Covid-19 vaccine for 5 to 11-year-olds is safe and shows “robust” antibody response, Pfizer says

Covid-19 vaccine for 5 to 11-year-olds is safe and shows “robust” antibody response, Pfizer says

 

In a highly anticipated announcement, Pfizer on Monday said that a Phase 2/3 trial showed its Covid-19 vaccine was safe and generated a "robust" antibody response in children ages 5 to 11.   These are the first such results released for this age group for a US Covid-19 vaccine, and the data has not yet been peer-reviewed or published. Pfizer said it plans to submit to the US Food and Drug Administration for emergency use authorization soon.   The trial included 2,268 participants ages 5 to 11 and used a two-dose regimen of the vaccine administered 21 days apart. This trial used a 10-microgram dose -- smaller than the 30-microgram dose that has been used for people 12 and older.   "The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age," Pfizer said in a news release.   "Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age," the company added.   Dr. Scott Gottlieb, a former FDA commissioner and current Pfizer board member, has said a vaccine for children ages 5 to 11 could be available by Halloween.   Acting FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of the FDA's Center for Biologics Research and Evaluation, said in a statement this month that the agency would review data for a vaccine for younger children "as quickly as possible, likely in a matter of weeks rather than months," once it was submitted for authorization.