Dynavax surges 70% after FDA greenlights hepatitis B vaccine according to : CNBC

While the FDA committee's review said Heplisav's treatments were effective, the FDA does not need to follow the advice of its committees. The immunotherapy company is developing Heplisav as a hepatitis B vaccine treatment for adults. The majority of an FDA advisory committee voted "yes" when asked whether data support the safety of Dynavax's Heplisav. "We now believe that Heplisav has a high probability of approval by the August 10th [FDA review deadline]." Dynavax stock rocketed up more than 70 percent in midday trading Monday after an FDA panel voted in favor of the company's primary drug under development.




During the trial, though, 14 people in the Dynavax group had heart attacks compared to just one in the conventional vaccine group. This article was updated to reflect the FDA's request for more information about the Dynavax vaccine. Since the Dynavax group was twice as large, the heart attack risk was seven times higher with the new vaccine. The advantages of the Dynavax vaccine were demonstrated in a randomized trial of more than 8,000 patients: About 5,600 received the new vaccine and about 2,800 received the existing standard hepatitis B vaccine. But if the 7-1 imbalance reflected a real increase in cardiovascular risk, then approving the Dynavax vaccine would be problematic.

Lyme disease vaccine is fast-tracked for FDA approval

The expedited approach with fast-tracked therapies, such as the Lyme vaccine, means the FDA will accept less data for approval and that studies of the vaccine can continue after it goes on the market. "A Lyme disease vaccine is important," Marcos said. Lyme disease cases are concentrated along the Eastern Seaboard and throughout portions of the Midwest, experts said. A vaccine to prevent Lyme disease is being fast-tracked for approval by the U.S. Food and Drug Administration to address what public health officials say is the most rapidly growing vector-borne disease in the United States. Photo Credit: Alamy Stock Photo / RGB VenturesLuft, who himself has developed a Lyme vaccine, said that any inoculation aimed at Borrelia burgdorferi — the bacterium that causes Lyme disease — must address the variations seen in the organism.


collected by :Lucy William

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