FDA Authorizes Pfizer-BioNTech, Moderna COVID Vaccines for Children 6 Months to 4 Years

FDA_Sarah Silbiger/Getty Images

Courtesy of Sarah Silbiger/Getty Images

Friday morning, the U.S. Food and Drug Administration granted Emergency Use Authorization to two COVID-19 vaccines for use in children ages 6 months to 4 years old: one developed by Moderna, and the other developed by Pfizer and BioNTech.

The Pfizer vaccine for this age group is a three-shot regimen, with the first two doses administered three weeks apart. The third dose is given eight weeks after the second vaccine. The Moderna vaccine remains a two-dose regimen, with shots delivered about one month apart.

The vote comes two days after the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously supported authorizing both vaccines for this age group. The authorization will open up avenues for increased protection of the youngest in America as new infections have climbed to about 100,000 per day for the past month across the country.

Although the latest surge is not as severe as previous surges, the Omicron variant and its subvariants have continued to be a problem, even among the vaccinated and those who have had previous infections. Those who have been vaccinated or were previously infected with COVID-19 have typically had less severe responses than those without some form of immunity.

Moderna has also received an EUA for a two-dose regimen of its vaccine, at different dosing levels, for children ages 6 through 17 years old. This means there are now multiple vaccines authorized in the U.S. for all age levels.

FDA Commissioner Robert M. Califf noted that parents and caregivers have been eagerly awaiting a vaccine for young children.

“As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death. Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data,” Califf said in a statement.

Albert Bourla, chairman and chief executive officer of Pfizer, hailed the latest authorization for the company’s vaccine. He said tens of millions of people across the globe have already been vaccinated with the drug co-developed with Germany’s BioNTech and have greater protection against severe disease and hospitalization. Bourla said the vaccine is safe for the youngest of children and can provide them with increased protection against the virus that has claimed the lives of more than 1 million Americans.

The EUA for the Pfizer-BioNTech vaccine was granted based on data from a Phase II/III study that included 4,526 children 6 months through 4 years of age.

“The data from our Phase II/III study show that a dose level of 3-µg of our vaccine, which we selected based on safety, tolerability and immunogenicity data, administered in a 3-dose series, provides young children and infants with a high level of protection, also during the recent Omicron wave,” Ugur Sahin, CEO and co-founder of BioNTech, said in a statement. “We are committed to providing access to our COVID-19 vaccine to all age groups. Parents in the U.S. now have the option to vaccinate their children under 5 years of age, and we are working to ensure that other countries worldwide will follow.”

Moderna’s clinical data showed that its vaccine provided statistically significant protection in children. The company’s trials included more than 14,000 children and adolescents.

"We are thrilled that the FDA has granted Emergency Use Authorization of Moderna's COVID-19 vaccine for children and adolescents, particularly for our vulnerable, youngest children," Stéphane Bancel, CEO of Moderna said in a statement. "Children need to live highly social lives to develop and flourish. With this authorization, caregivers for young children ages 6 months through 5 years of age finally have a way to safeguard against COVID risks in classroom and daycare settings."

Both Pfizer and Moderna intend to roll out doses of the vaccine for young children as quickly as possible. 

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