FDA Delays Meeting on COVID-19 Vaccine for Children Under Age 5
SAN FRANCISCO (KPIX) -- The U.S. Food and Drug Administration has delayed a meeting about a COVID-19 vaccine for children younger than 5 that was originally scheduled to take place next week, raising questions about when they'll be able to get vaccinated against the deadly virus.
The FDA said it wants to see more data from Pfizer before proceeding. Kids younger than 5 are the only age group in the U.S. that cannot yet get the vaccine.
The FDA said it is postponing a meeting by an expert panel -- scheduled for Feb. 15 -- to give the agency time to consider additional data, "allowing for a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines."
Many parents are hesitant about getting the vaccine for their young children. For them, this delay may shake their confidence but, for others, this simply means a longer wait before they can protect their kids.
"Some of us are really desperate and really want to get our kids protected as soon as possible," said Leah Russini. Russini was so eager to get her child vaccinated that she enrolled her almost 2-year-old into Stanford's clinical trials.
"Her world has been been shaped and constrained by this pandemic and getting a vaccine into her will make me feel so much more confident about being able to experience the joys of life," Russini said.
Russini doesn't know if her daughter Aviva got the actual vaccine or a saline solution but her daughter is helping researchers determine the efficacy of the two-dose vaccine which is just a tenth of the adult dose.
"I think it's probably not surprising that this very small dose given to these younger children probably didn't provide a sufficient antibody response," said infectious disease specialist Dr. Yvonne Maldonado with Stanford Health.
Now Pfizer is moving ahead with the 3-dose clinical trials.
"Looking at the 3-dose, might as well package it all as a 3-dose series and, if that looks good overall, that might encourage families to get their kids vaccinated," Dr. Maldonado said.
Only 23 percent of those 5 to 11-years-old are fully vaccinated in the United States. The numbers for the youngest age group may end up being even lower but some parents are ready for the wait to be over.
"We'll be first in line, as long as it's been tested and proven safe, we'll be there," said parent Deidre Lang.
Researchers will need roughly two months to gather and study the data. The earliest a vaccine might be available to this age group would be sometime in April.