Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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.

You may also be interested in...

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.

Related Content


Related Companies

Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts