Second vaccine doses raise the risk of myocarditis in young men, but the condition remains very rare.

Image

A second dose of the coronavirus vaccines made by Pfizer-BioNTech and Moderna can nearly triple the chances of a rare heart condition in young men, according to a large new study published on Monday. But the absolute risk of the condition, called myocarditis, remains extremely low.

The study found 5.8 cases per million second doses in men, with an average age of 25 years. The risk after the first dose was much less, at 0.8 cases per million, not more than normally would be seen in that age group. The findings were published in the journal JAMA Internal Medicine.

The results may be underestimates. The researchers tracked the medical status of vaccinated individuals for only a short time, and may have missed people whose heart problems were not severe enough to require hospitalization.

Concerns about myocarditis, an inflammation of the heart muscle, have been the subject of intense discussion among advisers to the Centers for Disease Control and Prevention, and may have led the Food and Drug Administration to ask vaccine manufacturers to expand their clinical trials in younger children.

Experts have thus far said that the benefits of the vaccines far outweigh the rare risk of myocarditis. But citing the heart condition as a worry, regulators in some countries like Britain and Hong Kong have recommended a single dose of the vaccine for adolescents aged 12 to 15 years.

Other studies have also found that vaccination increases the risk of myocarditis. An Israeli study published in August looked at the electronic health records of about 2 million people and found an additional 2.7 cases of myocarditis for every 100,000 vaccinated people, compared with unvaccinated ones.

But the same research found that the risk of myocarditis from having Covid-19 was much higher, resulting in an extra 11 cases of the condition for every 100,000 infected people.

The C.D.C. has estimated that of a million second doses given to boys ages 12 to 17, the vaccines might cause a maximum of 70 myocarditis cases, but would prevent 5,700 infections, 215 hospitalizations and two deaths.

In the new study, researchers analyzed the medical records of 2.4 million members of the Kaiser Permanente Southern California health care system, aged 18 years or older. The participants had received at least one dose of the Pfizer-BioNTech or Moderna vaccines between Dec. 14, 2020, and July 20, 2021.

The team identified individuals who were hospitalized within 10 days of receiving a vaccine dose and discharged with a diagnosis of myocarditis. The researchers found 15 cases of confirmed myocarditis in the vaccinated group, 13 of which were observed after the second dose.

None of those affected had a history of heart problems, and none were readmitted to the hospital after being discharged.

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.

Video

transcript

Back

transcript

Eliminating Covid-19 Is ‘Incredibly Difficult,’ Jacinda Ardern Says

Prime Minister Jacinda Ardern of New Zealand acknowledged an end to the country’s “Covid zero” strategy, seven weeks into a lockdown that had failed to halt an outbreak of the Delta variant.

The health advice has been that to date, we’ve managed to largely control the outbreak, but as you can see with this outbreak and with Delta, the return to zero is incredibly difficult. And our restrictions alone are not enough to achieve it quickly. In fact, for this outbreak, it’s clear that long periods of heavy restrictions has not got us to zero cases, but that is OK. Elimination was important because we didn’t have vaccines. Now we do, so we can begin to change the way we do things. We have more options, and there’s good cause for us to feel optimistic about the future, but we cannot rush. That’s why we need to continue to contain and control the virus as much as possible while we make our transition from a place where we only use heavy restrictions to a place where we use vaccines and everyday public health measures. We need to keep using the tools we have. We need to vaccinate. We need to test. We need to find cases. We need to isolate them and actively control any outbreak now and in the future.

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 like 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.”

LONDON — Britain on Monday streamlined England’s coronavirus restrictions on international travel in and out of the country and eased testing and quarantine requirements for fully vaccinated arrivals, citing the success of its vaccination campaign.

The change, which went into effect at 4 a.m. local time, replaced a three-tier traffic light-inspired system with a single “red” list of countries and territories that present the highest risk.

Critics had complained that the old system — which periodically involved the government altering the risk status of countries and which left Britons scrambling to figure out the latest rules during vacations — had caused confusion within the travel industry.

“We are accelerating towards a future where travel continues to reopen safely and remains open for good,” Grant Shapps, Britain’s transportation secretary, said in a statement, “and today’s rule changes are good news for families, businesses and the travel sector.” Mr. Shapps attributed the move to the vaccination rate; 67 percent of the population of the United Kingdom is fully vaccinated.

Under the new rules, fully vaccinated travelers entering England will no longer be required to take a pre-departure coronavirus test when returning from a country that is not on the red list. And though travelers must still pay for a test to take on the second day after their return, beginning later this month, the government said it would accept less expensive rapid tests over polymerase chain reaction, or P.C.R., tests.

Arrivals who tested positive, however, would still need to isolate and take a P.C.R. test, “which would be genomically sequenced to help identify new variants,” the government said.

Testing and quarantine requirements for those who are not fully vaccinated remain the same, as do rules for those entering from “red” list countries.

After the success of a pilot test involving arrivals from United States and Europe, England will also begin a phased approach to recognizing vaccinations that have been administered in other countries and territories, expanding that list on Monday to over 50 countries including the United Arab Emirates, Japan and Canada.

In the past week, Britain reported an average of 33,779 daily cases and 112 daily deaths, according to a New York Times database. Cases have increased by 16 percent from the average two weeks ago.

New York’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 at least one dose of a vaccine in the past week, leading to extremely high vaccination rates among educators, Mayor Bill de Blasio said Monday.

About 95 percent of all full-time school employees have received at least one dose of a coronavirus vaccine, the mayor said, including 96 percent of teachers and 99 percent of principals.

More than 18,000 shots were given to staff members since Sept. 24, and 43,000 doses have been administered since the mandate was announced in late August.

“Mandates work, they make us safer,” Mr. de Blasio said in a television interview on Friday. “I would urge every mayor in America: Do it now, get those vaccine mandates in place ahead of the cold weather, when things are going to get tougher. Do it now, or you will regret it later.”

New York’s mandate, which took effect when the school day started on Monday, is the mayor’s first attempt at requiring vaccination without a test-out option for any city workers. It could lay the groundwork for a much broader requirement for the city’s vast work force.

The requirement applies to well over 150,000 people who work in the nation’s largest school system, including teachers, principals, custodians, school safety agents and lunch aides.

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

While the mandate clearly pushed many employees to get vaccinated, the mayor’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, nearly all staff members are vaccinated, and 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.

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. At least 82 percent of agents had gotten at least one vaccine dose, police officials said.

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.

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.