An FDA panel voted 21 to 0 to authorize the Pfizer/BioNTech and Moderna COVID-19 vaccines in children between the ages of 6 months and 4 years of age.
Children under the age of 5 constitute the only age group that has not been eligible to be vaccinated against COVID-19.
“I know there are a lot of very relieved parents,” said Dr. Jon Portnoy, a voting member of the Vaccines and Related Biological Products Advisory (VRBPAC) panel. “I understand why parents are very nervous and fearful of doing normal activities, especially if their child actually catches COVID.”
The potential availability of two COVID-19 vaccines for young children “will certainly alleviate a lot of [parents’] concerns,” he added.
VRBPAC member Dr. Ofer Levy emphasized the importance of choice for parents with young children.
“They can partner with their pediatrician to make a decision,” Levy said. Vaccines are a vital tool for fighting COVID-19, especially in communities with high community spread of the virus or for families with family members who may have an elevated risk of severe infection, he added.
“We encourage [parents], if this moves forward, to avail themselves of this option,” Levy said.
Both the Pfizer/BioNTech and Moderna vaccines are based on a similar mRNA platform, but the Pfizer-BioNTech for young children would be administered as a three 3-μg dose series. Moderna’s vaccine would be provided in two 25-μg doses.
FDA generally follows the advice of its advisory committees, such as the Vaccines and Related Biological Products Advisory (VRBPAC).
PFE shares ticked up 1.23% to $48.51, while BNTX shares closed up 2.35% to $137.99. MRNA shares jumped 5.73% to $128.53.
Filed Under: clinical trials, Drug Discovery