Janssen’s Ad26.COV2-S is the latest COVID-19 vaccine to be authorized for emergency use in Brazil. The country’s drugs agency has also received an emergency use request from Lilly for its monoclonal antibody combination, banlanivimab and etesevimab, for treating COVID-19.
The Brazilian medicines regulator, Anvisa, has granted temporary emergency use authorization (EUA) to Janssen Pharmaceutical Cos.’ coronavirus vaccine, Ad26.COV2-S. It has also received a second emergency use request for Russia’s Sputnik V vaccine after the first was sent back to the applicant for more information in January.
Anvisa has approved manufacturing facilities for both of the vaccines. However, it refused good manufacturing practice (GMP) certification for the...
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.
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.
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