In the run-up to a major pandemic preparedness summit in London next month, CEPI has announced a new trial aimed at broadening access to vaccines in lower-income countries and has welcomed fresh funding for its plan to cut vaccine development times to 100 days.
An international trial has been launched to assess the benefits of administering reduced-dose COVID-19 booster shots in terms of maximizing global vaccine supplies, particularly in lower-income countries.
The trial is being led by the Coalition for Epidemic Preparedness Innovations (CEPI) and Australia’s Murdoch Children’s Research Institute (MCRI)....
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
An ongoing collaborative initiative involving global regulators assessing post-approval manufacturing changes has highlighted the need to establish a standardized platform that can facilitate the submission and regulatory evaluation of such changes.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
