Warp Speed Lives Up To Its Name: FDA Planning Late October Vaccine Advisory Committee

Preliminary plans for an Oct. 22 meeting of US FDA's vaccine advisory committee suggest a fast evaluation of COVID-19 immunizations, bringing mixed reactions from onlookers who say it could be a positive sign of needed public transparency or an indication the agency is rushing to approve a product ahead of the November presidential election.

Covid19_Vaccine_Vial
COVID-19 vaccines may be the subject of an October FDA advisory committee • Source: Shutterstock

Preliminary plans for a late October meeting of the US Food and Drug Administration’s vaccine advisory committee suggests FDA may be laying the groundwork for a potentially quick decision on one or more COVID-19 vaccine candidates, the first of which are just commencing Phase III studies.

Paul Offit, a member of the Vaccines and Related Biological Products Advisory Committee and director of the Vaccine Education Center...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

More from US FDA

PS-AgencyLeadership (Premium-1): Study Reveals How Immune System of Astronauts Breaks Down

Recent studies show that spaceflight can significantly weaken astronauts’ immune systems, making them more susceptible to infections and health complications during and after missions. Understanding these changes is crucial for ensuring the safety of future long-duration space travelers.

Nancy Test Circulable Section Geography

 

This is a short description

New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming

 

Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

 

The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.

More from Agency Leadership

New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming

 

Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

 

The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.