National Vaccine Program Office

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The National Vaccine Program Office (NVPO) is an office of the United States Department of Health and Human Services that plays a role in the coordination of vaccine policy. [1]

United States Department of Health and Human Services department of the US federal government

The United States Department of Health & Human Services (HHS), also known as the Health Department, is a cabinet-level department of the U.S. federal government with the goal of protecting the health of all Americans and providing essential human services. Its motto is "Improving the health, safety, and well-being of America". Before the separate federal Department of Education was created in 1979, it was called the Department of Health, Education, and Welfare (HEW).

Vaccine biological preparatory medicine that improves immunity to a particular disease

A vaccine is a biological preparation that provides active acquired immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins. The agent stimulates the body's immune system to recognize the agent as a threat, destroy it, and to further recognize and destroy any of the microorganisms associated with that agent that it may encounter in the future. Vaccines can be prophylactic, or therapeutic.

It was established by the National Childhood Vaccine Injury Act.

The National Childhood Vaccine Injury Act (NCVIA) of 1986 was signed into law by United States President Ronald Reagan as part of a larger health bill on Nov 14, 1986. NCVIA's purpose was to eliminate the potential financial liability of vaccine manufacturers due to vaccine injury claims in order to ensure a stable market supply of vaccines, and to provide cost-effective arbitration for vaccine injury claims. Under the NCVIA, the National Vaccine Injury Compensation Program (NVICP) was created to provide a federal no-fault system for compensating vaccine-related injuries or death by establishing a claim procedure involving the United States Court of Federal Claims and special masters.

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United States Public Health Service division of the U.S. Department of Health and Human Services concerned with public health

The United States Public Health Service (USPHS) is a division of the Department of Health and Human Services concerned with public health. It contains eight out of the department's eleven operating divisions. The Assistant Secretary for Health (ASH) oversees the PHS. The Public Health Service Commissioned Corps (PHSCC) is the federal uniformed service of the USPHS, and is one of the seven uniformed services of the United States.

The Strategic National Stockpile (SNS) is the United States' national repository of antibiotics, vaccines, chemical antidotes, antitoxins, and other critical medical supplies. When state, local, tribal, and territorial responders request federal assistance to support their response efforts, the stockpile ensures that the right medicines and supplies get to those who need them most during an emergency. Organized for scalable response to a variety of public health threats, this repository contains enough supplies to respond to multiple large-scale emergencies simultaneously. The Office of the Assistant Secretary for Preparedness and Response (ASPR) of the Department of Health and Human Services, has managed the Strategic National Stockpile since October 1, 2018. Prior to that, the Stockpile was managed by the Centers for Disease Control and Prevention (CDC).

National Institute of Allergy and Infectious Diseases institute of the National Institutes of Heath which conducts basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases

The National Institute of Allergy and Infectious Diseases (NIAID) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

A health department or health ministry is a part of government which focuses on issues related to the general health of the citizenry. Subnational entities, such as states, counties and cities, often also operate a health department of their own. Health departments perform food inspections and other health related inspections, vaccination programs, free STD and HIV tests, tobacco enforcement and cessation programs, and other medical assistance programs. Health departments also compile statistics about health issues of their area.The role of a health department may vary from one country to the other, but their primary objective is always the same; safeguarding and promoting health. In 1986, several of the world's national health departments met to establish an international guideline by which health departments operate. The meeting was in Ottawa, Ontario, Canada, and hence the guidelines established are known as the Ottawa Charter. The Ottawa Charter was designed to 'achieve Health for All'.

Donald Henderson American physician

Donald Ainslie Henderson was an American medical doctor, educator, and epidemiologist who directed a 10-year international effort (1967–1977) that eradicated smallpox throughout the world and launched international childhood vaccination programs. From 1977 to 1990, he was Dean of the Johns Hopkins School of Public Health. Later, he played a leading role in instigating national programs for public health preparedness and response following biological attacks and national disasters. At the time of his death, he was Professor and Dean Emeritus of the Johns Hopkins Bloomberg School of Public Health, and Professor of Medicine and Public Health at the University of Pittsburgh, as well as Distinguished Scholar at the UPMC Center for Health Security.

The Office of the Assistant Secretary for Health (OASH) is an operating agency of the United States Department of Health and Human Services and the managing personnel body for the United States Public Health Service. The office is under the direction of the Assistant Secretary for Health, who serves as the senior uniformed advisor on public health and science issues to the Department Secretary. The Office serves as the focal point for leadership and coordination across the Department in public health and science, provides direction to program offices within OASH, and provides advice and counsel on public health and science issues to the Secretary.

The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a postmarketing surveillance program, collecting information about adverse events that occur after administration of vaccines to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular vaccine.

Stewart Simonson was the first Assistant Secretary for Public Health Emergency Preparedness at the U.S. Department of Health and Human Services (HHS). He assumed office on April 28, 2004. He told the president in a resignation letter dated May 13, 2006 that he had accomplished what he had set out to do, and it was time to pursue other opportunities. Simonson joined HHS in August 2001 and was instrumental in building the HHS preparedness and response organization that grew out of the September 11th attacks.

United States Office of Research Integrity

The Office of Research Integrity (ORI) is a U.S. government agency that focuses on research integrity, especially in health. It was created when the Office of Scientific Integrity (OSI) in the National Institutes of Health (NIH) and the Office of Scientific Integrity Review (OSIR) in the Office of the Assistant Secretary for Health merged in May 1992. The Office of Research Integrity oversees and directs Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and Human Services with the exception of the regulatory research integrity activities of the Food and Drug Administration.

The Public Readiness and Emergency Preparedness Act (PREPA), passed by the United States Congress and signed into law by President of the United States George W. Bush in December, 2005, is a controversial tort liability shield intended to protect vaccine manufacturers from financial risk in the event of a declared public health emergency. The act specifically affords to drug makers immunity from potential financial liability for clinical trials of avian influenza vaccine at the discretion of the Executive branch of government. PREPA strengthens and consolidates the oversight of litigation against pharmaceutical companies under the purview of the secretary of Health and Human Services (HHS). PREPA provides $3.8 billion for pandemic influenza preparedness to protect public health in the case of a pandemic disease outbreak.

Influenza research

Influenza research involves investigating molecular virology, pathogenesis, host immune responses, genomics, and epidemiology regarding influenza. The main goal of research is to develop influenza countermeasures such as vaccines, therapies and diagnostic tools.

The National Center for Immunization and Respiratory Diseases (NCIRD), formerly known as the National Immunization Program until April 2006, is charged with responsibility for the planning, coordination, and conduct of immunization activities in the United States. NCIRD is a part of the Centers for Disease Control and Prevention, located in Atlanta, Georgia, and housed in the CDC’s Coordinating Center for Infectious Diseases (CCID). The National Center for Immunization provides consultation, training, statistical, promotional, educational, epidemiological, and technical services to assist state and local health departments across the US in planning, developing, contracting and implementing immunization programs.

Project Bioshield Act

The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack. This was a ten-year program to acquire medical countermeasures to biological, chemical, radiological, and nuclear agents for civilian use. A key element of the Act was to allow stockpiling and distribution of vaccines which had not been tested for safety or efficacy in humans, due to ethical concerns. Efficacy of such agents cannot be directly tested in humans without also exposing humans to the chemical, biological, or radioactive threat being treated, so testing follows the FDA Animal Rule for pivotal animal efficacy.

The Biomedical Advanced Research and Development Authority (BARDA) is a U.S. Department of Health and Human Services office responsible for procurement and development of countermeasures principally against bioterrorism, but also including chemical, nuclear and radiological threats as well as pandemic influenza and emerging diseases. BARDA reports to the Office of the Assistant Secretary for Preparedness and Response and manages Project BioShield. BARDA also procures materials, such as vaccines, for the Strategic National Stockpile, and more broadly is an established interface between the U.S. Government and the biomedical industry. BARDA also manages the governmental inter-agency Public Health Emergency Medical Countermeasures Enterprise, providing coordination across the government in development and deployment of such countermeasures.

Office of Inspector General, U.S. Department of Health and Human Services

The Office of Inspector General (OIG) for the United States Department of Health and Human Services (HHS) is charged with identifying and combating waste, fraud, and abuse in the HHS’s more than 300 programs, including Medicare and programs conducted by agencies within HHS, such as the Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health. Since 2004, Daniel R. Levinson has served as HHS’s Inspector General, a presidentially appointed, nonpartisan position.

H5N1 vaccine

A H5N1 vaccine is an influenza vaccine intended to provide immunization to influenza A virus subtype H5N1.

First Responder Anthrax Preparedness Act

The First Responder Anthrax Preparedness Act is a law introduced in the United States Senate by U.S. Senator Kelly Ayotte. The law will set up a pilot program that provides anthrax vaccines from the U.S. Strategic National Stockpile to first responders, the Department of Homeland Security (DHS) would create a tracking system for those who receive the vaccine, and the government would prioritize vaccines close to the end of their labeled dates. The Congressional Budget Office estimated that implementing the law would cost about $4 million over the 2016-2020 period.

A speculated link between vaccines and SIDS has been refuted, but remains a common anti-vaccine trope. The claim - attributed to Robert Mendelsohn in 1991 and promoted by anti-vaccination activists such as Viera Scheibner in the early 1990s - is that vaccines, especially the DTP vaccine that protects against diphtheria, tetanus and pertussis, cause sudden infant death syndrome. The World Health Organization has classified this as a "common misconception".

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