Federal officials are reviewing nearly 800 cases of rare heart problems following immunization with the coronavirus vaccines manufactured by Pfizer-BioNTech and Moderna Data presented at a vaccine safety meeting on Thursday.
It is likely that not all cases are reviewed or related to vaccines, and experts believe that the benefits of vaccination far outweigh the risk of these rare complications. But the reports have worried some researchers. More than half of 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 given.
“We clearly have an imbalance,” said Dr. Tom Shimabukuro, a vaccine expert from the Centers for Disease Control and Prevention, who presented the data. The agency’s advisors will meet on June 18 to investigate the possible 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 involved young men with an average age of 30 years. The numbers are higher than expected for this age group, officials said, but have not yet been definitively linked to the vaccines.
As of May 31, 216 people had developed myocarditis or pericarditis after a dose of either vaccine and 573 after the second dose. Most of the cases were mild, but 15 patients remain in hospitals. The second dose of Pfizer BioNTech vaccine has been linked to approximately twice as many cases as the second dose of Moderna’s vaccine.
There were 79 reported cases of heart problems in the 16- or 17-year-olds, compared to a maximum of 19 cases expected for this group. And in the group of adolescents aged 18 to 24, there were 196 cases, compared to an expected maximum of 83.
But the true incidence could be lower, said Dr. Shimabukuro. Vaccinations of younger adolescents only started last month and limited data are available, especially for this age group.
WASHINGTON – Federal regulators have told Johnson & Johnson that approximately 60 million doses of its coronavirus vaccine are at a troubled factory in Baltimore According to information from people familiar with the situation, it cannot be used due to possible contamination.
The Food and Drug Administration plans to distribute or ship around 10 million doses in the United States, but with warnings that regulators cannot guarantee that Emergent BioSolutions, the company that operates the facility, has good manufacturing practices followed.
The agency has not yet decided whether Emergent can reopen the factory, which has been closed for two months due to regulatory concerns, the people said.
The doses previously administered by Johnson & Johnson in the US were made at the company’s facility in the Netherlands, not by Emergent. For weeks the F.D.A. has been trying to figure out what to do with at least 170 million doses of vaccine left in suspension after the discovery of a major manufacturing accident involving two vaccines made at the Baltimore factory.
More than 100 million cans of Johnson & Johnson and at least 70 million cans of AstraZeneca were put on hold after Emergent discovered in March that its employees contaminated a batch of Johnson & Johnson’s vaccine with a key ingredient used in the manufacture of AstraZeneca. Federal officials then ordered the factory to suspend production, removed Emergent’s responsibility for manufacturing AstraZeneca’s vaccine, and instructed Johnson & Johnson to exercise direct control over the manufacture of its vaccine there.
Johnson & Johnson’s vaccine was once considered a potential turning point in the country’s vaccine inventory as it required only one shot and was particularly useful in vulnerable communities. But the federal government now has adequate supplies of vaccines from Pfizer-BioNTech and Moderna, the other two state-authorized vaccine developers, and no longer needs supplies from Johnson & Johnson.
Still, the loss of 60 million Johnson & Johnson doses undermines the Biden government’s plan to distribute vaccines to other countries still affected by the pandemic. The government had expected to split the Johnson & Johnson and AstraZeneca cans but had to postpone its plan while the F.D.A. a review of the system has been completed.
After President Biden arrived in the UK for the Group 7 Summit this week, he announced that he had found another source of donations. Pfizer-BioNTech has now agreed to sell its 500 million doses administration to low and middle income countries at cost over the next year. The World Health Organization estimates that 11 billion doses will be needed worldwide to eradicate the epidemic.
The leaders of the world’s richest democracies are expected to be promise a 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 possible,” said President Biden on Thursday evening in a speech in England to the meeting of the Group of 7 Wealthy Democracies. “When we see people hurting and suffering all over the world, we try to help as best we can.”
It is not just a race to save lives, restart the economy and lift restrictions that continue to take an immeasurable toll on people around the world.
Ever since Mr Biden landed in Europe on Wednesday to begin his President’s first overseas trip, he has made it clear that this is a moment when democracies need to prove they can face the world’s greatest challenges. And they have to do this in a way that the world can see, as autocrats and strong men – especially in Russia and China – propagate their systems of government as superior.
However, the notion of “vaccine diplomacy” can easily be woven into “vaccine nationalism” that the World Health Organization has warned that it could ultimately limit the availability of vaccines around the world.
When Mr Biden announced Thursday that the US would donate 500 million cans of Pfizer BioNTech, the president said they would be made available “unconditionally”.
“We are doing this to save lives, to end this pandemic,” he said. “That’s it. Period.”
But even as wealthy democracies step up their efforts, the scale of the challenge is enormous.
Covax, the global vaccine sharing program, is still underfunded and billions of doses are missing.
International Monetary Fund estimates that it will cost about $ 50 billion to help developing countries end the pandemic. 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 the G7 agenda on Friday, with leaders of the nations meeting face-to-face for the first time since the coronavirus essentially halted the diplomacy of the handshake, a host of other topics are also on the agenda Table.
G7 finance chiefs agreed to support last week a new global minimum tax rate of at least 15 percent that companies would have to pay regardless of the location of their headquarters.
Beyond the specific topics, the summit will be a test of how institutions that were created in another time to lead the world through crisis can meet the challenges of today.
On Thursday, Mr Biden and Prime Minister Boris Johnson of Great Britain turned to a World War II-era document to inspire a new generation of challenges and to renew the Atlantic Charter eight decades after it was signed to address the threats of today To take into account: from cyber attacks to nuclear weapons, climate and public health.
The G7 meeting is also, in many ways, a relic of another era. It was created in the 1970s Providing economical solutions after an oil supply shock triggered a financial crisis.
Ursula von der Leyen, President of the European Commission, 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 “United and determined to protect and promote our values.”
Emergency room visits after alleged teenage suicide attempts rose in the first few months of 2021 compared to rates in 2019, the Centers for Disease Control and Prevention reported on Friday.
The new study, which was based on data from the National Syndromic Surveillance Program, showed that emergency room visits for suspected suicide attempts in girls ages 12-17 increased an average of 51 percent in the four weeks ended March 20, compared with the same period in 2019. The rate started rising in the summer of 2020, the researchers said.
The number of suspected suicide attempts in boys of the same age and adults of both sexes, ages 18-25, remained relatively stable compared to the corresponding period in 2019, the study found.
“The results of this study suggest that young women are more exposed than previous reports during the pandemic, reinforcing the need for increased awareness and prevention for this population,” said the C.D.C. said.
The report comes on the heels of others current research that suggested higher rates of mental health problems in teenagers, including self-harm, attempted suicide, and suicidal ideation, which some experts fear may be related to pandemic stressors.
But Ellen Yard, an epidemiologist and lead author on the study, wrote in an email that “the analysis in this report was not aimed at assessing whether this surge was caused by Covid-19”.
“However, some researchers have suggested that the Covid-19 pandemic could increase the risk of suicide,” continued Dr. Yard away. “Adolescents may have been particularly affected by mitigation measures such as social distancing (including lack of connection with schools, teachers, and peers), barriers to treatment for mental health, and family health and economic problems.”
The researchers also said the increase in hospital visits for adolescent girls did not necessarily mean that there had been more suicides. Regarding the visits to the emergency room, the report said, “It is important that although this report found an increase in emergency room visits for suspected suicide attempts in adolescent women in 2020 and early 2021, it does not mean that the deaths are due to Suicide have increased. “
According to preliminary data from the C.D.C.s National vital statistics system, Suicides in the USA even declined overall in 2020 to 44,834 deaths from 47,511 in 2019, although preliminary studies based on local data showed an increase in suicides among black Americans and other colored people compared to previous years.
John Ackermann, the suicide prevention coordinator at Center for Suicide Prevention and Research at Nationwide Children’s Hospital in Columbus, Ohio, said the report reflects its experience since the pandemic began.
Dr. Ackerman, who was not involved in the study, said he saw low emergency room rates by teenagers for mental health problems at the start of the pandemic, perhaps because people were concerned about exposure to the virus, but those numbers rose over the months.
“You have started seeing emergency rooms here in Ohio and across the country reporting really high rates of hospital admissions for suicide attempts, depression, anxiety, self-harm, and those kinds of presenting factors,” said Dr. said Ackermann.
He said the pandemic was on additional source of fear for people in groups who are often at higher risk for suicidal ideation, such as People of Color and L.G.B.T.Q. Youth.
But many factors play a role, added Dr. Ackerman added, and the pandemic was just one of many stressors in what he called a “stormy year”.
“Many people felt isolated or devalued, or feel hopeless for many reasons, and all of these are risk factors for suicide, ”he said.
As the leaders of wealthy Western democracies step up efforts to bring Covid-19 vaccines to the world, they also seek to catch up with China’s efforts to establish itself as a leader in the fight against the coronavirus.
Last summer, China’s top leader Xi Jinping announced the promise of a China-made Covid-19 vaccine as global public good. So far he seems to be keeping this promise.
China is now the world leader in Covid-19 vaccine exports and is cementing its ambition to become a major player in global public health. According to Bridge Consulting, a Beijing-based consulting firm, the country’s vaccines have been launched in 95 countries that have received more than 260 million doses.
The World Health Organization recently approved the vaccines from the Chinese companies Sinopharm and Sinovac for emergencies, which further strengthen Beijing’s reputation.
So far, China has mainly followed a country-specific approach to the distribution of its vaccines. The country has given just 10 million doses to Covax, the global alliance supported by the World Health Organization to ensure developing countries have access to affordable vaccines. However, it has independently donated 22 million cans and sold 742 million cans, according to Bridge Consulting. Many of the donations went to developing countries in Africa and Asia.
“China is picking countries that could potentially return to China for more things in the future,” said Sara Davies, a Professor of International Relations with a major in Global Health Diplomacy at Griffith University in Australia. “This is the beginning of a long-term relationship.”
However, there are questions about the effectiveness of China’s vaccines, particularly that of the state-owned Sinopharm. Countries that have extensively vaccinated their populations with the Sinopharm vaccine, such as: the Seychelles and Mongolia, have had new coronavirus outbreaks.
The worldwide rollout was also followed by delayed deliveries. China is struggling to produce enough doses of its two-shot vaccines to meet the needs of its 1.4 billion people and overseas customers.
In April, the Turkish health minister said one reason for the country’s slow vaccination campaign was that Sinovac failed to meet a promised delivery schedule.
“This is not due to a lack of production, but because the Chinese government is using the vaccines for their own country,” Minister Fahrettin Koca was quoted as saying in the Turkish press.
In a regular press conference on Thursday, a spokesman for the Chinese Foreign Ministry urged the countries that conduct vaccine research and development to “take their responsibility” and support Covax.
“As we all know, until recently, the US emphasized that its top priority for vaccines is domestic introduction,” said spokesman Wang Wenbin. “Now that Covax has announced a donation, we hope that it will fulfill its obligation as soon as possible.”
Alexandra Stevenson contributed the reporting and Elsie Chen contributed to the 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 Philippinen 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.