BALTIMORE (WMAR) — The FDA’s willingness to consider emergency use authorization for a vaccine with no proven effectiveness is causing concern for doctors who battle vaccine hesitancy every day.
“We are really putting the cart before the horse in this situation,” said Johns Hopkins lung doctor Panagis Galiatsatos.
Tuesday, following a request from the FDA, Pfizer submitted safety data for an EUA for its vaccine for kids age 6 months to 4 years old.
It’s an unusual move because clinical trials showed two doses failed to generate adequate protection in children aged between 2 and 4.
“Many of us saw that and said we are gonna have to probably be waiting for some time for this vaccine to come out and I think that’s what caught many of us by surprise when they said no no we’ll go ahead and give you the data now,” said Galiatsatos.
Pfizer added a third dose to the series, hoping it raises antibody levels, but data on that won’t be ready for a few months.
The company decided to go ahead now because of the “urgent public health need.”
While Galiatsatos understands where they are coming from, he fears it could backfire and increase hesitancy.
“While the population from an age perspective disproportionately effects the elderly, there are still some who are young that are getting effected. In addition, they are still human beings that if they catch the virus can allow it to change into other variants,” said Galiatsatos. “But at the same time, hopefully the FDA and others are recognizing that when doctors go out to have these conversations, we’re not going out to a community who is arms wide open, whatever science says we’re ready to accept it. We’re going out to communities where there is a healthy sense of skepticism… People want to see any crack in science and to me this is a crack. We can’t go out there with the confidence.”
There are still several regulatory steps before authorization but in the past, they’ve have gone pretty quickly… sometimes less than a month.
Moderna is also testing its vaccine with this age group and plans to submit data next month.