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
- An Investigational New Drug application
- Pre-licensure vaccine clinical trials
- A Biologics License Application (BLA)
- Inspection of the manufacturing facility
- Presentation of findings to FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC)
- Usability testing of product labeling
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.
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.
When people set out the steps for getting a vaccine approved, and the many apparently-useful tests and trials the companies go through . . . we never see those vaccines being tested in a cumulative way, do we?
That each, as each new ( and "improved" !! ) vaccine is added to the ever-increasing list of vaccines -- why isn't it tested AS ADDED to the others?
Clinical trials for vaccines only test that particular one, right? Maybe if a child ( or anyone ) did receive just that single vaccine, maybe it would be safe. Who knows?
But adding on layer after layer, until there are 37 . . . and counting . . . on the list. That's a whole different ball game.
Posted by: Nonnymouse | February 21, 2019 at 07:15 PM
It is easy to force all adults and kids on a Federal Level to get Vaccinated because about half the population is Already Re-Vaccinated-from janitors and bill collectors at hospitals, nurses, doctors, preschool teachers, all military people, medical students and nursing students, nursing home staff, kids, and many others. I heard that in Argentina you can't get a drivers license or a passport without vaccines. The push to mandate children's vaccines in order to be allowed to go to school was never really about their health which as a result has morbidly declined, it was about getting to the Adult population and profits. It is especially important to vaccine maker's to do this now because many younger people have become sterile and others simply are choosing 0-1 children. Many girls lost their periods and their ovaries have dried up from HPV vaccines for starters. The only way to increase the shareholders profits is for Gottlieb or whoever is in charge to take away peoples' right to chose what goes in their bodies. They will use them like pawns while weeding out older Americans as they die from those vaccines like pneumonia shots and others especially made for folks over 65.
Posted by: Shelley Tzorfas | February 21, 2019 at 12:52 PM
Wobblies
Indeed, see my letter to the Chief Medical Officer to the British Government, particularly the latter part dealing in detail with the rise in ASD since 1988.
https://www.ageofautism.com/2019/01/confirmation-bias-and-the-united-kingdom-department-of-health.html
Posted by: John Stone | February 21, 2019 at 10:24 AM
Take note Washington state, the Kindergarten class in California following SB277 (summer 2015).
Year/Year increase in Autism:
2013, 7%
2014, 7%
2015, 9%
2016, 12%
The 2016 class had 8,281 cases of autism, 1,176 more than the previous year.
That's just kindergarten. The fake measles crisis pales in comparison and surely Dr. Gottlieb doesn't care.
https://dq.cde.ca.gov/dataquest/dataquest.asp
Posted by: Wobblies | February 21, 2019 at 10:13 AM
Exactly Bob its as if they have a bunker room somewhere or many ,tasked with PROJECT FEAR to target an individual a group a country anybody,It can be used many times over for controlling not all populations but the sheeple within which I must admit I was one,once upon a time..Baaaa!!!
Pharma For Prison
MMR RIP
Posted by: Angus Files | February 21, 2019 at 07:26 AM
Scott Gottlieb, MD in his appointment hearing:
“no causal link between vaccination and autism.”
note COI prior confirmation:
"Dr. Gottlieb serves on the board of directors of pharmaceutical companies Tolero Pharmaceuticals and Daiichi Sankyo and is on the investment board of GlaxoSmithKline (GSK). He reportedly received $413,000 during 2013-2015 in consulting and speaking fees from these firms."
and he won't settle for kids mandates:
"...Gottlieb has expressed support for strict enforcement of state mandatory vaccination laws, recommending that state vaccine exemptions, which allow people to opt out of federally recommended vaccines, should be reviewed and tightened. He also has expressed the opinion that adults may need to be required to get booster doses of MMR vaccine to prevent measles outbreaks."
https://thevaccinereaction.org/2017/04/fda-nominee-scott-gottlieb-rejects-links-between-vaccination-and-autism/
Posted by: greyone | February 21, 2019 at 07:19 AM
We have seen this "scaremongering" tactic many times before .. such as .. prior to invading Iraq we were told Saddam had vast storage of "weapons of mass destruction" and the possibility he would unleash a "mushroom cloud over Times Square" was very real. Panicked by the knowledge of Saddam's wmd .. of which we are assured existed and had the satellite photos to prove their existence .. we launched that vaunted "shock and awe" .. a "preemptive strike .. to effect a "regime change" in Iraq .. supposedly to "spread democracy" throughout the middle east.
It has been 17-18 years or so since we invaded Iraq .. no wmd were ever found .. yet our troops are still deployed in that country .. as well as in Afghanistan .. another country our troops remain deployed .. at the costs of TRILLIONS of dollars as well as thousands killed, injured and displaced.
It's probably just silly ole me .. but .. the "scare-mongering" over measles closely resembles what happened with Iraq's wmd .. and .. the consequences bode dire for our country should we once again fall victim to the "scare-mongers".
Posted by: Bob Moffit | February 21, 2019 at 06:35 AM