Trouble at Merck vaccine plant

[leerypolyp]

More problems at the Merck vaccine plant in eastern PA.

Remember, this is the place that was spilling cyanide into the Wissahickon Creek not too long ago...

[runes]

here is the letter from the fda to merck, which begins like this:

During the inspection, the FDA investigators documented significant deviations from current good manufacturing practice (CGMP) in the manufacture of licensed biological vaccine products, bulk drug substances, and drug components. These products include Liquid PedvaxHIB®, RECOMBIVAX HB®, ProQuad®, Gardasil®, VAQTA®, and COMVAX®.

and includes numerous points like this:

You failed to quarantine numerous process intermediates associated with the use of [redacted] filter membranes that were identified to cause foaming during filtration. This foaming was found to be associated with leaching of [redacted] into process intermediates. These process intermediates were used to further manufacture MMR®II, PedvaxHIB®, VAQTA®, VARIVAX® product lots.

redacted means that the word was edited out.

where is the "crap is hitting the fan" smiley?

[mommathea]

You know, it is almost every day that I thank God that we stoped vaxing out kids.

[pantufla]

The warning letter comes as the number of such FDA enforcement actions has dropped dramatically, from 1,154 in 2000 to 538 in 2006, according to the agency's Web site.

Merck's Montgomery County plant has been under pressure. Its vaccine products are much in demand. The company's vaccine sales surged from $1.1 billion in 2005 to $4.3 billion in 2007, even as production problems have been cropping up.

Interesting.

[leerypolyp]

Oh my god, the [redacted] stuff!

Eek.

[maxwill129]

Thanks for posting this. My anti-vax DH has lately been telling people we're not stopping vaccinations, but delaying them. Can't wait to show this to him!

[ameliasward]

"She reiterated that most of the production problems cited by the FDA were caught by Merck staff and that no contaminated vaccines were released to the public. The company stands behind the quality of its vaccines, she said."

...except that as I understand it they really aren't held responsible for their vaccines (the Vaccine Injury compensation program that WE pay for with tax dollars).

[leerypolyp]

Originally Posted by ameliasward

"She reiterated that most of the production problems cited by the FDA were caught by Merck staff and that no contaminated vaccines were released to the public. The company stands behind the quality of its vaccines, she said."

...except that as I understand it they really aren't held responsible for their vaccines (the Vaccine Injury compensation program that WE pay for with tax dollars).

Yeah, and how many issues would even be identified as having anything to do with contaminated vaccines? Who would know?

[APMomOfKimmyN-Maya]

Why are there words edited out?

[diamond lil]

I break out in a cold sweat when I read stuff like this. I am so glad my baby chicklet will not be getting that poison....

[eswh1987]

Scary stuff here! All my four kids have never been vaccinated and they are just fine. They've had chickenpox, mumps, rubella, whooping cough and for the most part were barely sick. I hate the scare tactics that the medical establishment uses to get everyone to immunize their kids. When I read letters like this, I know I've made the right decision!

[SoCaliMommy]

Wow how scary

[TanyaS]

Originally Posted by APMomOfKimmyN-Maya

Why are there words edited out?

So people don't get too frightened of vaccines.