The Food and Drug Administration cleared the Prizer-BioNTech coronavirus shot for use in children as young as 12 today. The emergency use approval means that younger adolescents will have access to the vaccine that was previously only available to those age 16 and up.
The FDA says the Pfizer-BioNTech COVID-19 Vaccine met the criteria and that the known potential benefits in those 12 years of age and older, outweigh known and potential risks.
“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D in a press release. “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
New Jersey is ready to get younger adolescents vaccines as quickly as possible. Governor Murphy today said the state is ready to quickly make the transition. “The New Jersey Department of Health is currently finalizing guidance for parents, guardians, and practitioners,” said Murphy. “We anticipate being able to transition to vaccinating eligible adolescents as soon as Pfizer receives its emergency use authorization. We’ve spent our time preparing so we can get this latest expansion underway with minimal lead time.”
“Vaccinating children for COVID-19 is a key component to reaching the two-thirds threshold necessary to obtain herd immunity and stop the pandemic from continuing to spread and mutate,” said Miguela Caniza, MD MPH, Director of the St. Jude Global Infectious Diseases Program at St. Jude Children’s Research Hospital in reaction to today’s news. “Today’s emergency authorization of the Pfizer vaccine for ages 12 to 15 is an important step in helping to control this virus in a safe and effective way for a larger percentage of the population. As the research continues to bear out the safety and efficacy of COVID vaccine use in children, it is likely these vaccines will become part of the current 14 routine vaccination in childhood.”
“Children and teenagers are highly mobile populations attending schools, sports, extracurricular activities and intersecting more often with various age groups including caretakers and older family members,” Dr. Caniza continued. “Because of the high percent of children and teenagers being asymptomatic or with minimal symptoms, most likely they will be effectively spreading during a very contagious period, and even more so, if they don’t follow the standard precautions (distancing, using masks and practicing hand hygiene). ”
Those in the 12 to 15-year-old age group will only be allowed to get the two-dose Pfizer vaccine, for now. Johnson & Johnson and Moderna vaccines have not been tested on younger kids. Canada is currently the only other country to have approved a COVID vaccine for this age group. It was approved there for use in adolescents 12 and up on May 5.