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COVID-19: FDA Approves Pfizer Vaccine; HHS Promotes Boosters

The Food and Drug Administration (FDA) on Aug. 23 approved the Pfizer-BioNTech COVID-19 vaccine for people ages 16 and older. The vaccine, which will be marketed as Comirnaty, was 91 percent effective in preventing COVID-19 in clinical trials.

The vaccine remains available under emergency use authorization for people ages 12 to 15 and as a third dose in immunocompromised people.

HHS Officials Announce Booster Shot Plan

Public health leaders with the Department of Health and Human Services (HHS) announced a plan to offer booster shots for the Pfizer-BioNTech and Moderna messenger ribonucleic acid (mRNA) COVID-19 vaccines.

Pending an evaluation by FDA and the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP), HHS is preparing to offer booster shots beginning the week of Sept. 20. The boosters will be available starting eight months after an individual’s second COVID-19 vaccine dose, to maximize the vaccine’s protection.

The agency also anticipates promoting booster shots for people who received the Janssen vaccine; more data will be available in coming weeks.

CDC Studies Highlight Vaccine Effectiveness

Three studies in the CDC Morbidity and Mortality Weekly Report underscore the effectiveness of mRNA vaccines. One study found mRNA vaccines were highly effective in providing at least 24 weeks of protection for fully vaccinated adults against severe COVID-19 illness requiring hospitalization.

A second study found COVID-19 vaccines were more than 90 percent effective against hospitalizations among fully vaccinated people in New York. However, overall effectiveness against new COVID-19 infections for all adults declined from about 90 to 80 percent, coinciding with the rise of the delta variant and relaxation of masking and physical distancing recommendations.

A third study shows that the mRNA vaccines were 75 percent effective in preventing the spread of COVID-19 among nursing home residents early in the vaccination program, from March to May 2021. However, after delta variant circulation predominated June and July, effectiveness declined to about 53 percent.

CMS to Mandate Vaccination for Long-Term Care Facility Staff

The Centers for Medicare & Medicaid Services (CMS) and CDC are working to develop an emergency regulation requiring COVID-19 vaccination for staff at Medicare- and Medicaid-participating nursing homes. As of Aug. 8, just 62 percent of nursing home staff nationwide were vaccinated. The agencies expect to issue the emergency regulation in September.

Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.

Contact Senior Director of Policy Erin O’Malley at or 202.585.0127 with questions.


About the Author

Emily Schweich is a communications manager at America's Essential Hospitals.

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