According the Yahoo News the FDA has issued a warning to Merck & Co. due to multiple violations at their West Point, PA, manufacturing facility. They have 15 days to give the FDA a plan of action to fix the problems. The news article doesn't explain what violations there are, but the FDA website offers a little more info on what was found.
http://www.fda.gov/foi/warning_letters/s6756c.htm
"1. You failed to thoroughly investigate any unexplained discrepancy of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed and to extend the investigation to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy [21 CFR 211.192]. For example:"
"c. Not all lots of product that may have been affected by fibers being shed from [redacted] lot [redacted] were assessed. Only [redacted] lots of product, where the fibers were observed during filling, were quarantined and assessed. Approximately [redacted] lots of lyophilized product and [redacted] lots of liquid products were filled during the time of receipt and use of [redacted] lot [redacted]."
"2. You failed to establish adequate written procedures describing the handling of all written and oral complaints regarding a drug product [21 CFR 211.198]. For example, Standard Operating Procedure (SOP) 283-316, [redacted] directs that a lot history be performed. This lot history is performed for the final finish lot number, which is the packaging/labeling lot number. However, complaints such as leaking vials/syringes and various container/closure defects would be associated with a fill lot number, and a fill lot number may be associated with several final finish lot numbers."
"3. Your firm failed to assure that there are written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess"
"4. You failed to assure that equipment used in the manufacture, processing, packing and holding of a drug product is calibrated, inspected, or checked according to a written program designed to assure proper performance [21CFR 211.68(a)]. Specifically, a set of control samples representing defect types are examined by the automated inspection equipment prior to beginning each inspection process. The reject set testing allows high rates of known rejects to be accepted by the equipment. In addition, the first time non-accepts are sent back through the equipment and only those rejected a second time are discarded. "
Ok, so you get the point.... The list goes on. Seriously. There are complaints of contamination, cleanliness and sanitization, equipement leaks, etc. Keep in mind this info is directly from the FDA website!
I would seriously hope that Merck is the exception to the rule, because if the other vaccine companies are anywhere close to being like Merck I will never allow a vaccine near my family again.
http://www.fda.gov/cber/faq/merckqa.htm
"The Warning Letter covers U.S. licensed biologics manufactured by Merck at the West Point, PA facility, including but not limited to the following vaccines: Liquid PedvaxHIB®, RECOMBIVAX HB®, ProQuad®, Gardasil®, VAQTA®, and COMVAX®."
The reason I bring this up is because of a recent death reported by the FDA caused by the Rotateq vaccine.
http://www.ageofautism.com/2008/04/rotateq-causes.htmlAccording to multiple stock market websites a death by intussusception was reported by the FDA, however the only FDA verification I could find was a letter to change the labeling of the vax to include the death.
http://www.fda.gov/cber/approvltr/rotateq043008L.htmFYI - Intussusception: "Intussusception occurs when one portion of the bowel slides into the next, much like the pieces of a telescope. When this occurs, it creates an obstruction in the bowel, with the walls of the intestines pressing against one another. This, in turn, leads to swelling, inflammation, and decreased blood flow to the intestines involved."
http://www.kidshealth.org/parent/system/surgical/intussusception.htmlAccording to VAERS there are over 50 reports of intussusception due to vaccines, however you will have to check out the report yourself as I don't have a program available to open the report. If I can get the exact number, I'll update as soo an I can.
What is Rotateq for?
The Rotateq vaccine is given to prevent Rotovirus. Rotovirus is very common and is also a highly contagious stomach virus. It can be very dangerous as it can cause extreme dehydration.
The symptoms are diarrhea, vomiting and fever. The key to preventing Rotovirus from becoming life threatening is to push fluids into your child. It can be very difficult when a child is vomiting constantly, but keep pushing them and take your child to the doctor or the ER if your child is becoming very dehydrated, they can insert an IV for fluids if neccessary.
Tovah Neryse had Rotoviruse when she was about 9 months old. She threw up on me more times than I could count, but I continued to breastfeed (against a non-BF friendly Doctor's recommendation) and only gave a little tiny bit of pedialyte and when she went to a different doctor they said they were surprised at how hydrated she was considering how often she was throwing up and commended me for continuing to breastfeed saying "thats exactly what she needs!" She had a very, very bad case of the virus, even though she had been vaccinated for it, but because I kept her hydrated she got better with no serious problems.
I don't think a vaccine is neccessary for something like this as long as parents take good care of their kids and make sure they get enough fluids, even if that means a trip to the ER. It's also a good idea to keep in mind that like all vaccines, the vax does NOT guarantee that your child won't get a nasty case of the virus, or (not even including all the other problems vaccines can cause) intussusception.
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