On September 28, Pfizer submitted data from its clinical trials to the FDA to begin reviewing for emergency use authorization (EUA) for kids ages 5 through 12. Pfizer filed their formal submission for EUA to the FDA on October 7, according to a tweet from the manufacturer. The FDA’s advisory committee will meet October 26 to review this request. In a news release, Pfizer said, “In participants 5 to 11 years of age, the vaccine was safe, well-tolerated, and showed robust neutralizing antibody responses.”
Pfizer recently announced that children ages 6 months to 5 years old were part of the 2,268 participants in the Phase 2 and 3 trials of the vaccine. Trials are done in three phases, the first to determine the ideal dosage for children in this age group, and the following two to study the vaccine’s efficacy and safety. Results for kids in this age group should be shared with the FDA as soon as the end of 2021.
Following their phase three clinical trial of 2,260 participants ages 12 to 15, Pfizer reported 100% efficacy in this teenage age group when administered the same two-shot vaccine approved for adults. On May 10, The New York Times reported the vaccine was officially approved for 12 to 15-year-olds.
When it comes to vaccinations, safety is a top concern for parents. Romper previously reported that “a vaccine safety group from the CDC is looking into reports of heart conditions developing in vaccinated teens.” Though the CDC report detailed presentations of myocarditis, or heart inflammation, in adolescents following vaccination, stating that “relatively few” experienced the side effect, that most cases are mild, and it is more common in males than females.
As Romper previously reported, Moderna announced in late May that their vaccine trials show a 100% efficacy in children ages 12 to 18. Moderna submitted data to the FDA in June for an EUA approval for kids 12 to 17, and Johnson & Johnson is still conducting trials in children of all ages, according to NBC News.
When Can Kids Under 12 Get Vaccinated?
If Pfizer’s formal EUA submission is approved, children ages 5 through 11 could begin receiving the Covid vaccine at the end of October, reports NBC News. For little ones younger than 5, the wait continues. Pfizer has not yet submitted clinical trial data on children from 6 months through 5 years old, but intends to do so at the end of the year or in early 2022.
Moderna has begun a children’s vaccine trial study through the National Institute of Allergy and Infectious Diseases that includes kids ages 6 months to 12 years old, NPR reported. The trial will include 6,750 children in the U.S. and Canada to measure the impact and efficacy of the vaccine’s two-dose shots, as well as monitor the effects of the vaccine on this age group.
Experts Weigh In On Vaccines & Kids
The high efficacy rates shown in trial phases for adults by the currently available vaccines and the beginning of vaccine trials for children mark a promising turn in the fight against Covid-19. However, the speed at which these vaccines have been developed and tested means that there is still much that researchers and physicians alike do not know about the long-term impacts of a vaccine.
To help address some of the concerns parents may have about Covid-19 vaccines and kids, Romper asked experts to weigh in on some of the biggest questions we have about the vaccine and kids.
Dr. Susan V. Lipton, MPH, Chief, Pediatric Infectious Diseases at Samuelson Children’s Hospital at Sinai Hospital of Baltimore and Chief, Section on Infectious Diseases, Maryland American Academy of Pediatrics
Dr. Bita Nasseri, Los Angeles-based physician
Dr. Niket Sonpal, New York-based internist, gastroenterologist, and adjunct professor at Touro College
Mobeen Rathore, M.D., board-certified pediatric infectious disease specialist and chief of Pediatric Infectious Disease and Immunology for Wolfson Children’s Hospital