The U.S. Food and Drug Administration (FDA) approved the Pfizer vaccine on Monday, which public health and government officials predict will increase corporate and academic institution mandates and advance vaccinations.
Full approval means the drug’s effects have been analyzed and reviewed by the Center for Drug Evaluation and Research and are believed to provide benefits that outweigh known and potential risks for the intended population, as defined by the FDA website.
Pfizer is the first U.S. vaccine to receive full approval.
According to a Tuesday Very Well Health article, pharmaceutical companies do not have a patent to create names for products, making “Pfizer” a descriptor rather than a name for the vaccine.
Since the vaccine’s approval, “Comirnaty” is recognized as the first official title for the Pfizer vaccine, according to the same website.
Very Well Heath is a website containing medically-reviewed articles written by healthcare professionals and health journalists.
Before full FDA approval, a large number of businesses and universities including San Jose State implemented vaccine mandates and other safety measures such as social distancing and mask requirements.
The Pfizer vaccine, now officially referred to as Comirnaty on the FDA website, was approved for emergency use by the FDA in December 2020.
Emergency use authorization (EUA) allows medical countermeasures, including vaccines, to be used during public health crises, according to the FDA.
While the vaccine was granted full FDA approval for individuals 16 years or older, it’s still under EUA for individuals 12 to 15 years of age, according to the Monday FDA news release.
According to a June 30 report by the Kaiser Family Foundation (KFF), 30% of unvaccinated adults said they were waiting on full FDA approval to receive the vaccine.
The KFF is an American nonprofit organization that focuses on national health issues by developing policy analyses and participating in occasional partnerships with news organizations.
President Joe Biden encouraged eligible U.S. citizens to receive the vaccine and urged businesses to require stricter vaccine mandates during a Monday news conference in the South Court Auditorium of the White House Campus.
"Today I’m calling on more companies in the private sector to step up the vaccine requirements that will reach millions more people," Biden said. "If you’re a business leader, a non-profit leader, a state or local leader, who has been waiting for full FDA approval to require vaccinations, I call on you now to do that.”
Mark McClellan, a former FDA commissioner and director of the Duke-Margolis Center for Health Policy, said in a Monday news conference although employers had some authority regarding vaccine requirements for employees, companies will be more comfortable with mandates considering the FDA approval, according to a Monday Forbes article.
The Duke-Margolis Center for Health Policy utilizes academic research from Duke University to inform policy making, according to its website.
“Companies who could [enforce the vaccination mandate] before, I think they’re going to be more confident now and I think they’ll get more acceptance from their workers,” McClellan said.
Booster shots
Shortly before the approval of the Pfizer vaccine, the Centers for Disease Control and Prevention (CDC) released an Aug. 18 statement suggesting booster shots would be needed for the Pfizer and Moderna vaccines to provide “long lasting protection.”
The current data suggests protection against the COVID-19 virus decreases over time following the initial dose of the vaccine, according to the same Aug. 18 statement.
The FDA is prepared to start offering booster shots for all Americans who have been fully vaccinated for at least eight months on Sept. 20, according to the same statement.
A third dose is recommended to those with compromised immune systems, which is currently available in Santa Clara County, according to an Aug. 14 Santa Clara County Public Health Department news release.
The CDC considers individuals immunocompromised if they have a weakened immune system, which can include people with HIV/AIDS, cancer and transplant patients and those with inherited diseases that affect the immune system.
Immunocompromised individuals don’t build enough protection or any protection after the first vaccination, according to the CDC website.
Those who are immunocompromised are more likely to become infected with COVID-19 and become severely ill because of it, according to the Santa Clara County news release.
Approximately 2.7% of the U.S. population is immunocompromised, according to the same Santa Clara County news release.
SJSU vaccination requirements
San Jose State President Mary Papazian stated in a campuswide email Tuesday the current California State University (CSU) vaccination requirement will still be in effect following FDA approval of the Pfizer vaccine.
Papazian stated SJSU students, faculty and staff must be fully vaccinated against COVID-19 by Sept. 30 if they are accessing campus facilities.
Those who are not fully vaccinated or have an approved medical or religious exemption must participate in mandatory COVID-19 testing. COVID-19 testing will be administered on campus Monday through Friday by Fulgent Genetics in room 1035 of the Event Center.
SJSU media relations specialist Robin McElhatton said the university strongly recommends using the “Report a Case portal” on the Health Advisories website if an individual tests positive or comes in contact with someone who’s infected with the COVID-19 virus.
While booster shots are expected to roll out in late September, McElhatton said it's unclear if the university or CSU system will require booster shots for eligible individuals.
“SJSU complies with local and state COVID-19 guidelines. It is too early to know what the guidelines will be in regards to COVID booster shots,” McElhatton said in an email.
Software engineering senior Soumya Trivedi said she’d be interested in a booster shot as long as it’s approved with her current vaccine.
Trivedi received Serum Institute of India's COVID-19 vaccine, called “CoviShield.”
The CoviShield vaccine is formally known as Oxford/AstraZeneca, named after its developers, the University of Oxford and pharmaceutical company AstraZeneca.
The vaccine is currently approved by the World Health Organization (WHO) for emergency use, according to the WHO’s COVID-19 vaccine tracker.
“I would definitely go for the booster shot if it is okay to get a different booster shot than the vaccine [I received], I would definitely go for it but it depends on the studies,” she said.
Kyle Tran, film and public relations sophomore, said in a phone call he received one of the three U.S. vaccines and would be interested in a booster shot.
However, Tran said he’d prefer a strong recommendation for a booster shot rather than any mandate.
“Maybe if you asked me a few weeks ago, I would have been a little bit hesitant about maybe a third shot, but recently I just had a good friend of mine whose mom passed away from [the COVID-19 virus],” Tran said in a phone call. “I just want to make sure everyone I care about is safe, so I would probably take that third shot if more information is available for it.”
