Pfizer Requests FDA Authorization of Covid-19 Vaccine in Children ages 5 to 11
Oct 7, 2021 By MarketDepth
Pfizer (NYSE: PFE) announced Thursday that it has requested emergency use authorization from the US Food and Drug Administration for its Covid-19 vaccine in children ages 5 to 11. If granted, it would be the first Covid-19 vaccine for children of that age group. The company’s vaccine is currently approved for people over the age of 16 and has an EUA for those ages 12 to 15.
Many parents are anxiously awaiting the vaccine for their children as the delta variant continues to spread. Pfizer released data last month showing that a two-dose shot of 10 micrograms is safe and created a “robust” immune response within children in the clinical trial. The pharmaceutical said that the shots ultimately produced a similar immune response and side effects to those witnessed in the study with people ages 16 to 25.
According to the Centers for Disease Control and Prevention, common side effects in teens and adults include fatigue, headache, muscle pain, chills, fever and nausea.
FDA officials had revealed that once vaccine data for younger children was submitted, the agency would be able to authorize it in just a couple of weeks and not months. However, the authorization would depend on the timing and quality of the data turned in.
“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,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement about the October 26 meeting.
