By Sahar Chmais
Pfizer-BioNTech’s COVID-19 vaccine is the first to receive FDA approval for individuals ages 16 and older, according to the FDA.
Pfizer’s vaccine will be marketed under the name Comirnaty.
The FDA gave its approval only to Comirnaty for certain age groups, but the vaccine will still be provided to individuals aged 12-15, under the Emergency Use Authorization (EUA).
“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
EUAs are used by the FDA during public health emergencies if a treatment is determined to prevent, diagnose or treat the disease while outweighing potential risks of the product.
In order to get FDA approval, the agency evaluates data and information included in the manufacturer’s submission of a Biologics License Application (BLA).
Comirnaty submitted extensive data and information that supported EUA use, which included preclinical and clinical data and information, details on the manufacturing process, vaccine testing results to ensure vaccine quality and inspections of the sites where the vaccine is made.
The FDA then conducts its own analyses of the information in the BLA to ensure the vaccine is safe, effective and meets the agency’s standards for approval.
Residents looking to receive Comirnaty in Hays County find them at:
- Dripping Springs Pharmacy
- CVS Pharmacy in Buda on 220 Farm to Market 1626
- Walgreen in Buda on 1660 Main St.
- Austin Regional Clinic in Kyle on 4100 Everett St.
- Walgreen in Kyle on 6205 FM 2770
- HEB in Kyle on 5401 Farm to Market 1626
- Kyle ER and Hospital
- Walgreen in Kyle on 5781 Kyle Parkway
- HEB in Wimberley on 14501 Ranch Rd. 12
- Walgreens in San Marcos on Ranch Rd. 12
- HEB in San Marcos on 200 W. Hopkins St.
- CVS Pharmacy in San Marcos on 920 Tx-80
- Walgreen in San Marcos on 639 E Hopkins St.
- Live Oak Clinic in San Marcos at 401 Broadway St.
Pharmacies receive the vaccine in different increments. To get the most up-to-date information, visit www.vaccines.gov to find the nearest vaccine provider, or visit www.hayscountytx.com/covid-19-information-for-hays-county-residents.
