Unlike its response to incidents of blood clots with J&J’s vaccine, the US FDA is not calling for a pause in its administration following reports of about 100 cases of Guillain-Barré syndrome. CDC advisory panel is to discuss the issue at an upcoming meeting.
Johnson & Johnson’s COVID-19 vaccine has been associated with a small risk of Guillain-Barré syndrome, but unlike with its link to rare incidents of blood clots, the US Food and Drug Administration and Centers for Disease Control and Prevention are not requesting a pause in the administration of the shot.
The CDC issued a statement on 12 July noting that the CDC and FDA are monitoring reports of Guillain-Barre syndrome...
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.’
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.
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.
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.
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
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.’
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.
