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Dynavax Hepatitis B Vaccine Could Get Comparative Post-Market Autoimmunity Assessment

This article was originally published in The Pink Sheet Daily

Executive Summary

The observational study would look at Dynavax’s Heplisav and GlaxoSmithKline’s Energerix-B, according to FDA briefing materials for the Vaccines and Related Biological Products Advisory Committee’s Nov. 15 review of Heplisav for adults 18 to 70 years of age.

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Heplisav’s Hopes For U.S. Approval Could Rest On Narrower Population

In a “complete response” letter for the novel, adjuvanted hepatitis B vaccine, FDA cites the need for more safety data in the broad population of adults for which approval was sought; however, Dynavax says the agency appears open to considering a more restricted use, such as in patients with chronic kidney disease.

Heplisav’s Hopes For U.S. Approval Could Rest On Narrower Population

In a “complete response” letter for the novel, adjuvanted hepatitis B vaccine, FDA cites the need for more safety data in the broad population of adults for which approval was sought; however, Dynavax says the agency appears open to considering a more restricted use, such as in patients with chronic kidney disease.

Vaccine Adjuvant Heightens Panel’s Worries About Rare Adverse Events With Heplisav

FDA’s Vaccines and Related Biological Products Advisory Committee recommended 8 to 5 with one abstention that Dynavax acquire more safety data pre-licensure for its hepatitis B vaccine.

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