FDA Approved Gardasil Without Safety Testing: Proof in FDA Document

Posted on Gaia Health

Would you willingly use a pharmaceutical product or subject your child to one if it hasn’t been safety tested?

If you’ve had the Gardasil vaccine or have allowed your daughter, and now your son, to be injected, that’s precisely what has happened. The proof has been hidden in plain sight on the FDA’s website since 2006.

The Food and Drug Administration’s (FDA’s) approval letter went out with statements saying that both short and long term studies were to be done. Approval was immediate, not predicated on the results of those studies.

From the approval letter sent to Merck in 2006:

You have committed to conduct a short-term safety surveillance study in a U.S. Managed Care Organization (MCO). The study will include approximately 44,000 vaccinated subjects who will be followed for 60 days for assessment of general short-term safety (i.e., emergency room visits, hospitalizations, and deaths). The subjects will also be followed for 6 months subsequent to vaccination for new autoimmune disorders, rheumatologic conditions, or thyroiditis. … The final study report will be submitted by September 30, 2009.

That references a single study that was to be performed in the United States for a short term 60 day assessment and another short term 6 month assessment.

Failure to Produce the Required Study

It’s now nearly 2½ years after the date that study was supposed to be submitted to the FDA. I searched the FDA’s database for a reference to it … any reference to it. The search terms used were “merck gardasil safety assessment”. I also tried to find a reference in the journal literature.

All that exists on the FDA site is information based on the sorely inadequate VAERS (Vaccine Adverse Event Reporting System) data, where it’s estimated that less than 10% of all adverse events are reported.

Read the entire article here.