TAMPA, Fla. — The FDA pushed back Pfizer’s meeting for emergency use authorization of their vaccine for children six months to five years old last week.
Pfizer’s data supported the safety of the vaccine, but researchers said the effectiveness wasn’t there with two shots.
“It was effective in the younger kids so those six months to two years but in the two to four-year-old age group it didn’t quite meet the levels of antibody response they expected to see,” said Dr. Christina Canody, BayCare Pediatric Service Line Medical Director.
Now instead of just having an EUA meeting about two doses, Pfizer is continuing their trial for three doses and will present that data once they have it.
“Based on doing a third dose booster eight weeks after those first two doses,” said Canody.
“They have more data and their data coming out suggests that the two doses of this pediatric dose vaccine is just not going to be effective and that they’re going to have to have that booster dose like they planned on with their trial,” said Dr. Michael Teng, Virologist and USF Health Associate Professor.
Vaccines for children ages five to 11 were authorized back in November.
Right now, Pfizer’s vaccine is the only one authorized for kids five and older.
The omicron variant challenged the efficacy of the vaccine for younger kids.
Researchers said while it will take longer to get a shot authorized for this younger age group, it’s best to err on the side of caution.
“We want to make sure that we have a vaccine that’s safe and effective for the younger children… I think like everything we do in medicine we have to have the data to support it and it has to be not only safe but effective. Nobody wants to administer a vaccine not knowing whether or not that third dose is going to be exactly what they need to get them to a level of protection that protects them from the severe effects of COVID,” said Canody.
Doctors said so far the trial has shown younger kids aren’t seeing as many mild side effects from the vaccine.
“As the dose of the vaccine gets lower, adults get 30 micrograms, adolescents in the five to 11 age range get 10 micrograms, the kids under the age of five are only getting three micrograms, the side effect profile has gone down significantly and much fewer side effects. So it was extremely well-tolerated and minimal side effects in those age groups,” said Canody.
“I think it’s trying to find the balance between what’s the effective dose without causing an increase in the side effects where they’re erring on the side of caution and let’s make sure that that third dose is going to boost enough where those two to four-year-olds will be protected,” she added.