Wyeth Prevnar Recall: "Not for Commercial Use?"
Can someone in the know please explain what it means when a vaccine is recalled because it was "not for commercial use" as in the case of Wyeth's Prevnar? One lot was just recalled. Prevnar does not contain Thimerosal so I don't assume there's a problem there. The press release went out tonight - a Friday night. The graveyard for press releases... Read the FDA recall HERE.
Recall: Prevnar Pneumococcal 7-valent Conjugate Vaccine, Wyeth
DATE RECALL INITIATED:
July 10, 2009
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Prevnar pneumococcal 7-valent Conjugate Vaccine
(Diptheria CRM197Protein)
0.5 mL single dose pre-filled syring (10 per package)
NDC: 0005-1970-50 (10’s)/0005-1970-49 (Singles)
Lot Number: D50002
Expiration Date: February 28, 2011
MANUFACTURER:
Wyeth
Philadelphia, PA
REASON:
Wyeth is voluntarily recalling the above lot of Prevnar®, Pneumococcal 7-valent Conjugate Vaccine, single dose pre-filled syringes. During a routine physical reconciliation of Prevnar® pre-filled syringes, Wyeth determined that a portion of a bulk lot of pre-filled syringes, which was not intended for commercial use, was inadvertently packaged and distributed with commercial product under Lot D50002. The product distributed as Lot D50002 met Wyeth’s quality acceptance criteria. Although some of the units of Lot D50002 were not intended for the commercial market, Wyeth performed a medical assessment and has concluded that the affected syringes present no health or safety risk to patients and that there is no need to revaccinate.
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The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
There are lots of reasons a lot might be "not for commercial use"
Say, you had a new piece of equipment for viusal inspection installed. You might run syninges through the old machine and through the new machine to compare them. Those syringes should be labled "not for commericial use" because they should be rejected because they didn't follow the normal manufacturing procedure (the extra run).
So, the material would be fine (or the same if you will) as regular lots that get released.
Since all FDA cares about is properly labeling they'll get crucified for this. Nobody cares that you're putting in a poison as long as your label reconcillation matches, you're golden.
Posted by: Jack R. | July 20, 2009 at 04:00 PM
What bothers me most about this particular recall is that nothing I've read (including in the respected Wall Street Journal) gives any more detail than the press release. Did no reporter think to ask the question that AoA is asking: What exactly made this lot "not for commercial use"?
Posted by: Theresa | July 19, 2009 at 02:45 PM
In my opinion all vaccines need to be recalled. A must read: "Inoculations: The True Weapons of Mass Destruction" by Dr. Rebecca Carley, M.D.
www.HealthTruthRevealed.com
Posted by: Bev | July 19, 2009 at 10:11 AM
They've had "hot lots" released before which caused an inordinate amount of SIDS and injuries limited to one geographic area-- potential PR disaster. Thus the practice of breaking up the lots and distrubuting widely to avoid "clustering" of vaccine side effects which could prove origin of local epidemics of child illnesses and even establish an association between certain illnesses and vaxes. Maybe this was a "hot lot", maybe just a processing mistake. Either way, this vax is dangerous.
I've read that Prevnar is associated with food allergies. Rita Hoffman's letter has been posted here before and a copy was posted in the blog below. Several studies on Prevnar included:
http://journeytocrunchville.wordpress.com/2008/04/10/vaccines-asthma-allergies/
Excerpt:
The Int Arch Allergy Immunol 1999 Jul; 119(3):205-11 Pertussis adjuvant prolongs intestinal hypersensitivity concludes: Our findings indicate nanogram quantities of PT (pertussis toxin), when administered with a food protein, result in long-term sensitization to the antigen, and altered intestinal neuroimmune function. These data suggest that exposure to bacterial pathogens may prolong the normally transient immune responsiveness to inert food antigens. PMID 10436392
Posted by: Gatogorra | July 18, 2009 at 08:36 PM
Did anyone ever hear of a Dr named Blaylock?
I heard him on a churchy show and he was Hell on vaccines. didn't like vaccines or vaccine schedules at all. marv
Posted by: Marvin Lewis | July 18, 2009 at 12:29 PM
Bensmyson,
If it was a reference lot or validation lot with a new piece of equipment or something like that it would not be intended for sale.
Practically, it would be identical to regular lots in everyway but should not be released as it is a test lot.
There probably really isn't any safety concern about this particular lot that they are recalling.
From a manufacturing point of view it is pretty big though as it demonstrates to the FDA a "loss of control" of the facility and your product. So, that's a big-time issue, but in terms of this particular item, probably not really a problem.
Posted by: Jack | July 18, 2009 at 10:36 AM
After my son's DPT shot, he had constant ear infections, constant fevers, asthma like symptoms, bronchitis like symptoms, pneumonia for my little one every four months!!!! I began to feel that he was going to die from pneumonia. When my son turned five I took him to an allergist who was from South Vietnam. Very nice man! He suggested a vaccine! A pneumonia vaccine! I know that a vaccine got us into this mess, but I am pretty sure the pneumonia vaccine got us out of one of our major problems.
Small companies use to make vaccines. I found out that the state of Michigan had a lot of small companies making their own vaccines. The schools in Michigan are also full of children with autism too.
Something so dangerous and ruin some ones life as easy as vaccines are like nuclear weapons, needs to be in as few of hands as possible.
Posted by: Benedetta Stilwell | July 18, 2009 at 09:59 AM
What is commercial use? Wouldn't all vaccines intended for sale be for commercial use?
Posted by: bensmyson | July 18, 2009 at 09:06 AM
I think David is on the right track.
Although we have many legitimate issues with vaccine safety, MANUFACTURING regulations are quite strict. To the point of absurdity and great cost. My personal belief is that this is a great hand-waving that covers the fact no one really knows what these things will do. And also it enables people like Wyeth to price out the smaller companies that can't afford to MFG per the regulations. The Wyeth's and Sanofi's of the world actually drive tighter regulation if you can believe that, but it serves them because they can't innovate new products and have to steal them on the cheap from biotechs that can't afford MFG.
Anyway, I don't know for sure (although I'm finding out) but I doubt 13-valent is even made at the same facility. It would be at a smaller scale at this point. Most likely it was what David said. They made some small change (like replaced a piece of equipment to a newer model, or got a new vendor for a salt-even though the mfg of that would be standard) and they had to do validation runs and some of that material got released. Probably nothing smelly, just a paperwork problem.
That said, I have big issues with Prevnar and it's next generation product that starts a sort of arms race against pneumonia we're sure to lose.
Posted by: Jack | July 18, 2009 at 07:08 AM
'Improved version' got out early? Interesting thread, whatever the case. Post #23 is my favorite.
http://www.cafepharma.com/boards/showthread.php?t=378619
"Prevnar, "Acceleration of plans"
CHICAGO, June 25 (Reuters) - Drugmaker Wyeth (WYE.N) is in talks with U.S. health authorities to speed production of an improved vaccine to treat pneumococcal disease, which might help prevent pneumonia deaths in a second wave of the new H1N1 flu, a company executive said on Friday...."
Posted by: Ralph | July 18, 2009 at 03:57 AM
When the hell are people going to wake up to this criminal cabal?
Posted by: Jeffry | July 18, 2009 at 01:30 AM
Here, too, more info on the 13-valent:
http://www.wyeth.com/news?nav=display&navTo=/wyeth_html/home/news/pressreleases/2009/1238506420199.html
Posted by: Garbo | July 17, 2009 at 11:09 PM
Thanks Theresa! I checked their clinical trials here:
http://www.wyeth.com/ClinicalTrialListings?query=Pneumococcal%20Infections
Looks like they are running lots of trials on a 13-valent vaccine, with lots of exclusions for anyone that's immune suppressed. Maybe that's what it was.
Posted by: Garbo | July 17, 2009 at 11:02 PM
There are a lot of strict regulations(ahem! ahem!) when it comes to manufacturing medical devices or pharma products. The processes and procedures must be strictly followed and documented along the way. Sometimes the process needs to change for assorted reasons(new machinery, more efficient routing, etc etc). If the new process, no matter how inconsequential the change may be, was followed before all the paperwork(validations) were approved, the product is suspect and must be quarantined. My guess is that the product was ok(i know thats relative in our world) but certain procedure wasnt followed and the product must be recalled regardless. It might not just be process but it could be ingredients used as well. I could be wrong here....but thats my guess.
Posted by: David A | July 17, 2009 at 10:27 PM
Hi, Garbo,
Most of this "not intended for commercial use" lot was, indeed injected into babies. From the WSJ: "Although the company believes most of the recalled lot has already
been used, doctors who have remaining vaccine can return it." (http://online.wsj.com/article/BT-CO-20090716-718758.html?mod=dist_smartbrief)
Posted by: Theresa | July 17, 2009 at 09:59 PM
We can't be sure it is the mercury or mercury alone that causes problems with vaccines harming people. Vaccines also contain glutamate which is a neurotoxin. I have found if I avoid glutamate I can avoid the melt downs that cost me greatly socially. Our "wonderful" FDA allows glutamate to hide under 30 different names including natural flavorings which may or may not be glutamate. The supplement glutamine can turn into glutamate and that's how I found out it was part of my problem glutamine supplements lead to 4 weeks of hell for me and my caregiver. Vaccines also contain live viruses. I know folks who became autistic after the measles disease itself and the MMR vaccine seems to be a big culprit in causing the condition. A recent study that seemingly found no connection actually did if you read the whole study. Vaccines also contain aluminum and other problem stuff. It may just be the sheer number of them we give our kids too. note the sick monkeys article here.
Posted by: Elizabeth Hensley | July 17, 2009 at 08:44 PM
The way I read this, there were some experimental vaccine syringes that "accidentally" got mixed in with a lot of regular approved vaccine. They don't say what's different about them, but do say that they've been medically evaluated and re-vax is unnecessary, so the experimental syringes must also be pneumococcal. But I really think FDA should be obligated to tell the public what's different about them. Especially if they've been injected into any babies. Like, what are all the excipients in this little experiment?
Posted by: Garbo | July 17, 2009 at 08:34 PM
"which was not intended for commercial use, was inadvertently packaged and distributed with commercial product under Lot D50002. "
Not intended for commercial use but was shipped WITH commercial product.... huh? How else is commercial product to be shipped? With non-commercial product? With attractive toys that light up and whirrrrr?
Smells don't it?
Posted by: bensmyson | July 17, 2009 at 08:25 PM