IP experts share views on a range of critical issues around the proposed US-backed patent waiver for COVID-19 vaccines. Proprietary materials once public can’t be pulled back, one cautioned, while others indicated the waiver risk may be the stick that pushes companies to toe the tech transfer line.
The US government’s decision to back the waiver of intellectual property (IP) protections for COVID-19 vaccines is seen as momentous. But some legal experts note that the text-based negotiations to follow are not going to be easy and will likely require heavy-duty diplomatic efforts to align views, if at all.
A cross-section of IP experts suggested there was still a long road ahead and the scope of the proposed waiver...
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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