Merck issues mass recall of Gardasil vaccines over glass shard contaminants

By Ethan A. Huff

Nearly three-quarters of a million doses of Merck & Co.’s Gardasil vaccine for HPV and cervical cancer have been recalled following the discovery that they may be contaminated. The U.S. Centers for Disease Control and Prevention (CDC), which actively promotes the vaccine for 11- and 12-year-old boys and girls, says that the affected vaccines may contain glass shards due to a manufacturing error that resulted in the breakage of vials.

A total of 743,360 Gardasil vials from Lot J007354 are included in the recall, which Merck says were distributed between August 20, 2013 and October 9, 2013. Among these vials, as many as ten vials of the vaccine may contain the shards, although most have probably already been administered to children. Merck says that the glass particles are so small that they can actually be transferred through the vaccine needle directly into the muscle tissue.

“If a vaccine containing glass particles (tiny enough to get through a needle) is given to a patient, mild reactions routinely seen after vaccination may occur (for instance, redness or swelling at the injection site),” explains the CDC.

Vaccinated individuals who think that they may have been harmed by the tainted vaccine are encouraged to report injuries to the Vaccine Adverse Event Reporting System, also known as VAERS, which can be accessed here. Clinicians who suspect adverse events from the administration of potentially tainted Gardasil vaccines are also encouraged to report them to VAERS.

“Since the vaccines were shipped out starting in August, it is likely that some patients have already received injections potentially contaminated with broken glass shards,” reads an article by Pintas & Mullins Law Firm, which covered the recall in a recent blog posting.

Standard Gardasil ingredients a much bigger threat than glass shards

The thought of young children being injected with tiny glass shards is disturbing, however, the standard ingredients used in the manufacture of Gardasil are surely worse, as the vaccine has been linked to thousands of injuries and hundreds of deaths since it was first approved by the U.S. Food and Drug Administration (FDA) in 2006.

In addition to the proteins contained in HPV types 6, 11, 16 and 18, Gardasil vaccines are loaded with chemical adjuvants, such as amorphous aluminum hydroxyphosphate sulfate and sodium borate, an ingredient used in cockroach killer. Each Gardasil shot contains the equivalent of 225 micrograms (mcg) of aluminum, which has been linked to neurological damage, loss of limb function and other serious health problems.

“Along with the introduction of the HPV vaccines, several cases of onset or exacerbations of autoimmune diseases following the vaccine shot have been reported in the literature and pharmacovigilance databases, triggering concerns about its safety,” reads a study on Gardasil recently published in the journal Autoimmunity Reviews.

A related study published in the Journal of Experimental Therapeutics and Oncology affirmed this statement, having found that autoimmune cross-reactions from the vaccine — that is, the triggering of an immune response so strong that it actually damages natural immunity — are “almost unavoidable.” This information runs contrary to the reassurances provided by the CDC that Gardasil and its counterpart, Cervarix (GlaxoSmithKline), are completely safe.

“The rate of serious adverse events is greater than the incidence rate of cervical cancer,” admitted Dr. Diane Harper, one of the developers of the Gardasil vaccine, during a 2009 interview with ABC News.

Sources for this article include:
http://www.cdc.gov/media/releases/2013/s1220…
http://www.examiner.com
http://www.drugrecallattorneysblog.com
http://www.merck.com
http://www.sciencedirect.com.ezproxy.med.nyu…
http://sanevax.org
http://www.pop.org
http://abcnews.go.com/m/story?id=8356717
https://vaers.hhs.gov/index