Dear Colleagues,
Greetings!
I am writing to raise a question regarding the recent WHO-prequalified Hexavalent vaccine (HEXASIIL) manufactured by SII. There has been growing interest in switching from Penta to Hexa due to its potential advantages, such as a reduction in the number of injections needed, potential cost savings, fewer cold chain requirements, waste reduction, and additional opportunities to administer IPV doses. However, upon reviewing the available information from WHO, UNICEF, and the product's package insert, I have noticed some critical data points are missing. Specifically, there is no indication of the Vaccine Vial Monitor (VVM) type or the reliability of the shake test in case of freezing exposure.
This information is essential as it can help us advocate more effectively for the switch. Having the Inactivated Polio Vaccine (IPV) as a combined antigen in a more stable formulation adds significant value to the Hexavalent vaccine, especially in fragile contexts. It increases resilience against cold chain failures, which is a crucial consideration in a challenging operational environment.
From the data available, it is understood that the Hexavalent vaccine is an aluminium-based adjuvant vaccine. Given this, is the applicability of the shake test in case of freezing exposure still relevant? Additionally, my understanding is that for combined, multi-antigen vaccines, the VVM corresponds to the most heat-sensitive antigen. In the case of Hexa, is it VVM 7 (as standalone IPV) or do we have a more stable vaccine with VVM Type 14?
Your insights and any additional information on these matters would be highly appreciated.
Thank you
Dear Mohamad, thank you for asking this interesting question.
The vaccine has an aluminum-based adjuvant and as such the shake test should apply.
https://iris.who.int/handle/10665/270736
Noting that the feasibility of the shake test is not assessed as part of the prequalification procedure. It is a generic test that is used, when necessary, in aluminium adjuvanted vaccines.
Regarding confirmation of the VVM type, I don't have the exact timeframe but I believe this will be provided by PQS colleagues shortly.
Hope this is helpful.
Dear Mohamad, thank you for tabling the issue .
Regarding the VVM type of Hexavalent vaccine , Please check GAVI detailed product profiles , It noted as VVM type 14 , diffrently with the IPV VVM type .
Thank you, Dan. I appreciate the clarification and the reference link.
Thank you, Mengesha. I'll review the GAVI product profiles for the VVM type of the Hexavalent vaccine.
Dear Mohamad,
Some updates for your questions based on my latest information:
The shake test is suitable to SIIPL (Serum India) hexavalent vaccine since it contains an aluminium phosphate adjuvant.
For VVM tyoe: If WHO approves the submitted study report, it will receive VVM-11.
Best Regards,
Murat
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