Note: The American FDA is responsible for regulating vaccine production and production safety through the division devoted to Vaccines, Blood and Biologics
. From the CDC Website
The U.S. Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER) is responsible for regulating vaccines in the United States.
The sponsor of a new vaccine product follows a multi-step approval process, which typically includes
After approving a vaccine, FDA continues to oversee its production to ensure continuing safety. Monitoring of the vaccine and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the vaccine product.
FDA can require a manufacturer submit the results of their own tests for potency, safety, and purity for each vaccine lot. FDA can require each manufacturer submit samples of each vaccine lot for testing.
Warning on the front page of the FDA site
We have an epidemic of opioid abuse in the USA and the the watchdog FDA just approved a "super Opioid" drug for 2019. If you look at the FDA site, they warn against -- please hide your children - the use of COCONUT OIL and other non-pharmaceutical products. The teething warnings particularly amused me - the Hylands Homeopathic teething tablets and the earache tables were LIFE SAVERS for all three of my daughters when they were infants.
"False Promises" Was the Name of Paul Offit's Book Against Autism Treatments
CNN and other news outlets are reporting that the FDA says the federal government may have to overstep states rights in the vaccine exemptions debate. And yet states from coast to coast are working on legislation to remove exemption rights. Measles outbreaks are the usual trigger in this shoot out. Measles in poverty stricken nations where malnutrition is rampant is deadly. Measles in the United States is treatable. Before the vaccine became widely available, measles was sitcom and pop music fodder from The Flintstones to Frank Sinatra. Fear creates the ability to steal liberty. Fear creates product demand.
The head of the US Food and Drug Administration says that if states don't require more schoolchildren to get vaccinated, the federal government might have to step in.
Nearly all states allow children to attend school even if their parents opt out of vaccines. These vaccine exemptions are especially popular in Washington state, where a measles outbreak started last month that has now sickened at least 67 people in four states. And New York has been working to contain its largest outbreak in decades, which began in October and has sickened more than 200 people.
"Some states are engaging in such wide exemptions that they're creating the opportunity for outbreaks on a scale that is going to have national implications," FDA Commissioner Dr. Scott Gottlieb said Tuesday in an interview with CNN.