Pfizer-BioNTech have submitted data on their COVID-19 vaccine in children age 5 to11 to the U.S. Food and Drug Administration for initial review, according to a Tuesday news release.
The companies first revealed their data on the age group last week, announcing their vaccine appears to be safe and effective in children between 5 and 11 years old with a dose that’s a third of the amount given to teens and adults. The Pfizer vaccine is currently available in the U.S. for anyone age 12 and up.
Next, the companies plan on sending the FDA a “formal submission to request emergency use authorization” in the coming weeks. The FDA and Centers for Disease Control and Prevention will then meet to review the vaccine’s safety and efficacy in kids age 5 to 11 before officially recommending and authorizing the shot for use.
Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, told USA Today that authorization of the Pfizer vaccine in this age group is expected within “a matter of weeks, not months.”
“FDA is committed to going through those as quickly as we (can),” Marks told the outlet. “These data will not lay around.”
However, experts are hesitant to speculate when children younger than 12 years old will be eligible for a COVID-19 vaccine. In upcoming weeks, the FDA can request more data or extend the initial clinical trial, depending on its review.
Dr. Evan Anderson, a physician at Children’s Healthcare of Atlanta and associate professor of pediatrics and medicine at Emory University School of Medicine in Georgia, told USA Today timelines are “a little unpredictable… so it’s a little speculative to really get too definitive about timelines at this stage.”
D. Anthony Fauci, President Joe Biden’s chief medical adviser, recently told MSNBC “there’s a really good chance” kids between 5 and 11 years old could get a Pfizer vaccine before Halloween, Bloomberg reported. Regardless of vaccination status, CDC Director Dr. Rochelle Walensky told CBS News on Sunday that she “absolutely” thinks it will be safe for children to trick-or-treat outdoors in small groups this Halloween, but warned against attending large parties.
Once Pfizer and BioNTech submit their formal request for emergency use authorization, experts say the timeline for vaccinations in young children will become more clear.
The companies plan on announcing their data on children between 2 and 5 years old and 6 months to 2 years of age by the end of the year. Moderna submitted data on its COVID-19 vaccine in kids between 12 and 17 years old to the FDA in June. Johnson & Johnson announced in April that it expanded its clinical trial in children age 12 to 17. Both vaccines are only available for adults in the U.S. as of Sept. 28.
Is the Pfizer COVID-19 vaccine safe, effective in kids age 5 to 11?
Pfizer said the “safety profile and immunogenicity data” of its vaccine in a lower dose in kids between 5 and 11 years old are “consistent” with those observed in older people at a higher dose. “Immunogenicity data” refers to antibody levels produced after vaccination.
The two shots given 21 days apart also brought on side effects that were “generally comparable” to those experienced by 16- to 25-year-olds. A total of 2,268 children were included in the clinical trial.
Pfizer did not mention reports of serious side effects, including myocarditis — inflammation of the heart muscle — which has been affecting younger recipients, mostly male, after Pfizer or Moderna COVID-19 vaccination. However, a Pfizer spokesperson confirmed with CNN there were no cases of myocarditis in its small clinical trial, and that more specific data will be available “in a near-term submission.”
Pfizer also did not mention how the highly contagious delta variant may have affected its vaccine’s efficacy in clinical trials among kids.
The vaccine is currently available for people age 16 and older under the FDA approved name “Comirnaty.” The shot is also available under an emergency use authorization for kids between 12 and 15 years old and as a third dose for people age 12 and older who have weakened immune systems.
As of Sept. 23, the Pfizer vaccine booster shot is available in people:
- 65 years of age and older;
- 18 through 64 years of age at high risk of severe COVID-19;
- 18 through 64 years of age whose workplace offers high risk of exposure to COVID-19, including health care workers, grocery store employees and corrections officers.