FDA Approves Pfizer-BioNTech Vaccine

Published on August 24, 2021

DENVER – The Food and Drug Administration (FDA) today issued full approval of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age 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 said. “We’re hopeful this provides greater assurance to those hesitant about being vaccinated against COVID-19.”

The Pfizer- BioNTech, Moderna, and Johnson & Johnson vaccines all completed extremely rigorous safety testing by the FDA and earlier this year were approved as safe to be administered under Emergency Use Authorization (EUA). It is expected that the Moderna vaccine will also be fully approved by the FDA in the coming weeks or before the end of the year. The Pfizer- BioNTech vaccine also continues to be available under EUA for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The COVID-19 vaccines have gone through more safety testing than many other mandated and fully approved vaccines,” said 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.”

COVID-19 vaccines are readily available and free to all Denver residents. No insurance or identification are required to receive a COVID-19 vaccine. More information about the COVID-19 vaccine is available here, or you can text your ZIP code to GETVAX (438829) in English, or VACUNA (822862) in Spanish, to get the contact information of three nearby locations with available vaccines.

Vaccine rates are increasing in Denver, but more work needs to be done.

Nearly 80% (78.2%) of Denver residents have received at least one dose of an approved COVID-19 vaccine, and 73% are fully vaccinated. However, case and hospitalization rates are also increasing. To limit the spread of COVID-19 and protect the most vulnerable, Denver issued a Public Health Order on Aug. 2 requiring all city employees, as well as private-sector workers in high-risk settings, to be fully vaccinated against COVID-19 by Sept. 30.

The vaccine requirement applies to personnel in high-risk settings such as nursing homes, shelters for people experiencing homelessness, hospitals and clinical settings including home healthcare, and correctional facilities, as well as teachers and staff in schools and post-secondary institutions.

Since the vaccine requirement was announced on Aug. 2, Denver has seen a steady increase in the number of vaccines being administered. In the two weeks following the vaccine mandate announcement, the number of COVID-19 vaccine doses administered to Denver residents increased nearly 10% when compared to the number of doses administered in the two weeks prior to the announcement. Vaccine rates fell sharply earlier in the summer.

“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,” said McDonald. “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.”

As a reminder, the following people in Denver are required to be fully vaccinated against COVID-19 by Sept. 30.

All Personnel who are onsite or in the field providing services to the following entities:

  • Hospitals, clinical settings, primary care settings, longer-term care facilities, and other locations where health care services are offered
  • Shelters for people experiencing homelessness, including day and overnight shelters
  • Correctional facilities, including jails, detention centers and community corrections sites and residences
  • Schools, including post-secondary and higher education, and childcare centers
  • Any entity providing home care to patients
  • Any entity providing first responder services
  • All City and County of Denver employees

The vaccine requirement applies to all personnel in these categories if they work in Denver, regardless of where their company is based. Included in the vaccine mandate are healthcare settings, including primary care offices, dental offices, physical therapy, home healthcare providers, among others. More information about Denver’s vaccine requirement is available here.

The City and County of Denver is committed to keeping businesses and the economy open while ensuring that employers and employees feel safe in the workplace. To that end, the city encourages all employers to ensure that their employees are vaccinated, and it is taking the lead on this initiative by mandating vaccinations.

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