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FDA Fully Approves Pfizer-BioNTech Vaccine, Mandates To Follow

gloved hands preparing a covid-19 vaccination
The Food and Drug Administration has granted full approval to Pfizer-BioNTech’s coronavirus vaccine. Mississippi now expects the first of many vaccine mandates to come for health-care workers. Photo by Mufid Majnun on Unsplash

The Food and Drug Administration has granted full approval to Pfizer-BioNTech’s coronavirus vaccine, lifting the emergency use authorization for individuals 16 and older. The decision is the regulatory agency’s final confirmation of the mRNA vaccine’s safety and efficacy, although use in children between the ages of 12 and 15 continues to operate under an emergency use authorization.

More than 428 million individual doses of vaccine have been delivered in the U.S. alone. Vaccine effectiveness is measured in prevention of symptomatic infection, hospitalization and death. Across all vaccine types currently available to Mississippians, efficacy in all three categories remains remarkably high. 

Although some combination of the delta variant and time have shown waning efficacy against preventing symptomatic infection, long-term protection against hospitalization and death is still quantifiably powerful.

Even among the older, immunocompromised populations much more susceptible to hospitalizations and deaths, Mississippi public-health leadership has pointed to enduring protection from the vaccines. 

The final approval of the Pfizer vaccine is expected to kick off a wave of vaccination mandates across the country. The University of Mississippi Medical Center is charging ahead with their own mandate, the first major institution in the state to demand vaccination for its employees. Managers and supervisors at the state’s largest hospital system now have less than a month to provide evidence of vaccination, regular employees following behind shortly.

Previously, Dr. LouAnn Woodward, UMMC’s vice chancellor, acknowledged that vaccine mandates for a formulation still under an emergency use authorization were legally murky. During the EUA period, UMMC staff could choose to wear an n95 mask at all times, rather than getting vaccinated. That option is now rapidly expiring.

The Mississippi State Medical Association has backed an effort to expand that vaccine mandate to all health-care and long-term care workers in the state. “We wholeheartedly agree with the American Medical Association and more than 50 other national healthcare and public health organizations that requiring healthcare and long-term care professionals to receive a COVID-19 vaccine ‘is the logical fulfillment of the ethical commitment … to put patients first and take all steps necessary to ensure their health and well-being,’” wrote Dr. Claude Brunson, MSMA’s executive director in late July.

The FDA’s additional trial of the Pfizer-BioNTech vaccine, which will now be marketed under the name “Comirnaty,” compared a group of 20,000 vaccinated adults to an equally-sized control group, which received a placebo dose. The vaccinated group showed a 91% reduction in symptomatic COVID-19 infections, in line with the optimistic trials that previously allowed the vaccine under an EUA.

“The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death,” the FDA wrote in a press release today.

Moderna’s vaccine, which uses the same mRNA method as Pfizer, submitted its request for full FDA approval about a month after Pfizer. If approval comes on the same timeline, it may be late September before the vaccine enjoys the same fully approved status.

Rolling approval for the various vaccines and their different applications is still an ongoing process. The vaccine is still yet to receive EUA approval in children under 12, and booster doses—third shots intended to shore up infection resistance, especially in older or immunocompromised adults, is still offered on an emergency use authorization.

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