Content created by Assistant Secretary for Public Affairs (ASPA)
COVID-19 Vaccine Development and Authorization
The federal government has been working since the pandemic started to develop, manufacture, and distribute safe and effective COVID-19 vaccines.
Years before the COVID-19 pandemic, scientists were already studying coronaviruses to find out how to protect against them. When the COVID-19 pandemic began, researchers were able to come up with vaccines for this new virus much faster because of work that was already happening.
FDA Authorization
The Food and Drug Administration (FDA) reviews and evaluates COVID-19 vaccines for quality, safety, and effectiveness. The FDA then issues Emergency Use Authorizations (EUAs), opens in a new tab for certain vaccines that meet rigorous, science-based standards. The FDA determines that these vaccines are safe and effective for public use.
CDC Recommendation
After the FDA authorizes the emergency use of a vaccine, an independent panel of medical and health experts called the Advisory Committee on Immunization Practices (ACIP), opens in a new tab provides recommendations and guidance to the Director of the Centers for Disease Control and Prevention (CDC) regarding the use of the vaccine.
FDA Approval
When the FDA approves a vaccine, it must undergo the agency's standard approval process, opens in a new tab for reviewing the quality, safety and effectiveness. The FDA's Center for Drug Evaluation and Research conducts an analysis of the benefits and risks to ensure the vaccine meets the FDA's standards for approval.
October
October 3, 2023
FDA authorized the updated Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) for individuals ages 12 and older, opens in a new tab
September
September 11, 2023
FDA approved and authorized the emergency use of the updated Moderna and -BioNTech COVID-19 vaccines, opens in a new tab formulated to better protect against currently circulating variants
April
April 18, 2023
FDA amended the emergency use authorization to simplify the vaccination schedule for bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines, opens in a new tab
April 24, 2023
HHS Secretary issued a directive on simplified and expanded use of bivalent mRNA COVID-19 vaccines, opens in a new tab [PDF, 226 KB]
December
December 8, 2022
FDA authorizes the emergency use of the updated (bivalent) Moderna and Pfizer COVID-19 vaccines for children ages 6 months and up, opens in a new tab.
December 9, 2022
HHS Secretary issued a directive on bivalent vaccines for children starting at 6 months of age, opens in a new tab [PDF, 160 KB]
October
October 13, 2022
HHS Secretary issued a directive on bivalent COVID-19 vaccine booster doses for individuals ages 5 years and older, opens in a new tab [PDF, 166 KB].
September
September 2, 2022
HHS Secretary issued a directive on bivalent COVID-19 vaccine booster doses for individuals ages 12 years and older, opens in a new tab [PDF, 146 KB].
July
July 13, 2022
FDA authorized emergency use of Novavax COVID-19 Vaccine, Adjuvanted, opens in a new tab for individuals 18 years of age and older.
July 21, 2022
HHS Secretary issued a directive on the use of a two-dose Novavax COVID-19 Vaccine, Adjuvanted for persons ages 18 years and older, opens in a new tab [PDF, 120 KB].
June
June 17, 2022
FDA authorized Moderna and Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age, opens in a new tab.
June 18, 2022
HHS Secretary issued a directive to expand eligibility of the Moderna COVID-19 vaccine for children 6 months through 5 years old and the Pfizer-BioNTech COVID-19 vaccine for children 6 months through 4 years old, opens in a new tab [PDF, 107 KB].
June 24, 2022
HHS Secretary issued a directive to expand eligibility of a two-dose series of the Moderna COVID-19 vaccine for children ages 6 years through 17 years, and an additional Moderna dose for children in that age group who are immunocompromised, opens in a new tab [PDF, 108 KB].
May
May 17, 2022
FDA expanded eligibility for the Pfizer-BioNTech COVID-19 vaccine to allow a single booster dose for children 5 through 11 years of age, opens in a new tab.
May 23, 2022
HHS Secretary issued a directive to expand eligibility for a single booster dose to children ages 5 through 11 years and updated the recommendation of a second COVID-19 vaccine booster dose to certain populations, opens in a new tab [PDF, 157 KB].
January
January 10, 2022
HHS Secretary issued a directive to expand eligibility for children ages 12 through 15 years, opens in a new tab [PDF, 107 KB] to receive a booster dose of the Pfizer COVID-19 vaccine, and to allow a third vaccine dose for immunocompromised children 5 through 11 years of age.
January 31, 2022
FDA approved the second COVID-19 vaccine, opens in a new tab, Spikevax (COVID-19 Vaccine, mRNA), which was previously known as Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older.
December
December 10, 2021
HHS Secretary issued a directive to expand eligibility for adolescents ages 16 and 17, opens in a new tab [PDF, 113 KB] to receive a booster dose of the Pfizer COVID-19 vaccine.
November
November 3, 2021
HHS Secretary issued a directive to expand eligibility for children five years and older, opens in a new tab [PDF, 93 KB] to receive an age-appropriate dose of the Pfizer COVID-19 vaccine.
November 8, 2021
A joint letter, opens in a new tab [PDF, 277 KB] from HHS Secretary Becerra and Education Secretary Cardona is issued about how schools can support COVID-19 vaccination for children.
November 21, 2021
HHS Secretary issued a directive to expand eligibility for all adults ages 18 and older, opens in a new tab [PDF, 113 KB] to receive a booster dose of COVID-19 vaccines.
October
October 20, 2021
FDA amended the emergency use authorizations (EUAs) to allow for a single booster dose the Moderna COVID-19 vaccine and Janssen (Johnson and Johnson) COVID-19 vaccine, opens in a new tab. FDA also authorized the use of heterologous (or "mix-and-match") booster dose of an available vaccine in eligible individuals following completion of primary vaccination with a different COVID-19 vaccine.
October 22, 2021
HHS Secretary issued a directive on Moderna and Janssen (Johnson and Johnson) vaccine boosters, opens in a new tab [PDF, 156 KB]*
October 29, 2021
FDA authorized the emergency use (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age, opens in a new tab.
September
September 22, 2021
FDA amended the emergency use authorization (EUA) to allow a single booster dose of the Pfizer-BioNTech COVID-19 vaccine, opens in a new tab to be administered at least six months after completion of the vaccine's primary series in certain populations.
September 25, 2021
HHS Secretary issued a directive to allow a booster dose of the Pfizer COVID-19 vaccine to certain populations, opens in a new tab [PDF, 143 KB].
August
August 23, 2021
FDA approved the first COVID-19 vaccine,, opens in a new tab Comirnaty (COVID-19 Vaccine, mRNA), which was previously known as Pfizer-BioNTech COVID-19 Vaccine, for the prevention of COVID-19 disease in individuals 16 years of age and older.
May
May 10, 2021
FDA amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to include adolescents 12 through 15 years of age, opens in a new tab.
April
April 19, 2021
The White House announced that all people age 16 and older are eligible for the COVID-19 vaccine, links to an external website.
March
March 2, 2021
Acting HHS Secretary directed that teachers, school staff, and child care workers are eligible for COVID-19 vaccinations, opens in a new tab [PDF, 155 KB]*.
March 17, 2021
Acting HHS Secretary issued a directive to expand COVID-19 vaccine eligibility to all Americans, opens in a new tab [PDF, 159 KB]* by May 1, 2021.
February
February 27, 2021
FDA issued the third EUA for use of the Janssen COVID-19 vaccine, opens in a new tab in persons aged 18 years and older for the prevention of COVID-19.
December
December 11, 2020
FDA issued the first emergency use authorization (EUA) for use of the Pfizer-BioNTech COVID-19 vaccine, opens in a new tab in persons aged 16 years and older for the prevention of COVID-19.
December 14, 2020
The first deliveries of the COVID-19 vaccines began.
December 18, 2020
FDA issued the second EUA for use of the Moderna COVID-19 vaccine, opens in a new tab in persons aged 18 years and older for the prevention of COVID-19.
Equitable Access to COVID-19 Vaccines
During the COVID-19 pandemic, each state, tribe, and territory received allocations of vaccines and developed its own plan for distributing vaccines to people in their jurisdiction.
Vaccinations in the United States began on December 14, 2020.
To ensure the equitable distribution of COVID-19 vaccines, the federal government stood up programs to reach high-risk communities directly and quickly.
- The Federal Retail Pharmacy Program sent doses to 21 pharmacy partners with over 40,000 activated stores, 40% of which are located in high-risk zip codes.
- The Health Center COVID-19 Vaccine Program allocated doses directly to community-based health centers who signed up to receive and administer COVID-19 vaccines. The program was open to more than 1,400 health centers nationwide. Over 91% of these health center patients were individuals or families living at or below 200% of the Federal Poverty Guidelines.
- The Rural Health Clinic COVID-19 Vaccine Distribution (RHCVD) Program, opens in a new tab distributed doses directly to Rural Health Clinics in medically-underserved rural communities.
- Tribal health programs and Urban Indian Organizations (UIOs) decided to receive vaccines either through the Indian Health Service (IHS) or through the State. To better understand the needs of American Indian and Alaska Native, HHS initiated tribal consultation in September 2020 to seek input from tribal leaders on COVID-19 vaccination planning for Indian Country.
Vaccine Data
The CDC’s COVID Data Tracker, opens in a new tab shows the total number of COVID-19 vaccinations administered in the United States.
*This content is in the process of Section 508 review. If you need immediate assistance accessing this content, please submit a request to digital@hhs.gov, opens in a new window. Content will be updated pending the outcome of the Section 508 review.