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By Vincent Iannelli, M.D., About.com Guide to Pediatrics since 2001

Hib Vaccine Recall

Wednesday December 12, 2007

The FDA and Merck, is recalling 1 million doses of its PedvaxHib and COMVAX vaccines, including 13 lots of vaccine, which were distributed since April 2007. The vaccines are being recalled because of a "lack of assurance of product sterility," after Merck found the Bacillus cereus bacteria on some of the manufacturing equipment. B. cereus is a common cause of food poisoning, although it can cause other infections too, including skin infections, meningitis, sepsis, etc.

Fortunately, none of the vaccines themselves were found to be contaminated and no children have been harmed. If your child recently received a Hib (Haemophilus influenzae type b) vaccine that was involved in the recall and is showing signs of an infection, such as swelling and redness at the infection site, be sure to see your pediatrician.

It is unlikely that your child recently got a PedvaxHib shot though, as Merck stopped shipments of the vaccine in mid November because of a "manufacturing problem." The current recall makes it more clear what that problem might have been.

The Hib vaccine is commonly given over three or four doses to infants and toddlers at their 2, 4, 6, and 12 to 15 month checkups to prevent bacterial meningitis, pneumonia, epiglottitis, and other infections. There is another version of the Hib vaccine, so even though the PedvaxHib and COMVAX is temporarily unavailable, there will hopefully be enough vaccine to go around to prevent a shortage.

Related:
CDC's Q&As on Hib Recall
Reporting Vaccine Reactions
Immunizations
Immunization Schedule

Comments

December 13, 2007 at 11:30 am
(1) concerned_mom_of4 says:

Ugh..will it EVER be safe to vaccinate!! This is just one of MANY reasons why I hate vaccines..my son had his 6 month vaccinations on monday december 10th..I really wish our pediatrician wouldn’t have pushed us so hard to have these stupid vaccines. I should have trusted my instincts!!

December 13, 2007 at 11:50 am
(2) concerned mom of 2 says:

I know just how you feel. Go with your instinct. We’ve started just having one type of vaccination at a time. The pediatrician doesn’t like it and makes us feel that we are putting our children and a constant unnecessary risk, but we trust God to watch over them first and they are our children to take care of here not the doctor’s, and the doctor does work with us even after we are not persuaded to go the AAP schedule.

December 13, 2007 at 11:51 am
(3) Vincent Iannelli, MD says:

will it EVER be safe to vaccinate!! This is just one of MANY reasons why I hate vaccines.

This could actually be seen as a good reason why it is important to have everyone vaccinated. Because vaccine levels for infants and toddlers are fairly high, even if there is a brief shortage of the Hib vaccine, it is predicted that the Hib bacteria won’t be able to cause any problems.

With lower vaccine coverage levels, even a brief shortage could quickly lead to outbreaks.

The Hib vaccine protects against meningitis and epiglotittis, both of which can extremely serious and devastating illnesses.

December 13, 2007 at 10:43 pm
(4) crystal says:

my 3 mont hold got one of the recalled vaccines and the health department said she didnt so i asked for the lot number and in fact she did….

December 18, 2007 at 9:00 pm
(5) Annie-Rae says:

My daughter has only recieved two shots and this was one of them, why on earth do drs. want us to give our children vaccines when they are no longer safe and can do more harm then good these days.

December 20, 2007 at 9:25 pm
(6) Candise says:

My son had heart surgery at a week old, and is having another heart surgery next month at 4 months old. He has been vaccinated with the tainted lot number. Though he has not shown the sited reaction, I cannot help but be terrified. We have done so much to protect him from infections, all the family getting flu shots, ect. . . then this. With his compromised immune system any infection could kill him.
My doctor said he would have already been ill, but I worry sepsis can hide and might become active at surgery.

January 10, 2008 at 8:52 pm
(7) gina says:

my 13 yr old son just had a menigitis vaccine on 1/8/08 and he has redness and a hard lump at the injection site is this normal or possibly a bad dose of the vaccine

January 20, 2008 at 11:02 am
(8) stephanie says:

My daughter is 7 months old now..but practically since birth she had been on the ventilator waiting for heart surgery..at 5 weeks she had her coarch. repaired..then at 8 weeks before we went home from the hospital she had a heart attack and after a heart cath. we found she had another defect..open heart surgery was performed the next day…2 months later we are home and Mady is doing so great!! Hitting her milestones..and everything..we go to the pediatrician for a check up and he mentioned vaccines to me..I said NO..and after much debate…I listened to the medical professional and let him give her her shots…I asked if we could do them 1 at a time and he said there was really no need and she was strong enough for all of them…a few hours later at home..Madyson died..I brought her back..it happened again…I brought her back..I was freaking out…we went to the hospital where they lost her 3 times and then on the way to another hospital in the helicopter they lost her heartbeat 4 times….thankfully and by the grace of GOD she lived. She has brain damage now and this is all from vaccines!!! I found out the dr. gave her her 2 month and 4 month vaccines at once!! To a baby with no immune system….her body went into shock and began to shut down….DO NOT VACCINATE YOUR CHILDREN without doing a lot of research first!!! Educate yourself and always follow your maternal instinct!!!

February 11, 2008 at 7:19 pm
(9) nancy says:

my granddaugther had recall shots and died 18 hours later she was only six weeks old been 3 months no answers how died i wont to stop getting shots for babies i know thats how she die the shots help fight no more shots

February 11, 2008 at 7:25 pm
(10) nancy says:

my granddaugther was 6 weeks old had recll shots die 17 hours later i know its the shots there still looking into the shots but its been 3 months but wont let them hide it i will go all the way

March 5, 2008 at 1:25 pm
(11) Mr&Mrs Stiller says:

Our baby boy received these recalled vaccninations and 2 weeks after receiving them had to be on LIFE SUPPORT!We almost lost him I cannot even begin to tell you how horrible that was!! Nancy please email me I want more info about yourgrandchild.I already have an attorney on this.

March 5, 2008 at 1:28 pm
(12) mr & mrs stiller says:

**************Nancy *****EMAIL ME PLEASE!
STILLEREST1995@AOL.COM

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