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Johnson & Johnson Will Seek U.S. Authorization for Boosters

Johnson & Johnson Will Seek U.S. Authorization for Boosters

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Alex Gorsky, left, Johnson & Johnson’s chief executive, watched as a person received a Johnson & Johnson vaccine in Union City, N.J., in March.
Credit…Bryan Anselm for The New York Times

Johnson & Johnson is planning to ask U.S. regulators early this week to authorize a booster shot of its coronavirus vaccine, according to officials familiar with the company’s plans. The firm is the last of the three federally authorized vaccine providers to call for extra injections, amid mounting evidence that at least older adults and others in high-risk groups need more protection.

Federal officials have become increasingly worried that the more than 15 million Americans who received the Johnson & Johnson vaccine face too much risk of severe Covid-19. The Food and Drug Administration on Friday scheduled an Oct. 15 meeting of its expert advisory committee to discuss whether to grant emergency use authorization of a booster shot of the vaccine.

That is part of a broader effort by the government to shore up the protection provided by all three vaccines. Regulators last month authorized a booster shot for many recipients of Pfizer-BioNTech’s vaccine and are contemplating doing the same this month for recipients of Moderna’s.

The fact that the advisory committee meeting on Johnson & Johnson was scheduled even before the company filed an application to the Food and Drug Administration reflects a particular sense of urgency in the Biden administration to provide more protection to recipients of that vaccine.

Although the federal government has emphasized for months that all three vaccines are highly effective, a recent study by the Centers for Disease Control and Prevention found that Johnson & Johnson’s single-dose vaccine was only 71 percent effective against hospitalization from Covid, compared with 88 percent for Pfizer-BioNTech’s vaccine and 93 percent for Moderna’s.

“Real-world data suggest that the two-dose Moderna and Pfizer-BioNTech mRNA vaccine regimens provide more protection” than the single dose of Johnson & Johnson, the researchers said. Other research found that Johnson & Johnson recipients were more likely to have breakthrough infections or symptomatic Covid than recipients of the other two vaccines.

Johnson & Johnson cites some studies with better results: A study of nearly two million people, funded by the company, estimated that the vaccine was 81 percent effective against hospitalization. Other research suggests that protection from Johnson & Johnson’s vaccine does not wane over time like protection from Pfizer-BioNTech’s vaccine.

Nonetheless, Johnson & Johnson now appears to agree with federal officials that a single shot of its vaccine is not enough.

Last month, the company announced that a second dose, given two months after the first, increased the vaccine’s effectiveness against symptomatic Covid by about 22 percentage points, to 94 percent. Johnson & Johnson also said two shots were 100 percent effective against severe disease, although that estimate was less conclusive.

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Credit…Mark Mitchell/Mark Mitchell/NZME, via Associated Press

Prime Minister Jacinda Ardern of New Zealand acknowledged an end on Monday to the country’s strategy of eliminating the coronavirus, announcing that restrictions would be gradually lifted in Auckland, the country’s largest city.

Ms. Ardern’s announcement — which came seven weeks into a lockdown that has failed to halt an outbreak of the Delta variant — signaled an end to the “Covid zero” strategy New Zealand has pursued for a year and a half, closing its borders and quickly enforcing lockdowns to keep the coronavirus in check.

The nation maintained that goal even as other Asia-Pacific countries transitioned to coexisting with the viral threat. On Monday, Ms. Ardern said the country would switch to “a new way of doing things.”

“With Delta, the return to zero is incredibly difficult, and our restrictions alone are not enough to achieve that quickly,” Ms. Ardern told reporters. “In fact, for this outbreak, it’s clear that long periods of heavy restrictions has not got us to zero cases.”

“What we have called a long tail,” she added, “feels more like a tentacle that has been incredibly hard to shake.”

Overall, New Zealand’s approach to the virus has been a spectacular success, giving it one of the lowest rates of cases and deaths in the world, and allowing its people to live without restrictions during most of the pandemic. But the transmissibility of the Delta variant has challenged the old playbook and made lockdowns effective at containing the virus.

New Zealand is still reporting dozens of new cases a day, almost all of them in Auckland, after the latest outbreak began in mid-August.

The mood among many in Auckland has soured as the most recent lockdown has stretched on, with thousands of people breaking a stay-at-home order on Saturday to demonstrate against the restrictions. Vaccinations have also lagged, with fewer than half of people 12 and older having been fully vaccinated, far behind most developed countries.

Ms. Ardern began to acknowledge the discontent two weeks ago, when she announced, after more than a month of a highly restrictive stay-at-home order, that some rules would be relaxed in Auckland even as much of the lockdown order remained in place.

In Australian cities such as Sydney and Melbourne, leaders have said they are abandoning a zero-Covid approach but have kept in place some heavy restrictions. Singapore, too, has shifted to what it calls living with the virus, using metrics like hospitalizations and deaths instead of caseloads to guide its reopening now that it has vaccinated much of its population. China is perhaps the last major country to pursue a Covid-zero approach.

To move away from lockdowns altogether, New Zealand will have to achieve widespread vaccination, Ms. Ardern said. Some 79 percent of people 12 and older have received at least one dose, and 48 percent have received two doses, according to data from the Ministry of Health. Full immunization of the population — New Zealand’s stated aim — could take months.

The country’s most at-risk communities are also its least vaccinated. While more than 95 percent of people of Asian descent and 80 percent of white people have received at least one dose, the figure falls to about 73 percent for Pacific Islanders and less than 57 percent for Maori people.

In a post on Twitter, the Maori writer and political commentator Morgan Godfery expressed concern about what abandoning the elimination strategy might mean for those in disadvantaged communities.

“The PM says we must now live with the virus,” he wrote. “But the ‘we’ means these same lines of inequality. The virus will now burrow in gangs, the transitional housing community, and unvaccinated brown people. In 2020, Jacinda asked for shared sacrifice. In 2021, it’s a particular sacrifice.”

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Credit…Anna Watts for The New York Times

New York City’s requirement that virtually everyone who works in the city’s public schools be vaccinated against the coronavirus compelled thousands of Department of Education employees to get a Covid shot in the past week, leading to extremely high vaccination rates among educators, according to preliminary data released on Friday.

At least 98 percent of principals and 93 percent of teachers, as well as 90 percent of non-education staff members, had been vaccinated by Friday, city officials said.

The union that represents city teachers, which has been tracking vaccinations among its members separately, said that about 95 percent of its members had received at least one vaccine dose.

New York’s mandate, which takes effect when the school day starts on Monday, is the mayor’s first attempt at requiring vaccination without a test-out option for any city workers. The requirement applies to well over 150,000 people who work in the nation’s largest school system.

School employees who did not show proof that they had received at least one vaccine dose were automatically placed on unpaid leave late Friday. Anyone who got a shot over the weekend would be allowed to report to school Monday and added back to the payroll.

Educators who do not provide vaccination proof will be barred from entering schools and placed on unpaid leave, with health insurance, for a year. Those who get vaccinated after Monday can return after they have received a first dose.

While the mandate clearly pushed many employees to get vaccinated, Mayor Bill de Blasio’s decision to impose it will be further tested this week, as some schools grapple with possible staff shortages caused by the departure of unvaccinated employees.

At many schools, the mandate will have little to no effect. But some schools are likely to have to call on large numbers of substitute teachers. Others will probably have to switch from serving hot lunches to offering grab-and-go options because of a lack of cafeteria aides.

As of Friday afternoon, about 4,000 teachers were still unvaccinated, and about 30 principals or assistant principals had not received a shot. About 15,000 non-education staff members were not vaccinated.

Union officials said they were particularly concerned about school safety agents who had refused to get vaccinated. They work for the Police Department and cannot be easily replaced.

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Credit…Jeff Chiu/Associated Press

Andrew Wiggins, the Golden State Warriors guard who had resisted getting a Covid-19 vaccine, has received one, the team’s coach, Steve Kerr, told reporters on Sunday.

This means Wiggins will be able to play in home games in San Francisco, since city ordinances require individuals to be fully vaccinated to enter facilities such as indoor gyms. Wiggins had attempted to circumvent those restrictions by filing for a religious exemption, which the N.B.A. denied.

The N.B.A. had said publicly that if players in markets with similar mandates — meaning the Nets and the Knicks, who play in New York, and the Warriors, who play in San Francisco — could not play because of their unvaccinated status, they could lose salary.

Initially, it seemed Wiggins would hold out and miss the home games. He told reporters last week that his back “was against the wall, but I’m just going to keep fighting for what I believe.”

The league has said in recent days that 95 percent of N.B.A. players had received at least one dose of a Covid-19 vaccine. The players’ union has rejected instituting a leaguewide vaccine mandate. Wiggins was one in a small group of prominent players who were unvaccinated. But Wiggins did receive support from vaccinated teammates like Draymond Green, who said he wouldn’t push Wiggins to take the vaccine.

“To me, it feels like it has turned into a political war,” Green told reporters last week. “When you are talking about vaccination and nonvaccinated, I think it’s become very political. And for someone who is not extremely into politics, when you make something so political and not everyone is into politics, then you can also turn those people off. I think there is something to be said for people’s concern about something that’s being pressed so hard. Like, why are you pressing this so hard?”

Green’s comments received support from the N.B.A.’s biggest star, LeBron James, as well as a frequent critic of the N.B.A., Senator Ted Cruz, Republican from Texas. The senator also said in a Twitter post on Wednesday, “I stand with Andrew Wiggins,” as well as other unvaccinated players, including Jonathan Isaac of the Orlando Magic and the Washington Wizards’ Bradley Beal.

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Credit…Jim Wilson/The New York Times

The churning disruption in the global supply chain has now reached the world of books, just as the holiday season — a crucial time for publishers and bookstores — approaches.

Publishers are postponing some release dates because books aren’t where they need to be. Older books are also being affected, as suppliers struggle to replenish them.

To get a book printed and into customers’ hands, there are essentially two different supply chains. On both paths, at virtually every step, there is a problem.

Books that require a lot of color, like picture books, are often printed in Asia. But transporting cargo to the United States has become excruciating, with every imaginable product jostling for position.

First, there aren’t enough shipping containers. Publishing professionals say that a container, which can hold roughly 35,000 books, used to cost them about $2,500 but can now be as much as $25,000.

Once books get into a container, the ship carrying it is likely to wait in line to dock at a backed-up port. Last month, a record 73 ships were bobbing around in the water near the Port of Los Angeles and the Port of Long Beach.

Worker shortages are also slowing down operations at warehouses and distribution centers. Companies are raising wages to attract more staff members, but they’re competing with others who are doing the same thing. And the virus has aggravated staffing issues, as some workers get sick and others are told to quarantine. At some book distribution centers, one executive said, vaccination rates are low.

All of these problems compound one another, and there isn’t much anyone in the book business can do to fix things.

Source: https://www.nytimes.com/live/2021/10/04/world/covid-delta-variant-vaccine