How CDC Is Making COVID-19 Vaccine Recommendations
Johnson & Johnson’s Janssen COVID-19 Vaccine: CDC and FDA have recommended a pause in the use of Johnson & Johnson’s J&J/Janssen COVID-19 Vaccine in the United States out of an abundance of caution, effective Tuesday, April 13. The Advisory Committee on Immunization Practices (ACIP) will hold its second emergency meeting to discuss J&J/Janssen COVID-19 Vaccine on April 23, 2021. People who have received the J&J/Janssen COVID-19 Vaccine within the past three weeks who develop severe headache, abdominal pain, leg pain, or shortness of breath should seek medical care right away.
When the Food and Drug Administration (FDA) authorizes or approves a COVID-19 vaccine, the Advisory Committee on Immunization Practices (ACIP) will quickly hold a public meeting to review all available data about that vaccine (sign up to receive email updates whenever ACIP’s Meeting Information is updated). Before making recommendations, ACIP reviews all available clinical trial information, including descriptions of:
- Who is receiving each vaccine (age, race, ethnicity, underlying medical conditions)
- How different groups respond to the vaccine
- Side effects of each vaccine
From these data, ACIP will then vote on whether to recommend the vaccine. ACIP also votes on recommendations for who should be offered COVID-19 vaccine first when supplies are limited.
COVID-19 Vaccination Recommendations
- On Dec. 1, 2020, ACIP recommended that health care personnel and long-term care facility residents be offered COVID-19 vaccination first (Phase 1a).
- On Dec. 11, 2020, the FDA issued an Emergency Use Authorization (EUA) for use of the Pfizer-BioNTech COVID-19 vaccineexternal iconin persons aged 16 years and older and on Dec. 13, 2020, ACIP issued recommendations for the use of the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19.
- On Dec. 18, 2020, the FDA issued an EUA for the use of the Moderna COVID-19 vaccineexternal iconfor use in individuals 18 years of age and older and on Dec. 20, 2020, ACIP issued recommendations for the use of the Moderna COVID-19 vaccine for the prevention of COVID-19.
- On Dec. 20, 2020, ACIP updated interim vaccine allocation recommendations. In Phase 1b, COVID-19 vaccine should be offered to people aged 75 years and older and non–health care frontline essential workers, and in Phase 1c, to people aged 65–74 years, people aged 16–64 years with high-risk medical conditions, and essential workers not included in Phase 1b.
- On Feb 27, 2021, the FDA issued an EUA for the use of Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 vaccineexternal icon in persons aged 18 years and older and on Mar. 2, 2020, ACIP issued recommendations for the use of the J&J/Janssen COVID-19 vaccine for the prevention of COVID-19.
Learn more about ACIP and CDC recommendations for COVID-19 Vaccines.
ballot check light icon ACIP Resources: Recommendation process, meeting agendas, minutes, live meetings, and presentation slides
ACIP identified four ethical principles to guide their decision-making process when supply is limited:
- Maximize benefits and minimize harms — Respect and care for people using the best available data to promote public health and minimize death and severe illness.
- Mitigate health inequities — Reduce health disparities in the burden of COVID-19 disease and death, and make sure everyone has the opportunity to be as healthy as possible.
- Promote justice — Treat affected groups, populations, and communities fairly. Remove unfair, unjust, and avoidable barriers to COVID-19 vaccination.
- Promote transparency — Make a decision that is clear, understandable, and open for review. Allow and seek public participation in the creation and review of the decision processes.
Learn more about ACIP’s Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine.
Input from the public and the following professional groups is informing ACIP’s discussions on who should receive COVID-19 vaccines when supply is limited:
- Johns Hopkins Bloomberg School of Public Health: Interim Framework for COVID-19 Vaccine Allocation and Distribution in the United Statesexternal icon
- The National Academies of Sciences, Engineering, and Medicine: Framework for Equitable Allocation of COVID-19 Vaccineexternal icon
- World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE): WHO SAGE Values Framework for the Allocation and Prioritization of COVID-19 Vaccination pdf icon[337 KB, 14 pages]external icon
- WHO SAGE: WHO SAGE Roadmap for Prioritizing Uses of COVID-19 Vaccines in the Context of Limited Supply pdf icon[394 KB, 32 pages]external icon
Learn about CDC’s vaccine recommendation process