Experts from FDA Recommend COVID-19 Vaccines for American Children Under Five

Finally, a panel of experts brought together by US Food and Drug Administration (FDA) unanimously recommended COVID-19 vaccines for children under five, filling a "significant unmet need for a really ignored younger population," said one of the 21 experts.

With just over a year-and-a-half after the first COVID vaccines were endorsed to adults and elderly, immunization of the age group in the US is expected early next week, according to ScienceAlert, with formal authorizations for Moderna and Pfizer to follow.

Worldwide, FDA's stamp of approval is considered standard, which is why it offered livestream of its internal deliberations discussing the Pfizer-BioNTech and Moderna's Covid-19 vaccines for young children, according to Forbes, reporting that FDA's independent analyses of the pharmaceutical companies' vaccines deemed both safe and effective.

Senior FDA scientist Peter Marks opened the discussion with a warning that last winter's Omicron wave among infants, toddlers, and young children calls the urgent need for vaccination.

"We are dealing with an issue where we have to be careful we don't become numb to the pediatric deaths because of the overwhelming number of older deaths," he said. "Every life is important and vaccine-preventable deaths are something we would like to try to do something about."

COVID Cases in the 0-4 Age Group

US has recorded 480 COVID deaths so far among the 0-4 age group, "higher than even a bad flu season," according to Marks, with around 45,000 hospitalizations as of May 2022, of which nearly a quarter required intensive care.

Finally, both vaccines, which are based on messenger RNA and considered the leading COVID vaccination platform, are authorized among the younger group. Pfizer is authorized to give three doses at three micrograms to children aged six months through four years, while Moderna is authorized by FDA to give two doses of a higher 25 micrograms for ages six months through five years.

Both were tested in trials of thousands of children and found to show similar levels of mild side effects and levels of antibodies as in older age groups.

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Efficacy of Doses

In terms of efficacy, the experts find Pfizer to fight infection higher at 80 percent, however they considered the result preliminary as the figure is based in very few cases. Meanwhile Moderna's estimates of 51 percent for children aged six-months to two years old and 37 percent for those aged two to five years.

Pfizer would take three doses to achieve protection, with the third shot given eight weeks after the second, which is given three weeks after the first, while Moderna's vaccine can give the strongest protection at two doses, given four weeks apart.

Booster shot is now on the table as the company studies if it raises efficacy levels against mild disease.

As for the side effect, Moderna's higher dose is likely to be associated with higher levels of fevers compared to Pfizer.

Of some 20 million children aged four years and under in the US, FDA believes the panel's recommendation would make a difference for the young generation, to be concurred by Centers for Disease Control and Prevention.

In a 2020 article published by NBC News, Dr. Nusheen Ameenuddin, a pediatrician at the Mayo Clinic in Rochester, Minnesota said "the sooner we can get our youngest vaccinated, the less stress families will be under after an already long two years."

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