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With parents and politicians alike agreeing that keeping children learning in the classroom after a lost year in 2020, Pfizer is pushing to allow its vaccine to be administered among younger Americans.
Pfizer tweeted this week that the company had submitted their formal request for Emergency Use Authorization of the vaccine to the FDA.
"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," the company posted.
According to data released by Pfizer, a two-dose vaccine regimen that is smaller than that used in teenagers and adults is safe in children in that age group and provided a “robust” immune response in initial clinical trials.
The study found that the shots were well tolerated by participants in the study and side effects were similar to those experienced in a study of people between the ages of 16 and 25.
Side effects in the children were similar to those of teens and young adults that include fatigue, headache, muscle pain, chills, fever, and nausea.
Children are less likely to become severely ill from COVID-19, but the Delta variant led to nearly 30,000 hospitalizations in August alone, according to the American Academy of Pediatrics.
In total, nearly 6 million Americans under the age of 18 have been infected by the virus.
If approved by the FDA, shots could be administered in children beginning as soon as early November, pending a timely review by federal officials.
According to reports, the FDA vaccine advisory group has a meeting scheduled for Tuesday, Oct. 26, which could expedite the approval process.
Acting FDA Commissioner Janet Woodcock said that: “We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults..”
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