Japan Suspends Use of Pfizer, Sanofi Pediatric Vaccines
The deaths of four infants have caused the Japanese government to suspend the use of two vaccines Pfizer’s Prevenar(meningitis and pneumonia) and Sanofi’s ActHIB (Haemophilus influenzae type b):
The deaths of the children in Japan occurred from March 2 to March 4, the ministry said. ActHIB was given to three of the four children, who were simultaneously vaccinated with at least one other vaccine from a different manufacturer, Carey said.
Pfizer’s Prevenar is a so-called pneumococcal conjugate vaccine that aims to prevent invasive disease caused by serotypes of the Streptococcus pneumoniae bacterium. The vaccine that protects against 13 serotypes generated $2.42 billion last year and a shot that fights seven serotypes had $1.25 billion in 2010 sales, according to data compiled by Bloomberg.
Surveillance in North America and Europe, where Prevenar has been used for at least a decade, hasn’t identified any major safety concerns, the WHO said in a 2007 report. Evidence suggests pneumococcal conjugate vaccines will have a “considerable impact on pneumococcal disease and overall infant mortality,” the United Nations health agency said.
Forbes interviewed a few vaccine experts, all of whom seemed to think the suspension was unnecessary. One has called the Japanese government’s decision “foolish”:
“I think the Japanese Ministry of Health was foolish to suspend the HIB and pneumococcal programs,” says Paul Offit, a researcher at Children’s Hospital in Philadelphia who co-invented a Merck vaccine used to combat rotavirus. “It was the wrong thing to do.”
In all likelihood, Offit says, the four deaths are likely to be sudden infant death syndrome or another cause; he says two of the children had serious underlying health conditions. Any time a large number of people are given a vaccine, some of them will get sick and die just by chance.
In contrast, Offit argues, the problems caused by the bacteria the vaccines immunize against are very real. Pfizer’s vaccine, Prevenar or Prevnar, prevents illnesses causedby pneumococcal bacteria; Sanofi’s ActHIB prevents infection with the Haemophilus influenza. Both bacteria can cause meningitis, pneumonia, and other infections. Offit said the decision to stop giving the vaccines, even for a moment, represents “a really poor assessment of where the risks lie.”
Offit profited from the creation of the rotavirus vaccine, but does not get ongoing money from vaccine manufacturers for speaking, consulting, research, or as royalties.
William Schaffner, chairman of the department of medicine at Vanderbilt University School of Medicine, said that the deaths were “most likely, by far, a coincidence.” He does get some consulting and speaking money from vaccine makers.
America’s Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have announced that they will not be taking action regarding the vaccines, as there is no reliable information that links the vaccines to deaths.
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