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

Executive Summary

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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The Other COVID-19 Vaccine Race: GSK Leads In Adjuvant Field, But Dynavax And Novavax Making Moves

The certainty that any COVID-19 vaccine will see demand outstrip supply could be an inflection point for the once-quiet field of novel vaccine adjuvant research, which promises to enhance immune response and lower the vaccine dose required.

Dynavax Will Not Pursue Narrow Indication For Heplisav After Meeting With FDA

The company will be collecting additional safety data for approval of its hepatitis B vaccine in adults 18 to 70 years old; the size, duration and cost of the study are yet to be determined.

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.

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