CDC panel approves new hepatitis B vaccine for adults

Dynavax Technologies Corporation's hepatitis-B has received unanimous approval from a Centers for Disease Control and Prevention advisory committee to add the product to the list of recommended vaccines for adults 18 and older. Photo by pixabay/PhotoLizM

Feb. 22 (UPI) — A new vaccine to prevent hepatitis B in adults has received unanimous recommendation from a Centers for Disease Control and Prevention advisory committee, Dynavax Technologies Corporation announced Wednesday.

In November, the U.S. Food and Drug Administration issued an approval for Heplisav B for adults 18 and older against hepatitis-B, which has no cure.

The vaccine has been on the market commercially since last month in the United States, and field sales team will actively begin selling Heplisav-B next week, the company said on Tuesday. The CDC still must review and publish the approval recommendation before it can be added to the agency’s list of recommended vaccines.

“With the ACIP’s recommendation, Heplisav-B has cleared an important milestone needed to position Dynavax to meet our long-term commercial goals,” Eddie Gray, chief executive officer of Dynavax, said in a press release. “Additionally, this recognition emphasizes the important role of Heplisav-B in the prevention of hepatitis B infection in adults, reinforcing our belief that our unique two-dose vaccine with demonstrated higher rates of protection versus Engerix-B, and a safety profile similar to three-dose vaccines, will become the new standard of care for adults.”

Dynavax’s vaccine requires two doses one month apart, compared with the three doses over a six-month period required by GlaxoSmithKline’s Engerix-B. Heplisav-B’s $115-per-dose wholesale price is also higher than GlaxoSmithKline’s $22.40 pricetag, according to FiercePharma.

Hepatitis B, a viral disease of the liver that is 100 times more infectious than HIV, can become chronic and lead to cirrhosis, liver cancer and death.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The CDC recommends adults age 19 to 59 with diabetes receive the vaccination, and for people age 60 and older with diabetes depending on their doctor’s opinion.

In the United States, an estimated 850,000 to 2.2 million people have chronic hepatitis B, according to the CDCIn 2015, the number of cases increased by 20 percent.


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