Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have submitted clinical study data for their COVID019 vaccine to the FDA for children 5-11 years. The companies are requesting for emergency approval for the use of the vaccine in children and anticipate authorization to be in the coming weeks.
Over 2,000 children were evaluated in study
The FDA will take several weeks to evaluate the clinical trial data that enrolled over 2,000 children before issuing an emergence use authorization. Although the Pfizer vaccine has been available for children above 12 years since May, most elementary school-going children are still vulnerable. In addition, most children have returned to schools in recent weeks, and some districts require children to wear masks, triggering a national debate.
Infectious disease expert Dr. Anthony Fauci told MSNBC, “The FDA takes very seriously the importance of getting vaccines, shown to be safe and effective in children. So I would imagine in the next few weeks they will examine that data and hopefully give the O.K. so we can start vaccinating children hopefully by the end of October.”
Pfizer said the two-dose COVID-19 vaccine has been demonstrated to be safe and was well tolerated leading to neutralizing antibody response among the children.
Children received lower doses than those above 12 years
According to the company, the vaccine dosages given to the children in Pfizer’s study were two times lower than those given to those aged 12 and up. In addition, antibody responses were comparable between the lesser dosages and those reported in a trial of participants aged 16 to 25 who were given full doses. Unfortunately, the vaccine had side effects the same as to those reported in adults, such as exhaustion and arm discomfort.
The company indicated that the company had shared the data with the FDA for initial review. Next, Pfizer and BioNTech will submit the findings to other regulators such as the EMA for approval. Results for children below five years are anticipated in Q4.