Joe Gastaldo, MD, System Medical Director of Infectious Diseases explains the starts and stops for a vaccine for children under age 5 and when he predicts one will be authorized for them.
In December of 2021, Pfizer had a press release stating that for children aged two to five, the antibody levels from a two dose vaccine were not high enough to induce immunity.
Subsequently, Pfizer’s initial plan was to do a three phase trial and then submit the data after. The FDA, in an unprecedented move, decided that they were going to do a rolling review and only review the two dose study, knowing the information from a three dose study was going to follow.
That decision was then rescinded, and they are now back to the original plan. The FDA has decided to wait for the three dose clinical trials for the vaccine. Hopefully that will be reviewed sometime this spring.
Dr. Gastaldo feels confident saying we will have a vaccine for children down to the age of six months, hopefully by sometime this summer.
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