Federal officials are reviewing nearly 800 cases of rare heart problems following immunization with the coronavirus vaccines made by Pfizer-BioNTech and Moderna, according to data presented at a vaccine safety meeting on Thursday.
Not all of the cases are likely to be verified or related to vaccines, and experts believe the benefits of immunization far outweigh the risk of these rare complications. But the reports have worried some researchers. More than half of the heart problems were reported in people ages 12 to 24, while the same age group accounted for only 9 percent of the millions of doses administered.
“We clearly have an imbalance there,” said Dr. Tom Shimabukuro, a vaccine expert at the Centers for Disease Control and Prevention who presented the data. Advisers to the agency will meet on June 18 to explore the potential links to the complications: myocarditis, inflammation of the heart muscle, and pericarditis, inflammation of the membrane surrounding the heart.
About two-thirds of the cases were in young males, with a median age of 30 years. The numbers are higher than would be expected for that age group, officials said, but have not yet been definitively linked to the vaccines.
As of May 31, 216 people had experienced myocarditis or pericarditis after one dose of either vaccine, and 573 after the second dose. Most cases have been mild, but 15 patients remain in hospitals. The second dose of the Pfizer-BioNTech vaccine was linked to about twice as many cases as the second dose of the vaccine made by Moderna.
There were 79 reported cases of the heart problems among those 16 or 17 years old, compared with a maximum of 19 cases expected for that group. And in the group of young people ages 18 to 24, there were 196 cases, compared with an expected maximum of 83.
But the true incidence may be lower, Dr. Shimabukuro said. Immunizations of younger teenagers began only last month, and data from that age group in particular are limited.
WASHINGTON — Federal regulators have told Johnson & Johnson that about 60 million doses of its coronavirus vaccine produced at a troubled Baltimore factory cannot be used because of possible contamination, according to people familiar with the situation.
The Food and Drug Administration plans to allow about 10 million doses to be distributed in the United States or sent to other countries, but with a warning that regulators cannot guarantee that Emergent BioSolutions, the company that operates the plant, followed good manufacturing practices.
The agency has not yet decided whether Emergent can reopen the factory, which has been closed for two months because of regulatory concerns, the people said.
The Johnson & Johnson doses administered in the United States so far were manufactured at the firm’s plant in the Netherlands, not by Emergent. For weeks the F.D.A. has been trying to figure out what to do about at least 170 million doses of vaccine that were left in limbo after the discovery of a major production mishap involving two vaccines manufactured at the Baltimore factory.
More than 100 million doses of Johnson & Johnson and at least 70 million doses of AstraZeneca were put on hold after Emergent discovered in March that its workers had contaminated a batch of Johnson & Johnson’s vaccine with a key ingredient used to produce AstraZeneca’s. Federal officials then ordered the plant to pause production, stripped Emergent of its responsibility to produce AstraZeneca’s vaccine and instructed Johnson & Johnson to assert direct control over the manufacturing of its vaccine there.
Johnson & Johnson’s vaccine was once considered a potential game-changer in the nation’s vaccine stock because it required only one shot and was particularly useful in vulnerable communities. But the federal government now has an ample supply of the vaccines from Pfizer-BioNTech and Moderna, the two other federally authorized vaccine developers, and no longer needs Johnson & Johnson’s supply.
Still, the loss of 60 million Johnson & Johnson doses puts a dent in the Biden administration’s plan to distribute vaccines to other countries that are still in the grip of the pandemic. The administration had been counting on sharing doses of both Johnson & Johnson and AstraZeneca but had to delay its plan while the F.D.A. completed a review of the facility.
After he arrived in Britain for the Group of 7 summit this week, President Biden announced he had found another source for donations. Pfizer-BioNTech has now agreed to sell his administration 500 million doses at cost for donation to low and lower-middle income countries over the next year. The World Health Organization estimates that 11 billion doses are needed globally to stamp out the epidemic.
The leaders of the world’s wealthiest democracies are expected to pledge one billion doses of Covid vaccines to poor and middle-income countries on Friday as part of a campaign to “vaccinate the world” by the end of 2022.
The stakes could hardly be higher.
“This is about our responsibility, our humanitarian obligation, to save as many lives as we can,” President Biden said in a speech in England on Thursday evening, before the meeting of the Group of 7 wealthy democracies. “When we see people hurting and suffering anywhere around the world, we seek to help any way we can.”
It is not just a race to save lives, restart economies and lift restrictions that continue to take an immeasurable toll on people around the globe.
Since Mr. Biden landed in Europe for the start of his first presidential trip abroad on Wednesday, he has made it clear that this is a moment when democracies must prove that they can rise to meet the world’s gravest challenges. And they must do so in a way the world can see, as autocrats and strongmen — particularly in Russia and China — promote their systems of governance as superior.
Yet the notion of “vaccine diplomacy” can easily be intertwined with “vaccine nationalism,” which the World Health Organization has warned could ultimately limit the global availability of vaccines.
When Mr. Biden announced on Thursday that the U.S. would donate 500 million Pfizer-BioNTech doses, the president said they would be provided with “no strings attached.”
“We’re doing this to save lives, to end this pandemic,” he said. “That’s it. Period.”
But even as wealthy democracies move to step up their efforts, the scale of the challenge is enormous.
Covax, the global vaccine-sharing program, still remains underfunded and billions of doses short.
The International Monetary Fund estimates that it will cost about $50 billion to help the developing world bring the pandemic to an end. In addition to the countless lives saved, the I.M.F. says that such an investment could bring a dramatic return: $9 trillion in increased global economic growth.
While the pandemic is at the center of Friday’s G7 agenda, with the leaders of the nations meeting face to face for the first time since the coronavirus essentially put a stop to handshake diplomacy, a host of other issues are also on the table.
Finance leaders from the G7 agreed last week to back a new global minimum tax rate of at least 15 percent that companies would have to pay regardless of where they locate their headquarters.
Beyond the specific issues, the summit will be a test of how institutions created in another era to help guide the world through crises can stand up to the challenges of today.
On Thursday, Mr. Biden and Prime Minister Boris Johnson of Britain turned to a World War II-era document to provide inspiration for a new generation of challenges, renewing the Atlantic Charter eight decades after it was signed to take into account the threats of today: from cyberattacks to nuclear, climate to public health.
The gathering of the G7 is also, in many ways, a relic of another era. It was created in the 1970s to provide economic solutions after a shock in oil supply triggered a financial crisis.
Ursula von der Leyen, the European Commission president, said in a preview of the conference on Thursday that the “return of the United States to the global arena” would help strengthen the “rules-based system” and that the leaders of the G7 were “united and determined to protect and to promote our values.”
Emergency room visits following suspected suicide attempts by teenage girls spiked in the first months of 2021, compared with rates in 2019, the Centers for Disease Control and Prevention reported on Friday.
The new study, which relied on data from the National Syndromic Surveillance Program, showed that visits to emergency rooms for suspected suicide attempts rose about 51 percent on average for girls aged 12 to 17 in the four weeks ending March 20, compared with the same period in 2019. The rate began rising in summer of 2020, the researchers said.
The numbers of suspected suicide attempts among boys the same age and adults of both genders aged 18 to 25 remained relatively stable, compared with the corresponding period in 2019, the study found.
“The findings from this study suggest more severe distress among young females than has been identified in previous reports during the pandemic, reinforcing the need for increased attention to, and prevention for, this population,” the C.D.C. said.
The report comes on the heels of other recent research that suggested higher rates of mental health problems among teenagers, including self-harm, suicide attempts and suicidal ideation, which some experts worry could be related to stressors from the pandemic.
But Ellen Yard, an epidemiologist and the study’s lead author, wrote in an email that “the analysis in this report was not designed to assess whether this increase was caused by Covid-19.”
“However, some researchers have suggested that the Covid-19 pandemic could increase suicide risk,” Dr. Yard continued. “Youth may have been especially impacted by mitigation measures such as social distancing (including a lack of connectedness to schools, teachers, and peers), barriers to mental health treatment, and family health and economic problems.”
The researchers also said that the jump in hospital visits for adolescent girls did not necessarily mean there had been more suicides. Referring to emergency department visits, the report said, “Importantly, although this report found increases in ED visits for suspected suicide attempts among adolescent females during 2020 and early 2021, this does not mean that suicide deaths have increased.”
According to provisional data from the C.D.C.’s National Vital Statistics System, suicides actually declined overall in the United States in 2020, to 44,834 deaths from 47,511 in 2019, though preliminary studies based on local data showed a rise in suicides among Black Americans and other people of color, compared with previous years.
John Ackerman, the suicide prevention coordinator at the Center for Suicide Prevention and Research at Nationwide Children’s Hospital in Columbus, Ohio, said that the report matched his experience since the start of the pandemic.
Dr. Ackerman, who was not involved in the study, said that he had seen low rates of emergency room visits from teenagers for mental health issues early in the pandemic, perhaps because people were concerned about exposure to the virus, but that those numbers increased as the months wore on.
“You’ve started to see emergency departments, locally here in Ohio but also throughout the country, start to report really high rates of hospitalizations due to suicide attempts, depression, anxiety, self-injury, these types of presenting factors,” Dr. Ackerman said.
He said that the pandemic was an added source of anxiety for people in groups that are often at higher risk of suicidal thoughts, like people of color and L.G.B.T.Q. youth.
But there are many factors at play, Dr. Ackerman added, and the pandemic was just one among many stressors in what he called “a tumultuous year.”
“A lot of people have felt isolated, or invalidated, or feeling hopeless for many reasons, and all of those are risk factors for suicide,” he said.
As the leaders of wealthy Western democracies step up their efforts to provide Covid-19 vaccines to the world, they are also racing to catch up with China’s moves to establish itself as a leader in the fight against the coronavirus.
Last summer, China’s top leader, Xi Jinping, heralded the promise of a Chinese-made Covid-19 vaccine as a global public good. So far, he appears to be making good on that pledge.
China now leads the world in exporting Covid-19 vaccines, cementing its bid to be a major player in global public health. The country’s vaccines have been rolled out to 95 countries, which have received more than 260 million doses, according to Bridge Consulting, a Beijing-based consultancy.
The World Health Organization recently approved the vaccines made by the Chinese companies Sinopharm and Sinovac for emergency use, giving Beijing’s reputation a further boost.
So far, China has taken a mainly country-by-country approach in doling out its vaccines. The country has given only 10 million doses to Covax, the global alliance backed by the World Health Organization to ensure that developing countries get access to affordable vaccines. But it has independently donated 22 million doses and sold 742 million doses, according to Bridge Consulting. Many of the donations were made to developing nations in Africa and Asia.
“China is picking countries that could potentially be coming back to China for more things in the future,” said Sara Davies, a professor of international relations specializing in global health diplomacy at Griffith University in Australia. “This is the start of a long-term relationship.”
But there are questions about the Chinese vaccines’ effectiveness, in particular those made by Sinopharm, a state-owned company. Countries that have vaccinated their populations widely with the Sinopharm vaccine, such as the Seychelles and Mongolia, have had new surges of the coronavirus.
The global rollout has also been dogged by delayed deliveries. China is struggling to manufacture enough doses of its two-shot vaccines to meet the needs of its 1.4 billion people and its customers abroad.
In April, Turkey’s health minister said that one reason for the country’s slow vaccination campaign was that Sinovac did not comply with a promised delivery schedule.
“This is not because of lack of production, but it is because Chinese government is using the vaccines for its own country,” the minister, Fahrettin Koca, was quoted in the Turkish press as saying.
In a regular news briefing on Thursday, a Chinese Foreign Ministry spokesman called on countries undertaking vaccine research and development to “assume their responsibility” and support Covax.
“As we all know, until recently, the U.S. has been stressing that its top priority with vaccines is its domestic rollout,” said the spokesman, Wang Wenbin. “Now that it has announced donation to Covax, we hope it will honor its commitment as soon as possible.”
Alexandra Stevenson contributed reporting, and Elsie Chen contributed research.
Italy will stop administering AstraZeneca’s Covid vaccine to people under the age of 60, the Italian government announced on Friday, amid a drop in the country’s level of infections that meant the risks of distributing the vaccine to younger people was judged to outweigh the benefits.
The AstraZeneca vaccine has been under scrutiny after a smattering of reports of rare and severe blood clots in those who had received the vaccine emerged in Europe.
Younger Italians who have already received one dose of the AstraZeneca vaccine will get a different shot for their booster dose, said Francesco Paolo Figliuolo, an army general in charge of Italy’s vaccination effort, during a news conference. He added that the change would have minimal impact on the country’s vaccination rollout.
The announcement was the latest in a series of reversed decisions about the use of the AstraZeneca vaccine, which was developed with Oxford University. Some doctors worry that the back and forth could further undermine the trust in the vaccine, and hamper Italy’s inoculation campaign.
Government regulators and AstraZeneca “communicated very very badly,” Roberto Burioni, one of Italy’s leading virologists, said in an interview. “We are losing the trust of even the most enthusiastic people.”
In Italy, as in other European countries, the rollout of AstraZeneca’s vaccine has been rocky. After the European Union approved its use in January, Italy recommended its use only for people under the age of 55.
The country then raised the threshold to 65 on Feb. 22, and then dropped the age limit March 8. A week later, Italy become one of a number of European countries to suspend using the vaccine altogether over concerns about the reports of rare, severe blood clots that afflicted a small number of recipients,.
Italy resumed using the vaccine March 19, but about two weeks later, after the European drug regulator reported a possible link to the rare blood clots, the government recommended reserving the vaccine for those over 60.
However, some Italian regions, in a rush to vaccinate as many people as possible, started offering AstraZeneca vaccines to younger people during “open day” and “open night” events that skipped the government’s priority schedule. Tens of thousands of young Italians signed up. In May, the board of scientific advisers to the government gave the reenlight to the “open” initiatives.
But some doctors raised objections, and news spread of an 18-year-old girl who had received a dose in the northern region of Liguria, was hospitalized with thrombosis and then died. On Friday, the government said the recommendation to only give the AstraZeneca vaccine to people over 60 had now become “mandatory.”
In other news around the world:
Greece detected its first confirmed case of the Gamma variant of the coronavirus, also known as P.1.2 and first detected in Brazil, the country’s National Public Health Authority said on Friday. Still, the average daily new cases is falling and the country has decided to allow vaccinated tourists to enter the country. Greece has steadily removed restrictions since May to try to revive its shuttered tourism industry.
The Philippines began loosening restrictions on movements across the capital, Manila, and nearby provinces, allowing a range of activities to restart, the government said on Friday. The government said indoor sports venues, such as gyms, fitness studios, skating rinks and racket sport facilities, would be allowed to reopen at about 30 percent of their capacity. Historical sites and museums would also be allowed to resume operations at limited capacity, but guided tours would remain prohibited. Older adults who had been fully vaccinated would be allowed to move more freely, with proof of inoculation.
In April, rumors began swirling in some New York City neighborhoods with large Orthodox Jewish communities about how the Covid-19 vaccine could pose a threat to women’s fertility.
In WhatsApp groups, recordings of rabbis warning against what they said were the vaccine’s adverse effects proliferated among mothers of teenage girls who don’t want their daughters vaccinated.
There is no current evidence that any vaccines, including Covid-19 vaccines, cause fertility problems. Many prominent mainstream Orthodox leaders in the New York region and in Israel, where the virus has all but disappeared, have advised their communities to get the Covid-19 shots.
But in ultra-Orthodox circles in New York — where women marry at a younger age and birthrates dwarf those of the general population — the spread of unsubstantiated rumors about the coronavirus vaccine’s potential adverse effects on fertility and pregnancy have been particularly effective in dissuading young women from getting the vaccine. These neighborhoods have some of the lowest vaccination rates in New York City.
A concern for New York officials is that vaccine resistance in Orthodox neighborhoods could play a part in endangering the city’s long-term prospects for recovery.
In the past few days, after the listing for a coming book by Dr. Anthony S. Fauci, the Biden administration’s top adviser on Covid-19, was taken down from Amazon’s and Barnes & Noble’s websites, right-wing outlets and social media commentators spread the rumor that the it had been removed because of public backlash to the idea of Dr. Fauci’s “profiteering” from the pandemic.
In truth, Dr. Fauci is not making any money from the book, which is about lessons he has learned during his decades in public service, and the listing was pulled for a simple reason: the publisher had posted it too early.
Dr. Fauci “will not earn any royalties from its publication and was not paid” for the book, “Expect the Unexpected,” said Ann Day, a spokeswoman for National Geographic Books, its publisher. She said Dr. Fauci also would not earn anything for a related documentary. (Dr. Fauci did not respond to a request for comment.)
The book, which compiles interviews and speeches given by Dr. Fauci during his 37 years as the director of the National Institute of Allergy and Infectious Diseases, was taken off the websites because “it was prematurely posted for presale,” Ms. Day said. She added that proceeds would “go back to the National Geographic Society to fund work in the areas of science, exploration, conservation and education and to reinvest in content.”
In a statement, the national institute noted that the book had not been written by Dr. Fauci himself. The institute also confirmed that he would not earn any royalties from its publication.
The falsehood about the book and Dr. Fauci spread widely online. On May 31, the right-wing outlet The Daily Caller published an article about the book’s appearing for presale online. Some conservative Republicans, including Representatives Andy Biggs of Arizona and Dan Bishop of North Carolina, seized on the article and claimed without evidence that Dr. Fauci would be profiting from the book.
“His lockdown mandates destroyed livelihoods and threatened our children’s futures,” Mr. Bishop posted on Twitter on June 1. “Now he’ll be profiting nicely off it.” The post was liked and shared more than 2,700 times.
That same day, Newsweek and Fox News published articles highlighting the “backlash” that Dr. Fauci faced from right-wing commentators “for profiting from pandemic” after the announcement of his book. The articles did not mention that he would not make money from the book. They reached as many as 20.1 million people on Facebook, according to data from CrowdTangle, a social media analytics tool owned by the social network.
On June 2, a conservative outlet, Just the News, posted an article asserting that Dr. Fauci’s book had been “scrubbed” from Amazon and Barnes & Noble because of the backlash. The founder of the site, John Solomon — a Washington media personality who was instrumental in pushing falsehoods about the Bidens and Ukraine — tweeted the misleading article. So did the pro-Trump activist Jack Posobiec, who once promoted the false Pizzagate conspiracy.
“Books are removed from bn.com from time to time if the details are loaded incorrectly,” a Barnes & Noble spokeswoman said in a statement to The Times. “This book was not removed proactively by Barnes & Noble. We expect it will be available again shortly for purchase as soon as the publisher decides to list it.” Amazon did not comment.
Some articles on June 2, including on Fox News and The Daily Mail, included similar comments from National Geographic Books. But many outlets on the far right continued to push the version of events that the book had been “scrubbed” from online listings because of the backlash, without the updated information. The articles collected more than 32,000 likes and shares on Facebook and reached as many as six million people on Facebook, according to CrowdTangle data.
Days later, people like the Fox News host Sean Hannity and Representative Ronny Jackson, a Republican from Texas and former President Donald J. Trump’s onetime doctor, continued to push the false idea on Twitter.
“Anthony Fauci is set to make a fortune on his upcoming book; meanwhile our country continues to SUFFER from his ENDLESS non-scientific policies,” Mr. Jackson said on Twitter. His post collected nearly 4,000 likes, comments and shares.
Jacob Silver contributed research.
Hawaii has had the strictest entry rules of any American state since the onset of the pandemic. In recent days, Gov. David Ige has issued a series of guidelines on reopening, including an end to testing and quarantining for vaccinated travelers once 60 percent of the state’s residents are fully vaccinated (it’s currently at 53 percent).
His words were welcomed by travelers eagerly planning trips to the islands. But for many who have recently been to the state — and locals who have traveled between the islands — the governor’s plans come a little too late and after causing a great deal of confusion, frustration and what they say is wasted money.
At the moment, to visit the islands or move between them, travelers have to show a negative coronavirus test taken within 72 hours — whether they have been vaccinated or not. These tests range in price, with some paying $200 or $300.
Vaccinated travelers complain that the tests are expensive and unnecessary and that getting the correct information about what is required is too difficult.
“Today’s Hawaii travel is much tougher than you might think,” said Cheryl Temple, a former mayor of the town of Orting in Washington State who is currently on Kauai, one of the islands.
Several McDonald’s outlets in Indonesia were forced to close this week after a special “BTS Meal,” named for the wildly popular Korean boy band, drew crowds of delivery drivers that violated safe distancing measures, the police said.
On Wednesday, the first day that the limited edition meal was available, a rush of orders was placed — but because of Covid-19, most were made online. That resulted in flocks of motorcycle delivery drivers showing up at outlets across Indonesia, with most of the restaurants unprepared to manage the turnout.
In Jakarta, the capital, the police said on Wednesday that they had temporarily closed 32 McDonald’s outlets “because they were found to have violated health protocols,” including limiting capacity to 50 percent and avoiding crowds.
The BTS Meal consists of nine chicken nuggets, two sauces, medium fries and a drink, and comes in a box with a purple logo. Introduced in nearly 50 other countries, it is available in Indonesia until next month.
But because nearly anything related to BTS provokes a frenzy, there have been concerns that the introduction of the meal could draw crowds in some Asian countries where coronavirus cases have risen recently and where vaccination levels remain relatively low. The meal’s rollout in Singapore was delayed last month after the government tightened distancing rules, including a ban on dining in restaurants.
Indonesia, which has one of the highest coronavirus caseloads in Asia, has seen a surge of infections in recent weeks as more people gathered and traveled during Eid al-Fitr, which marks the end of the Muslim holy month of Ramadan. New daily cases have risen 26 percent over the last two weeks, and only 4 percent of the population is fully vaccinated, according to a New York Times database.
Indonesian fans of the Korean band have acknowledged that delivery drivers faced long lines and possible exposure to the coronavirus to bring them their BTS Meal. Online message groups have called on customers to reward drivers with handsome tips. On Kitabisa, a crowdfunding site, several initiatives are raising money for drivers and their families.
One user named Vanessa Egas asked for donations to reach a target of 25 million rupiah, about $1,750, to “repay the kindness of our brother drivers who stood in line for hours to deliver the BTS Meal.” By Friday, she had surpassed that goal and begun to disburse the funds, according to the website.