Manufacturers test the vaccines they make

Phase 4 is an ongoing study that looks at the vaccine’s safety and effectiveness over a longer period of time. This phase includes several thousand volunteers. The benefits of receiving the vaccine outweigh any risksĪpproved vaccines can go through more testingĪfter FDA approves a new vaccine for use, it may move to a fourth clinical trial phase, called Phase 4.The Rural Health Clinic COVID-19 Vaccine Distribution (RHCVD) Program distributes doses directly to Rural Health Clinics in medically-underserved rural communities.If a vaccine is successful in all three phases of clinical trials, FDA reviews all the gathered research data to consider approving it for use in people.Over 91% of these health center patients are individuals or families living at or below 200% of the Federal Poverty Guidelines. The program is open to more than 1,400 health centers nationwide. The Health Center COVID-19 Vaccine Program allocates doses directly to community-based health centers who sign up to receive and administer COVID-19 vaccines.The Federal Retail Pharmacy Program sent doses to 21 pharmacy partners with over 40,000 activated stores, 40% of which are located in high-risk zip codes.To ensure the equitable distribution of COVID-19 vaccines, the federal government stood up programs to reach high-risk communities directly and quickly. View a list of tribal health programs and UIOs receiving vaccines from IHS.To better understand the needs of American Indian and Alaska Native, HHS initiated tribal consultation in September 2020 to seek input from tribal leaders on COVID-19 vaccination planning for Indian Country. Tribal health programs and Urban Indian Organizations (UIOs) decided to receive vaccines either through the Indian Health Service (IHS) or through the State. Vaccinations in the United States began on December 14, 2020. Find more resources to promote vaccine confidence.ĭuring the COVID-19 pandemic, each state, tribe, and territory received allocations of vaccines and developed its own plan for distributing the vaccine to people in their jurisdiction.

Read about common myths and learn the facts.If you want to do more to build vaccine confidence in your community, join the COVID-19 Community Corps, a nationwide, grassroots network of local voices and trusted community leaders. We are working to meet people where they are and help them understand that vaccines are safe, effective, and the best way to combat COVID-19. Some people have questions before they get vaccinated. The FDA's Center for Drug Evaluation and Research conducts an analysis of the benefits and risks to ensure the vaccine meets the FDA's standards for approval. When the FDA approves a vaccine, it must undergo the agency's standard approval process for reviewing the quality, safety and effectiveness.

CDC RecommendationĪfter the FDA authorizes the emergency use of a vaccine, an independent panel of medical and health experts called the Advisory Committee on Immunization Practices (ACIP) provides recommendations and guidance to the Director of the Centers for Disease Control and Prevention (CDC) regarding the use of the vaccine. The FDA determines that these vaccines are safe and effective for public use. The FDA then issues Emergency Use Authorizations (EUAs) for certain vaccines that meet rigorous, science-based standards. The Food and Drug Administration (FDA) reviews and evaluates COVID-19 vaccines for quality, safety, and effectiveness. When the COVID-19 pandemic began, researchers were able to come up with vaccines for this new virus much faster because of work that was already happening. Years before the COVID-19 pandemic, scientists were already studying coronaviruses to find out how to protect against them. The federal government has been working since the pandemic started to develop, manufacture, and distribute safe and effective COVID-19 vaccines. COVID-19 Vaccine Development and Authorization

Infographic on vaccines