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FDA vaccine advisory committee meets Thursday

The Food and Drug Administration (FDA) will hold an advisory committee meeting on Thursday to discuss progress towards a vaccine for COVID-19.  The FDA says the discussion will cover “the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting.”

According to the biotech pharmaceutical journal BioPharma Dive, FDA advisory committee updates are usually staid affairs–but this one may have thousands of online viewers.

There is no expectation any specific vaccine candidate will be discussed in depth, and no decisions on Emergency Use Authorization will be made.  But according to BioPharma Dive, “Late-stage clinical trials enrolling hundreds of thousands of volunteers are underway. The outside experts comprising the advisory committee will be asked what additional research must be done to assess the shots’ safety and effectiveness. In particular, the discussion could focus on the use of vaccines in under-studied or at-risk populations, safety evaluations for any granted emergency authorization and the likely durability of any protective benefit shown.”

For the BioPharma Dive story, click here.

The FDA meeting is scheduled for Thursday, Oct. 22, starting at 4 a.m. HST and going until around 11 a.m. HST, and may be viewed at the FDA’s You Tube Channel…click here.

BioPharma Dive provides in-depth journalism and insight into the most impactful news and trends shaping biotech and pharma. The newsletter and website cover topics ranging from clinical readouts to FDA approvals, gene therapy to drug pricing and M&A to research partnerships.

 

 

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