A new procurement deal will add to the rollout of COVID-19 vaccines at global level. However, the leaders of the COVAX Facility say that by the end of June they will face a shortfall of 190 million doses, mainly because of the crisis in India, and are calling on wealthier countries to increase their donations.
In a move that could signal the entry of Russia’s Sputnik V vaccine into global procurement schemes for the first time, UNICEF and the Russian Direct Investment Fund have signed a long-term agreement (LTA) for the supply of up to 220 million doses of the vaccine.
Procurement of Sputnik V under the LTA, which was signed with the RDIF’s wholly owned subsidiary, Human Vaccines LLC, is...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
