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Extra Dose of J. & J. Vaccine Raises Protection, Company Says

Extra Dose of J. & J. Vaccine Raises Protection, Company Says

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Two shots of Johnson & Johnson’s Janssen vaccine delivered 94 percent efficacy against mild to severe Covid-19, the company said.
Credit…Tobias Schwarz/Agence France-Presse — Getty Images

A second dose of Johnson & Johnson’s vaccine substantially increased its protection against Covid-19, the company announced Tuesday morning.

In a clinical trial, researchers found that two doses of the vaccine delivered 94 percent efficacy against mild to severe Covid-19 in the United States, up from 74 percent conferred with a single shot, the company reported. And two shots showed 100 percent efficacy against severe disease, although that estimate had a wide range of uncertainty.

The data, presented in a news release, has been submitted to the Food and Drug Administration, Johnson & Johnson said. Since the company received emergency authorization in February, 14.6 million people in the United States have received its one-shot vaccine.

On Friday, an F.D.A. advisory committee recommended that the agency authorize Pfizer-BioNTech booster shots for people who are at least 65 or at high risk of Covid. That vaccine, like Moderna’s, offers high levels of initial protection after two doses, which then seem to diminish slightly over several months.

By contrast, Johnson & Johnson’s vaccine has shown little sign of waning. Researchers released a study last week comparing 390,517 vaccinated people to 1,524,153 unvaccinated ones. Up to five months after vaccination, the effectiveness of the Johnson & Johnson vaccine against hospitalization remained steady at around 81 percent.

As the pandemic has unfolded, people who received the Johnson & Johnson vaccine have waited for guidance about whether they’ll need a booster. The new clinical trial, which recruited 32,000 volunteers around the world, compared people who received one dose of Johnson & Johnson to those who received two doses eight weeks apart.

The researchers found that the second shot lifted the level of antibodies in the blood of volunteers four times as high as the level produced by the first shot. That improvement translated into stronger protection.

Many people got their Johnson & Johnson shot far more than eight weeks ago. Other research suggests that the extra time between doses could mean even better protection.

In a separate study announced last month, Johnson & Johnson gave boosters to clinical trial volunteers six months after their first dose, and then measured their antibody levels.

Initially, the researchers reported that the antibodies rose nine times as high as after the first dose. But in Tuesday’s news release, the company announced the level had continued to rise, reaching 12 times as high as the initial levels.

Some preliminary studies suggest that higher levels of antibodies against the coronavirus produce higher levels of protection against Covid. If that’s true, then a second Johnson & Johnson shot given after a wait of several months may prove even more effective than after just eight weeks.

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Credit…Tamir Kalifa for The New York Times

With Pfizer-BioNTech’s announcement on Monday that its coronavirus vaccine had been shown to be safe and effective in low doses in children ages 5 to 11, a question looms: How many parents will have it given to their children?

If authorized by the Food and Drug Administration, the vaccine could be a game changer for millions of American families and could help bolster the U.S. response to the highly contagious Delta variant. There are about 28 million children of ages 5 to 11 in the United States, far more than the 17 million of ages 12 to 15 who became eligible for Pfizer’s vaccine in May.

But it remains to be seen how much of the younger group will be vaccinated. Uptake among older children has lagged, and polling indicates reservations among a significant number of parents.

Lorena Tule-Romain was up early Monday morning, getting ready to ferry her 7-year-old son to school in Dallas, when she turned on the television and heard the news.

“I was like, ‘Oh my gosh, this is exciting,’” said Ms. Tule-Romain, 32, who said she felt a surge of hope and relief. She has spent months in limbo, declining birthday party invitations, holding off registering her son for orchestra in school and even canceling a trip to see her son’s grandparents in Atlanta.

Ms. Tule-Romain will be among those eagerly waiting to learn whether federal officials authorize the vaccine for the younger group, a step that is expected to come first on an emergency-use basis, perhaps as soon as around Halloween.

However the F.D.A. rules, Michelle Goebel, 36, of Carlsbad, Calif., said she was nowhere near ready to vaccinate her children, who are 8, 6 and 3, against Covid-19.

Though Ms. Goebel said she had been vaccinated herself, she expressed worry about the risks for her children, in part because of the relatively small size of children’s trials and the lack of long-term safety data so far. She said the potential risk from a new vaccine seemed to her to outweigh the benefit, because young children have been far less likely than adults to become seriously sick.

Only about 40 percent of children ages 12 to 15 have been fully vaccinated so far, compared with 66 percent of adults, according to federal data. Polling indicates that parental openness to vaccination decreases with a child’s age.

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Credit…Allison Zaucha for The New York Times

About 20 percent of parents of 12- to 17-year-olds said they definitely did not plan to get their child vaccinated, according to polling by the Kaiser Family Foundation published last month. The “definitely not” group grew to about 25 percent in parents of children ages 5 to 11, and 30 percent among parents of under-5s.

René LaBerge, 53, of Katy, Texas, said she planned to vaccinate her 11-year-old son when he became eligible. “But I’m not impatient. I want them to do the work,” she said.

She said she had heard about some rare, but serious, side effects in children, and she was eager for federal officials to thoroughly review the data.

“I don’t want my son to take something that is unsafe,” she said, but added, “I believe Covid is dangerous. There aren’t any good easy answers here.”

Among the side effects scientists have been studying is myocarditis, an inflammation of the heart. In rare cases, the vaccine has led to myocarditis in young people. But a large Israeli study, based on electronic health records of two million people aged 16 and older, also found that Covid was far more likely to cause these heart problems.

The Pfizer trial results were greeted enthusiastically by many school administrators and teachers’ organizations, but are unlikely to lead to immediate policy changes.

“This is one huge step toward beating Covid and returning to normalcy. I don’t think it changes the conversation around vaccine requirements for kids,” said Randi Weingarten, president of the American Federation of Teachers, a national union.

Ms. Weingarten predicted that there would not be widespread student vaccine mandates until the 2022-2023 school year. She noted that parents and educators were still awaiting full F.D.A. approval of vaccines for children aged 12 to 15, and that mandates for adults did not come until months after the shots first became available.

A significant barrier to child vaccination, she said, were widespread conspiracy theories about the shots affecting fertility.

“When people have these conversations prematurely about requirements, it adds to the distrust,” she said.

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Credit…Michael Probst/Associated Press

BERLIN — A 20-year-old student working at a gas station in southwestern Germany was shot and killed after refusing to sell beer to an unmasked customer, the local prosecutor said.

When an unmasked 49-year-old man entered the gas station on Saturday night and placed two six-packs of beer on the counter in the town of Idar-Oberstein, near the French border, the cashier insisted that he wear a mask, said Kai Fuhrmann, the district attorney in charge of the case, in a telephone interview.

Masks have been mandatory in shops in Germany since shortly after the pandemic started.

The man then left the store only to return an hour later, still unmasked but with a gun — one not licensed under Germany’s strict weapons laws. When the clerk asked him a second time to put on a mask, Mr. Fuhrmann said, he killed him with a single shot to the head.

The authorities are withholding names of both the victim and the suspect in accordance with German privacy laws.

Although Germany has seen protests, sometimes including violence, over its mask and hygiene rules, this is believed to be the first death in the country directly linked to the restrictions.

The suspect, who has no previous police record, told the authorities that he saw the cashier as “responsible for the situation because he was enforcing the rules,” Mr. Fuhrmann said.

The police and district attorney’s office are now evaluation the suspect’s electronic devices to ascertain whether the killing was somehow planned. Mr. Fuhrmann said it would take several weeks to determine what charges might be brought.

Until then, the man remains in custody on suspicion of murder.

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Construction workers in Melbourne, Australia, clashed violently with the police for the second day in a row on Tuesday in a dispute over mandatory vaccinations.

Up to 2,000 protesters descended into the city’s central business district, the police said. Videos posted to social media showed workers hurling bottles at the police and setting off flares, while officers in riot gear fired rubber bullets and used pepper spray. One TV journalist said he had urine thrown in his face.

The protests began after the state government in Victoria, where Melbourne is the largest city, mandated vaccinations for workers as it struggles to contain a quickly growing outbreak of the Delta variant. The demonstrators have promised to keep protesting, chanting “every day” as they marched.

The union representing construction workers has not supported mandatory vaccinations but has distanced itself from the protests, saying they were “heavily infiltrated by neo-Nazis and other right-wing extremist groups.”

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Credit…William West/Agence France-Presse — Getty Images

Construction has been among the few industries that have largely stayed open throughout the pandemic in Victoria but the authorities have become increasingly concerned that it may be a hotbed for coronavirus transmission.

After media reports last week that three out of four construction sites were breaching virus safety rules, the state government mandated vaccinations for workers in the industry.

Australian authorities have been reluctant to mandate vaccinations beyond high-risk sectors like health care.

In response, construction workers staged sit-ins on Friday, before escalating to protests this week. On Monday, a small number of workers gathered in front of the offices of the construction union and threw projectiles at the building.

Hours later, Victoria’s premier, Daniel Andrews, ordered a two-week halt on all construction work in the state, citing “continued concern about case numbers, transmission risk and reduced compliance.”

On Tuesday afternoon, the police said they had made 44 arrests, with the number expected to grow, and that three officers had been injured and police cars attacked and damaged.

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Credit…Pool photo by John Angelillo

Unlike in 2020, when the U.N. General Assembly session was conducted almost entirely virtually because of the pandemic, more than 100 world leaders and other high-ranking representatives intend to deliver their speeches in person this year.

But access to the 16-acre United Nations complex in Manhattan remains strictly limited, with mandatory mask-wearing and other Covid prevention measures. Ambassador Linda Thomas-Greenfield of the United States told reporters that the measures were meant to ensure that the General Assembly “does not become a superspreader event.”

Confusion erupted last week over a New York City requirement that all General Assembly participants show proof of vaccination. This year’s president of the General Assembly, Foreign Minister Abdulla Shahid of the Maldives, endorsed the requirement. But exactly how it will be enforced is unclear.

U.N. officials have said that the organization’s headquarters staff must be vaccinated, but that an honor system remains in place for visiting V.I.P.’s and other guests.

In what appeared to be a good-will gesture, New York City’s municipal government deployed a mobile vaccine clinic outside the United Nations complex, offering free testing and Johnson & Johnson vaccines.

Many speakers this year still chose to deliver their addresses via prerecorded video, as was done by all leaders last year when vaccines were still under development and each delegation in the General Assembly hall was limited to two people. Nearly all events at the 2020 event were conducted virtually.

This year each member state may seat as many as four people in the General Assembly hall.

President Jair Bolsonaro of Brazil, an avowed vaccine skeptic whose popularity has fallen at home partly over what critics call his disastrous handling of the pandemic, vowed ahead of his speech that he would not be vaccinated.

He was infected with Covid more than a year ago and then claimed to have cured himself by taking hydroxychloroquine, an antimalarial drug that has not been shown to be effective in Covid treatment.

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Credit…Stefan Jeremiah/Reuters

The decision of President Jair Bolsonaro of Brazil to not get vaccinated against the coronavirus has loomed large over his first couple of days in New York, where world leaders are gathering this week for the United Nations General Assembly.

It made for an awkward moment during a meeting on Monday with Prime Minister Boris Johnson of Britain, who hailed the AstraZeneca vaccine, which was developed at Oxford University.

“Get AstraZeneca vaccines,” Mr. Johnson said during his meeting with the Brazilian president. “I’ve had it twice.”

Mr. Bolsonaro pointed to himself and said: “Not yet.”

Brazil’s far-right president has led one of the world’s most criticized responses to the pandemic. Mr. Bolsonaro repeatedly downplayed the threat the virus posed, railed against quarantine measures and was fined for refusing to wear a mask in the capital.

His government was slow to secure access to coronavirus vaccines even as the virus overwhelmed hospitals across the country. Covid-19 has killed more than 590,000 people in Brazil.

Mr. Bolsonaro, who had a mild case of Covid-19 in July of last year, has said he is in no hurry to get a shot. Earlier this year, the president said he was undecided about getting a vaccine.

“I already had the virus,” he said in a televised video. “I think what must happen is that after the last Brazilian gets vaccinated, if there’s a spare shot, I will decide whether or not I get vaccinated.” He added that “that’s the example the boss must provide.”

This has caused logistical problems when it comes to finding a place to eat in New York, where restaurants require that patrons show proof of vaccination for indoor seating. Mr. Bolsonaro and his traveling party have been taking the rule in stride. On Sunday, one of his ministers posted a photo of the president and several top aides eating pizza standing up on the street.

“A luxurious dinner in NYC,” joked the minister, Luiz Ramos.

During Mr. Bolsonaro’s speech on Tuesday, activists plan to protest near U.N. headquarters against Mr. Bolsonaro’s environmental and economic policies, which critics say have contributed to devastation of the Amazon rainforest and widespread hunger in Brazil.

Earlier, campaigners projected messages onto a building next to the Brooklyn Bridge that read, “Bolsonaro will lie at the United Nations” and “Bolsonaro is burning your future.”

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Credit…Imani Khayyam for The New York Times

The roughly 15 percent of the population living in rural America includes some of the oldest and sickest patients in the country — a disparity that has grown starker during the coronavirus pandemic. The Biden administration is investing more in telemedicine, the use of which has grown sharply during the pandemic, to improve their access to care.

Last month, the Department of Health and Human Services announced that it was distributing nearly $20 million to strengthen telehealth services — usually medical appointments by video or phone — in rural and underserved communities. While the amount is relatively modest, it is part of a broader push to address the long-neglected health care infrastructure in those areas.

The spending includes about $4 million to help bring primary, acute and behavioral health care to patients via telehealth in 11 states, including Arkansas, Arizona and Maine. The money will update technology in rural clinics, train doctors and nurses on telehealth and teach patients how to take advantage of virtual appointments.

An additional $4.3 million will help specialists at academic medical centers train and support primary care providers in rural and other underserved areas via “tele-mentoring,” so that they can treat patients with complex conditions such as long Covid or substance-use disorders.

“Telehealth expands access to care and is a vital tool for improving health equity,” said Diana Espinosa, the acting administrator of the Health Resources and Services Administration, an agency within the department that is distributing the money. “This funding will help drive the innovation necessary to build clinical networks, educational opportunities and trusted resources to further advance telehealth.”

Rural Americans are at greater risk of dying from heart disease, cancer, accidental injury, chronic respiratory illnesses and strokes than their urban counterparts, according to the Centers for Disease Control and Prevention. The pandemic, too, has hit them disproportionately: I.C.U. beds have been sparse in rural Idaho during virus surges. The Navajo Nation in rural Arizona once had a higher virus death rate than New York City.

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Credit…Alex Plavevski/EPA, via Shutterstock

Harbin, a city in far northern China, ordered gyms, cinemas, bathhouses, mahjong parlors and other leisure venues to close on Tuesday after a single resident in the city of 10 million was confirmed to have Covid.

The closures in Harbin were part of a raft of measures that kicked in, enforcing the Chinese government’s “zero tolerance” approach that seeks to extinguish even small outbursts of infections with sweeping measures.

China had heavily limited inward travel in an effort to avoid surges of infection, but scattered outbreaks across the country have continued to dog the authorities, prompting them to limit activities in infection-hit cities. The actions taken in Harbin, the capital of Heilongjiang Province, typified how far the government is willing to go to curb outbreaks.

A city government announcement said that residents should not leave Harbin “unless necessary.” Temples, churches and other religious venues were ordered closed, and visitors to scenic spots must book ahead to ensure that numbers are limited.

Harbin, which grew from a railway town near the frontier with Russia, is already entering cooler weather, and the authorities may worry that crowded indoor venues could help spread the coronavirus.

The patient found with the virus had ranged around in the two weeks before confirmation, the authorities said. The patient had returned from a trip to southern China two weeks ago, and then visited hotels, a hotpot restaurant, a bathhouse and a bookstore, as well as making three visits to a gaming den to play a popular murder-mystery board game.

Source: https://www.nytimes.com/live/2021/09/21/world/covid-delta-variant-vaccine/