Companies and organizations that signed the contracts deny any heavy-handedness, with Johnson & Johnson saying it worked closely with South Africa on vaccine supply, and the vaccine alliance Gavi noting that the COVAX Facility provided the country with more than nine million doses free of charge.
The COVID-19 vaccine procurement contracts signed with the South African government were “overwhelmingly one-sided” in favor of multinational companies,” and were characterized by “unusually hefty demands and conditions,” including secrecy and a lack of transparency.
That is the view of the non-governmental organization, Health Justice Initiative, which claims that “Big Pharma held South Africa to...
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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