Covid-19: Moderna vaccine effective and safe for kids under the age of 5, says FDA

US scientists with the Food and Drug Administration said in a new analysis of data released on Friday that Moderna's coronavirus vaccine is safe and effective for young children and infants. At a meeting next week, the FDA's outside advisors will review this information and decide whether to approve the company's vaccine for babies and children under the age of five.

Children under the age of five are still the only people in the United States who are not eligible for a coronavirus vaccine.

In April, Moderna submitted an emergency use permission request to the FDA for the vaccination of children aged 6 months to under 6 years.

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Pfizer and BioNTech are also requesting emergency use permission for their coronavirus vaccine for children. Next Monday, the FDA's outside advisers will review Pfizer and BioNTech's vaccine.

On June 17 and 18, the CDC's advisory committee will meet to approve the vaccinations developed by the firms.

The Biden administration announced this week that it has made 10 million COVID-19 vaccine doses available for young children and newborns, anticipating acceptance of the authorization. The first dosages are expected to be available by June 21.

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The Food and Drug Administration (FDA), which examined data from Moderna's clinical studies independently, found that vaccine effectiveness against symptomatic Covid-19 cases was 51% in babies aged six months to less than two years old and 37% in children aged two to five years.

According to the FDA, the statistics are lower than those found in adult clinical trials because the trials for very young children were conducted during a wave connected to the Omicron variation.

"Although the VE (vaccine efficacy) ... in children six months to five years is lower than that observed in the pivotal adult or older paediatric studies, it is highly consistent with real-world vaccine effectiveness observed against Omicron in adults," the FDA said in a statement.

Despite the fact that Moderna's vaccine is less effective against the Omicron variety, the FDA noted that it is still quite effective against severe cases of the disease.

As a result, the FDA determined that the Moderna data "supports the administration" of the vaccine in two doses of 100 micrograms each in teenagers aged 12 to 17, 50 micrograms in children aged six to eleven, and 25 micrograms in toddlers aged six months to five years.

Moderna's vaccination is currently only available to those aged 18 and up in the United States.

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