J&J COVID-19 Vaccine Pause Expected To Be Brief, But Subsequent Use May Be Restricted

 
• By Brenda Sandburg
  
Generate a summary of this article
Listen to this article
Beta

CDC’s ACIP likely to discuss criteria needed to lift pause and whether to recommend that the vaccine not be used in specific groups. Former CBER official says FDA and CDC will look at reports for other adenovirus vector vaccines, including J&J’s Ebola vaccine, and the biological plausibility that cases of rare blood clots are directly associated with the vaccine.

J&J vaccine pause.
The US FDA, CDC, J&J have all hit the pause button on its COVID vaccine. • Source: photo illustration/Shutterstock

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will take the immediate next steps to determine what happens with Johnson & Johnson’s COVID-19 vaccine following the call for a pause in its administration. Experts believe use of the vaccine will resume as government agencies continue to investigate the cause of severe rare blood clots in women aged 18 to 48 and that there is a possibility a subgroup will be directed to use other vaccines.

Norman Baylor, former director of the Office of Vaccine Research and Review in the FDA’s Center for Biologics Evaluation and...

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.