Pfizer formally requested that Food and Drug Administration authorize its COVID-19 vaccine for emergency use among kids ages 5 to 11.
“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” Pfizer tweeted. “We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat.”
Currently, the Pfizer vaccine is fully approved for those aged 16 and older and authorized for teens aged 12-15.
Pfizer 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 micrograms (μg) doses of the vaccine.
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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 test 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 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 by the end of the year.
“Delta has made COVID a pediatric problem,” said Dr. Andrew Pavia, pediatric infectious disease specialist at the University of Utah. The Delta variant, the most dangerous of the coronavirus variants to date, has dramatically affected the general population, with pediatric cases increasing from 71,726 per week at the beginning of August to more than 243,000 in September. Kids who have gone back to school have few options to protect themselves without a vaccine.
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So far, Pfizer’s vaccine has been administered to more than 230 million Americans and has proven safe in teenagers, Pavia said.
Now, Booster doses, or a third shot of the vaccine may be administered to people 65 years of age and older, those who are 18 through 64 years of age at high risk of severe COVID-19, and to people 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at increased risk of severe complications of COVID-19 including severe COVID-19, six months after their second dose.