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Prevnar: Vaccines
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The HMO trial in which Prevnar was approved had no placebo group. The control group received another experimental vaccine for mennigococcus. This was the ONLY trial that was done to establish the safety and efficacy to recommend this vaccine for every newborn in the US.
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"In light of the vaccines that are coming down the pike, Prevnar is an instructive lesson for all who make, market, regulate and administer vaccines," he says. "It's still not clear to what extent practices, parents and insurers will invest in increasingly expensive vaccines."
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Sokol, a Wyeth manufacturing scientist for Prevnar, filed a separate lawsuit against the company in federal court in New York in September 2007, alleging he was improperly fired from the company in retaliation for raising concerns about the vaccine. Sokol, a Pennsylvania resident, had been a manufacturing scientist involved in the production of Prevnar between 2003 and 2005, according to his lawsuit. He said Wyeth misrepresented and concealed data from FDA. Sokol was fired in September 2005, his lawsuit said.
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Side effects of Pediarix and Prevnar are similar to other vaccinations and include tenderness, swelling, and redness at the site of injection. Fever, loss of appetite, fussiness, and drowsiness can ... occur. However, fever is more likely to occur with Pediarix than with separately administered vaccinations. As with any medicine or vaccination, Pediarix and Prevnar can cause severe allergic reaction.
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When Prevnar is injected along with the other childhood vaccines, does it interfere with the promised efficacy of the other vaccines? Incredibly, the manufacturer states that in some cases it does and in other cases they just do not know. Under "Simultaneous Administration with Other Vaccines," the package insert states:
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Prevnar® helps to protect infants and toddlers from certain pneumococcal bacteria that can cause life-threatening meningitis and blood infections. Prevnar® is approved for use in infants as part of their routine vaccination schedule. Prevnar® was approved by the FDA in February 2000, but has been available only in single-dose vials. Prevnar® is now available in prefilled syringes, the exclusive delivery system.
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