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 events 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.
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 approves 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.”
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.
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
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.
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.
The singer Ed Sheeran announced Sunday on social media that he had tested positive for the coronavirus and would be canceling public appearances and working at home, in quarantine.
It wasn’t immediately clear what appearances would be canceled or rescheduled, or whether Mr. Sheeran was sick with symptoms of Covid-19.
The news came days before the Friday release of his new album, “=,” pronounced “equals.” The 14-song album includes his recently released single “Bad Habits.”
And it comes just after Mr. Sheeran had been announced as the musical guest for “Saturday Night Live” on Nov. 6.
The four-time Grammy winner took a break from work and social media in late 2019 after two years of touring in support of his best-selling album “÷” (or “divide”).
Ed Sheeran reveals he has tested positive for COVID-19 and will be self-isolating:
“I’m now unable to plough ahead with any in person commitments for now, so i’ll be doing as many of my planned interviews/performances from my house.” pic.twitter.com/7SB8vfAoG7
— Pop Crave (@PopCrave) October 24, 2021
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 has 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.