hearing.

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Credit…Jamie Kelter Davis for The New York Times

Chicago will end its mask and coronavirus vaccine mandates for some public places such as restaurants starting on Monday after a recent plunge in cases of the Omicron variant, the city’s mayor said on Tuesday. The move aligns with Illinois’s plan to end a statewide indoor mask mandate that same day.

The announcement by Mayor Lori Lightfoot does not apply to some spaces — notably health care settings and public transit, where masks will still be required.

“It’s important for us to recognize this moment for what it is: a huge step forward in our effort to overcome Covid-19,” Ms. Lightfoot said. “We would not have been in a position even a few weeks ago to be making this kind of announcement today.”

Democratic-led states and cities announced similar moves this month as Omicron cases declined after a devastating wave that began in December. Connecticut, Illinois and Massachusetts will also lift some mask mandates starting Monday. Washington, D.C., will end a mask mandate for schools that day.

The United States is seeing a daily average of 89,000 cases, a 65 percent decrease over two weeks, while daily average hospitalizations have also declined 43 percent to about 66,000 during that time, according to a New York Times database. Despite the optimistic data trends, the average daily death toll from the virus still exceeds 2,000.

Chicago officials said the decision to ease the mandates was made as key metrics — including daily cases, test positivity and hospitalizations — were all in a significant reversal from the surge. The city’s number of cases and hospitalizations have been halved over the past two weeks.

“This doesn’t mean Covid is gone,” Dr. Allison Arwady, the city’s public health commissioner, said in a statement. “It simply means transmission levels are lower than they have been during surges. I still encourage people to take precautions and definitely get vaccinated to protect yourself and your loved ones.”

Sam Toia, the president of the Illinois Restaurant Association, said he welcomed the decision by Ms. Lightfoot to lift the mandates, which were put in place in January. “It’s been a tough January and February for restaurant operators,” he told The Chicago Sun-Times on Tuesday.

It was unclear what Ms. Lightfoot’s decision meant for Chicago Public Schools. Debates over pandemic mandates at schools have been among the most acrimonious, as parents opposed to masking have showed up in force to school board meetings.

The district and the Chicago Teachers Union did not immediately respond to messages left by a reporter, and the mayor said she expected an announcement from the district “in a couple days.”

For her part, Ms. Lightfoot, who caught the coronavirus during the Omicron surge, said that she would continue to wear a mask in public places. “That’s my personal choice,” she said.

She said she would be particularly careful in restaurants, now that there was no longer a requirement to show proof of vaccination to enter. “I’ll be wearing a mask,” she said.

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Credit…The New York Times

ISTANBUL — Turkey’s economy was already in recession before the pandemic hit, and because it relies heavily on tourism and the hospitality industry, the months of lockdown have badly hurt many businesses and robbed many residents of income. Now the country is grappling with runaway inflation.

The Turkish lira has sunk to record lows. Food and fuel prices have already more than doubled. Now it is electricity.

It began with a few outraged customers posting photographs of their electricity bills to social media, showing how charges had almost doubled at the end of January. But such complaints have quickly snowballed into a full-blown political crisis for the government of President Recep Tayyip Erdogan.

When Mr. Erdogan raised the minimum wage last month to help low-income workers, his government warned that there would be an increase in the utilities charges it sets. But few expected such a shock.

Restaurants and cafes trying to recover after two years of losses from the pandemic were reeling this month after electricity and gas bills doubled.

“During the pandemic, we were closed for 19 months,” said Ilker Tiniz, 37, who runs a family-owned restaurant in the southern city of Adana. “We did delivery. My credit cards exploded, and we were taken to the debt enforcement office.”

In January, his rent rose to 15,000 lira (about $1,150 at the time). Then the electricity bill came in even higher at 17,000 lira. Mr. Tiniz went on Twitter to voice his alarm in among the first of what has grown into a storm of complaints from citizens.

Despite the difficulties during the pandemic, there had always been hope that things would get better, Mr. Tiniz said in an interview at his restaurant, but the galloping inflation was shaking everything in the whole food chain, from the farmers to market traders to the customers in his restaurant.

“I wrote that tweet so that the government hears my voice,” he said.

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Credit…Clodagh Kilcoyne/Reuters

Ireland will end social distancing in schools and lift its mask requirement “in all settings where currently regulated,” officials announced on Tuesday. Public health officials will still recommend the use of masks on public transportation and in health care settings.

The new guidance, to go into effect on Monday, came after a recommendation by the National Public Health Emergency Team.

“Following a recent moderate increase — particularly amongst young adults — the number of infections detected per day remains high but has stabilized, and may be starting to decrease,” the government said in a statement. “While the burden on our hospitals remains significant, it is relatively stable.”

The outlook for Covid in the country is “broadly stable and positive,” Stephen Donnelly, the health minister, said in a statement on Friday. The advice from the public health team “is a key indicator that we are moving forward in terms of our ability to live with Covid-19,” he said.

7–day average

4,288

Source: Center for Systems Science and Engineering (CSSE) at Johns Hopkins University. The daily average is calculated with data that was reported in the last seven days.

Mr. Donnelly credited the Irish people and the country’s vaccine program. The daily average of new cases has dropped 18 percent in the past two weeks, and 80 percent of the country is fully vaccinated, according to a New York Times database.

Ireland has gradually loosened its pandemic restrictions this year. Last month, the country cleared the way for its first full public celebration of St. Patrick’s Day in two years when it announced that most Covid restrictions would end.

That decision allowed bars and restaurants to remain open past 8 p.m., the closing time that had been mandated in the run-up to the holiday season as Omicron cases surged. It also eliminated restrictions on the number of people who could attend events like weddings, concerts, sporting events and funerals.

“Spring is coming, and I don’t know if I have ever looked forward to one as much as this one,” the prime minister, Micheal Martin, said last month. “Humans are social beings, and we Irish are more social than most. As we look forward to this spring, we need to see each other again; we need to see each other smile; we need to sing again.”

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Credit…Constantn Zinn/EPA, via Shutterstock

The European Council recommended on Tuesday that the 27 member nations of the European Union end testing and quarantine requirements for visitors who have received coronavirus vaccines that are authorized within the union or approved by the World Health Organization.

The guidance from the council, which brings E.U. leaders together to set the bloc’s political agenda, is not binding, but it is in line with a wider trend in Europe toward relaxed regulations, especially those covering travel and tourism. It is meant to apply beginning March 1.

If it is put into effect, the policy would mean that visitors who received a booster dose of a vaccine, or completed an initial full vaccination at least 14 days but no more than 270 days before arrival, could enter a member country without presenting a negative coronavirus test result or spending time in quarantine. The same would be true for visitors who had recovered from a coronavirus infection within the past 180 days. The rules would apply to adults and to children over 6.

The guidance also recommends more relaxed rules for deciding which countries qualified for the European Union’s “safe travel” list. The new requirement for eligibility would be a two-week average of fewer than 100 new cases a day for every 100,000 population; the current ceiling is 75 cases per 100,000. The United States is well under the ceiling, with a current average of 27 per 100,000, according to a New York Times database.

The European Union bars most nonessential travelers from countries that do not qualify for its safe travel list, and those it does admit may be subject to testing and quarantine requirements.

The union’s regulatory agency has authorized five coronavirus vaccines, developed by Pfizer and BioNTech, Moderna, AstraZeneca, Johnson & Johnson, and Novavax. The W.H.O. has approved some other vaccines as well; travelers who have received those may still be asked to show a negative P.C.R. test result or to quarantine on arrival, the European Council said.

In late January, the union recommended that vaccinated residents should not be required to undergo testing or quarantine when traveling to other member states. On Feb. 1, Denmark lifted all of its domestic pandemic restrictions, the first member nation to do so. Denmark’s move was followed in quick succession by similar announcements in Austria, Germany, Slovakia and several regions of Spain, as well as nonmember countries like Switzerland and Britain.

One of the council’s recommendations on Tuesday — that tourists not be exempt from restrictions if they got their last dose of vaccine more than 270 days before arrival — raised the possibility that people who were vaccinated very early and have not received boosters could be barred from entry.

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Credit…Maciek Nabrdalik for The New York Times

Poland will lift most of its remaining coronavirus restrictions on March 1, but it will keep in place a mask mandate for public transportation and indoor venues.

“We’re abolishing most of the restrictions and leaving only those that are most necessary,” Prime Minister Mateusz Morawiecki said to reporters on Wednesday, adding that office workers would no longer be required to work remotely.

Deaths and hospitalizations, mainly fueled by the Omicron variant, have been lower than anticipated, Mr. Morawiecki said. While the pandemic was not over, he added, the encouraging trends made the risk of shifting to an endemic approach to the virus worthwhile.

The move is a turnaround for the Eastern European nation, which was among a handful of countries in the region that were hit especially hard by earlier variants. Last spring, Poland reported some of highest excess death rates in Europe.

To curb the spread of Omicron-driven infections, Poland stepped up its testing efforts and instated remote learning for some students.

On Wednesday, officials said the country reported 20,456 new coronavirus cases, a 30 percent drop from the previous week, and 360 deaths. A majority of those deaths were people who had not been fully vaccinated, Polish health officials said.

According to a New York Times tracker, about 58 percent of the country’s population is fully vaccinated.

Poland is the latest in an increasing lineup of European countries that have announced intentions to scrap coronavirus rules after a long winter that saw Omicron drive new waves of infections across the continent.

England said this week that it planned to remove its remaining legal curbs and end free coronavirus testing. And Germany announced this month that it would abolish most of the country’s remaining restrictions by March 20.

Isabella Kwai and Tolek Magdziarz

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Credit…Dieu-Nalio Chéry for The New York Times

While New York State officials have begun lifting certain coronavirus pandemic restrictions, not all residents are happy to see them go, according to a new poll released Tuesday by the Siena College Research Institute.

Forty-five percent of registered voters in the survey said the state should have kept in place its rule requiring masks or proof of full vaccination in indoor public places, which was recently rescinded. Some 31 percent said the mandate should have been ended earlier, and 20 percent said it ended at the right time, the poll found.

When it comes to masks in schools, 58 percent of respondents said they agreed with Gov. Kathy Hochul’s decision to wait to review virus data for early March before deciding whether to extend the state mandate, while just 30 percent said they thought the school mask mandate should have ended already, and 10 percent said they wanted to see it end after this week’s midwinter break.

The poll was conducted from Feb. 14 to Feb. 17 and surveyed 803 registered voters in New York State, with a margin of sampling error of plus or minus 3.9 percentage points. Polls of registered voters offer a snapshot of political sentiment at a particular moment in time, but are less predictive of electoral outcomes.

Respondents without children at home were the group most likely to agree with Governor Hochul’s plan to review March data before acting on the school mask mandate, with 64 percent saying they supported waiting and seeing. Those with children at home were more evenly split, with 46 percent saying Ms. Hochul should review the March data before acting and 40 percent saying the mandate should have ended already.

Voters were essentially aligned across demographic groups, except for Republicans and conservatives, who said by wide margins that the mandate should already have ended.

“Waiting to see data from early March before deciding to lift the school mask mandate — as opposed to lifting that mandate as schools reconvene next week or wishing it had been lifted previously — is how the majority of New Yorkers would like to proceed,” Steven Greenberg, a Siena College pollster, wrote in a news release that accompanied the poll.

Ms. Hochul recently let the state’s indoor mask policy expire, allowing businesses to stop asking for proof of full vaccination or requiring masks indoors. She made that decision as the spread of the coronavirus slowed in the state. Average daily reports of new cases in New York have fallen by 57 percent over the past two weeks, according to a New York Times database. Hospitalizations fell 47 percent over the same time period.

The metrics were similar in New York City, where cases fell by 55 percent and hospitalizations by 47 percent over the past two weeks.

Katie Glueck contributed reporting.

Source: https://www.nytimes.com/live/2022/02/23/world/covid-19-tests-cases-vaccine