By CBSMiami.com Team *
MIAMI (CBSMiami) — Pfizer announced Monday that a medical trial shows its coronavirus vaccine is “safe” for children ages five to 11. Pfizer said the trial showed the vaccine was “well tolerated” and resulted in “robust neutralizing antibody responses.”
Those positive results mean Pfizer will now send this data to regulatory agencies around the world, including the FDA and European Medicines Agency, for approval.
“If the FDA looks at this data and feels confident that it demonstrates this vaccine is safe and effective for children five to 11, you could have a vaccine within a month to six weeks,” Former FDA Commissioner Scott Gottlieb said during an interview on CBS Mornings.
Dr. Gottlieb is a member of Pfizer’s Board of Directors. “Pfizer tested multiple doses to find the optimal dose, that had the best compromise between reducing the number of vaccine-related side effects, while still providing efficacy that is on par with what we saw in 16 to 25 year olds,” he said.
The vaccine has already been approved by the FDA for use in children 12 and up.
Pfizer’s announcement comes at a pivotal time in the fight against COVID-19. The most recent American Academy of Pediatrics report showed the second highest number of childhood COVID cases for any week since the pandemic began (more than 243,000 cases for the week of September 2nd through September 9th). The spike in cases has been driven by the Delta variant, which has disproportionately affected the unvaccinated.
Dr. Richard Chung is an Adolescent Medicine Specialist at Duke Health in Durham, North Carolina. Chung’s youngest son, eight-year-old Joshua, took part in Pfizer’s recently completed trials for children ages five to 11 years old.
“I think it’s just been a really wonderful privilege really to contribute in this way,” Dr. Chung said. Joshua added, “I think that everybody should get vaccinated so that things can return back to normal.”
Joshua is not sure whether he received a placebo shot or the real vaccine. He told CBS News his symptoms were not severe.
Dr. Chung’s older son Caleb took part in the trials for children 12 and up.
“I wanted to participate in the trial in order to help motivate other kids to get the vaccine,” Caleb said.
Dr. Chung said, “I’m really proud of them and, you know, seeing them kind of courageously take this step and to do so really enthusiastically has just been a remarkable experience, not just as a pediatrician, but certainly as a dad.”
Pfizer also said that trial results in children under five could be available by the end of the year.