COVID-19 vaccine development: Clinical information

Clinical guidance

Find clinical vaccine guidance from the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and other health organizations. 

FDA

• Vaccines and Related Biological Products Advisory Committee
• FDA information on COVID-19 Vaccines

CDC

• Myocarditis and Pericarditis Following mRNA COVID-19 Vaccination
• Clinical Considerations: Myocarditis and Pericarditis after Receipt of mRNA COVID-19 Vaccines Among Adolescents and Young Adults
• Advisory Committee on Immunization Practices
• Healthcare Professionals: Preparing for COVID-19 Vaccination
• COVID-19 Vaccination Communication Toolkit For Medical Centers, Clinics, and Clinicians

Janssen/J&J COVID-19 vaccine

• FDA: The FDA has issued an EUA to permit the emergency use of the Janssen COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years of age and older.
• FDA: The FDA has issued an amended EUA with warnings and precautions for Thrombosis with Thrombocytopenia.
• FDA: Fact Sheet for Healthcare Providers Administering the Janssen COVID-19 Vaccine
• CDC HAN: Cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after Receipt of the Johnson & Johnson COVID-19 Vaccine (includes recommendations for clinicians)
• American Society of Hematology Guidance: Thrombosis with Thrombocytopenia Syndrome (also termed Vaccine-induced Thrombotic Thrombocytopenia)
• CDC Morbidity and Mortality Weekly Report: Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients—United States, April 2021

Pfizer-BioNTech COVID-19 vaccine

• FDA: The FDA has issued an Emergency Use Authorization (EUA) to permit the emergency use of the Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 16 years of age and older.
• FDA: Fact Sheet for Healthcare Providers Administering the Pfizer-BioNTech COVID-19 Vaccine
• CDC Morbidity and Mortality Weekly Report: The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine—United States, December 2020
• CDC: What Clinicians Need to Know About the Pfizer-BioNTech COVID-19 Vaccine

Moderna COVID-19 vaccine

• FDA: The FDA has issued an EUA to permit the emergency use of the Moderna COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years of age and older.
• FDA: Fact Sheet for Healthcare Providers Administering the Moderna COVID-19 Vaccine
• CDC Morbidity and Mortality Weekly Report: The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Moderna COVID-19 Vaccine—United States, December 2020

Additional resources

AMA COVID-19 resource center

AMA EdHub: COVID-19 Vaccines

Health equity in a pandemic