F.D.A. Panel Endorses Pfizer-BioNTech Vaccine for Children 5 to 11

Video

transcript

Back

0:00/0:52

–0:00

transcript

Municipal Workers Protest Against N.Y.C. Vaccine Mandate

A large crowd, including many fire, police and sanitation workers, took to the streets in New York to protest the city’s vaccine mandate.

[siren] “No vaccine mandate. “No vaccine — ” “No vaccine mandate.” “No vaccine mandate.” “No vaccine mandate.” “U.S.A., U.S.A.” “No vaccine mandate.” “No vaccine mandate.” [siren] [crowd cheering]

The largest police union in New York City asked a judge on Monday to allow unvaccinated police officers to continue working, despite the city’s recently imposed vaccine mandate, which requires all municipal workers to have received at least one coronavirus vaccine dose by Nov. 1.

In a lawsuit filed in Staten Island, which is home to many police officers and has a vaccination rate that lags behind the citywide average, the Police Benevolent Association of New York said it opposed a vaccine mandate for police officers that does not allow the option of being tested weekly instead of being vaccinated.

The lawsuit also claimed that the mandate — which the mayor announced last week — does not contain sufficient protections for officers who might object to the vaccines because of religious beliefs. Mayor Bill de Blasio has said that the city will be “offering religious accommodation,” but that “valid religious exemptions” are rare.

While most lawsuits trying to stop government vaccine mandates in New York and elsewhere have failed to gain traction, some federal judges have appeared more sympathetic to suits that narrowly attack vaccine mandates for not accommodating religious beliefs.

Police unions across the country, from Chicago to Washington State, are urging members to resist Covid vaccine requirements — despite Covid being by far the most common cause of officer duty-related deaths this year and last, according to the Officer Down Memorial Page.

The New York police union’s lawsuit argues that the city did not give officers enough time to seek religious exemptions. Officers seeking exemptions are required to apply by Wednesday — one week after the mandate was announced — to avoid being placed on leave without pay.

As of last week, about 70 percent of employees of the New York Police Department had received at least one shot of a coronavirus vaccine. The P.B.A., which represents rank-and-file officers, has been generally supportive of an earlier policy that had allowed unvaccinated officers to test weekly for the virus. The lawsuit claims that “test-or-vax” rule was effective in protecting public safety.

The lawsuit was filed on a day when a large crowd of people — including many fire, police, and sanitation workers — marched in protest against the vaccine mandate. Walking across the Brooklyn Bridge to City Hall, some demonstrators carried large American flags and loudly chanted, “We Will Not Comply.”

Children under the age of 18 who are unvaccinated against the coronavirus, and a limited category of foreigners arriving from countries with low vaccination rates, are among the travelers exempted from forthcoming requirements that will determine who can enter the United States, Biden administration officials said on Monday.

The Biden administration has announced that it would lift travel restrictions on Nov. 8 and reopen the United States to fully vaccinated international travelers who had been barred for nearly a year and a half from entering the country by air or crossing the land borders.

But the new travel system also comes with stringent requirements, and will seal the United States off from most foreigners who have not yet received a vaccine cleared by the World Health Organization or U.S. federal regulators. On Monday, senior officials detailed opportunities to enter the United States for certain travelers who struggled to obtain a vaccine because of a lack of uniform vaccine eligibility for minors, as well as limited access to the global supply.

Unvaccinated children under the age of 18 will be permitted to enter the United States when the new system takes effect, officials said, confirming an earlier report from The New York Times. Children older than 2 who are traveling with a fully vaccinated adult will need to show a negative coronavirus test within three days of their departure date. Those traveling alone or with an unvaccinated adult will need to show such a result one day before they travel to the United States.

The exemptions will also apply to adults flying from countries where less than 10 percent of the overall population is fully vaccinated, if they can show a “compelling reason” for entering the United States, officials said. That carve-out, they said, would apply to a narrow group of unvaccinated travelers; entering the United States for tourism would not clear the bar for an exemption.

Others who show a U.S. government-issued letter approving an emergency or humanitarian need to travel will also be allowed to cross U.S. borders.

Many leaders in the tourism industry have praised the new rules, which will signal a new chapter in the U.S. recovery from the pandemic. The restrictions imposed in the early days of the pandemic have barred tourists and separated family members from traveling to the United States for nearly 18 months.

But on Nov. 8, the country will open to those who can show that two weeks have passed since they received either a second shot of the two-dose vaccines cleared by U.S. federal regulators or the W.H.O. (in any combination), or a single shot of a one-dose vaccine greenlit by those organizations, like the one from Johnson & Johnson. Digital or print proof of vaccination status will be required.

In addition, fully vaccinated American citizens or legal permanent residents arriving by sea or air will need to show proof of a negative coronavirus test taken within three days of traveling. Those who are unvaccinated will need to test negative within one day of traveling. Those crossing the land border from Canada or Mexico will not have a testing requirement.

Travelers will also be required to provide their personal information for potential contact tracing after arriving in the United States.

The coronavirus vaccine made by Moderna is safe and produces a powerful immune response in children 6 through 11, the company said on Monday.

One month after immunization was complete, the children in Moderna’s trial had antibody levels that were 1.5 times higher than those seen in young adults, the company said.

Moderna did not release the full data, nor are the results published in a peer-reviewed journal. The results were announced one day before an advisory committee of the Food and Drug Administration is scheduled to review data for the Pfizer-BioNTech vaccine in children 5 through 11.

Moderna tested two shots of the vaccine given 28 days apart in 4,753 children. They received 50 micrograms of vaccine, half the adult dose, in each shot. (Last week, based on data showing that the half dose is still highly effective, the F.D.A. authorized a booster shot of the Moderna vaccine at this dose.)

Moderna submitted study results for the vaccine’s use for adolescents 12 through 17 in June, but the F.D.A. has not yet announced a decision for that age group.

Some research indicates that the Moderna vaccine may increase the risk of a rare side effect called myocarditis, an inflammation of the heart muscle, in boys and young men. In July, the F.D.A. asked both Pfizer and Moderna to expand the size of their trials in order to detect less common side effects.

In children aged 6 through 11, most of the side effects were mild or moderate; the most common were fatigue, headache, fever and pain at the injection site, Moderna said in its statement on Monday. An independent committee will continue to review the vaccine’s safety in the trial participants for 12 months after the second dose.

Moderna is still recruiting children aged 2 through 5 and 6 months to under 2 years for trials of the vaccine in those age groups. The company has enrolled about 5,700 children in the United States and Canada in the trial.

Moderna plans to submit the results soon to the F.D.A. and to regulatory agencies in Europe and elsewhere, the company said.

With less than three months to go before the 2022 Australian Open, confusion remains as to whether unvaccinated players will be able to participate in the marquee event.

Novak Djokovic, the reigning champion and a nine-time winner of the Australian Open, expressed uncertainty last week over whether he would attend the tournament if he were required to prove his vaccination status. His comments set off a flurry of speculation and contradictory remarks by government ministers and tennis officials.

“Things beings as they are, I still don’t know if I will go to Melbourne,” Mr. Djokovic, who is tied with Roger Federer and Rafael Nadal for the most men’s Grand Slam singles titles in a career, told Blic Sport. “I will not reveal my status whether I have been vaccinated or not, it is a private matter and an inappropriate inquiry.”

In June 2020, Mr. Djokovic tested positive for the coronavirus after hosting a tournament in Serbia and other Balkan nations, after which other players and coaches were also found to be infected.

In response to Mr. Djokovic’s comments, Australia’s immigration minister, Alex Hawke, said last week that unvaccinated players “will have to be double vaccinated to visit Australia.”

“That’s a universal application, not just to tennis players,” he told Australian Broadcasting Corporation radio on Wednesday.

Confusion remains, however. While organizers of this year’s tournament are hoping all players can participate, they have not yet released any formal vaccination or quarantine guidelines for the athletes. And neither Australia’s federal government nor the government of Victoria, the state in which the tournament is held, have made a formal announcement about how or when international tennis players will be able to enter the country and what they can or can’t do once they’re allowed in.

When asked for clarification by The New York Times, the Australian federal government suggested via email that any rulings regarding the players’ participation in the tournament fell under the jurisdiction of the state government: “Participants at the Australian Open may be subject to varying quarantine arrangements, depending on their vaccination status, or declared status in accordance with State and Territory requirements.”

Noncitizens are broadly barred from visiting Australia, but they can be granted entry if they agree to quarantine for two weeks, which is how players participated in the 2021 Australian Open in February.

That tournament drew backlash from citizens for seeming to prioritize admitting international tennis players over the many Australians who were stranded overseas because of travel restrictions.

In a leaked email, the Women’s Tennis Association directly contradicted Mr. Hawke’s comments, insisting that unvaccinated players would be able to attend the tournament if they quarantined for two weeks.

But the Victorian government rebutted this claim on Monday afternoon, with the sports minister, Martin Pakula, telling 3AW radio that the matter would not be settled for “another couple of weeks.”

Tennis Australia, the organizer of the tournament, said in a statement on Monday that it was “working with the Victorian and Federal Governments on the conditions for players at Australian Open 2022 and look forward to having the details confirmed soon.”

“We are optimistic that we can hold the Australian Open as close to pre-pandemic conditions as possible,” the statement said.

Australia, home to the world’s longest lockdown, is scrapping quarantine requirements for vaccinated residents returning from overseas. New Zealand, famed for its commitment to a “Zero Covid” strategy, abandoned it this month. Around the world, people are vacationing, visiting family and resuming business trips across international borders.

Not China.

The country where the coronavirus pandemic began is also the only one in the world still trying to completely eradicate the virus within its borders. Officials have repeatedly dismissed the idea of living with the virus, citing China’s large population and their success in containment so far — even as the country has continued to record sporadic outbreaks, triggering mass testing and strict lockdowns.

“Every locality should firmly adhere to the policy of ‘Defend externally against importation, defend internally against rebound,’” Mi Feng, a spokesman for the National Health Commission, said at a news conference on Sunday. “The current control measures cannot be relaxed.”

China has continued to record local cases — around 130 in recent days, after a spate of cases linked to domestic tourists. Parts of Beijing, Inner Mongolia and Gansu Province are under lockdown. Schools and businesses in those areas of Beijing are closed, and organizers of the Beijing Marathon, which had been planned for this weekend, announced on Sunday that it would be indefinitely postponed.

China’s tough stance on loosening Covid restrictions is possible in part because of China’s huge domestic consumer base, which has helped to keep retail spending afloat, and because of the ruling Communist Party’s tight grip on power. The authorities can implement lockdowns and mandate multiple rounds of testing with astonishing efficiency.

In addition, many Chinese are satisfied with the government’s approach. Domestic travel has surged in areas with no cases, and the country’s low death rate — it has officially recorded fewer than 5,000 deaths — has become a source of nationalistic pride, especially at a time when China’s relations with many other countries are growing increasingly fraught.

Xi Jinping, China’s leader, has repeatedly pointed to China’s success in containment as proof of the superiority of its governance model. When Zhang Wenhong, a prominent virologist, suggested this summer that China learn to live with the virus, he was attacked viciously online as a lackey of foreigners.

There is a clear incentive for China to remain closed off, at least in the short term: With Beijing set to host the Winter Olympics in February, officials have acknowledged that they are under pressure to keep cases under control.

Still, the question of sustainability looms. China’s economic growth is slowing. The country’s diplomatic efforts may also suffer from its long isolation; Mr. Xi has not left China or received foreign visitors since early 2020, even as other world leaders prepare to gather in Rome for a Group of 20 summit and in Glasgow for climate talks.

Some officials have started to tentatively broach the idea of loosening restrictions, though without any timelines or firm commitments. Zhong Nanshan, one of the country’s most prominent doctors, told a Chinese magazine this month that China could begin opening up when vaccination rates had exceeded 85 percent, a goal that could potentially be reached this year.

But, he added, there was another caveat: Other countries would also need to get cases under control.

Joy Dong contributed research

A study of more than 32 million Covid vaccine recipients in England published on Monday found that people given the AstraZeneca vaccine were at slightly increased risk of Guillain–Barré syndrome, a rare but potentially serious neurological condition.

Even so, the coronavirus vaccine posed a far smaller risk of the disorder than did Covid itself, the researchers said.

“The neurological complications of SARS-CoV-2 vaccines are much rarer than the neurological complications of Covid-19,” said Dr. Peter Openshaw, a professor of experimental medicine at Imperial College London.

For every 10 million people who received a first dose of the AstraZeneca shot, the study estimated, 38 additional people would be expected to develop Guillain-Barré syndrome. In comparison, for every 10 million people who contracted the coronavirus, 145 would be expected to develop Guillain-Barré.

Concerns about the syndrome have already prompted regulatory action in Britain and the European Union. The European Medicines Agency said last month that it was “at least a reasonable possibility” that the AstraZeneca vaccine caused Guillain-Barré in very rare instances. And last week, Britain’s medicines regulator added it as a very rare side effect.

Guillain-Barré is a condition in which the body’s immune system attacks nerve cells, potentially causing muscle weakness or paralysis. The symptoms often pass within weeks, but in some cases, the condition can cause permanent nerve damage.

Researchers have reported that the Johnson & Johnson shot may also be associated with a small increased risk of Guillain-Barré. That shot and the AstraZeneca vaccine both rely on a virus known as an adenovirus. The study on Monday said that further studies were needed to assess whether antibodies against the vaccine can react with components of the peripheral nerves to cause Guillain-Barré.

Several European countries have already limited the use of AstraZeneca’s vaccine because of an apparent link with other rare but serious clotting disorders. In the United States, the Johnson & Johnson vaccine has largely been sidelined amid concerns about the same clotting problems and the wide availability of alternative vaccines.

The new study also found a small increased risk of hemorrhagic strokes — caused by the leaking or rupture of a blood vessel in the brain — after a first shot of the Pfizer vaccine, but scientists cautioned that any association was far from certain. The study said that there was no increased risk evident from a different set of Scottish vaccination data, and scientists noted that the diagnoses in England had not all been verified by stroke experts.

President Moon Jae-in of South Korea announced on Monday that the country had achieved its goal of fully vaccinating 70 percent of its population of about 52 million and would be implementing a phased recovery plan next month.

While Seoul, the capital, has been under the strictest level of social-distancing regulations since the summer, limiting social gatherings to a maximum of two at one point and barring customers from sitting in cafes, regulations were eased starting last week. Last week, South Korea also added five countries to the list of those whose vaccinated tourists will be eligible for quarantine exemptions.

Under the phased recovery plan that starts next Monday, restrictions will loosen further, including allowing gatherings of up to 10 people, lifting restrictions on business operating hours, allowing spectators at some sporting events and allowing the use of showers at fitness centers. The new regulations will be observed for a four-week period, followed by a two-week evaluation term.

While South Korea’s vaccination program had a slow start compared to those in the United States and several countries in Europe and Asia, it quickly picked up its distribution to surpass the United States. The country was a week early in reaching its immunization quota on Saturday.

On Monday, South Korea’s government also said it would donate one million AstraZeneca Covid shots to Iran, in recognition of the 60-year friendship between the two countries. Earlier this month, South Korea donated over a million doses of the AstraZeneca vaccine to Vietnam and Thailand.

On Monday, South Korea reported 1,190 daily new cases. According to a database by Our World in Data, the country has seen a 35 percent decrease in cases over the past two weeks. The country has faced four waves of the pandemic since February, with its latest spike starting in July and still ongoing, the worst in terms of case count.

The government also announced a $519 billion budget for 2022 to help recover the pandemic-induced economic fallout. The proposed budget for next year is 8.3 percent higher than this year’s.

“We will do our best to recover both financially and in our daily lives,” Mr. Moon said at the National Assembly.

Covid-19 vaccines could be approved and available for younger American children soon, but the question of how quickly parents will allow them to get inoculated is another matter.

Children ages 5 to 11 could begin getting vaccinated in early November, Dr. Anthony Fauci, the nation’s top infectious disease official, said Sunday.

That means those children could be fully immunized by the holidays, if an advisory panel to the Food and Drug Administration endorses Pfizer’s application for vaccine use in that age group on Tuesday. Children 12 and up have been eligible for vaccination since May.

But hesitancy among parents of these children could be a hurdle. Only about one in three parents of 5- to 11-year-olds planned to get their children inoculated “right away” once a vaccine is authorized, according to polling by the Kaiser Family Foundation conducted last month. Another third said they wanted to “wait and see” how the vaccine affected children.

But that same polling showed that reluctance among parents of teenagers had dropped in the months since vaccines became available to that age group.

“This is critically important, and we know we have a lot of work to do,” Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention, said on the NBC program “Meet the Press.” “Those survey data look very much consistent with where we were with adults last December, when we rolled out vaccines for adults. We have done a huge amount of hard work over the last 10 months, education, communication, providing information, getting vaccines to really convenient places and trusted messengers.”

F.D.A. regulators on Friday released their evaluation of data from the Pfizer-BioNTech submission for emergency authorization of a lower-dose vaccine for young children.

Pfizer’s data “look good as to the efficacy and safety,” Dr. Fauci said on the ABC program “This Week.” He said “if all goes well,” it is “entirely possible, if not very likely, that vaccines will be available for children from 5 to 11 within the first week or two of November.”

According to Pfizer and BioNTech, the children who were vaccinated as part of the clinical trial, who received doses that were one-third the size of the adult doses, developed robust immune responses after receiving the regimen of two shots three weeks apart. The companies have said the efficacy rate of the vaccine in children reduced the risk of developing a symptomatic infection by 91 percent.

The most common side effects in children were fatigue, headache, muscle pain and chills. According to the F.D.A., the data submitted indicated no cases of myocarditis, inflammation of the heart muscle, or pericarditis, inflammation of the outer lining of the heart, both of which are rare complications that have been reported among young boys and men receiving the vaccine.

Over the past week there has been a lot of regulatory guidance on who can receive booster doses of Covid vaccines, giving a large segment of the U.S. population access to more protection.

Both Dr. Walensky and Dr. Fauci sought to dispel confusion about booster shots and explain the option of “mixing and matching” initial vaccines and boosters.

Boosters of all three vaccines available in the United States have been authorized. Additional shots of the Pfizer and Moderna vaccines, which use mRNA technology, have been approved for people 65 and older, those with underlying health conditions and all adults whose living or working conditions place them at high risk of exposure to the virus. Anyone over 18 who received the single-dose Johnson & Johnson vaccine at least two months ago is also eligible for a booster.

People can receive a booster shot that is different from the initial vaccine they first received, the health authorities said.

“If you were originally vaccinated with one product, could you and would it be appropriate and safe and effective to get boosted in the third shot for the mRNA and the second shot for J.&.J. by another product?” Dr. Fauci said. “The answer is, it’s perfectly fine.”

Papua New Guinea is facing its highest daily number of new Covid-19 cases since the pandemic began, and the surge threatens to overwhelm the country’s rudimentary health system, the Red Cross said on Monday. Data from global health organizations suggest that the crisis may be far deeper than the story told by official figures.

Since March 2020, the country has reported 27,627 confirmed cases of the coronavirus and 335 deaths. Figures from the World Health Organization indicate that the true number of infections may be more than twice that, according to an Agence France-Presse report.

At least 2.6 million people, or more than a quarter of the population of nine million, have visited clinics with symptoms consistent with flu or pneumonia since the pandemic began.

Papua New Guinea’s health services are poorly equipped to deal with a major outbreak. The country has only 500 doctors and fewer than 4,000 nurses, according to Human Rights Watch. With most of the population living outside of urban centers, access to health care is limited.

“Hospitals are full, and patients are being turned away in Port Moresby and provincial areas,” said Uvenama Rova, the top Red Cross official in Papua New Guinea, in a statement. “We are deeply concerned that the risks of hospitalization and death from Covid-19 are skyrocketing due to limited health infrastructure, high rates of illness, all compounded by poor access to safe water, hygiene and sanitation facilities.”

As of Sunday, just 207,207 people in the country had been vaccinated, because of problems with the rollout and a lack of supplies. Intense misinformation and vaccine hesitancy have affected even the country’s health staff: One survey of 130 people working in an emergency department in Port Moresby, the capital, showed 24 percent would refuse a vaccine and 37 percent were unsure, according to A.F.P.

After a series of endorsements over the last month by scientific panels advising federal agencies, tens of millions of Americans are now eligible for booster shots of coronavirus vaccines.

But the recommendations — even those approved unanimously — mask significant dissent and disquiet among those advisers about the need for booster shots in the United States.

In interviews last week, several advisers to the Centers for Disease Control and Prevention and to the Food and Drug Administration said data show that, with the exception of adults over age 65, the vast majority of Americans are already well protected against severe illness and do not need booster shots.

All the advisers felt that they were obligated to make difficult choices, based on sparse research, in the middle of a public health emergency. But some said they felt compelled to vote for the shots because of the way the federal agencies framed the questions that they were asked to consider.

Other committee experts said that they wanted to avoid confusing the public further by dissenting, or that they voted according to their views of the evidence and were simply overruled.

After a series of votes, the official position of the F.D.A. and C.D.C. now is that older adults, people with certain medical conditions and those whose jobs or living situations regularly expose them to the virus can opt for a booster dose of any of the three vaccines.

The C.D.C. also advised last week that people in certain high-risk groups who got one type of vaccine could choose a different one for their booster.

In interviews, the experts bemoaned the limited data on the safety and efficacy of the booster shots. Still, some said they felt they had to vote in favor of booster shots of the Moderna and Johnson & Johnson vaccines because they had already recommended boosters of the Pfizer-BioNTech vaccine and did not want to deny other Americans.

An independent committee of experts advising the Food and Drug Administration met on Tuesday and voted to recommend authorizing the Pfizer-BioNTech coronavirus vaccine for children 5 to 11 years old, opening the way to inoculating 28 million children in the United States.

An evaluation of data released by regulators on Friday from a clinical trial showed that Pfizer’s vaccine was very effective at preventing symptomatic Covid-19 in children in that age range, and that the vaccine’s benefits outweighed the risk of rare side effects.

More needs to happen at the F.D.A. and the Centers for Disease Control and Prevention before children 5 to 11 will be able to receive the vaccine. But if both federal agencies rule in favor, the children could become eligible for shots in the first week of November.

Here’s what comes next.

At the F.D.A.

• The F.D.A. considers its advisory panel’s recommendation. The panel’s votes are not binding, but the F.D.A. typically follows them.

• Dr. Janet Woodcock, the acting commissioner of the F.D.A., issues the agency’s final decision, usually within a few days of the advisory committee’s meeting.

At the C.D.C.

• An advisory panel to the C.D.C., the United States’ public health agency, reviews the F.D.A.’s decision and makes recommendations. That panel is scheduled to meet to consider the issue next week.

• The C.D.C. considers its panel’s recommendations, which are not binding, though the agency usually follows them. There was a rare exception in September, when Dr. Rochelle P. Walensky, the director of the C.D.C., endorsed Pfizer-BioNTech booster shots for frontline workers even though the C.D.C.’s panel had not recommended the step. That move by Dr. Walensky aligned the C.D.C.’s guidance with the F.D.A.’s authorization.

• Dr. Walensky issues the agency’s guidance, which is powerfully influential for states, the general public and health care institutions and professionals.

In the states

• State health departments generally follow the recommendations of the C.D.C.

• Federal officials have said that if pediatric doses of the Pfizer-BioNTech vaccine are authorized, 15 million doses of vaccine will immediately be shipped to the states for distribution.

Video

transcript

Back

0:00/0:33

–0:00

transcript

F.D.A. Panel Endorses Pfizer-BioNTech Shots for Young Children

A Food and Drug Administration advisory committee voted to recommend a pediatric dose of the Pfizer-BioNTech coronavirus vaccine for children between the ages of 5 and 11.

“Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech Covid-19 vaccine when administered as a two-dose series, 10 micrograms each dose three weeks apart, outweigh its risks for use in children 5 to 11 years of age?” “This concludes the vote: Out of 18 voting members, 17 voted yes and we had one abstain.”

An expert committee advising the Food and Drug Administration on Tuesday recommended that regulators authorize Pfizer-BioNTech’s coronavirus vaccine for 5- to 11-year-olds, bringing about 28 million children a major step closer to becoming eligible for shots.

If the F.D.A. follows the panel’s advice in the coming days, as is expected, the Biden administration will have expanded vaccine access to all but the youngest Americans, while providing booster shots for many as well.

Biden administration officials see the pediatric dose as crucial to keeping schools open and restoring a sense of normalcy to family and work life as the pandemic hurtles toward the end of its second year. The administration wants to be seen as doing everything possible to combat the virus and build upon positive trends, as the Delta variant ebbs and the daily drumbeat of infections and deaths fades.

Younger children would start getting their shots at a time when coronavirus cases are dropping sharply. But public demand for a pediatric vaccine has been high, and some panel members said that even though young children are less likely to get severely ill from Covid-19, parents and doctors alike are anxious to protect them.

Dr. Jay Portnoy, a medical director at Children’s Mercy Hospital in Kansas City, Mo., said he had seen critically ill children in the intensive care unit and “terrified” parents. “I’m looking forward to being able to actually do something to prevent that,” he said.

The vote was 17-0 in favor, with one abstention. Federal regulators and scientists made a strong push, arguing that 8,300 children between 5 and 11 had been hospitalized with Covid-19 and nearly 100 had died over the course of the pandemic.

Covid-19 is “the eighth-highest killer of kids in this age group over the past year,” said Dr. Amanda Cohn, a top C.D.C. vaccine official. “Use of this vaccine will prevent deaths, will prevent I.C.U. admissions and will prevent significant long-term adverse outcomes in children.”

Data from Pfizer showed that the vaccine had a 90.7 percent efficacy rate in preventing symptomatic Covid-19 in a clinical trial of 5- to 11-year-olds. Still, many advisory committee members expressed concern about limited safety data, turning repeatedly to the risk of myocarditis, a rare condition involving inflammation of the heart muscle, in young vaccine recipients. Myocarditis and pericarditis, inflammation of the lining around the heart, have been tied to the Pfizer-BioNTech and Moderna vaccines, particularly in younger men.

The Pfizer dose for younger children would be one-third of the strength given to people 12 and older, with two shots given three weeks apart. Experts have said that could diminish the risk of the heart-related side effects.

If F.D.A. regulators follow the committee’s advice, as they typically do, an authorization could come within days. The Centers for Disease Control and Prevention’s own panel of outside experts is scheduled to meet Tuesday and Wednesday, and is also expected to endorse a pediatric dose. The C.D.C., which sets vaccine policy, would likely then quickly recommend the rollout of shots.

During a long debate before the vote, some committee members questioned whether every child in the age group really needed the vaccine or whether it should be limited to those at high risk of severe Covid-19 — an easily identifiable group, with underlying conditions such as obesity or other risk factors.

Dr. James E.K. Hildreth, the president and chief executive of Meharry Medical College, said that since many children between 5 and 11 may already have some immunity after contracting the virus, the need to vaccinate broadly in the age group might be less urgent.

“It just seems to me that in some ways we’re vaccinating children to protect the adults, and it should be the other way around,” he said. “I do believe that children at highest risk do need to be vaccinated. But vaccinating all of the children to achieve that just seems a bit much for me.”

MEXICO CITY — As U.S. officials prepare to expand Covid vaccine eligibility to children ages 5 to 11, the Mexican government has resisted calls to vaccinate youths, despite a court order that it do so.

This month a judge ordered Mexico’s government to vaccinate anyone aged 12 to 17 after the parents of a 15-year-old girl sued to get their daughter vaccinated, just one of many lawsuits from parents demanding that their children be inoculated.

But President Andrés Manuel López Obrador dismissed the ruling as “not definitive” and hinted at challenging the decision, saying during a news conference that “legally this is going to be respected, but at the same time, we are going to go to the relevant authority to clarify” the court’s decision.

Whether the government would mount such a challenge remains unclear, but the president’s rhetoric is emblematic of Mexico’s continued resistance to allow minors to be inoculated, even as regulators in the United States and other countries have increasingly approved shots for children.

Mexico’s medical safety agency has granted the Pfizer-BioNTech vaccine emergency use authorization for youths 12 and over, but the government has refused to allow the shots to be administered to most minors, and has played down the risks Covid-19 poses to children.

Mexico has fully vaccinated only about 41 percent of its population, according to Our World in Data. The government has said it should concentrate on vaccinating the millions of adults who have yet to get shots, and put off vaccinating otherwise healthy children until the vaccines are proved to be safe for them.

The stance has been criticized by public health and political experts. Some say the government’s resistance to vaccinating children stems from a lack of planning and insufficient vaccine supplies.

“This mess comes from the lack of preparation,” said Xavier Tello, a public health policy expert in Mexico City, adding that the government has “no strategy.”

Hundreds of parents have taken the government to court and demanded shots for their children, and many have succeeded.

In the wake of the mounting media and legal pressure, Mr. López Obrador’s government said last month that it would begin vaccinating children over 12 who had an underlying condition, which could mean that more than one million are now eligible. But the government is holding firm on its commitment to vaccinate adults first.

“There is a vaccination plan,” Mr. López Obrador said this month, regarding the recent ruling mandating vaccines for teenagers. “A public policy cannot be defined based on the interest of a person or a group.”