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The Food and Drug Administration is reviewing reports suggesting the coronavirus vaccine made by Moderna can cause heart problems in some adolescents, the company said on Sunday.
Moderna requested authorization from the F.D.A. for use of its vaccine in children ages 12 to 17 years in June. The adolescents would receive 100 micrograms of the vaccine — the same dose given to adults 18 and above. But the agency has not yet made a ruling on the application, prompting speculation about reasons for the delay.
In a statement on Sunday, Moderna said the F.D.A. “requires additional time to evaluate recent international analyses of the risk of myocarditis after vaccination.”
The European Medicines Agency approved the vaccine for use in adolescents in July. But since then, several European countries have paused the vaccine’s use in people 30 and younger, citing concerns about myocarditis — an inflammation of the heart muscle.
Moderna said more than 1.5 million adolescents worldwide have received its coronavirus vaccine, and the data thus far do not suggest an increased risk of myocarditis. But studies from Israel and the United States have linked both the Pfizer-BioNTech and Moderna vaccines to rare and transient cases of myocarditis, with a higher risk from the Moderna vaccine.
The F.D.A. notified Moderna on Friday that it would need more time to assess the vaccine’s safety and may not deliver a decision until January 2022, the company said in a statement on Sunday. The agency took roughly a month to authorize the Pfizer-BioNTech vaccine for children ages 12 to 15 years. That vaccine has been available to adolescents in the United States and Europe since May.
Even with the heightened risk, myocarditis as a result of the vaccine is rare, mild, and resolves quickly, noted Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the F.D.A.’s vaccine advisory committee.
Covid-19 is much more likely to cause myocarditis, Dr. Offit noted, because the virus can infect and damage the lining of the heart. “That would be the decision point I would make for my child,” he said.
In studies from Israel and the United States, the incidence of heart problems among people who had received Pfizer-BioNTech or Moderna vaccine is highest in males aged 16 to 29 years. The risk appears to decline in children 12 to 15, and is expected to be even lower in younger children, Dr. Offit said.
The F.D.A. in July asked Pfizer-BioNTech and Moderna to enroll more children in their clinical trials in order to detect less common side effects. Last week, after reviewing data from a clinical trial of the Pfizer-BioNTech vaccine in children aged 5 through 11 years, the F.D.A. authorized the vaccine for that age group.
Results from Pfizer’s vaccine trial in children under 5 are not expected till the fourth quarter of this year at the earliest. Last week, Moderna said its vaccine produced a potent immune response in children ages 6 through 11 who received half the adult dose. The company plans to request authorization from the F.D.A. for the vaccine’s use in this age group.
Approximately 28 million American children will be newly eligible for Pfizer-BioNTech’s coronavirus vaccine as soon as this week, if the Centers for Disease Control and Prevention clears the shots for those ages 5 to 11.
The Food and Drug Administration authorized those pediatric doses on Friday. After a review from an advisory panel, the C.D.C. will issue its guidance.
But getting shots in arms takes more than official permission, and the federal government, state and local officials, and health care institutions are working to ensure that vaccines are available for children across the country.
The Biden administration said last week it had 15 million doses ready to ship immediately, and that it would make them accessible at children’s hospitals, pharmacies, community health centers and pediatricians’ offices. States started ordering doses, free of charge, last week based on the number of children they count in the age group.
California’s Department of Public Health said in an email on Friday that the state had initially ordered approximately one million doses, and planned to request more soon. The vaccines will be made available to the state’s 3.5 million newly eligible children at thousands of sites, including medical practices, pharmacies and schools.
In Illinois, Gov. J.B. Pritzker said on Monday that more than 2,200 locations and providers were already prepared to provide the more than 500,000 pediatric doses that the state will initially receive.
State health officials in Texas said on Monday that the federal government would initially allocate approximately 1.3 million pediatric doses to the state.
Mayor Bill de Blasio of New York City said on Thursday that shots would be available for children at city-run vaccination sites within 24 hours after federal clearance, and at locations like doctors’ offices and pharmacies by 48 hours.
“This is a moment parents have been waiting for, to know their kids will be safe,” Mr. de Blasio said at a news conference. “Now, New York City will be ready.”
The city has ordered 231,000 pediatric doses and is working with nearly 1,500 community pediatricians and family doctors to plan vaccination logistics and engage with patients, said Dr. Dave A. Chokshi, the health commissioner.
Much of the rollout of children’s shots is expected to fall on pediatricians and family physicians, who have relationships with patients and children. Many of those physicians, however, are also strained by staffing shortages and a long line of patients trying to book appointments delayed by the pandemic.
Dr. Sterling Ransone Jr., the president of the American Academy of Family Physicians and a physician in rural Deltaville, Va., said that he would keep his office open later on weekdays and on Saturdays to accommodate the demand for pediatric shots.
Some experts have warned, however, that the same inequities that plagued the vaccine rollout for adults earlier this year could hinder the rollout for children.
“We cannot see what we saw in the earliest stages of rolling out the vaccines for adults, in which advantaged persons and persons of means figure out a way to be first in line,” said Dr. James E.K. Hildreth, the president of Meharry Medical College, a historically Black institution.
He said that school nurses, churches and local health officials would be key in reaching some children and families who might not have insurance or access to pediatricians.
Black and Hispanic children are less likely to be tested for the virus but more likely to be infected, get hospitalized and die from Covid-19 than white children are, according to the Kaiser Family Foundation. Hospitalization rates in the 5-to-11 age group are three times as high for Black, Hispanic and Native American children as for white children, according to the C.D.C.
Vaccine hesitancy among all parents is another concern. A survey from the Kaiser Family Foundation released on Thursday found 27 percent of parents of 5- to 11-year-olds were eager to vaccinate their children right away, while a third said they would wait and see how the rollout went.
The uptake among adolescents has been slower than public health experts hoped: Pfizer’s vaccine became available to children 12 to 15 in May, but only roughly 40 percent of that age group is now fully vaccinated, compared to 69 percent of adults.
Daniel E. Slotnik contribued reporting.
LONDON — Health care workers in Britain will visit more than 800 schools beginning Monday to administer Covid vaccines to 12 to 15-year-olds as part of a continuing program to vaccinate the country’s children.
The move comes amid a surge in cases driven primarily by high infection levels in school-age children — more than a third of all recent reported cases were in those under 15 — and as experts warn that the National Health Service could face intense pressure this winter.
More than 600,000 children have received a vaccine since last month, when the vaccination campaign extended to those 12 to 15, the N.H.S. said, adding that health care teams had already visited thousands of schools and inoculated children in the age group after receiving consent from a parent or guardian.
“The vaccines are safe and will help keep children in the classroom,” Sajid Javid, Britain’s health secretary, said in a statement. “I encourage everyone to come forward for their jab to protect themselves and the people around them.”
The effort to vaccinate students will begin as many return from a midsemester break.
Case rates have fallen in recent days, but Britain is reporting an average of 40,700 new daily infections, according to a New York Times database, and deaths have increased by 32 percent in the past two weeks. About 68 percent of the population is fully vaccinated, and more than six million people have received a booster shot.
Britain lifted the bulk of coronavirus restrictions over the summer, though some nations moved more slowly than others. Nightclubs reopened in England in July but only opened in Northern Ireland on Sunday as social distancing restrictions were lifted.
As Republican governors and attorneys general around the country sue, or threaten to sue, to challenge President Biden’s sweeping vaccine requirements, state legislators of both parties are also taking action on Covid-19 mandates.
Mr. Biden said in September that companies with at least 100 employees must require all their employees to be vaccinated or undergo weekly testing. He also moved to mandate shots for health care workers, federal contractors and the vast majority of federal workers.
The rules have ignited a fierce debate across the country. Republicans insist that it infringes on personal liberty, while Democrats maintain that it is simply sound public health policy.
In a special session, Iowa lawmakers passed a bill late on Thursday in the State Legislature to create exceptions to employer vaccine mandates and to give unemployment benefits to people fired for refusing to be vaccinated.
Minutes before Iowa’s lawmakers were to meet in a special session on redistricting, the assembly released a bill that would allow employers to waive vaccine requirements for religious or health reasons. Crucially, the bill allows Iowans to receive a medical waiver without a doctor’s note.
Gov. Kim Reynolds of Iowa, a Republican who opposes government requirements for masks and vaccines, signed the bill into law on Friday, saying in a statement that “no Iowan should be forced to lose their job or livelihood over the Covid-19 vaccine.” Though Republicans have the majority in the Iowa House and Senate, there was bipartisan support for the bill.
Elsewhere, the Republican-controlled legislature in Tennessee approved a slate of bills early Saturday limiting the enforcement of Covid-19 protections, though lawmakers backed off provisions that would have prevented many businesses in the state from enforcing mask mandates, The Associated Press reported.
The legislation prohibits government entities and public schools, as well as many private businesses, from mandating vaccinations or requiring proof of vaccination, according to the Knoxville News Sentinel. After pushback from the business sector, however, the lawmakers agreed to carve out various industries from the ban on Covid-19 vaccine mandates, including many health care facilities and entertainment venues.
Under the new legislation, government entities will largely be prohibited from implementing mask mandates, unless they meet specific criteria. The changes limits public schools from requiring masks, except in extreme circumstances, according to the education news website Chalkbeat Tennessee.
In Florida, Gov. Ron DeSantis, a Republican who has been a strident opponent of federal vaccine mandates, on Friday called for a special session of the State Legislature in two weeks to consider protections for workers who could lose their jobs because of vaccination requirements, saying in a statement that a person’s “right to earn a living should not be contingent upon Covid shots.”
On Saturday, hundreds rallied outside the Statehouse in Topeka, Kan., expressing opposition to federal Covid-19 mandates as a legislative committee considered recommendations for the Republican-controlled legislative body, The Associated Press reported. The very name of the panel — the Special Committee on Government Overreach and the Impact of Covid-19 Mandates — signaled the political resistance to federally imposed requirements.
By contrast, the Illinois General Assembly, which is controlled by Democrats, raced on the final day of its fall session to make it harder for people to avoid Covid mandates. The legislature updated the state’s “conscience” law that was approved in the 1970s to protect doctors and other health care workers from having to provide abortions that conflict with their beliefs.
The bill, which will be signed into law by Gov. J.B. Pritzker, a Democrat, states that it is not a violation of the law for an employer to take any measures or impose any requirements that help prevent contraction or transmission of Covid-19.
Supporters said that the original 1970s law was never intended to allow residents to use moral or religious objections to avoid vaccination. They said the additional language would close what they argued was a loophole.
Víctor Manuel Ramos contributed reporting.
Shanghai Disneyland will temporarily close and is requiring all visitors to undergo Covid testing on their way out of the park, as part of China’s no-holds-barred campaign to eliminate the virus.
The amusement park will be closed Nov. 1 and 2, with no guarantee of reopening after then, although some hotels within the resort will remain open. The news of the temporary closure on Sunday followed an announcement earlier that day that the park was suspending entries.
The park did not specify the reason for the announcements, except to say that it had received notice from other provinces and cities and was cooperating with their epidemiological investigations. China has raced since mid-October to contain a fresh outbreak tied to domestic tourists, which has so far infected more than 370 people across at least 11 provinces and regions. On Sunday, the National Health Commission reported 48 new locally transmitted cases in the previous 24 hours, though none in Shanghai.
Guests leaving the resort would need to be tested for the coronavirus, followed by another one 24 hours later, the park’s announcement said. They would then need to self-monitor for 12 days.
Images on social media showed large groups of workers in full personal protective equipment circulating throughout the park, and long lines of visitors waiting to leave.
A spokesman for the National Health Commission had said on Saturday that the latest outbreak was “still developing rapidly” and that the situation was “severe and complicated.” The newest round of infections, though small compared to outbreaks in many other countries, is relatively large for China, which has officially reported just about 97,000 cases since the start of the pandemic.
On the Chinese social media platform Weibo, where the news of the suspension was trending, some commenters who said they had already bought tickets expressed disappointment. But many comments expressed support for the measure and concern about photos of crowds at the park during the Halloween weekend. China’s commitment to a “zero Covid” policy — which has made it an outlier globally — has widespread support domestically, as it has allowed relatively restriction-free travel within the country.
Still, some experts have warned that the economic toll of repeated lockdowns and other strict prevention measures may eventually become too heavy. Throughout the pandemic, domestic tourism and consumption have suffered when new outbreaks are reported, as people seek to avoid becoming trapped in high-risk areas.
Claire Fu contributed research.
New York City’s sweeping effort to compel most city employees to receive the coronavirus vaccine before Monday appears to have rapidly boosted inoculation rates and pressured thousands of police officers, firefighters and other government workers who had long held out to get the shot.
The vaccination rate among workers affected by the city’s mandate rose to 83 percent at the end of Friday, from 71 percent on Oct. 19, the day before the requirement was announced, according to city data. Some individual agencies reported jumps in vaccination rates of nearly 10 percentage points between Thursday and Friday alone.
The last-minute rush in the nation’s largest municipal work force mirrored similar patterns involving other vaccine mandates. Thousands of health care workers around the state rushed to get their first doses in the days before a requirement for employees at hospitals and nursing homes took effect last month.
We issued a #COVID19 vaccine mandate and our workforce stepped up. Here are some of the latest numbers:
• NYPD - 84% (up from 80% this morning)
— Mayor Bill de Blasio (@NYCMayor) October 30, 2021
• EMS - 84% (up from 77%)
• FDNY - 72% (up from 67%)
• DSNY - 76% (up from 67%)
Still, more than 25,000 city workers affected by the mandate remain unvaccinated and will be placed on unpaid leave on Monday if they do not receive the shot over the weekend. And speculation was fueled in recent days that some employees in agencies including the Sanitation and Fire Departments had already begun to slow down work in protest of the mandate.
New Yorkers across several boroughs, for example, have reported garbage pileups and significant delays in trash pickups in their neighborhoods.
Sanitation officials say the most severe delays have been seen across Staten Island and in parts of southern Brooklyn, including the Bay Ridge and Bensonhurst areas. Data shows that overall 311 complaints soared last week with more than 1,000 reports of uncollected trash and recycling on some days, as the local news outlet Gothamist reported. (The number had hovered between 100 and 250 through the rest of October.)
Mayor Bill de Blasio said this week that he believes some of the delays may be attributed to declines from workers in protest of the vaccination requirement.
“I’m assuming it is related to people expressing their views on this new mandate,” Mr. de Blasio said at a recent news conference. “You want a protest, go protest. But when you’re on the clock, you have to do your job.”
Similar problems were reported among some workers in other agencies as the vaccination deadline approached.
Fire officials said that an uptick in sick calls among employees toward the end of the week was responsible for the temporary closures of several fire stations across the Bronx and other boroughs.
“The excessive sick leave by a group of our firefighters because of their anger at the vaccine mandate for all city employees is unacceptable, contrary to their oaths to serve and may endanger the lives of New Yorkers,” the fire commissioner, Daniel A. Nigro, said in a statement.
Union leaders for both fire and sanitation workers denied reports of the changes in work patterns.
Still, the overall rise in the vaccination rate for municipal workers offered a measure of optimism that significant disruptions to government agencies and city life could be avoided as enforcement of the mandate begins on Monday.
Before the requirement was announced on Oct. 20, and an option to opt into weekly testing was removed, only about 60 percent of employees in the Fire and Sanitation Departments had received at least one vaccine dose. The Police Department’s rate sat around 70 percent.
Holdout workers were offered $500 as a bonus if they got vaccinated by the end of the workday on Friday. By that deadline, more than 75 percent of fire and sanitation workers had been vaccinated — along with nearly 85 percent of the Police Department’s 36,000 uniformed and 15,000 civilian employees.
Joseph Goldstein contributed reporting.
President Xi Jinping of China and President Vladimir V. Putin of Russia on Saturday called for “mutual recognition” of Covid-19 vaccines by global health authorities.
Both leaders delivered the remarks by video to the Group of 20 summit in Rome after deciding not to attend the meeting in person.
Mr. Putin said global access to Covid vaccines was suffering “in part because of protectionism, because of inability and unwillingness by some countries to recognize and register vaccines,” according to a video posted online by RT, a state-controlled Russian TV network.
A Russian vaccine, Sputnik V, has been authorized by 70 countries, Mr. Putin said. But it has not been authorized by the European Union’s main drug regulator, the European Medicines Agency, or the World Health Organization. Markus Ederer, the European Union’s ambassador to Russia, said this month that the Russian authorities had delayed inspections.
“The Russian side has repeatedly postponed the timing of the inspection requested by the E.M.A., which slows down the process,” Markus Ederer told the local outlet RBC. “These are the facts.”
Mr. Putin called on the W.H.O. to expedite the vaccine registration process. “As soon as this is done,” he said, “we will be able to restore and restart the economy.” He said he would also like the Group of 20 to “address the problem of mutual recognition of vaccine certificates.”
Over the summer, many countries opened to international travel, but the patchwork of rules regarding which vaccines would be accepted led to confusion and frustration for travelers, especially those who had received vaccines that were not widely accepted.
Two vaccines made by China, Sinopharm and Sinovac, are on the W.H.O.’s emergency authorization list. Across Asia and South America, millions of people have received doses of those vaccines, and millions more have received doses of vaccines, like Sputnik V, that have been authorized by individual governments only.
On Saturday, Mr. Xi said China had provided more than 1.6 billion shots to the world and was working with 16 countries on manufacturing vaccines, according to a transcript published by the official Xinhua news agency, Reuters reported.
Mr. Xi expressed support for a World Trade Organization decision that waived intellectual property rights for Covid-19 vaccines, Reuters said, and he called for vaccine manufacturers to transfer technology to developing countries.
Britain, Australia and South Korea have reached agreements with the drugmaker Pfizer to purchase its antiviral pills used to treat Covid-19 once regulators approve them, the company said on Friday.
Under the terms of the agreements, Australia will buy 500,000 courses of Pfizer’s pill, known as PF-07321332, and Britain will purchase 250,000, the company said. Earlier this month, Australia secured 300,000 courses of another antiviral pill, molnupiravir, made by the drug manufacturer Merck, and Britain agreed to buy 480,000.
South Korea secured 70,000 courses of Pfizer’s pill, the health ministry said in a statement on Friday. It has also signed a purchase agreement with Merck for 200,000 courses of its pill.
The United States has not yet agreed to buy Pfizer’s pills, a spokeswoman for the company, Roma Nair, said by telephone on Friday. The United States has reached a deal with Merck to buy 1.7 million courses of molnupiravir.
Merck’s and Pfizer’s pills could be a milestone in the fight against the coronavirus because they do not require a visit to the hospital and are relatively inexpensive, unlike the antibody treatments currently being used.
Both pills are designed to interfere with viral replication. If approved by regulators, both pills could be prescribed at the first sign of infection or exposure without requiring hospitalization.
Merck has already reported data from its Phase 3 trials that showed molnupiravir reduced the risk of hospitalization or death by half. Merck has submitted an application to the U.S. Food and Drug Administration to authorize its pill. European Union regulators said on Monday that they had begun a review of molnupiravir.
Meanwhile, Pfizer said in a statement that it had begun Phase 2/3 trials to evaluate the efficacy and safety of its pill.
France has ordered 50,000 courses of Merck’s pills to be delivered starting in the end of November, the health minister, Olivier Véran, said on Tuesday.
The Philippines said this week that it had procured 300,000 courses of molnupiravir. Malaysia and Singapore have also secured supplies of Merck’s pills.
South Korea’s health ministry said it planned to purchase enough antiviral pills for 404,000 patients in total, and to have supplies available starting in the first quarter of 2022. It said it would closely monitor the progress of clinical trials for pills under development at several companies, including Merck, Pfizer and Roche, as it considers its options.
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