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New Hepatitis Vaccine May Soon Be Available

Posted: January 3rd, 2013 | Author: | Filed under: Travel Vaccines Updates | Tags: , , , | Comments Off on New Hepatitis Vaccine May Soon Be Available

California’s Dynavax Technologies scored a win when FDA staff said the company’s Heplisav vaccine works against the contagious liver disease hepatitis B.

The FDA said in a report that Heplisav worked as well after two doses as three doses of GlaxoSmithKline’s Engerix-B vaccine. The vaccine also had a similar safety profile to Engerix-B.

Company stock rose 13% upon the news, closing Tuesday at $4.74. This marks the largest single-day jump since September 2011.

Dynavax does not yet have a product on the market, so Heplisav will be first should the FDA approve the vaccine Feb. 24, when the organization is scheduled to make a decision. The product could rake in an estimated $775 million in worldwide sales come 2020, Katherine Xu, an analyst with William Blair & Co., told Bloomberg.

In a study of about 2,400 patients ages 18 to 55, 95% of those who took two doses of Heplisav were protected from hepatitis B. By comparison, 81% of those who took three doses of Glaxo’s Engerix-B were protected.

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Potential New Malaria Vaccine Tests Poorly

Posted: January 1st, 2013 | Author: | Filed under: Travel Vaccines Updates | Tags: , , , , | Comments Off on Potential New Malaria Vaccine Tests Poorly

A GlaxoSmithKline malaria vaccine posted surprisingly lackluster results in a Phase III trial, putting a damper on solid results from previous studies. The vaccine against the mosquito-borne illness proved only 30% effective when given to African children in a clinical trial.

Still, GSK plans to move forward with development of the vaccine. The trial included 6,537 babies aged 6 to 12 weeks; the vaccine offered “modest protection,” knocking down episodes of the disease 30% compared with the immunization with a control vaccine.

“The efficacy is lower than what we saw last year with the older 5-17 month age category, which surprised some of us scientists at the African trial sites,” Dr. Salim Abdulla, a principal investigator for the trial from the Ifakara Health Institute in Tanzania, said in a release. “It makes us even more eager to gather and analyze more data from the trial to determine what factors might influence efficacy against malaria and to better understand the potential of RTS,S in our battle against this devastating disease.”

In 2010, malaria caused an estimated 655,000 deaths, mostly among African children, the World Health Organization says.

The Phase III trial, completed in conjunction with PATH Malaria Vaccine Initiative, was backed by $200 million from the Bill & Melinda Gates Foundation. Bill Gates, whose organization commits billions of dollars to improving global health, said the study marked an important milestone.

“The efficacy came back lower than we had hoped, but developing a vaccine against a parasite is a very hard thing to do,” Gates said in a statement. “The trial is continuing and we look forward to getting more data to help determine whether and how to deploy this vaccine.”

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