The Food and Drug Administration postponed its meeting of expert advisers on February 15 about using Pfizer’s two-dose Covid-19 on young kids under five years old after new data was submitted late last week.
On Friday, Pfizer said that it would wait for its data on a three-dose series of the vaccine.
“Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” Pfizer said in a statement.
Former FDA Commissioner and Pfizer Board Member Dr. Scott Gottlieb said the FDA delayed its decision to vaccinate kids 6 months old to 4 years old due to new data about the vaccine’s efficacy during his interview on Face the Nation.
“There were no new safety issues coming out of the data set. The issue here is the ability for the FDA and provider to clearly define the level of efficacy that the vaccine is delivering,” Gottlieb said during the interview.
“It’s hard for the FDA to give its advisors a fixed snapshot of what the absolute efficacy is of this clinical trial, of the data set. And so if they wait a little longer, if they administer the third dose in that clinical trial, they’re not only going to have perhaps a better measure of effectiveness from this trial, but they’ll also have a settled data set. They’ll have a very firm picture of what level of effectiveness the vaccine is delivering,” he continued.