Hib Vaccine Recall Due to Sterilization Issues, Shortage of Meningitis Shot FearedDec 13, 2007 | Parker Waichman LLP
More than 1 million doses of the Hib vaccine are being recalled in what Merck Inc. is calling a “precautionary” measure because the vaccines may not be sterile. While no injuries have been reported in relation to the possibly defective Hib vaccine, the recall will likely create a vaccine shortage.
The Hib vaccine protects children from Haemophilus influenzae type b (Hib), a bacterium that infects the lining of the brain, causing meningitis. Meningitis is caused by several different bacteria. However, before the Hib vaccine, Hib was by far the most common cause of meningitis. Children with meningitis often have fever, stiff neck and drowsiness. Symptoms can progress to include coma and death. Some children recover from the disease but are left permanently paralyzed, deaf, blind or mentally retarded. Hib bacteria also can cause Sepsis (bloodstream infection); Epiglottitis (severe swelling of the epiglottis, a tissue that closes off the windpipe during swallowing); Arthritis; Osteomyelitis (infection of the bones) and Pneumonia.
According to Merck, sterilization problems at its manufacturing plant in Pennsylvania necessitated the recall of 1.2 million doses of the Hib vaccine. The recall includes all Merck Hib vaccines shipped from the plant since April. Merck said the Hib vaccine recall is only a precaution, and it does not appear as though the vaccine itself was contaminated. Merck has not said how many of the recalled Hib vaccines have already been used. Pediatricians are telling parents with children who have recently received the vaccine to call a doctor if the child develops redness at the site of the shot or has a fever soon after. According to the Centers for Disease Control, there have been no adverse events related to the recalled Merck Hib vaccine.
However, health officials are concerned that the Merck Hib vaccine recall will result in a shortage of this important immunization. The Hib bacteria is highly contagious, and it is recommended that most infants receive a dose of the Hib vaccine. Before the Hib vaccine, about 20,000 children every year would get serious and occasionally fatal infections from the Hib bacteria. Now, there are only about 100 cases of Hib infection reported each year.
Merck produces about half of the US Hib vaccine supply, while drug maker Sanofi-Aventis makes the rest. There is a small chance unvaccinated children could develop these illnesses. But experts say because 94 percent of toddlers have already been vaccinated, the illnesses should not be circulating in the U.S. Officials plan to meet to analyze the vaccine supply and determine whether changes need to be made to vaccine recommendations.
Merck said that as a result of the problems at the Pennsylvania plant that produced the recalled Hib vaccine, the facility will be shut down for about 9 months. It is hoped that some other drug maker wills step in to produce the vaccine.