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Today, 8/23/21, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
“Approval from the FDA for Comirnaty (Pfizer) vaccine is a huge hurdle we’ve cleared as we continue to battle COVID. While this and other vaccines have met the FDA’s rigorous standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, our community can be very confident that this vaccine meets high standards.” said Rachel Willard, Wilkes County Health Director. “We still have a long way to go, as of today only 35% of Wilkes County residents are fully vaccinated, and 40% of residents have received their first shot.”
FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA to individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021.
“We urge people to get their vaccination as soon as possible, please don’t wait.” Willard said. “If you are unvaccinated, you are at increased risk of getting COVID-19 and we don’t want to see anyone experience adverse outcomes due to this virus. I am very concerned with the increase in cases within our community. With a low percentage of our residents being vaccinated we will continue to see this virus impact our everyday lives. The vaccines are doing their job. They were created to help prevent severe illness, hospitalization and death and they are doing that. Please continue to wear your mask indoors regardless of vaccination status, as we know this is the best way to slow the spread of the virus.”