BREAKING NEWS: FDA is expected to authorize Pfizer’s Covid vaccine for children aged 5-11 TODAY
- The FDA is expected to authorize Pfizer-BioNTech’s COVID-19 vaccine for children aged five to 11 on Friday, The New York Times reports
- The final step before the vaccine can be rolled out is a recommendation from the Centers for Disease Control and Prevention’s (CDC) advisory committeee
The U.S. Food and Drug Administration (FDA) is expected to authorize Pfizer-BioNTech’s COVID-19 vaccine for children between ages five and 11 on Friday, sources told The New York Times.
The move would come just three days after the agency’s advisory committee recommended emergency use of the vaccine be expanded to young children.
About 28 million American kids would be approved to receive the two-dose vaccine, which is one-third the dose given to those aged 12 and older and is administered 21 days apart.
After the FDA authorizes the shot, the final step will be a recommendation by the Centers for Disease Control and Prevention’s (CDC) advisory committee next week, meaning the first children may be dosed starting Wednesday.
Parents have been split 50/50 over vaccinating children because kids rarely get severely ill and make up less than 0.1 percent of all Covid deaths in the U.S.
The FDA is expected to authorize Pfizer-BioNTech’s COVID-19 vaccine for children aged five to 11 on Friday, The New York Times reports. Pictured: Lydia Melo, 7, is inoculated with one of two reduced doses of the Pfizer COVID-19 vaccine during a trial at Duke University in Durham, North Carolina, September 2021
It coms after Pfizer posted details of a study online last week showing its COVID-19 vaccine is about 91 percent effective against infection in elementary school-aged children.
According to clinicaltrials.gov, Pfizer recruited 2,268 children between ages five and 11 for the study.
About half of the kids were given two doses 21 days apart and the other half were given placebo shots.
The team then tested the safety, tolerability and immune response generated by the vaccine by measuring antibody levels in the young subjects.
Pfizer said it had selected lower doses for COVID-19 vaccine trials in children than are given to teenagers and adults.
Those aged 12 and older receive two 30 microgram (μg) doses of the vaccine.
However, children between ages five and 11 were given 10 μg doses – one-third of the size given to adolescents and adults.
Sixteen children who received the placebo contracted COVID-19 compared with three in the vaccinated group – while Pfizer said equates to 90.7 percent efficacy.
In the vaccination group, one participant each had two, three and four Covid symptoms.
Comparatively, in the placebo group, half of the pediatric patients had five or more symptoms.
No life-threatening adverse events were reported with the most common side effect being pain at the injection site, reported in more than 70 percent of kids.
This is about equal with the up to 83 percent of 16-to-25-year-olds in the adult clinical trial who reported the same thing.
No deaths occurred in either the vaccine group or the placebo group.
This is a breaking news story and will be updated.