US health authority says Moderna vaccine effective in under-fives

• Covid-19 vaccine effectiveness is 51% in babies aged six months to less than two years, FDA says.
• Vaccine effectiveness is 37% in children aged two to five years, according to data submitted by Moderna.
• FDA will decide next week whether to allow two inoculations for very young children.

WASHINGTON – US health officials confirmed on Friday that data submitted by drugmaker Moderna on the efficiency of its Covid-19 vaccine in very young children was correct, ahead of a decision next week on whether to allow two inoculations against the virus in children aged six months to five years.

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 reported in pivotal adult or older paediatric studies,” the FDA said in a statement, “it is extremely comparable with real-world vaccination effectiveness observed against Omicron in adults.”

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.

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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.

The current paper, which is more than 100 pages long and was issued by the US agency, will serve as the foundation for the authorization talks next week.

An expert advisory council must convene for two days to review the vaccine’s request for permission, as well as Pfizer’s, and give a recommendation.

Early next week, the FDA is anticipated to release its independent study of Pfizer data.

Pfizer has submitted a request for approval for children aged six months to four years, albeit the vaccine would be given in three doses.

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