Pfizer/BioNTech's Three-Dose COVID-19 Vaccine Safe, Effective In Younger Kids

According to the FDA briefing document, Pfizer Inc PFE -BioNTech's SE BNTX COVID-19 vaccines were effective and safe for children aged six months to 4 years.

The FDA reviewers said that their evaluation did not reveal any new safety concerns related to using the vaccine in young children.

The FDA analysis of data from Pfizer's trial was published ahead of a June 14-15 meeting of its outside advisers. 

Related: US Schedules Covid-19 Vaccines For Children Below Five Years.

"Based on the observed safety and effectiveness profiles following three doses of BNT162b2 at the 3-µg dose level to children <5 years of age, it is expected that the known and potential benefits outweigh the known and potential risks at this time," FDA staff said in the review.

Related: Pfizer Seeks FDA Approval For Three Covid Vaccine Doses For Children Below Five.

An early analysis of data from Pfizer-BioNTech's vaccine based on symptomatic COVID-19 cases identified when the omicron coronavirus variant was dominant suggested a vaccine efficacy of 80.3% in the under-5 age group.

Wall Street Journal reports that overall demand might be modest after that initial rush. According to a recent poll, only 18% of parents are eager to vaccinate their young children right away. About 38% of parents of young children will wait and see before getting their kids vaccinated, while 27% will not and 11% will do so only if required.

Price Action: PFE shares are down 1.84% at $49.05, and BNTX stock is down 2.24% at $140.63 during the premarket session on the last check Monday.

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