FDA seeks more data on COVID-19 vaccine for children

(CMR) Parents of children six months to four years old will have to wait a bit longer to know if their child can receive the Pfizer COVID-19 vaccine as the US Food and Drug Administration wants more data.

Pfizer and BioNTech filed a request with the US Food and Drug Administration earlier this month for an emergency use authorization of their vaccine in children from six months old. The FDA's Vaccines and Related Biological Products Advisory Committee was scheduled to meet on 15 February to go over data from vaccine trials and make a recommendation on whether a two-dose vaccine regimen should be authorized.

However, the FDA said with new data emerging, the agency wanted to see data from an ongoing trial of a third vaccine dose in these younger children in order to move forward with emergency use authorization.

Pfizer and BioNTech said Friday that they expect to have data on three doses available in early April.

Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said, “it makes sense for us to wait until we have the data from the evaluation of a third dose before taking action.”

“The data that we saw made us realize that we needed to see data from a third dose as in the ongoing trial in order to make the determination that we could proceed with doing an authorization,” he added.

Dr. William Schaffner, professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, said that with cases and hospitalizations going down across the country, there is a little more breathing room to look at the data and determine the right vaccine schedule up-front.

“Let's take a step back and take a deep breath. When we recommend ‘should we do vaccines for all children aged six months to 4 years of age,' we want to be able to communicate to the parents exactly what they can expect regarding effectiveness and safety,” said Schaffner, a vaccine adviser to the CDC.

“If that takes us a few more days to secure those data, analyze them, think about them and then present them, let's take a few more days because we want to be able to do this in the best possible way we can,” he added.