June 22, 2010

FDA Proposes Dangerous Vaccine Rule Change

Because what we need is less oversight of pharma shenanigans in vaccine manufacturing? So much corruption.

From NVIC:

FDA Proposes Dangerous Vaccine Rule Change

by Barbara Loe Fisher

This past spring, the FDA took a hands-off approach to Merck's admission that DNA from a lethal pig virus is contaminating doses of RotaTeq vaccine being swallowed by millions of newborn babies. Now the agency responsible for making sure pharmaceutical products do not hurt people is proposing a Rule Change to give one staff employee the sole authority to allow "exceptions or alternatives" when drug companies want to change vaccine ingredients, such as preservatives (like thimerosal) or adjuvants (like aluminum) or the amount of residual protein and antibiotics in vaccines.

June 28 Deadline for Public Comment

The FDA's proposed change to Requirements for Constituent Materials was quietly published in The Federal Register on March 30 and the deadline for public comment is only days away - on Monday, June 28.

The FDA is arguing that the rule change is necessary to "reduce burdens on industry" and to provide "greater flexibility and reduced regulatory requirements." It gives one FDA staff Director the power to give drug companies the green light to "employ advances in science and technology as they become available" when companies want to make new vaccines really fast and get more bang for the buck.

Will There Be ANY Checks & Balances?

If the proposed Rule Change is put into effect, a vaccine manufacturer could request a change in the content or amount of vaccine ingredients by simply writing a "brief statement describing the basis for the request and supporting data" as part of the original license application or for a pending or approved application. There is no information about how much scientific evidence the drug companies will have to submit to prove the new ingredients are safe; or whether the FDA's Vaccine Advisory Committee will be able to review that evidence; or whether the American public will have a chance to comment before vaccine ingredients are changed.

This does not look like the transparency, public participation and collaboration in government that President Obama said he supports. It removes the checks and balances necessary for good government.

Could Warehoused Squalene Be Quickly Approved?

Last year when federal health officials declared a pandemic H1N1 "swine flu" national emergency, drug companies put a full court press on the FDA to fast track licensure of highly reactive oil based squalene adjuvants and the use of new technology, like insect cells, to make pandemic influenza vaccines. During meetings of the FDA's Vaccine Advisory Committee, the National Vaccine Information Center opposed both the quick licensure of squalene adjuvants, which hyperstimulate the immune system and have been associated with autoimmunity, and the use of insect cells, which could be contaminated with insect viruses. Click here to watch a video, read the entire commentary with live links to 35 references and learn how YOU can take action.


Jim Thompson said...


The speed of the revolving door between USCDC/USFDA and Pharma apparently needs to be turned up a notch-FDA vaccine Czar today, Pharma president of vaccine sales tomorrow.

AJ said...

NVIC should be supporting this change.

The language doesn't apply to the safety and effectiveness of the vaccine itself. Changing a vaccine that doesn't contain a squalene based adjuvant to one that does would be a change in safety and effectiveness.

What it will allow is what vaccination opponents should love --- no more thimerosal in vaccines, even the flu vaccine in 10 dose vial. Current regulations require a preservative in 10 dose vials. If you have a technology that allows you to attach a device to the top of a 10 dose vial and allow it to be used multiple times and still keep the vial aseptic, then you don't need thimerosal. This change allows for easy adoption of this type of technology.

I don't know if Ms. Fisher doesn't understand this or wants to keep her followers upset

WiseMama said...

Actually, to my understanding many vaxes DO contain thimerosal, but since it is only in "trace" amounts, it doesn't have to be labeled...

PERFECT, people keep living w/the false assumption that there is no mercury in vaes, so then they falsely believe vaxes don't cause autism... I mean since there is no publicly known mercury in vaxes any more (minus the flu shot & H1N1) & autism is still occurring like gang busters, there is no connection (**wink, wink**)...makes perfect sense!! Surely big pharma nor big bro would never **gulp** lie to us, right?!?!? They know what is best for us & our kids... baaaaahhh, baaaaahhhh!!

Furthermore, aluminum is at least equal to thimerosal if not more dangerous in many ways... so not only is there a "trace" amount of mercury, I mean NO mercury, but now there is yet ANOTHER neurotoxin in them, PERFECT (**sarcasm**)!!

"Changing a vaccine that doesn't contain a squalene based adjuvant to one that does would be a change in safety and effectiveness."

WHAT?!?!? Squalene is DANGEROUS!! It makes vaccines more effective?? You mean even more damaging & deadly?!?!?

What makes anybody assume that big pharma wants to make anything "safer??" I mean seriously, why would they want to use toxic-less techonology?!?!? This is NOT about using any new techonology that would make things safer or to be able to make vaxes w/out thimerosal... and even if they did have a plan for something as such, I am sure somehow it would make the vax cocktail even more deadly... it also opens up Pandora's box for all kinds of unregulated, untested (I know... as if they truly test anything using ethical means & UNbiased studies as is it is), UNsafe vaxes, drugs, etc.

I find this VERY disturbing!!

Minority said...

Sheldon has infinite faith in the goodness of the government agencies and the pharma companies when it comes to vaccines. I've run into him in other places.

It is okay Sheldon. Even if you were totally right about squalene and thimerosal in this particular case, once the oversight is loosened just about anything could be shoved into vaccines and approved by that single FDA employee. Whatever happened to checks and balances?

Ginger Taylor said...

"new technologies"????

Shouldn't you call them "random novel experimental compounds previously unknown to mankind whose long term side effects are completely unknown but will certainly be cheaper for pharma to use so they are gonna try to sneak them in and when word gets out they will try to sell them to the public by calling them 'new technology'?"

The vaccine program is a disaster. Pharma is a run away train that does not know or care what their 'new technology' is doing to children. $$$

Sales pitch fail.