Today, 18 September 2024, Gavi, the Vaccine Alliance, and Bavarian Nordic signed an Advanced Purchasing Agreement (APA) for the supply of 500K vaccinesโso let’s look at the process.
Following lessons learned from the COVID-19 pandemic, Gavi, the Vaccine Alliance, established the First Response Fund in June 2024. The fund provides funds for the purchase of vaccines in the event of a public health emergency, but only under certain conditions.
1. ๐๐ฒ๐ฐ๐น๐ฎ๐ฟ๐ฎ๐๐ถ๐ผ๐ป ๐ฏ๐ ๐๐ต๐ฒ ๐ช๐๐ข
The fund cannot be triggered unless the WHO declares a Public Health Emergency of International Concern (PHEIC). Thus, even though the Mpox situation was evolving, the fund could not be triggered before the WHO’s declaration on August 14. This creates a dependency on the WHO, which could result in delays, while also possibly putting pressure on the WHO to declare a PHEIC. In my view, this dependence should be reevaluated.
2. ๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐ฎ๐ฝ๐ฝ๐ฟ๐ผ๐๐ฎ๐น
Only vaccines with WHO prequalification can be purchased using the fund. As a result, there was pressure on the WHO to speed up authorization. Last week, the WHO prequalified Bavarian Nordic’s MVA-BNยฎ mpox vaccine (see my previous post).ย In my view, this dependency should be reevaluated, particularly in circumstances where other strict regulatory agencies (like the FDA or EMA) have authorized the vaccines.
3. ๐ฃ๐ฟ๐ถ๐๐ฎ๐๐ฒ ๐๐ผ๐ป๐๐ฟ๐ฎ๐ฐ๐๐ถ๐ป๐ด
After getting the regulatory declarations and approvals, contracting begins. The good news is that GAVI and Bavarian Nordic signed an Advance Purchase Agreement today, committing to supply 500K doses in 2024. Bavarian Nordic is also preparing to sign a supply contract with UNICEF, which will deliver the doses in Africa.
There will be more regulatory and contractual matters at the national level. That’s why having the legal infrastructure in place is so critical for dealing swiftly with health emergencies.
For more details on Gavi’s First Response Fund, see here. For more details about the APA, see here. My post on LinkedIn, is here.