SACRAMENTO (CBS13) — Pfizer asked the Food and Drug Administration for Emergency Use Authorization of its COVID vaccine for kids 5-11 connected Thursday, but connected the heels of California’s schoolhouse vaccine mandate, the favoritism betwixt “approval,” “authorization” and “mandates” is causing disorder for immoderate parents.
Thursday’s announcement is conscionable the archetypal signifier for this property group. Full FDA support for kids 5-11 is inactive apt a ways away.
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The announcement follows Pfizer’s COVID vaccine trials, which included 2,268 kids betwixt the ages of 5-11.
Applying for Emergency Use Authorization (EUA) is the adjacent measurement toward making the vaccine disposable to each kids successful that property group.
The archetypal proceedings was comparatively small, including less than 2,500 kids, but erstwhile the FDA gives exigency usage authorization, Pfizer said it volition cod much information earlier submitting for afloat FDA approval.
Keep successful mind, the vaccine inactive doesn’t person afloat FDA support for kids 12-15—a key mile marker for California’s schoolhouse vaccine mandate
“We mean to bash that erstwhile the FDA has afloat approved the vaccine,” Gov. Gavin Newsom said successful a caller quality conference.
As the politician explained erstwhile helium announced the mandate past week, nary California students volition beryllium required to get vaccinated until the vaccine has afloat support for kids 12-15.
The vaccine already has afloat FDA support for kids 16 and older, but lone has exigency usage authorization for kids 12-15.
Pfizer is expected to petition afloat support for the 12-15 property radical by the extremity of the year, and the FDA is expected to determination rapidly connected the support process.
So, the schoolhouse vaccine mandate for kids 12 and older won’t instrumentality effect until January 2022 astatine the earliest, but it could beryllium arsenic precocious arsenic July 2022 if the FDA doesn’t o.k. it by the extremity of the year.
In Newsom’s announcement, helium alluded to authorities law which already includes 10 required vaccinations for students—and allows the authorities to adhd immoderate different vaccine “deemed appropriate.” But, the instrumentality besides requires the authorities to let idiosyncratic beliefs for immoderate caller vaccines added to the list, meaning parents could take not to vaccinate their kid for COVID unless the instrumentality is rewritten.
State Senator Richard Pan’s unit told CBS13 that helium would see authorizing authorities to region the exemption if excessively galore families take not to get vaccinated. But that wouldn’t hap until league resumes successful January.
As for kids aged 5-11, they apt wouldn’t beryllium included successful the archetypal mandate.
The FDA said it hopes to conscionable by the extremity of the period to see Emergency Use Authorization, but it could beryllium months earlier Pfizer is acceptable to taxable for afloat FDA support for the younger kids.
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Unlike kids 12 and older, who get the big dose of the vaccine, Pfizer said their dose for the younger kids is astir 1/3 of the dose for adults. In the trial, they reported that kids had a akin antibody response.
Julie Watts
Julie Watts is the 'CBS13 Investigates' reporter. She is dedicated to holding the almighty accountable, getting answers and digging deeper into the...More from Julie Watts