Reports indicate that the U.S.-based agency has issued a warning to British pharmaceutical giant GlaxoSmithKline (GSK), urging the company to make some swift changes to its manufacturing process or else face further scrutiny and possible penalties.
GSK’s Ste-Foy plant is the global headquarters for manufacturing the Flulaval vaccine, a seasonal flu shot rxlist.com. This particular vaccine also contains formaldehyde and the mercury-based preservative thimerosal.
According to reports, GSK has had a lot of trouble in recent years producing uncontaminated batches of the vaccine. Just this year alone, the company has had to dump more than 20 percent of its vaccine lots due to bacterial contamination, a situation that, if we were talking about vitamin supplements, would have resulted in the company being immediately shut down and all of its products confiscated by SWAT teams.
But because we are talking about a multi-billion dollar drug company here, the only consequence so far has been a gentle slap on the wrist by the FDA. In a recent letter, the FDA warned GSK that if it did not comply with legal manufacturing requirements for safety — you know, the kind that provide at least minimal protection for the millions of elderly, pregnant women, and children that will be receiving the Flulaval vaccine later this year — then perhaps further action would be taken.
“The deficiencies described in the Form FDA 483 issued at the close of the inspection … are an indication of your quality control unit not fulfilling its responsibility to assure the identity, strength, quality and purity of your licensed biological drug product and intermediates,” chided the FDA in its letter to GSK.
Even if Flulaval ends up harming or killing children, GSK is protected from lawsuits
This all sounds nice, and gives the appearance that the FDA is taking legitimate action here. But GSK has had problems at the Flulaval plant for months. And while the company has reportedly responded to FDA warnings some three times, according to FierceVaccines, nothing substantial has been done to address the problem, which could put millions of people at risk during the upcoming flu season.
If this were any other company producing defective and potentially deadly products, you can be sure that swift action would be taken to avoid potential lawsuits. But because the vaccine industry is sheltered from litigation thanks to a corrupt Supreme Court decision that upheld the illegitimate and criminal Vaccine Act, vaccine companies like GSK have little to worry about in terms of being sued by harmed consumers.
If innocent children are poisoned to death by Flulaval, in other words, there is little their parents can do to seek justice. This is why parents need to think long and hard about the risks associated with vaccines before subjecting their children to them, especially since vaccine adverse events are often permanent — and in some cases completely debilitating, as in the case of autism spectrum disorders (ASD).
“The deck is stacked against families in vaccine court,” stated Rebecca Esteep from the Coalition for Vaccine Safety following the Supreme Court ruling that protects companies like GSK from being sued by parents.
“Government attorneys defend a government program using government-funded science before government judges. Where’s the justice in that?” she added, referring to the fraudulent kangaroo “vaccine courts” that handle injuries caused by vaccines.
Ethan A. Huff
Sources for this article include: