‘Show Us The Data': Plan To Speed Pfizer COVID Vaccine OK In Kids Under Five Draws Questions

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

Experts express cautious optimism that FDA and Pfizer have some data signaling potential efficacy for a vaccine in children under 5 despite an initial trial flop but raise concerns about the absence of public communication amid the apparent rush to an EUA. An advisory committee is scheduled for 15 February.

very cloudy day
FDA and Pfizer Have Offered Little Clarity On What New Data May Justify Earlier Than Expected Vax OK In Under 5 • Source: Alamy

Pfizer Inc. and BioNTech SE initiated a rolling submission of an emergency use authorization on 1 February for a two-shot version of the sponsors' COVID-19 vaccine in children under 6 months through 4 years of age following reports that the US Food and Drug Administration and other government officials had said there may be a way to move forward with an authorization in this age group despite a failed immunobridging study in the 2 to 4 cohort.

The FDA simultaneously announced it will convene its Vaccines and Related Biologics Advisory Committee to review the EUA on 15...

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.