Walensky Defends Decision To Go Against Advisors On Pfizer COVID Booster Recommendation

 
• By Sarah Karlin-Smith and Sue Sutter
  
Generate a summary of this article
Listen to this article
Beta

‘If I had been in the room, I would have voted yes,’ CDC director says of ACIP. ‘This was a scientific close call. ... And that was how my recommendations came out after listening to all of their scientific deliberations.’

CDC Director Rochelle Walensky
CDC Director Speaks About Pfizer Booster Decision At White House Briefing • Source: screenshot

US Centers for Disease Control and Prevention Director Rochelle Walensky said that the “close call” nature of the agency’s vaccine advisor’s decision not to recommend a third dose of the Pfizer Inc./BioNTech SE’s Comirnaty vaccine in people at high risk of COVID-19 due to their occupational or institutional setting, gave her the prerogative to make her own determination.

Walensky, speaking 24 September at a White House COVID-19 briefing, ostensibly argued that when decisions come down to judgement calls...

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".

SpotifyApple PodcastsWebsite

More from Vaccines

COVID Vaccines: US FDA Changes Course, Wants New Formulas To Target KP.2 Subvariant ‘If Feasible’

 
• By Sue Sutter

Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’

GSK’s Bexsero Dangles No More: Meningococcal B Vaccine Converts To Regular Approval

 
• By Sue Sutter

US FDA’s 2015 accelerated approval called for confirmatory trial completion by 2018, but study initiation was delayed. Completed in 2022, the trial not only verified Bexsero’s clinical benefit, it also served as the pivotal study for GSK’s pentavalent meningococcal vaccine candidate.

WHO To Finalize Preferred & Critical Characteristics Of New Mpox Human Vaccines

 
• By Vibha Sharma

To help sponsors developing candidate mpox vaccines, the World Health Organization will soon be finalizing guidance on the preferred and minimum characteristics these products must satisfy regarding efficacy, dose regimen and other aspects to secure regulatory approval.

WHO Urges Countries To Curb Spread Of Mpox With Vaccines, Therapeutics & Other Actions

 
• By Ian Schofield

The WHO’s emergency committee has warned of a lack of understanding of the epidemiology of mpox, the limited availability of vaccines, and the complexities of donations and procurement.

More from Pink Sheet

COVID Vaccines: US FDA Changes Course, Wants New Formulas To Target KP.2 Subvariant ‘If Feasible’

 
• By Sue Sutter

Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’

Nancy Tests New Podcast Template

 
• By Derrick Gingery

Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.

PinkSheet-R&D-Free: ‘Ranking’ article that includes different Composer content

 
• By Nabil, Olga Zviezdicheva, Reed Miller, Mary Jo Laffler, Ian Schofield, João Andrés-Ruíz de la Fontaine-LeBlanc, Chloë Anastasía-Stojanović del Castillo-Ribeirão, and Nabil

To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.