FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health

Committed to making decisions guided by science and data regarding the authorization or approval of COVID-19 vaccines. Guidance on Development and Licensure of Vaccines to Prevent COVID-19 (see below), additional guidance on EUA

Importance of diversity in clinical trial participants. FDA strongly encourages enrollment of all people – including racial and ethnic minorities, older adults, pregnant women and women of childbearing age and, as appropriate, children

FDA’s career scientists and physicians facilitating development and evaluation of safe and effective vaccines. Expertise in clinical trial design and analysis, adequacy of manufacturing and facilities for producing high-quality vaccines, and post-marketing safety surveillance

Importance of being as transparent as possible.  Public meeting of Vaccines and Related Biological Products Advisory Committee on October 22


GUIDANCE: Development and Licensure of Vaccines to Prevent COVID-19

Overview of key considerations to satisfy regulatory requirements per IND regulations and licensing regulations for chemistry, manufacturing, and controls (CMC), nonclinical and clinical data through development and licensure, and for post-licensure safety evaluation

CMC : General Considerations, Manufacture, Facilities, Inspections

Nonclinical data: Toxicity Studies, Immune Response characterization, Potential for Vaccine-associated Enhanced Respiratory Disease

Clinical trials: Populations, Design, Efficacy Considerations, Statistical Considerations, Safety Considerations

Either laboratory-confirmed COVID-19 or laboratory-confirmed SARS-CoV-2 infection is an acceptable primary endpoint

Primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50%

Post-licensure safety evaluation: Pharmacovigilance, Reqd post-marketing safety studies

Diagnostic and serological assays

Additional considerations: Vaccine effectiveness, EUA


GUIDANCE: Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency

Guidance for manufacturers as they transition from operations impacted by the public health emergency to normal manufacturing operations. Recommendations include:

  • Addressing deviations from established cGMP activities
  • Risk Management and other important elements of a plan to resume normal drug manufacturing
  • Prioritizing activities to resume normal drug manufacturing


Food and Cosmetics Information Center (FCIC) Answers Your Questions

FCIC provides information and answers questions related to nutrition, safety, labeling of food, dietary supplements and cosmetics. Pandemic related, Complaints, Safety and Labeling, Expert advice


Multilingual COVID-19 Resources

CDC COVID-19 Communication Toolkit: For Migrants, Refugees, and Other Limited-English-Proficient Populations in various languages

Image credit: FDA