FDA Report Cites 49 Safety Issues At Merck Vaccine Plant

Between November of last year and this past January, the FDA “cited 49 areas of concern, including a failure to follow good manufacturing practices” at Merck & Co. Inc’s vaccine plant in Pennsylvania. A Merck spokesman says that most of the incidents were found and reported by Merck’s own employees, and that they occurred in the manufacturing process, not the vaccines themselves: “He stressed that no contamination was found in finished vaccines and that Merck was addressing all the problems.”

The Philadelphia Inquirer used the Freedom of Information Act to obtain a 21-page FDA report, then had experts review it for feedback:

FDA inspectors spent a total of 30 days at the West Point plant between Nov. 26, 2007, and Jan. 17, 2008. The agency could go on to issue a warning letter and take other actions if its concerns are not addressed. The FDA declined repeated requests to comment.
 
The report cites cases where bulk lots of PEDVAX and ProQuad were contaminated. Unwanted “fibers” were found on the vial stoppers of MMR, the measles, mumps and rubella vaccine, among others. They were caused by “lesser quality” supplies from a vendor, the FDA report said.
 
The report noted defective vials had to be rejected twice to be discarded, and that one internal quality investigation went on for more than a year.
 
Several experts said no single finding was horrendous but that the overall pattern was troubling. “It’s the sum of many small things that puts the whole operation in question,” said consultant Wheelwright. 
“FDA report shows problems at Merck vaccine plant” [Philly.com]
(Photo: Getty)

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  1. bohemian says:

    That many violations here in PA. I saw something a while back that all the drug manufacturing plants in Puerto Rico are far worse than the ones in the main states and rarely if ever get inspected.

  2. Juggernaut says:

    “Several experts said no single finding was horrendous but that the overall pattern was troubling.”

    Wouldn’t you think that when it comes to medicine, any and every finding/incident has the potential to be horrendous?

  3. Sweet, not all the vaccine/autism cooks can come back out of the woodwork! GREAT JOB MERCK!

  4. Islandkiwi says:

    I have to go get my daughter’s 6-month shots next week, and it pisses me off that this type of thing happens. Vaccines should be prepared with the utmost care…don’t these assholes have children?!?

  5. coryj says:

    42-43 of these items were brought to the FDA by Merck along with what action was being taken to improve them well before the audit.

  6. AmbiUbi says:

    As someone who works in the pharmaceutical industry, I have to say that word is that this is not all that unusual for Merck….

    @bohemian: True. Canada also. Good Manufacturing Practices (GMP) are still very lax in other countries, the problem is that the FDA is just way too underfunded to really focus on incoming shipments from other countries and IMO, should be split into FOOD and DRUG factions instead of both being under the same umbrella.

    @Juggernaut: Maybe. Sometimes a “finding” could be something as simple as a stain on the tiled floor in a lab, or some dust on a shelf.

  7. katya0303 says:

    @ Islandkiwi: I work at Merck, I have a kid (who is getting vaccinated on schedule btw), and I’m not an asshole.

  8. Chaosium says:

    “the problem is that the FDA is just way too underfunded to really focus on incoming shipments from other countries and IMO, should be split into FOOD and DRUG factions instead of both being under the same umbrella.”

    EXACTLY.

    The same idiot political factions that complain about “big pharma” are the same variety that want to completely defund and make powerless the FDA.

  9. Islandkiwi says:

    @katya0303:
    I have a friend who’s a Merck sales rep, and I don’t think she’s an asshole either. And if you’re not one of the people screwing up, kudos to you.

    But this report along with the voluntary recall in December says to me that all is not well in the immunization industry, and don’t you think it should be?

  10. dragonfire81 says:

    The thing is most of the time the drug companies are probably paying the inspectors under the table to ignore the violations.

  11. tz says:

    This is why Vaccine producers have immunity. Legal immunity. And then why they are “forcing you” to have your infant vaccinated.

    Investigate. Learn. Make an informed decision as to which you think the benefits outweigh the risks, and there are often more than one version of a vaccine, so you don’t have to expose your infant to small doses or weakened versions of a half dozen diseases all at the same time.

    Sheep are all vaccinated. So are all sheeple.

  12. pkrieger says:

    Wow… this post has turned into a hangout for the foil hat brigade. If someone wants to actually become informed about this issue instead of spouting off tired conspiracy theories, they should read “Vaccine” by Arthur Allen (who writes for Slate.) It’s a great book and well researched.

  13. rsbryswrrl says:

    You know you really don’t “have” to get your daughter’s shots. As a parent, you are in charge of her health and wellness. I think every parent should read up on every single thing that will be going into their child’s body, especially when they are infants. You can forego all vaccinations if you like, or you can choose a “delayed vaccination schedule” whereby you stagger the vaccines so your child does not get 3 or 4 at once. There seem to be particular problems with the barrage of vaccines between 12 and 18 months. My son is 2, and he has received only the shots that I received when I was a baby (the communicable diseases, such as measles, rubella, mumps, etc.). I am not giving him the Prevnar because that one was developed to vaccinate against a rare strain of meningitis but is being marketed to protect against ear infections. He’s never had one ear infection – he doesn’t need it. Likewise he’s not getting a chicken pox shot or a rotovirus shot. It’s up to you as a parent to do some digging and take a stand for your child’s well-being. If your pediatrician doesn’t like that or somehow threatens you – find a new pediatrician. Remember that you are a consumer of healthcare just as you are a consumer of any other product.