Merck Vaccine Recall
Thursday, December 13, 2007
Merck Recalls 1.2 Million Doses of HIB and HIB/Hep B Vaccines Due to Possible Contamination
This week Merck announced a recall of over a million doses of their PedVaxHIB brand of HIB vaccine that protects against a now rare form of infant meningitis as well as their ComVax brand of HIB/Hepatitis B combination vaccine. Routine testing of their manufacturing facility found some equipment was contaminated with a bacterium called Bacillus Cereus. Under normal conditions, the manufacturing process is sterile to avoid contaminant bacterial growth within the vaccine product. Bacillus Cereus is a common cause of diarrhea food poisoning when consumed in contaminated food. If any of these bacteria happened to contaminate any of the batches of vaccines and was injected into a baby, the possible effects are unknown, although it is thought that it may only result in a rash around the injection site. It is not yet known if any of the bacteria actually made it into the vaccine bottles. The problem is expected to shut down Merck’s production of these two vaccines for about 9 months.
What can parents do? The first thing is to find out if your doctor even uses the Merck brand of these two vaccines. Many doctors use another brand of HIB vaccine called ActHIB, and don’t use the combination HIB/Hep B vaccine. IF your doctor uses the Merck brands, ask the office manager if your child received any doses from the recalled batches. The nurse will have written the batch numbers your child received in the chart. If your child did not receive a recalled batch, then you have nothing to worry about. If your child DID receive a possibly contaminated vaccine, and shows no unusual rash or signs of skin or muscle infection around the injection site, then there is most likely nothing you need to do or worry about. Granted, the effects of injecting these bacteria into the body may be unknown, but theoretically the body’s immune system should be able to kill the germs. And keep in mind, we don’t even know if any of the germs made their way into any of the vaccine bottles.
The bottom line is that there is no treatment and nothing to do right now as long as you don’t see any problems. You can be concerned, even angry, and I’m sure you’ll worry, like any parent would. But there’s nothing you really need to do as long as the injection site seems fine and your baby did not show any bothersome reactions to the vaccine.
This week Merck announced a recall of over a million doses of their PedVaxHIB brand of HIB vaccine that protects against a now rare form of infant meningitis as well as their ComVax brand of HIB/Hepatitis B combination vaccine. Routine testing of their manufacturing facility found some equipment was contaminated with a bacterium called Bacillus Cereus. Under normal conditions, the manufacturing process is sterile to avoid contaminant bacterial growth within the vaccine product. Bacillus Cereus is a common cause of diarrhea food poisoning when consumed in contaminated food. If any of these bacteria happened to contaminate any of the batches of vaccines and was injected into a baby, the possible effects are unknown, although it is thought that it may only result in a rash around the injection site. It is not yet known if any of the bacteria actually made it into the vaccine bottles. The problem is expected to shut down Merck’s production of these two vaccines for about 9 months.
What can parents do? The first thing is to find out if your doctor even uses the Merck brand of these two vaccines. Many doctors use another brand of HIB vaccine called ActHIB, and don’t use the combination HIB/Hep B vaccine. IF your doctor uses the Merck brands, ask the office manager if your child received any doses from the recalled batches. The nurse will have written the batch numbers your child received in the chart. If your child did not receive a recalled batch, then you have nothing to worry about. If your child DID receive a possibly contaminated vaccine, and shows no unusual rash or signs of skin or muscle infection around the injection site, then there is most likely nothing you need to do or worry about. Granted, the effects of injecting these bacteria into the body may be unknown, but theoretically the body’s immune system should be able to kill the germs. And keep in mind, we don’t even know if any of the germs made their way into any of the vaccine bottles.
The bottom line is that there is no treatment and nothing to do right now as long as you don’t see any problems. You can be concerned, even angry, and I’m sure you’ll worry, like any parent would. But there’s nothing you really need to do as long as the injection site seems fine and your baby did not show any bothersome reactions to the vaccine.
Labels: Vaccine News
posted by Dr. Bob Sears @ 1:29 PM
11 Comments:
At December 13, 2007 5:52 PM ,
jenna said...
Hi Dr Sears,
Thanks so much for the info on the recall. My daughter did receive the combo HIB/HepB shot back at her 4 month appointment in August. Could this still possibly have been a recalled vaccine? Is there a timeline when the recalled vaccines were distributed and used? I guess I am going to have to call the doctor's office in the morning to find more out.
At December 13, 2007 10:02 PM ,
April said...
I went to the doctor this morning and was planning on my son getting Hib and Pneumococcal (he's 5 mos, I'm using the alternative vaccine schedule). When I asked about the Merck recall they said they didn't know anything about the recall. I am a little concerned that I found out about this on Wednesday evening and they didn't have the information on Thursday morning. What is the process that Merck has to go through to notify the doctor's offices?
At December 14, 2007 8:27 AM ,
jenna said...
I did call my pediatrician's office this morning and found out that it is a more recent batch of the vaccine that is possibly contaminated, so luckily I don't have anything to worry about (at least regarding that vaccine - there are of course many other worries I have!)
At December 14, 2007 9:15 AM ,
Dr. Bob Sears said...
I don't yet know what the timeline is on WHEN these batches were made or distributed. The Merck or the FDA website may post that info.
At December 20, 2007 7:59 AM ,
melissa said...
hello, my daughter received the HIB three months ago and was in a lot of pain. she wouldn't move her leg for a day. she was very cranky and upset and nursed all day long. i called the dr's office, concerned of course, where the nurse continued to tell me that there are no side effects from this shot. my husband and i have our daughter on a delayed vac schedule. anyway, one of the doctors in the practice has made it her duty to make sure that we are made to feel we're bad parents for the delayed schedule and she thinks we need to do this or that for kindergarden enrollment. our daughter is only 6 months. this doctor has come up with her own schedule and has called us at home twice to discuss it. to my dismay. this isn't our usual doctor at the practice but she has made such a stink that now the practice will refuse to see us if we don't go according to her schedule. obviously we need to find a new practice. my reason for writing is that our daughter is due for another HIB in two weeks and we're very concerned after her reaction to the last one and now the recall. we have to find another doctor and in the interim we were going to go back and see our regular doctor at this practice because we have a concern for our daughter's shoulder which she's had trouble with since birth. because they've made such a stink about these vacs we're afraid they'll lie to us about whether our daughter was injected with the bad batch or if they carry merck, etc. unfortunately these types of things due happen. i don't know what our rights are but i know i should be able to choose what goes into my child's body. she's my responsibility. we currently live in NJ. do you know what our rights are or what site i can find the info on? i've been to various links this far and am becoming a frustrated mom as our little girl leaves me few moments to get online. thank you dr. sears!
At December 20, 2007 10:22 PM ,
Anonymous said...
my daughter did receive the contaminated vaccine about a montha nd a half ago. The sight was raised, bumpy, and red for about one month, and it is still bruised. What are the possible side effects?
At December 22, 2007 10:15 AM ,
dr. bob sears said...
Melissa - having this type of a reaction is a concern, but not necessarily bad enough to skip the rest of the shots. It's a borderline situation, so I can't tell you which way to go.
I understand your frustration with your doctor, as many parents face the same thing.
Living in NJ, you DO have the right to refuse vaccines in the early years, BUT by the time your child enters school you either have to get them or claim a religious exemption.
Anonymous - that reaction is fairly common, so may not be related to the contamination. Even if it IS a small infection from the contamination, it sounds like it's gone away on its own and you have nothing to worry about now.
At January 9, 2008 6:30 PM ,
Anonymous said...
Thank you Dr. Sears for the info on the recall. I am very conflicted now. I delayed my daughters vaccines until I had a plan I was comfortable with & could find a participating physician (the later being more difficult!). We decided on following the alternative vaccine schedule & my baby received HIB & DTaP @ her 4 month well baby. 2 days later I saw the recall on the news!! & of course my baby received one of the recalled doses! Now I am very conflicted as just as I came to peace with our vaccination decision this happens & I am not sure how I want to proceed. I still believe in vaccinations just am concerned about safety.
I know you can't offer guidance in this situation; just needed to voice my frustrations as I try to decide how to proceed from here .
Thank You,
At January 18, 2008 4:11 AM ,
Anonymous said...
My son received his first dose of the Comvax vaccine in November (I'm unsure if it was part of the contaminated lot) and a few hours after vaccination he started screaming, inconsolable, for a little over 3 hours, to the point that his voice became hoarse. He never cries, and when he does, is always soothed within a few minutes. This has been a real concern for me and my husband, but our doctor dismissed it and "fired" us from his practice if we don't get on board with vaccinating. I feel that there is no right decision with vaccinations, but isn't inconsolable screaming for that long a real concern? The injection site was not red or swollen.
At January 29, 2008 12:59 PM ,
Anonymous said...
when i heard about this recall, i called my daughter's pediatrician to ask if it was possible my daughter had received a recalled dose. they acted as if i was being difficult and first told me to just not worry about it. i said i was upset and just wanted to know. so, i was put on hold rather abruptly and bounced around then got someone else who told me as much: don't worry about it. i asked if i could just please find out if she got one of the recalled shots and after being put on hold again, i got someone on the phone who proceeded to read me lot numbers. i interjected that the numbers didn't mean anything to me and could they please just tell me if my daughter had received a recalled vaccine. i was told "no" and hung up on.
i'm so glad to see a doctor saying that it's ok to upset, angry, and worried. i wasn't mad at my doctor's office; after all, how would they have known? it's just upsetting and it seems like my doctor's office reacted defensively and rudely and i'm just really put off by the whole thing. it makes me sick the lack of empathy that was shown and i almost feel as if i was lied to so that i wouldn't leave the practice or cause more trouble. i still wonder if my daughter DID get the recalled vaccine. i hate this feeling that i can't trust my pediatrician's office.
how should this have been handled?
At January 31, 2008 10:09 AM ,
Dr. Bob Sears said...
Anon Jan 18 - this type of reaction sounds like a very mild case of encephalitis. Check out that section in the book. I would say that with that type of reaction you should avoid this shot, or that brand of HIB and HepB in the future. As for other shots, this reaction to comvax doesn't necessarily mean there will be a reaction to other shots. But at least maybe only do one shot at a time.
Anon - Jan 29 - sorry to hear that. I would say that most peds offices weren't prepared to answer any questions right away. Since I don't use that brand, I wasn't notified of any recall specifics. I'm sure those doctors that did use the brand were notified, but you might have called before they knew details and caught them off guard.
Anyway, I know this issue was a lot more concerning to the parents it happened to than the doctors, since it is most likely a harmless issue.
Also, they haven't found any contamination in the actual vaccine vials yet, so that's good.
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