needed to see data from a third dose in the ongoing trial in order to make a determination that we could proceed with doing an authorization,” he shares.
Marks also noted that the speed with which Omicron spread also speeded up the collection of trial data.
“Think about what’s happened in the past month. I don’t know whether anyone could have really predicted what happened real well. We had days when we were getting above three quarters of a million cases a day of Omicron, and we started to see a tremendous number of children affected by Omicron,” Marks adds. “You could imagine that if a clinical trial were going on, any clinical trial, not necessarily this one, where someone was looking at outcomes, one might see information coming in very quickly.”
Pfizer first announced in December that a two-dose regimen didn’t generate a strong enough immune response in some children.
“The decision to evaluate a third dose … for children 6 months to under 5 years of age reflects the companies’ commitment to carefully select the right dose to maximize the risk-benefit profile,” Pfizer said at the time.
The FDA had planned to go forward with a review of the two-dose series out of a sense of urgency, but the postponement should also reassure parents, Marks says.
“Rather than having any issue of causing anyone to question the process, I hope this reassures people that the process has a standard, that the process is one that we follow, and we follow the science in making sure that anything we authorize has the safety and efficacy that people have come to expect from our regulatory review of medical products,” he concludes.
In the meantime, parents can protect their children that aren’t able to get vaccinated by making sure that everyone around them is fully vaccinated and following safety guidelines.