December 31, 2016 1 Comment
In a second episode dealing with the Lies of Vaxxed published by More Truth © an old standard of the anti-vaccine lobby is subject to facts.
The lie Del Bigtree smothers his uncritical audience with is that, “there is not a safe vaccine out there” presumably because as he continues to lie, “there is not a decent safety study on any of the vaccines”.
What we learn from the video above is that there are six main stages of vaccine development is the US. Including;
- Clinical development
- Regulatory review and approval
- Quality control
During the exploratory stage scientists focus on identifying an antigen that can prevent a specific disease. Without success during this process development goes nowhere. It cannot continue. Nonetheless, the exploratory stage takes years of diligent laboratory research.
When the exploratory stage yields viable results production continues into the pre-clinical stage. Here progress with tissue or cell-culture preparation involves animal testing. This aspect of the pre-clinical stage will assess the safety, or lack thereof, of any potential vaccine. Another aspect of the pre-clinical stage is assessing the ability of the potential vaccine to stimulate an immune response.
Despite the cost and time invested by this point, the majority of potential vaccines do not satisfy the rigour of the pre-clinical stage. In these cases again development cannot continue.
The diligence of the clinical stage can be seen as a three part process.
- In the quest to ascertain safety, trial vaccines are tested on a small sample of healthy adults.
- Vaccines are tested on a sample of several hundred adults.
- Finally the clinical stage involves testing the vaccine on tens of thousands.
With vaccines being developed for children the clinical stage process continues. The age of test subjects is lowered incrementally until the target age is safely reached.
The final stages of clinical development include randomised and double blind trials. The potential vaccine is tested against a placebo. It takes from six to ten years to complete these safety tests.♣ Whilst medications in the USA are subject to the same intense testing it’s worth noting that sample populations are three times smaller than for vaccine studies.
There are six more stages overseen by the FDA for regulatory review and approval of vaccines. This involves safety inspection of manufacturing facilities♥ by the FDA and even more testing.
Safety monitoring, including phase IV trials, continues indefinitely once a vaccine has been approved. In the USA there is the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink – a nationwide set of linked databases.
I certainly recommend watching this video because it is clear that safety is the primary element in vaccine manufacture. Claims to the contrary by Del Bigtree and the Vaxxed cronies are demonstrable lies. Under present manufacturing guidelines and restrictions most potential vaccines do not reach clinical development. As is clear in this video the reason is safety.
Professional anti-vaccinationists like Bigtree, or any who promote Vaxxed in order to consciously profit from their manufactured controversy, are a malignant force in public health. As such they deserve our derision.
♣ Despite this reality, in Australia the self appointed “vaccine experts” from the anti-vaccine lobby such as Meryl Dorey, Judy Wilyman and Tasha David insist no randomised double blind trials or testing against placebo has ever been carried out.
♥ Australians may likely remember from 2010, a significant number of AEFI. Febrile seizures in children aged 6-59 months following administration of CSL’s Trivalent Influenza Vaccine. One chid was ultimately compensated. This event resulted in the FDA inspecting CSL laboratories and outlining five “objectionable conditions”. Australia’s TGA reported at length on the event, the FDA inspection and the process of TGA inspection of CSL manufacturing facilities.
Whilst this was an unwanted, unfortunate event, it is also an example of safety and quality control procedures being firmly implemented.