COVID-19 Vaccines: BIO Pushes For EUA Guidance, While HHS’ Azar Downplays Its Importance

Guidance's release would provide regulatory clarity to scientists and strengthen public confidence in any vaccine authorized by the FDA, trade group says, but Alex Azar tells Congress the controversy over the unpublished document is overblown and making a ‘mountain out of a molehill.'

assorted molehills
To HHS' Alex Azar, the vaccine EUA guidance is a molehill turned into a mountain. • Source: Shutterstock

US Food and Drug Administration guidance on emergency use authorization for COVID-19 vaccines should be publicly released to provide regulatory clarity to scientists and researchers and strengthen public confidence in any vaccine authorized by the agency, the Biotechnology Innovation Organization says.

“All new FDA guidance should be finalized and communicated with those on the frontlines developing potential vaccines,” BIO president and...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Vaccines

Pink Sheet Podcast: CBER Director’s Political Spin On COVID-19 Vaccines And US FDA RIFs Finalized

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad using an unproven theory to help explain his COVID-19 vaccine decisions and the impact of the recently finalized reduction-in-force at the FDA.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.

Valneva Expects UK And France to Lift Ixchiq Age Restriction Following EMA Decision

 

Other authorities are expected to mirror the European Medicines Agency’s decision to lift the temporary restriction it placed on using Valneva’s chikungunya vaccine in people aged 65 years and older.

Senate Panel Approves US CDC Director Candidate Monarez With Measles Outbreak Growing

 
• By 

The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.

More from Pink Sheet

Blenrep Review Highlights US FDA Oncology Trial Site Selection, Comparator Issues

 
• By 

The FDA will take a hard line on trial design and site selection to ensure applicability to the US, Oncology Center of Excellence Director Richard Pazdur said during a meeting on GSK's Blenrep.

340B Transparency: CMS Proposes Claims Repository For Medicare Part D Drugs

 
• By 

The plan was announced as the White House Office of Management and Budget discusses with stakeholders a widely anticipated guidance about the 340B rebate model, which is being advanced by manufacturers to enhance transparency and control ballooning discounts in the program.

US FDA Commissioner Makary Is Learning To Appreciate His Staff

 

After three months on the job, FDA Commissioner Martin Makary is sounding much more effusive about the quality of the agency staff. Better late than never?