Principles of Vaccine Licensure, Approval, and Recommendations for Use

Abstract

The licensure and recommendation processes for vaccines are complex. In the United States, vaccines are licensed for the civilian and military populations on the basis of review of Biologics License Applications submitted to the Food and Drug Administration (FDA) by vaccine manufacturers. For FDA-licensed vaccines, the product label includes indications, contraindications, and precautions for each vaccine. Package inserts do not include recommendations for vaccine use from the Advisory Committee on Immunization Practices (ACIP). The ACIP is chartered as a federal advisory committee to provide expert external advice and guidance to the director of the Centers for Disease Control and Prevention on the use of vaccines and related agents for control of vaccine preventable diseases in the civilian and military populations of the United States. As an external advisory committee to the Centers for Disease Control and Prevention, the ACIP has no regulatory authority but the committee does have responsibility for approving vaccines to be covered under the Vaccines for Children program. To implement ACIP vaccine recommendations in the public and private sectors, a collaboration of federal, state, and local governments as well as private organizations dealing with public health, vaccine supply, vaccine administration, vaccine finance, outcomes monitoring, public perception, and public trust and support must work together. Issues including vaccine misinformation, declining community immunity (herd protection), and need for risk communication add stress to this complex and fragile system. This study describes the functions of and interactions between FDA and ACIP.

COVID-19 pandemics Stage II – Energy and environmental impacts of vaccination

“… Both energy- and time-related results can be evaluated. Vaccine approval and licences Endorsement of the biological product [ 36 ] All manufacturing methodologies and analytical methods have been approved. Examination of the facility and quality Specifications the development and application of vaccines Post trademark licence monitoring A post-registration audit Ensure no violation or other problems occur.…”

Vaccine Development: Steps to Approval of an Investigational Vaccine

“…Once licensed by the FDA, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) provides advice as to how a vaccine is to be used in the civilian US population [10]. The committee advises the CDC on population groups and/or circumstances in which a vaccine is indicated in addition to making recommendations on contraindications and precautions for use of the vaccine.…”