Advisory Committee on Immunization Practices recommends vaccination based on shared clinical decision-making in individuals ages 27-45 years old – but says only those at high risk of contracting HPV are likely to benefit and should get the vaccine.
A US advisory committee endorsed a significant expansion of the population recommended to receive Merck & Co. Inc.’s human papilloma virus vaccine Gardasil 9 but attached an important caveat – vaccination is justified only for high-risk individuals, who likely represent a fraction of this broader group.
The question remains, however, how individuals at high risk of contracting the sexually transmitted virus will be identified.
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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