California Community Colleges Chancellor Eloy Oakley announced in a May 6 press conference that his office will be issuing guidance for schools to mandate a COVID-19 vaccination. This can only occur after one of the vaccines is fully approved by the Food and Drug Administration.
“We’re leaving it up to individual districts to decide rather or not to require [COVID-19] vaccination, but as soon as the FDA fully licenses [a vaccine], the chancellor’s office will be sending guidance to California Community Colleges to require the vaccine,” Oakley said.
Currently, COVID-19 vaccinations have only been given emergency use authorization. Oakley has repeatedly stated in press conferences throughout the semester that CCC cannot legally require students to get vaccines with emergency use authorization, but this will change once the FDA “lifts its restrictions,” he said.
“We think this is an important step,” Oakley said.
As fully approved vaccines for all student-aged groups become closer to being available, making school-required COVID-19 vaccinations a possibility, intense debate has broken out across Orange County about vaccinating students,- especially children, culminating in large protests drawing crowds outside of recent OC Board of Supervisors meetings.
Orange Coast College officials said in an April 30 town hall on re-opening, that the district is not requiring COVID-19 vaccinations at this time, but it is not immediately clear if they will follow Oakley’s guidance to make it mandatory once a vaccination receives full FDA approval.
Both Orange Coast College and CCC leaders urge all eligible students over 16 to get vaccinated for COVID-19. Oakley also reminded students that University of California and California State University schools are requiring a COVID-19 for the fall 2021 semester, so those transferring will have to get vaccinated.
“We want students, staff and faculty to be in a position where they can help protect the community by getting vaccinated,” Oakley said. “The vaccine is there, it’s available and we encourage you to get it.”
One COVID-19 vaccination, produced by Pfizer and BioNTech, has begun the process to get fully authorized by the FDA, as opposed to the emergency use authorization that was originally granted to the vaccine in December 2020. Pfizer-BioNTech was the first COVID-19 vaccine given emergency use authorization by the FDA.
The Biologics License Application (BLA) that Pfizer and BioNTech have initiated requires at least six months of data and includes data from Pfizer’s most recent Phase 3 clinical trial. The trial studied the vaccine’s efficacy and safety six months after the 12,000 participants observed received the second dose.
Pfizer and BioNTech will continue to send the FDA additional data as the BLA is completed and formally accepted by the FDA for review in the coming weeks. A goal date for the FDA’s decision on whether to fully authorize the vaccination will be set at that time.
It was requested for the application to receive priority review. According to information available from the FDA, priority review applications typically have a timeline of six months, but certain programs’ applications can be expedited faster.
“Following the successful delivery of more than 170 million doses to the U.S. population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., CEO and co-founder of BioNTech, in a press release from earlier this month. “We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”
On May 10, the FDA approved the Pfizer-BioNTech COVID-19 vaccination for emergency use for adolescents aged 12-15 years old. The companies plan to submit the additional BLA for this age group to also apply for full authorization six months after second doses are administered. Various testing sites across the county, including Stanford Medicine, are currently researching the effect of the vaccine on children under 12.
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