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On Dec. 11, FDA issued an EUA for the Pfizer-BioNTech COVID-19 vaccine, making it the first vaccine to be authorized for the prevention of COVID-19, according to a news release.
“The new COVID-19 vaccine is an incredible accomplishment that is going to save millions of lives around the world,” said ADA President Daniel J. Klemmedson, D.D.S., M.D. “It's also going to make it possible for dentists and their teams to continue treating patients more safely during the ongoing pandemic.”
According to the Centers for Disease Control and Prevention, the Pfizer-BioNTech COVID-19 vaccine has been delivered to hospitals and clinics in all 50 states and vaccinations are already underway. The FDA will also consider a second vaccine, produced by Moderna, for EUA later this week.
Many dentists may be wondering if they will be included in the first wave of vaccinations taking place in their states. In the new fact sheet, ADA explains that “final authority rests with the individual states” to prioritize who receives the vaccine. It also notes that current CDC guidance has indicated the vaccine “should be offered to both health care personnel with potential for direct or indirect exposure to patient or infectious materials” and “residents of long-term care facilities.”
Dr. Klemmedson added that he's looking forward to personally receiving the vaccine, which is currently scheduled for Friday. As an oral surgeon who regularly provides care to patients in a hospital, Dr. Klemmedson was included in the first round of vaccinations in his home state of Arizona.
"As a trusted, essential health care provider, I am proud to serve as a resource for evidence-based information and helping to educate colleagues and the public about COVID-19 vaccination," he said.
This CDC guidance was partly based on the National Academies of Science, Engineering and Medicine’s proposed framework which outlined a phased approach for equitable allocation of the vaccine and prioritized health care workers with direct or indirect exposure to patient or infectious materials (including dentists and dental hygienists) and first responders in Phase 1a.
The Pfizer-BioNTech vaccine has met the statutory criteria for issuance of an emergency use authorization, or EUA, and “in making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information,” according to a statement by the FDA.
The agency also pointed out that an EUA is different than an FDA approval (licensure) of a vaccine.
“In determining whether to issue an EUA for a product, the FDA evaluates the available evidence and assesses any known or potential risks and any known or potential benefits, and if the benefit-risk assessment is favorable, the product is made available during the emergency,” FDA said.
The new vaccine contains a lipid envelope containing messenger RNA (mRNA) coding for the virus’ distinctive “spike” protein and mRNA for replicase that instructs the cells that take up the enveloped mRNA to amplify it. The cells then use the mRNA to synthesize the spike protein which stimulates the body’s immune response.
“When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2,” according to the FDA release. The vaccine is administered as a series of two doses, three weeks apart.
The ADA will continue to monitor developments related to COVID-19 vaccine approval and administration on behalf of the profession and public. Visit ADA.org/virus for the latest information.