Moderna is moving ahead in its proposal process for the COVID-19 vaccine in children ages 6 months to 5 years. Newsday's Steve Langford reports. Credit: Newsday file; Kendall Rodriguez; AP

Drugmaker Moderna announced Wednesday it is moving ahead in the approval process for a COVID-19 vaccine for children ages 6 months to under 6. But while leading Long Island medical experts welcomed the announcement, they said more research is needed to determine the vaccine's safety and efficacy.

Moderna said it studied the vaccine's effectiveness in 7,000 children and found the shot is safe and works in babies, toddlers and preschoolers. The Massachusetts-based company is hoping to get the vaccine approved by the CDC and FDA in the coming weeks, with two small-dose shots for youngsters under 6 by summer.

Children under 5 are the only age group not yet eligible for vaccination. Pfizer currently offers child-sized doses for school-age children and full-strength shots for those 12 and older.

Health experts contacted by Newsday Wednesday welcomed Moderna's announcement yet were far from unanimous on whether enough research has been conducted to ensure the vaccine is safe.

What to know

  • Moderna said it is moving ahead in the approval process for a COVID-19 vaccine for children ages 6 months to 5 years.
  • Long Island medical experts welcomed the announcement but said more research is needed to determine the vaccine's safety. 
  • Moderna will need to get FDA and CDC approval for the vaccine.

According to Moderna, the vaccine was just under 44% effective at preventing milder infections in babies up to age 2, and nearly 38% effective in the preschoolers.

Dr. Matthew Harris, medical director of Northwell’s vaccine program, said those percentages raised concerns for him about the potential use of the vaccine, and he is not ready to endorse it, though he hopes Moderna can adjust it to make the vaccine effective enough.

“The 40% is nothing to scoff at,” Harris said, also noting that the Moderna vaccine's effectiveness in the 7,000 children is encouraging.

“We’ve had years where the flu vaccine was 40%," he said, "and it’s certainly better than nothing.”

The vaccine’s reported efficacy for the youngest children is less than the shots for adults when they were originally introduced by Pfizer and Moderna, though the CDC has reported that the omicron variant reduced those numbers as well.

Just how effective the vaccine will prove to be for children “remains an important question,” Harris said.

Other experts expressed confidence in the latest Moderna's vaccine's ability to prevent serious illness among the youngest despite charting lower rates of preventing COVID-19 infection.

“When I think about how best to protect them, this is a great step forward,” said Dr. Sharon Nachman, chief of the division of pediatric diseases at Stony Brook Children's Hospital.

The Moderna study taking place during the surge of the omicron variant, which is much more contagious than the original COVID-19 virus, could have contributed to the new vaccine's lower level of protection in young children, Nachman said. 

“I think that this is very important news because until now we really don’t have any vaccine for those children,” she said. “And they’re back in school, they’re back in day care, they’re in preschool, and they’re being exposed on an ongoing basis to other kids and their siblings.”

Moderna said that early results found that children in its study developed high levels of virus-fighting antibodies from shots containing a quarter of the dose given to adults — although less effective against omicron than prior variants.

The children in the Moderna study received 25-microgram doses of the vaccine. Adults get 100-microgram doses. 

While COVID-19 generally isn’t as dangerous to youngsters as it is to adults, some do become severely ill. The U.S. Centers for Disease Control and Prevention has said about 400 children younger than 5 have died from COVID-19 since the pandemic’s start. The omicron variant hit children especially hard, with those under 5 hospitalized at higher rates than at the peak of the previous delta surge. 

Dr. Aaron Glatt, chair of the department of medicine at Mount Sinai South Nassau in Oceanside, also said he sees the Moderna announcement as a hopeful development, though more data is needed to confirm it.

“If in fact the data are good, it will be a very welcome and very important addition,” he said. “The trick will be to show that it works at these lower doses. But if it does work, and if it’s shown to be safe, I think it will be fantastic.”

Harris noted that the Moderna study has yet to be peer-reviewed or published, and medical experts will need to see more data before fully endorsing the shots.

“I think it’s a good first study,” he said. But “I think we need to see the rest of the data before we can really feel ready to put this into the arms of children.”

Pfizer is expected to submit a request for approval of a vaccine for children under 6 by the end of the month or in April.

Harris said it is important that a vaccine for the youngest age group have a good efficacy level and ability to curb serious illness because some parents are already reluctant to put the shots in their children.

“I don’t think we want to put ourselves in the position where we further lose the confidence of parents,” he said.

The latest COVID-19 test results showed the virus is persisting on Long Island, though not at the record-breaking levels of January.

The seven-day positivity average on Long Island on Tuesday inched up to 1.99% from 1.91% the previous day. Nassau and Suffolk counties registered a total of 348 new cases, while New York City tallied 1,484.

Statewide, seven people, including one in Nassau, died on Tuesday of causes linked to the virus.

With Steve Langford and AP

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