Kid COVID Vaccine Confusion: Who's Approved, Authorized Or Mandated?
SACRAMENTO (CBS13) — Pfizer asked the Food and Drug Administration for Emergency Use Authorization of its COVID vaccine for kids 5-11 on Thursday, but on the heels of California's school vaccine mandate, the distinction between "approval," "authorization" and "mandates" is causing confusion for some parents.
Thursday's announcement is just the first phase for this age group. Full FDA approval for kids 5-11 is still likely a ways away.
The announcement follows Pfizer's COVID vaccine trials, which included 2,268 kids between the ages of 5-11.
Applying for Emergency Use Authorization (EUA) is the next step toward making the vaccine available to all kids in that age group.
The initial trial was relatively small, including fewer than 2,500 kids, but once the FDA gives emergency use authorization, Pfizer said it will collect more data before submitting for full FDA approval.
Keep in mind, the vaccine still doesn't have full FDA approval for kids 12-15—a key mile marker for California's school vaccine mandate
"We intend to do that once the FDA has fully approved the vaccine," Gov. Gavin Newsom said in a recent news conference.
As the governor explained when he announced the mandate last week, no California students will be required to get vaccinated until the vaccine has full approval for kids 12-15.
The vaccine already has full FDA approval for kids 16 and older, but only has emergency use authorization for kids 12-15.
Pfizer is expected to request full approval for the 12-15 age group by the end of the year, and the FDA is expected to move quickly on the approval process.
So, the school vaccine mandate for kids 12 and older won't take effect until January 2022 at the earliest, but it could be as late as July 2022 if the FDA doesn't approve it by the end of the year.
In Newsom's announcement, he alluded to state law which already includes 10 required vaccinations for students—and allows the state to add any other vaccine "deemed appropriate." But, the law also requires the state to allow personal beliefs for any new vaccines added to the list, meaning parents could choose not to vaccinate their child for COVID unless the law is rewritten.
State Senator Richard Pan's staff told CBS13 that he would consider authorizing legislation to remove the exemption if too many families choose not to get vaccinated. But that wouldn't happen until session resumes in January.
As for kids aged 5-11, they likely wouldn't be included in the initial mandate.
The FDA said it hopes to meet by the end of the month to consider Emergency Use Authorization, but it could be months before Pfizer is ready to submit for full FDA approval for the younger kids.
Unlike kids 12 and older, who get the adult dose of the vaccine, Pfizer said their dose for the younger kids is about 1/3 of the dose for adults. In the trial, they reported that kids had a similar antibody response.