A Food and Drug Administration (FDA) briefing document released Sunday said that Pfizer and BioNTech’s COVID-19 vaccine is safe and effective for children under 5.
The document comes before a meeting scheduled for Wednesday during which the FDA’s independent experts will consider emergency use authorization of the vaccine for young children, which could quickly pave the way for widespread availability.
The FDA documents indicated that the vaccines were 75.6 percent effective in preventing symptomatic COVID-19 for children ages six to 23 months old and 82.4 percent effective for children between ages 2 and 4.
Overall, they were 80.4 percent effective in a combined analysis of both age groups, the FDA said.
“Available data support the effectiveness of the Pfizer-BioNTech COVID-19 Vaccine 3-dose primary series (3 µg each dose) in preventing COVID-19 in the age group of 6 months through 4 years,” the document said.
Agency staff added that “the available safety data from a total database of over 3,000 vaccine recipients do not suggest any new safety concerns compared with the safety profile described in older age groups.”
The FDA will also consider a similar request from Moderna.
Last week, the FDA’s briefing documents similarly said Moderna’s COVID-19 vaccine is both effective and safe for children under 6 years old.
After the experts issue their guidance following this week’s meeting, the FDA will decide whether or not it will follow the advice.
Should the FDA and the Centers for Disease Control and Prevention sign off on the shots for younger children, they could be available as early as next week, The Washington Post reported.
