News Punch: Pfizer Asks FDA To Authorize Its Covid Vaccine For Children Aged 5 To 11
Pfizer and its German partner BioNTech have announced that they have asked the US Food and Drug Administration (FDA) to expand emergency use of its coronavirus ‘vaccine’ to include children between the ages of 5 and 11 years.
Pfizer’s vaccine was authorized on a similar basis for children aged 12 and over in May and in late August they got full approval for people 16 and older.
The FDA is currently planning to move quickly and has a meeting scheduled to discuss the matter on October 26.
MSN reports: Officials are expected to make a decision – which would make 28 million kids eligible – between Halloween and Thanksgiving.
Some parents are eagerly awaiting the authorization while others say they do not want to inoculate their children because of their low risk of severe illness, making up less than 0.1 percent of all Covid deaths in the U.S.
According to clinicaltrials.gov, Pfizer’s study in younger children worked similarly to the way it did in older children and adults.
A total of 4,500 younger kids aged six months and older were enrolled at nearly 100 clinical trial sites in 26 U.S. states, Finland, Poland and Spain.
Of those children, 2,268 were between ages five and 11.
About half of those in the five-to-11 group 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 and kids from six months to four years old received three μg doses.
Unlike the larger clinical trial conducted in adults, the pediatric trial did not measure efficacy by comparing the number of COVID-19 cases among the vaccine group to the number in the placebo group.
Instead, scientists looked at levels of neutralizing antibodies in young vaccine recipients and compared the levels to those seen in adults.
The companies expect data on how well the vaccine works in children between ages two and five and between six months and two years of age by the end of the year.