FDA Approves Pfizer-BioNTech COVID-19 Vaccine

Anyone stalling to get their COVID-19 vaccine because they “aren’t even FDA approved” can go ahead and make that appointment: The Food and Drug Administration issued full approval of the Pfizer-BioNTech COVID-19 vaccine for the prevention of coronavirus in individuals 16 years and older.

“This is another milestone in the fight against COVID-19 and further solidifies our path out of the pandemic,” Mayor Michael B. Hancock says. “We’re hopeful this provides greater assurance to those hesitant about being vaccinated against COVID-19.”

All vaccines—from Pfizer-BioNTech, Moderna, and Johnson & Johnson—all underwent rigorous safety testing by the FDA and were approved as safe to be administered under Emergency Use Authorization (EUA) earlier this year. The Moderna vaccine is expected to be fully approved in the coming weeks, or by the end of the year. In addition, the Pfizer-BioNTech vaccine is available under EUA for individuals 12 through 15 years of age, as well as for the administration of a third dose in certain immunocompromised people.

“The COVID-19 vaccines have gone through more safety testing than many other mandated and fully approved vaccines,” says Bob McDonald, executive director of the Denver Department of Public Health & Environment. “Vaccines are critical to the health and safety of all residents, and we must continue to raise Denver’s vaccination rate to limit hospitalizations and save lives. This is a major step forward in that effort.”

In Denver, nearly 80 percent of residents have received at least one dose of an approved COVID-19 vaccine, and 73 percent are fully vaccinated. However, with cases and hospitalization rates still increasing, Denver issued a Public Health Order on August 2 requiring all city employees and private-sector workers in high-risk settings to be fully vaccinated against COVID-19 by September 30.

Since the requirement was announced, Denver has seen a steady increase in the number of vaccines being administered, the number of doses administered to Denver residents increasing nearly 10 percent in the two weeks following the mandate versus the two weeks prior to the announcement, according to a release from the city and county.

“We need more eligible people to be fully vaccinated to avoid straining our hospital systems during the colder fall and winter months, when we expect another spike in COVID-19 case rates,” McDonald says. “I encourage everyone to get vaccinated as soon as possible. I also encourage residents to ask their health care providers, and others impacted by Denver’s vaccine mandate, if they have been vaccinated yet.”