The data was posted on the US Food and Drug Administration’s website Friday ahead of a committee meeting slated for next week.
Pfizer and BioNTech say their Covid-19 vaccine is more than 90% effective at protecting young children in 5- to 11-year-olds from symptomatic infection, Associated Press (AP) reported.
The data was posted on the US Food and Drug Administration’s website Friday ahead of a committee meeting slated for next week. An initial review of the data is expected later Friday, according to the news agency.
Details of Pfizer’s study were posted online. The Food and Drug Administration (FDA) was expected to post its independent review of the company’s safety and effectiveness data later in the day.
Advisers to the FDA will publicly debate the evidence next week. If the agency ultimately authorizes the shots, the Centers for Disease Control and Prevention (CDC) will make the final decision on who should receive them.
Also read: US study reveals COVID-19 vaccine 1st dose can boost mental health, Indian doctors affirm
In the study, 2,263 children ages 5 to 11 received either two 10 µg doses of the Pfizer-BioNTech vaccine or a placebo administered 21 days apart, the AP reported.
The children’s doses, which were one-third the size of the 30 µg shots approved for adults, were nearly 91% effective, according to the data. The vaccine appeared to be safe for children, as well, the companies said.
Full-strength Pfizer shots already are authorized for anyone 12 or older, but paediatricians and many parents are anxiously awaiting protection for younger children to stem rising infections from the extra-contagious delta variant and help keep kids in school.
The news came two days after the White House detailed plans to allow elementary-age children to get Covid-19 vaccine shots as soon as next month, pending authorization from the FDA and the Centers for Disease Control and Prevention.