COVID-19 News: Scientific, regulatory oversight of vaccine, Guidance on vaccine development, Guidance on manufacturing, Food-Cosmetics information center, Multilingual resources
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