Merck Recalls HIB Vaccine: Contamination Risk
by Barbara Loe Fisher
In what appears to be a pattern involving vaccine quality control production problems, on Dec. 12, 2007 Merck & Co. announced that it was recalling 13 Lots containing 1.2 million doses of HIB vaccine (PedvaxHIB and the combination COMVAX containing HIB and hepatitis B vaccines) for possible contamination with the common bacterium called Bacillus cereus (B. cereus). The microorganism makes spores that causes diarrhea and vomiting from eating contaminated foods (also known as food poisoning). Reportedly, a piece of equipment in Merck's West Point, PA manufacturing facility failed a sterility test and the bacterium was identified.
The CDC recommends that infants receive HIB vaccine at two, four and 12-15 months. The 13 lots of HIB containing vaccines began to be distributed in April 2007 and had expiration dates of 2009 and 2010. The FDA has released a list of the HIB vaccine Lot numbers: http://www.fda.gov/cber
At a 5 p.m. Dec. 12 press teleconference, CDC officials reportedly said that there is no proof the 13 Lots of HIB vaccine suspected of being contaminated are, in fact, contaminated. However, they added that if some HIB Lots are contaminated with B. cereus bacteria, then healthy children could experience skin irritation around the site of the injection and children with weakened immune systems could suffer more serious health problems within a week of vaccination In a media advisory, the CDC indicated that a transcript of the press teleconference would be made available at: http://www.cdc.gov/od/oc/media
This is not the first time that Merck has had a quality control problem in its vaccine manufacturing plants. In August 2001, Merck temporarily suspended operations in one of its facilities manufacturing MMR and Varicella (chicken pox) vaccines to address issues raised by FDA inspectors during a plant inspection and to make modifications to its facility. According to the 2002 GAO report, the time it took to make plant modifications and difficulties in meeting FDA manufacturing requirements contributed to shortages of MMR and varicella vaccines between the end of 2001 and summer of 2002.
Almost all of the vaccine shortages that the U.S. has experienced in the past two decades have been due to vaccine manufacturer production and government regulation compliance problems, even though vaccine patent-holders and those advocating mandatory use of all vaccines licensed for children have attempted blame vaccine injury lawsuits for vaccine shortages. http://vaccineawakening
Merck, which produces about half of the 14 million doses of HIB vaccine administered to American babies, will be unable to supply HIB vaccine to the U.S. for at least nine months according to Merck officials. French pharmaceutical giant, Sanofi-Aventis, is reported to be considering ramping up production of its HIB vaccine to fill in the U.S. HIB supply gap.
In the meantime, parents who have recently gotten their infants vaccinated with HIB vaccine are left to wonder if their babies will get sick because they got a vaccine contaminated with bacteria. Only time will tell. All suspected HIB vaccine reactions should be immediately reported to the federal Vaccine Adverse Events Reporting System (VAERS) at http://wonder.cdc.gov/wonder
NVIC has maintained a Vaccine Reaction Registry since 1982. To report a vaccine reaction, injury or death to NVIC, go to