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Submission: On October 10 via api from US — Scanned from DE
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* Skip to main content * Skip to FDA Search * Skip to in this section menu * Skip to footer links An official website of the United States government Here’s how you know The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. U.S. FOOD AND DRUG ADMINISTRATION * Search * Menu Search FDA Submit search FEATURED * Contact FDA * FDA Guidance Documents * Recalls, Market Withdrawals and Safety Alerts * Press Announcements * Warning Letters * Advisory Committees * En Español PRODUCTS * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood, and Biologics * Animal and Veterinary * Cosmetics * Tobacco Products TOPICS * About FDA * Combination Products * Regulatory Information * Safety * Emergency Preparedness * International Programs * News and Events * Training and Continuing Education * Inspections and Compliance * Science and Research INFORMATION FOR * Consumers * Patients * Industry * Health Professionals * Federal, State and Local Officials In this section: Vaccines, Blood & Biologics * Vaccines * Emergency Use Authorization for Vaccines Explained * Approved Vaccine Products * Questions about Vaccines 1. Home 2. Vaccines, Blood & Biologics 3. Vaccines 1. Vaccines, Blood & Biologics VACCINES Subscribe to Email Updates * Share * Tweet * Linkedin * Email * Print Image Vaccines, as with all products regulated by FDA, undergo a rigorous review of laboratory and clinical data to ensure the safety, efficacy, purity and potency of these products. Vaccines approved for marketing may also be required to undergo additional studies to further evaluate the vaccine and often to address specific questions about the vaccine's safety, effectiveness or possible side effects. According to the Centers for Disease Control and Prevention, vaccines have reduced preventable infectious diseases to an all-time low and now few people experience the devastating effects of measles, pertussis and other illnesses. The Center for Biologics Evaluation and Research (CBER) regulates vaccine products. Many of these are childhood vaccines that have contributed to a significant reduction of vaccine-preventable diseases. VACCINE INFORMATION * Emergency Use Authorization for Vaccines Explained * Biologics License Applications (BLA) Process (CBER) * CDC National Immunization Program * Questions about Vaccines * Vaccines and Related Biological Products Advisory Committee * Vaccine and Related Biological Product Guidances * Vaccines Licensed for Use in the United States * Vaccine Notices, Proposed and Final Rules VACCINE SAFETY & AVAILABILITY * Common Ingredients in U.S. Licensed Vaccines * Vaccine Adverse Events * Vaccine Safety & Availability * Influenza Virus Vaccine Safety & Availability * Vaccine Safety Questions and Answers * Recommendations for the Use of Vaccines Manufactured with Bovine-Derived Materials * Thimerosal in Vaccines * MMWR - Guillain-Barre Syndrome Among Recipients of Menactra Meningococcal Conjugate Vaccine * Vaccines for Use During Pregnancy to Protect Young Infants from Disease - FDA Update MEDICAL COUNTERMEASURES * Anthrax * Smallpox * Key Facts About Vaccines to Prevent Monkeypox Disease PANDEMIC * Update: COVID-19 Vaccine Booster Composition * Memorandum Re: Fall 2022 COVID-19 Vaccine Strain Composition Selection Recommendation * Pandemic Influenza Information SEASONAL INFORMATION * Is It a Cold or the Flu? Prevention, Symptoms, Treatments * Influenza Virus Vaccine Safety & Availability -------------------------------------------------------------------------------- RELATED INFORMATION * Vaccines and Related Biological Products Advisory Committee * Vaccine and Related Biological Product Guidances * Vaccine Notices, Proposed and Final Rules * Vaccines Research Sub-Topic Paragraphs FOLLOW CBER Division of Communication and Consumer Affairs Office of Communication, Outreach and Development Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave WO71-3103 Silver Spring, MD 20993-0002 ocod@fda.hhs.gov (800) 835-4709 (240) 402-8010 For Updates on Twitter, follow @fdacberExternal Link Disclaimer * Resources for You (Biologics) * About the Center for Biologics Evaluation and Research (CBER) * Report a Problem to the Center for Biologics Evaluation & Research * Recalls (Biologics) * CBER-Regulated Products: Shortages and Discontinuations * Biologics Products & Establishments CONTENT CURRENT AS OF: 08/18/2022 * REGULATED PRODUCT(S) * Biologics * Vaccines * Vaccines * Emergency Use Authorization for Vaccines Explained * Approved Vaccine Products * Questions about Vaccines SUBSCRIBE FOR CBER UPDATES Get e-mail updates on What’s New at CBER! Enter your email address to subscribe: FOOTER LINKS * FDA Archive * About FDA * Accessibility * Visitor Information * Website Policies / Privacy * No FEAR Act * Vulnerability Disclosure Policy * FOIA * HHS.gov * USA.gov Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds FDA Homepage Contact Number 1-888-INFO-FDA (1-888-463-6332) Back to Top