August 6, 2018
FDA Approves Experimental Hepatitis B Vaccine for Adults Despite Higher Incidence of Heart Attacks by [Rishma Parpia
](FDA Licenses New Hepatitis B Vaccine Despite Big Safety Concerns – The Vaccine Reaction)The Vaccine Reaction
In February 2018, the Advisory Committee on Immunizations Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) approved the recommendation for a new hepatitis B vaccine, Heplisav-B (HepB-CpG) targeting for adults over the age of 18.1
Heplisav-B is manufactured by Dynavax Technologies Corp. and the new vaccine is given in a two-dose series versus the three dose recommendation for Merck’s Recombivax hepatitis B vaccine licensed in 1986 and Glaxo Smith Kline’s Engerix-B vaccine licensed in 1989.
The U.S. Food and Drug Administration (FDA) had twice rejected Dynavax’s application for licensure for Heplisav-B in the past four years because of safety signals.2
In Dynavax’s third attempt, the FDA granted the license in November 2017, despite unresolved safety concerns. Below is the sequence of events leading to licensure of Heplisav-B.
In 2013, the FDA rejected Dynavax’s license application for Heplisav-B for the first time due to the regulatory agency’s concern that the experimental vaccine’s new adjuvant, which was designed to boost immunogenicity, could lead to development of autoimmune disorders.3
Heplisav-B differs from other licensed hepatitis B vaccines in that it contains a new synthetic adjuvant known as cytosine phosphoguanine 1018 (CpG 1018) composed of short synthetic DNA molecules.4
Hepatitis B vaccines previously licensed in the U.S contain alum adjuvants (aluminum salts), which stimulate a general inflammatory response.3
CpG 1018 is believed to stimulate a more specific inflammatory response by producing hepatitis B surface antigen-specific antibodies against the hepatitis B virus.3
According to an article published in Medscape, the first application by Dynavax Technologies for licensure of Heplisav-B vaccine was rejected by the FDA for the following reason:
Heart attack Testimonies from Israel
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