The vaccine recall announcement came from the U.S. FDA but the company also has put out a press release on Hib Vaccine Recall.
In the release Merck says "Merck & Co., Inc. announced today that the Company has initiated a voluntary recall of 11 lots of its Haemophilus influenzae type B vaccine, PEDVAXHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)], and two lots of its combination Haemophilus influenzae type B/ hepatitis B vaccine, COMVAX [Haemophilus b Conjugate (Meningococcal Protein Conjugate)]. The recall is specific to these 13 lots and does not affect any other vaccines manufactured by Merck. The affected doses of PEDVAXHIB and COMVAX were distributed starting in April 2007.
"Merck is conducting this vaccine recall because it can not assure sterility of these specific vaccine lots. The potential contamination of these specific lots was identified as part of the Company's standard evaluation of its manufacturing processes. Sterility tests of the vaccine lots that are the subject of this recall have not found any contamination in the vaccine."
CDC also has a very interesting Q&A about this recall, providing helpful information about Merck's Hiv Vaccine Recall.
In it CDC identifies that the following are the recalled lots:
The lots that are being recalled are:
Product Description - Lot # - Expiration Date
PedvaxHIB® 0677U 11 January 2010
PedvaxHIB® 0820U 12 January 2010
PedvaxHIB® 0995U 16 January 2010
PedvaxHIB® 1164U 18 January 2010
PedvaxHIB® 0259U 17 October 2009
PedvaxHIB® 0435U 18 October 2009
PedvaxHIB® 0436U 19 October 2009
PedvaxHIB® 0437U 19 October 2009
PedvaxHIB® 0819U 09 January 2010
PedvaxHIB® 1167U 10 January 2010
COMVAX® 0376U 05 January 2010
COMVAX® 0377U 08 January 2010
The rest of CDC Q&A about Merck's Hib vaccine recall is presented below.
Why are these lots being recalled?
Merck is taking this step as a precautionary measure. The company cannot assure sterility for these specific vaccine lots. The potential contamination in these specific lots was identified as part of Merck’s standard evaluation of their manufacturing processes. In routine testing of the vaccine manufacturing equipment used to produce PedvaxHIB® and COMVAX®, Merck identified the presence of a certain bacteria called Bacillus cereus. Sterility tests of the vaccine lots themselves have not found any contamination.
The potential for contamination of any individual vaccine is low, and, if present, the level of contamination would be low. However, because they cannot guarantee the sterility of these specific lots of vaccine, Merck is conducting this recall.
What is the extent of the recall?
About 1 million doses of vaccine are being recalled, including ten lots of PedvaxHIB® and two lots of COMVAX® that were distributed in the U.S. as well as vaccine lots within the CDC stockpile.
Will children who received vaccine from affected lots need to be revaccinated?
No. Children who received Hib vaccine from affected lots do not need to be revaccinated. No potency concerns have been identified for these vaccine lots.
What are the risks to children who received vaccine from affected lots?
Sterility tests of the vaccine lots themselves have not found any contamination. Merck has not received any reports of abscesses or disseminated B. cereus infection in children who received vaccines from affected lots. In addition, no problems have been detected by the Vaccine Adverse Event Reporting System (VAERS) related to the Hib vaccine affected by this recall. However, since sterility of the vaccine cannot be assured, if a child was vaccinated with a vial of PedvaxHIB® or COMVAX® that contained B. cereus or other microorganisms, there may be a risk of developing localized or disseminated infections. Immunocompromised children may be at the greater risk for these infections. These infections are most likely to occur within one week after vaccination.
VAERS will continue to monitor adverse events following vaccination as they are reported. Any potentially vaccine-related adverse events should be reported to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 (or at www.vaers.hhs.gov (exit)), and to Merck at 1-800-672-6372.
What should providers do if they have recalled lots in their office?
Providers should immediately discontinue use of any of the affected lots and follow Merck’s instructions for returning recalled vaccine (both VFC and non-VFC vaccine).
How does this impact the nation’s Hib vaccine supply? Are there other Hib vaccine manufacturers?
As a result of this recall, providers who only use Merck Hib vaccines may have none, some or all of their vaccine recalled, and about half of the Hib vaccine in CDC’s stockpile is being recalled. CDC realizes that some providers will be faced with the prospect of having children to vaccinate with no vaccine available. There are two U.S. Hib vaccine manufacturers – Merck & Co., Inc. and sanofi pasteur. In the past, each manufacturer has produced about half of the nation’s Hib vaccine supply.
What is CDC doing in response to the shortage of Hib vaccine?
CDC is in contact with the two U.S. Hib vaccine manufacturers – Merck and sanofi pasteur. CDC is assessing availability of Hib vaccine and timing of future supply, and will make appropriate recommendations soon. Key considerations being addressed by CDC, along with partners such as the American Academy of Pediatrics, the American Academy of Family Physicians, and a representative of CDC’s Advisory Committee on Immunization Practices, include whether to change recommendations for Hib vaccine temporarily and how to allocate the smaller CDC stockpile of Merck’s Hib vaccines.
Will the shortage of Hib vaccine result in an increase in disease occurrence of Haemophilus influenza type b?
Fortunately, current immunization rates in the U.S. for Hib vaccine are high. In 2006, about 94% of U.S. children 19-35 months of age were vaccinated against Hib. This has resulted in a dramatic decline in transmission of this bacteria; however, it has not gone away completely. Experience has shown that we cannot let down our guard against vaccine-preventable diseases such as Hib. When immunization rates fall we are susceptible to increases in disease occurrence, so we are taking the current situation very seriously.
What should providers tell their patients?
For the time being, providers should continue to use Hib vaccine not affected by this recall according to current ACIP recommendations. If concerned parents contact their providers, they should be informed that children who were vaccinated with vaccine affected by this recall do not need to be revaccinated. Although there have been no reports of any adverse reactions among children who have been vaccinated, parents of children recently vaccinated with recalled vaccine should watch for any signs of infection (such as redness and swelling at the injection site) and contact their providers if such reactions occur. It should be emphasized that sterility tests of samples from the recalled lots have not found any contamination and the potential of contamination of any individual dose of Hib vaccine is very low.
What should providers do if they have no vaccine or little vaccine in their office?
Providers with shortages of vaccine may defer the booster (12-15 month-old) dose of Hib-containing vaccine in fully immunized children who are not otherwise at increased risk of invasive Hib disease (see question 13). Providers who are completely out of Hib vaccine, can contact sanofi pasteur regarding the availability of Hib vaccine to meet immediate short term needs.
What should providers do if they have no or little vaccine in their office and they are a VFC provider?
VFC providers should contact their health department. CDC anticipates additional guidance will be available soon.
Are some children at high risk for Hib?
Yes. Children at increased risk for Hib include: children with sickle cell disease, leukemia and malignant neoplasms, HIV and certain other immunocompromising conditions, asplenia, as well as American Indian and Alaska Native children. Vaccinating these children according to the recommended schedule is a high priority.
Note: Merck has a National Service Center that can answer questions about medical and other issues related to this recall, 1-800-672-6372. - By HULIQ, Merck, CDC reports.
Comments
Merck's Vaccine Recall- and this is supposed to be a vaccine?
Vaccines are supposed to prevent people from illness and fight bacterial. I would like Merck to further elaborate on how exactly the contaminated bacteria entered in the equipment that is supposed to be crystal clean. Just saying that Merck voluntarily recalls Hib vaccine may not be enough. This is a huge risk to people and our children. I would expect Merck to be most watchful about this issue and exclude this from happening again.
As a worker for a company
As a worker for a company that made products for the motor industry it would be inconceivable to allow 1 million production units through without quality control.
Does the vaccination of USA children by Merck mean that 1 million children can be injected with toxic matter and that fact is of no concern to Merck?
What confidence can we have that the Merck vaccine given at age 1 day is not also causing problems?
I have repeatedly tried to contact Merck on this issue.
They cannot control quality of their vaccines and they cannot respond to proper and serious complaints regarding other vaccines of theirs.
It is no wonder that the USA even in 2007 uses the most toxic non radioactive element in its vaccines and believes the toxin is safe.
It is no wonder the medical bill for the USA is second to none.
It is no wonder that USA has more autistic children than any other country.
All this chaos plus the chaos of ignorance, evasion and denial of harm.
I can be contacted at johnfryer at orange dot fr but how do you discuss the safety of vaccines with people who ignore you???
John Fryer MSc BSc Advanced Analytical Chemist
As a parent of a toddler, I
As a parent of a toddler, I was always concerned as to whether I should vaccinte my child or not. Of course I should, what IF somehting happened and I had not. But now, what IF something happens cause I did?????
Nothing is safe anymore. Do we REALLY know what our children are being injected with anyhow????? Scary... May GOD protect us.
Hib Vaccine
My 2 month old neice had the Hib Vaccine shot and the next day was fussy and then 2 days after having the shot we found here dead on in her bed with blood comming out of her nose and mouth....When the coroner came to the house the first thing he said is that he was rulung out SIDS b/c of the blood..but when the autopsy came back nothing and we think it was the shot but we need to figure out how to go about this we still trying to figure out whether it would be worth fighting it..but something tell's us it was the shot and now there's a recall we need help finding out and are trying everyday. But i just wanted to tell u this.
Thanks,
Christina SLiney
Blacksburg S.C.
Merck's 007 'Licence to Kill'
The 12 different lot numbers given by Merck correspond to 9 reported adverse events in the VAERS register as at 13th December 2007. This gives a report of less than 1 adverse report per lot of vaccines.
Is this the new 'gold standard' to recall dangerous vaccines?
I note particularly that an earlier lot number of HibV namely 007 (7U) does have a licence to be injected into babies and evidently a “licence to kill”. Has this lot number been recalled? Evidently not, as it is still deemed safe! There are 3 recorded deaths alone during August 2007 from multiple vaccines containing Merck HibV 0077U vaccine. In all cases the little child died after just one day.
The record is informal, may be subject to errors and often other adverse events may not get onto the record.
But this is an extract from a blog about vaccines by an unqualified but curious friend of a father whose child died suddenly in his arms. It was written three years ago:
“The kids died 2 or 3 days after having multiple vaccines administered, and one after another, the autopsy showed cause of death to be SIDS. In some cases, they died IN THE DR's OFFICE!....still...cause of death: SIDS.”
Where is the evidence that multiple vaccines are safe and how do we pin point the blame if death occurs from a melange of vaccines?
The blog also notes that those who dislike vaccines cannot pick and choose the safe ones. Why not? Do they have refuse to take a mercury containing vaccine for a trivial illness knowing the mercury will destroy all brain cells they come into contact with and thereby they are forbidden to take a vaccine to prevent a very dangerous illness when this vaccine has a 100% good safety record.
The world of vaccines is indeed the world of the Mad Hatter!
John Fryer MSc BSc Advanced Analytical Chemist
MERCK is used to murdering
MERCK is used to murdering people with the FDA's blessing.......
vioxx is the prime example. merck knew of the danger and continued to sell their poison
AND NOW THEY ARE TRYING TO BRUSH IT AWAY WITH A 4.6 BILLION SETTLEMENT...SOUND LIKE ALOT...IT'S NOT..IT BOILS DOWN TO ABOUT 50 THOUSAND EACH..
A SMALL PRICE FOR A DEATH OR DISABLED LIFE
BOYCOTT MERCK