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Child COVID-19 Vaccine: Moderna is seeking an emergency authorization for child COVID-19 vaccine ages 6 months to 5 years

NEW YORK — Moderna is applying to the U.S. Food and Drug Administration for an emergency use authorization for its Covid-19 vaccine for children ages 6 months to 5 years, the company said Thursday.

“We believe that mRNA-1273 will be able to safely protect these children from SARS-CoV-2, which is so important in our ongoing fight against COVID-19, and is particularly welcomed by parents and caregivers,” said Stéphane Bancel, Moderna’s chief executive officer, said in a press release.

In late March, Moderna announced the results of a clinical study that enrolled 2,500 children aged 6 to 24 months and 4,200 children aged 2 to 5 years. The company said two 25-mcg doses of its vaccine produced a similar immune response in young children as two 100-mcg doses in adults aged 18 to 25. And it said this should predict protection against Covid-19 and severe Covid-19 up to 6 months of age.

In Thursday’s press release, the company said the data showed “a robust neutralizing antibody response” and “a favorable safety profile.”

“We like to see anything above 1,000 units, and what we’ve actually seen here is somewhere between 1,400 and 1,800 units,” said Dr. Paul Burton, Moderna’s chief medical officer, on Wednesday. “So that’s very reassuring.”

Burton also said the vaccines are very safe for this age group. The most common reactions were pain at the injection site and fever. There were no cases of cardiac inflammation or myocarditis in the study. Heart inflammation is an extremely rare side effect of mRNA vaccines. Myocarditis occurs more frequently after Covid-19 infection than after vaccination.

The results, announced in March, were largely collected during the Omicron wave and included home testing for Covid-19. As a result, the company said the vaccines looked less effective for children than for older age groups.

The data presented by Moderna on Thursday limited the analysis to only cases confirmed positive by sensitive reverse transcription polymerase chain reaction tests. In the revised analysis, the vaccines were 51% effective in preventing symptoms in children aged 6 months to less than 2 years; They were 37% effective in preventing symptoms in children aged 2 to 5 years. The company said these efficacy estimates are similar to adults versus Omicron after two doses.

Pfizer/BioNTech’s Covid-19 vaccine for young children has also stalled. In clinical studies, two 3-mcg doses in children aged 2 to 4 years did not appear to produce the same level of immunity as in young adults, leading the company to offer a third dose to children aged 6 months to 4 years give . The FDA also delayed its review of those shots until the company reports data on a third dose.

Boosters for younger kids?

On Tuesday, Pfizer asked the FDA to give the green light to a third, or booster, dose for children ages 5 to 11. Studies have shown that the effectiveness of the vaccine in this age group decreased significantly during Omicron.

Burton said Wednesday that Moderna is also testing boosters, including variant-specific formulations.

“Our main contender now is something against the original strain and Omicron,” he said, predicting that this would be the booster formulation for fall and winter.

“And I think for these little kids, we need to continue to follow natural history and see what the variant is? What’s going on with the little kids as we get into the fall? And then the FDA and CDC and regulators around the world can make recommendations on whether they need another refresher later in the year.”

What next for vaccines for younger children?

No Covid-19 vaccines have been approved for children under the age of 5 in the US – about 18 million people.

Moderna’s mRNA Covid-19 vaccine is approved for people ages 18 and older, and Pfizer/BioNTech’s for people ages 5 and older.

The FDA will review Moderna’s application and has announced it will convene its Vaccines and Related Biological Products Advisory Committee to consider approving vaccines for younger children.

The director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci said the FDA is considering whether to consider emergency use approval for Moderna’s and Pfizer/BioNTech’s infant COVID-19 vaccines at the same time, rather than reviewing them separately.

Pfizer has announced data on a third dose of the vaccine will be available this month. Pfizer CEO Albert Bourla said the younger children’s vaccine could be available in June if the FDA approves it.

The CNN Wire
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https://abc13.com/moderna-vaccine-children-6-months-to-5-years-emergency-use-authorization-fda/11799967/ Child COVID-19 Vaccine: Moderna is seeking an emergency authorization for child COVID-19 vaccine ages 6 months to 5 years

Dais Johnston

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