Moderna is seeking to be the first to offer a COVID-19 vaccine for the youngest American children, as it asked the Food and Drug Administration Thursday to clear low-dose shots for babies, toddlers and preschoolers.
Frustrated families are waiting impatiently for a chance to protect the nation’s littlest kids as people shed masks and other public health precautions while highly contagious coronavirus mutants continue to spread. Already about three-quarters of children of all ages have shown signs they’ve been infected at some point during the pandemic.
Moderna submitted data to the Food and Drug Administration that it hopes will prove two low-dose shots can protect children younger than 6, although the effectiveness wasn’t nearly as high in kids tested during the omicron surge than it was earlier in the pandemic.
“There is an important unmet medical need here with these youngest kids,” Dr. Paul Burton, Moderna’s chief medical officer, told The `. Two kid-size shots “will safely protect them. I think it is likely that over time they will need additional doses. But we’re working on that.”
FILE – Hudson Diener, 3, peeks into a cabinet during an appointment for a Moderna COVID-19 vaccine trial in Commack, N.Y., Nov. 30, 2021.
Moderna said two kid doses were about 40% to 50% effective at preventing symptomatic COVID-19, not a home run, but for many parents, any protection would be better than none.
That effectiveness is “less than optimal. We were hoping for better efficacy, but this is a first step,” said Dr. Nimmi Rajagopal of Cook County Health in Chicago. She’s anxiously awaiting vaccinations for her youngest patients and her own 3-year-old son, who’s ready to enter preschool.
“It gives me such peace of mind to know that hopefully by fall I’ll get him in school and he’ll be fully vaccinated,” she said.
Now, only children age 5 or older can be vaccinated in the U.S., using rival Pfizer’s vaccine, leaving 18 million younger tots unprotected.
Moderna’s vaccine isn’t the only one in the race. Pfizer is soon expected to announce whether three of its even smaller-dose shots work for the littlest kids, months after the disappointing discovery that two doses weren’t quite strong enough.
Evaluation process
Whether it’s one company’s shots or both, FDA vaccine chief Dr. Peter Marks said the agency will “move quickly without sacrificing our standards” in deciding if tot-sized doses are safe and effective.
While questions are swirling about what’s taking so long, Marks pointedly told lawmakers earlier this week that the FDA can’t evaluate a product until a manufacturer completes its application. In a statement Thursday, the FDA said that it would schedule a meeting to publicly debate Moderna’s evidence with its independent scientific advisers, but that the company still must submit some additional data. Moderna expects to do so next week.
“It’s critically important that we have the proper evaluation so that parents will have trust in any vaccines that we authorize,” Marks told a Senate committee.
If the FDA clears vaccinations for the littlest, the Centers for Disease Control and Prevention would next have to recommend who needs them — all tots or just those at higher risk from COVID-19.
“It’s very important to get the youngest children vaccinated,” but “moving quickly doesn’t mean moving sloppily,” said Dr. Philip Landrigan, a pediatrician and public health expert at Boston College. The FDA must “see if it’s safe. They need to see if it’s effective. And they need to do so swiftly. But they won’t cut corners.”
Many parents are desperate for whichever vaccine gets to the scientific finish line first.
“We’ve been kind of left behind as everybody else moves on,” said Meagan Dunphy-Daly, a Duke University marine biologist whose 6-year-old daughter is vaccinated and whose 3-year-old and 18-month-old sons are part of Pfizer’s trial.
The family continues to mask and take other precautions until it’s clear if the boys got real vaccine or dummy shots. If it turns out they weren’t protected in the Pfizer study and Moderna’s shots are cleared first, Dunphy-Daly said she’d seek them for her sons.
“I will feel such a sense of relief when I know my boys are vaccinated and that the risk of them getting a serious infection is so low,” she said.
FILE – A health worker administers a dose of a Moderna COVID-19 vaccine during a vaccination clinic in Norristown, Pa., Dec. 7, 2021.
The FDA will face some complex questions.
In a study of 6,700 kids ages 6 months through 5 years, two Moderna shots — each a quarter of the regular dose — triggered high levels of virus-fighting antibodies, the same amount proven to protect young adults, said Burton of Moderna. There were no serious side effects, and the shots triggered fewer high fevers than other routine vaccinations.
But depending on how researchers measured, the vaccine proved at best about 51% effective at preventing COVID-19 cases in babies and toddlers and about 37% effective in the 2- to 5-year-olds. Burton blamed the omicron variant’s ability to partially evade vaccine immunity, noting that unboosted adults showed similarly less effectiveness against milder omicron infections. While no children became severely ill during the study, he said high antibody levels are a proxy for protection against more serious illness — and the company will test a child booster dose.
“That’s not totally out of the realm of what we would have expected,” said Dr. Bill Muller of Northwestern University, who helped with Moderna’s child studies. “Down the road I would anticipate it’s going to be a three-shot series.”
Another issue: So far in the U.S., Moderna’s vaccine is restricted to adults. Other countries have expanded the shot to kids as young as 6. But while Moderna has filed FDA applications for older kids, too, the FDA hasn’t ruled on them. Months ago, the agency cited concern about a rare side effect, heart inflammation, in teen boys, a concern that hasn’t been reported in much younger children.
It’s not clear if the FDA will consider Moderna’s vaccine for children of all ages now or focus first on the littlest. But Muller already has had lots of parents ask why shots were being tested in tots before older kids were vaccinated — and says pediatricians and pharmacists must be ready with answers.
Burton said safety data from millions of older children given Moderna vaccinations abroad should help reassure parents.
While COVID-19 generally isn’t as dangerous in youngsters as adults, some do become severely ill or even die. About 475 children younger than 5 have died from COVID-19 since the pandemic’s start, according to the CDC, and child hospitalizations soared at omicron’s peak.
Yet it’s not clear how many parents intend to vaccinate the youngest kids. Less than a third of children ages 5 to 11 have had two vaccinations, and 58% of those ages 12 to 17.
Athens —
Greece lifted COVID-19 restrictions on Sunday for foreign and domestic flights, its civil aviation authority said, ahead of the summer tourism season that officials hope will see revenues bouncing back from the pandemic slump.
To fly in or out of the country, travelers were previously required to show either a vaccination certificate, a certificate saying they had recovered from coronavirus or a negative test.
From May 1, passengers and crew will need only to wear a face mask, the civil aviation authority said.
The summer tourism season typically begins after the Greek Orthodox Easter, which was on April 24. Greece is expecting high numbers of visitors this year, with officials predicting revenues reaching 80% of 2019 levels. That was a record year before the pandemic brought travel to a halt.
With infections waning, restaurants and retail shops returned to 100% capacity on Sunday, allowing customers in without proof of vaccination but with a mask.
Taipei, Taiwan —
China’s lockdowns to control the spread of COVID-19 are “cruel” and Taiwan will not follow suit, Premier Su Tseng-chang said on Sunday.
Having controlled the pandemic with tough border controls and quarantines, Taiwan has been dealing with a surge in domestic infections since the start of this year, with some 75,000 infections driven by the omicron variant.
But with more than 99% of those having mild or no symptoms, a handful of deaths so far and high vaccination levels, the government has moved to ease restrictions as it seeks normalcy and to gradually reopen the island of 23 million people to the outside world.
Taiwan’s giant neighbor China, by contrast, has enacted tough lockdowns in Shanghai and tightened controls in capital Beijing.
Speaking during a visit to Taiwan’s Centers for Disease Control, Su said their pandemic-containment measures had been “praised by the world.”
“We will not lock down the country and cities as cruelly as China,” he said, adding Taiwan’s methods were “gradual.”
“We have a plan, and there is a rhythm to it.”
China claims democratically governed Taiwan as its own territory, and the two have rarely missed an opportunity to exchange barbs during the pandemic.
Last week, China’s Taiwan Affairs Office said Taiwan’s new model of handling the pandemic would lead to many deaths.
Life has continued mostly as normal in Taiwan, though there has been disruption to some schools, and the government is eyeing further easing of quarantine rules.
All arrivals into Taiwan have to isolate for 10 days, rules that large parts of Asia have already ditched.
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Hong Kong’s next leader unveiled a manifesto Friday vowing to restore the business hub to its former glory but would not be drawn on when the city might discard zero-Covid controls that have left it internationally cut off.
John Lee, a former top cop and security chief, is expected to be appointed Hong Kong’s new chief executive by a committee of some 1,500 Beijing loyalists on May 8.
He faces no competition but will inherit a city convulsed by huge democracy protests, an ongoing crackdown on political freedoms and more than two years of pandemic curbs that have left residents and businesses internationally isolated.
“Covid is not going to live with us forever, at some stage it will be under control,” Lee told reporters when asked when Hong Kong would reopen to the world.
“It is important we will do a good balancing act,” he added.
China is the only major economy still sticking to the zero-tolerance strategy even as the highly transmissible Omicron variant breaks through those defenses and forces painful restrictions in both Hong Kong and on the mainland.
Hong Kong is at the tail end of a deadly Omicron wave, killing some 9,000 residents and sparking an exodus from the city’s business community.
Lee said Friday his 44-page manifesto will guide his attempt to restore Hong Kong’s sheen when he takes over from outgoing leader Carrie Lam on July 1 — the 25th anniversary of the city’s handover to China by Britain.
But despite fronting a campaign with the slogan “Starting a new chapter for Hong Kong together”, Lee’s policies so far indicate minimal change from the current Beijing-directed course under Lam’s administration.
Lee, 64, was a key figure in the suppression of huge democracy protests and is among 11 top Hong Kong and Beijing officials sanctioned by the United States.
He vowed Friday that a host of new national security crimes will be outlawed in local legislation, bolstering the already sweeping law Beijing imposed on Hong Kong in 2020 designed to quash dissent.
Efforts to “cultivate a new generation that loves the country and Hong Kong” will continue, he added.
Like other chief executives since the handover, Lee pinpointed the chronic shortage of affordable housing as a key area his administration needed to tackle.
Hong Kong has long held the title of the world’s most unaffordable housing market, where a study this year showed the median property price is 23 times the median household income.
“After all the big debates on land use, it’s time for execution,” Lee said, vowing to build more housing as well as speed up and streamline land sales.
BEIJING —
Many Chinese are marking a quiet May Day holiday this year as the government’s zero-COVID approach restricts travel and enforces lockdowns in multiple cities.
All restaurants in Beijing are closed to dine-in customers from Sunday through the end of the holiday on Wednesday, open only for takeout and delivery. Parks and tourist attractions in the Chinese capital are limited to 50% of their capacity. The Universal Studios theme park in Beijing, which opened last year, said it had shut down temporarily.
The pandemic situation varies across the vast nation of 1.4 billion people, but the Transport Ministry said last week that it expected 100 million trips to be taken from Saturday to Wednesday, which would be down 60% from last year. Many of those who are traveling are staying within their province as local governments discourage or restrict cross-border travel to try to keep out new infections.
China is sticking to a strict zero-COVID policy even as many other countries are easing restrictions and seeing if they can live with the virus. Much of Shanghai — China’s largest city and a finance, manufacturing and shipping hub — remains locked down, disrupting people’s lives and dealing a blow to the economy.
The major outbreak in Shanghai, where the death toll has topped 400, appears to be easing. The city recorded 7,872 new locally transmitted cases on Saturday, down from more than 20,000 a day in recent weeks. Outside of Shanghai, only 384 new cases were found in the rest of mainland China.
Beijing, which has tallied 321 cases in the past nine days, is restricting activity to try to prevent a large outbreak and avoid a city-wide lockdown similar to Shanghai. Individual buildings and housing complexes with coronavirus cases have been locked down. Visitors to many office buildings and tourist sites such as the Great Wall must show proof of a negative COVID-19 test within the previous 48 hours.
Online booking agency Ctrip said last week that people were booking travel to cities that were mostly virus-free, such as Chengdu in Sichuan province and the nearby city of Chongqing. Other popular destinations included Wuhan, where the world’s first major outbreak of COVID-19 occurred in early 2020. About half the orders on the Ctrip platform were for travel within a province.
