FDA could authorize Pfizer vaccine for kids 12 to 15 this week; experts say it will help herd immunity

Posted at 6:17 AM, May 10, 2021

TAMPA, Fla. — The Food and Drug Administration is expected to authorize Pfizer’s COVID-19 vaccine for children 12 to 15 as early as this week.

Doctors say the ability to get more teens vaccinated will be a big deal in the fight against COVID-19.

“I think this is really fantastic in particular, you know considering the summer and then of course the next school year,” said Dr. Carina Rodriguez, Professor of Pediatrics and Division Chief of Infectious Diseases at the University of South Florida.

While this potential emergency use authorization for this age group comes sooner than some experts originally predicted, Rodriguez says researchers now have a lot of data from multiple clinical trials.

“We have a lot of data from the adult trials and also adolescents 16 and older, so that information already actually gives us an idea, a little bit of an idea how younger cohorts will also respond to these vaccines,” said Rodriguez.

The Pfizer Vaccine is already approved for teens 16 and older.

“Parents need to be reassured that all these clinical trials really are putting a lot of emphasis on the safety of the children and adolescents,” said Rodriguez.

As experts wait to see Pfizer’s data in more detail, they believe children 12 to 15 will likely have similar mild side effects to the vaccine as adults. Those include headache, soreness at the injection site, and fever.

“The data that so far we have learned from Pfizer seems very promising with no symptomatic infections in the patients that participated in the trials,” said Rodriguez.

Pfizer officials announced last week that they plan to submit for FDA emergency use authorization to vaccinate children two to 11 years old in September.

“I think that that is also very promising so most of these trials will require some additional work in relation to the dose,” said Rodriguez.

The vaccine safety and efficacy study in children ages six months to 11 years old is happening right now.

“A 6-month-old may not be the same as a 12-year-old. So all these protocols are going to take that into account and study the different kinds of escalation of the dose to assure safety and also that the dose is adequate for the age group,” said Rodriguez.

Experts say getting kids vaccinated is a key part in ending this pandemic.

“To reach a significant amount of immunity in the population that definitely includes pediatrics. To build that kind of herd immunity or reach the level of protection to finish with this pandemic we’ll need the immunization of younger patients,” said Rodriguez.