A groundbreaking oral vaccine called Euvichol-S has recently received prequalification from the prestigious World Health Organisation.
According to a recent press release by WHO published on their official website, this significant milestone was achieved on the 12th of April, 2024.
WHO’s mission with vaccine prequalification is to guarantee the safety and effectiveness of vaccines utilized in immunization programs. By prequalifying vaccines, WHO meticulously assesses whether they meet international standards in terms of safety and efficacy.
In addition, WHO ensures the ongoing safety and efficacy of prequalified vaccines through regular assessments, site visits, targeted examinations, and thorough investigations of any concerns or adverse events post-immunization.
National regulatory bodies and control laboratories within countries play a crucial role in WHO’s vaccine prequalification process, as they oversee regulatory matters, testing, and the distribution of WHO-prequalified vaccines.
The recently prequalified inactivated oral vaccine, Euvichol-S, has been recognized by WHO for its comparable efficiency to existing vaccines. The streamlined formulation of this vaccine opens up possibilities for rapid scale-up in production capacity.
The development and production of Euvichol-S is the outcome of a collaborative effort involving EuBiologics, the International Vaccine Institute, and the Bill and Melinda Gates Foundation.
Dr. Rogerio Gaspar, Director of WHO’s Department for Regulation and Prequalification, expressed his optimism stating, “The new prequalification will hopefully facilitate an accelerated increase in production and supply, addressing the urgent needs of communities grappling with cholera outbreaks.”
In Nigeria, cholera remains a prevalent seasonal disease, particularly during the rainy season and predominantly in areas with inadequate sanitation.
Notably, 2022 witnessed a significant surge in reported cholera cases, doubling in number compared to the previous year. An additional increase of 700,000 cases was projected for 2023. Presently, 23 countries are combatting cholera outbreaks, with severe impacts seen in nations such as Comoros, the Democratic Republic of the Congo, Ethiopia, Mozambique, Somalia, Zambia, and Zimbabwe.
Recognizing the paramount role of vaccines in preventing and managing cholera outbreaks, WHO highlighted the challenges faced by several countries due to insufficient supply. This underscores the crucial need for adequate resources in essential areas like safe water, hygiene, and sanitation.
Embracing the news of the newly prequalified vaccine, Gavi, the Vaccine Alliance, and the United Nations Children’s Fund emphasized the positive impact that this development would have on expanding vaccine availability and accessibility at a reduced cost.
As the largest-ever global deployment of cholera diagnostic tests is announced, Gavi, UNICEF, and partners are set to distribute over 1.2 million diagnostic tests across 14 high-risk countries in the upcoming months.
Dr. Derrick Sim, Managing Director of Vaccine Markets & Health Security at Gavi, hailed the prequalification of Euvichol-S as a crucial lifeline for vulnerable communities around the globe. This approval comes at a pivotal time amidst the escalating cholera outbreaks worldwide.
Eager to facilitate more countries in accessing cholera vaccines, UNICEF has already secured access to the newly approved doses and is committed to expediting their delivery.
With the approval of this new vaccine, UNICEF anticipates a significant increase in procurement and distribution, further strengthening the response against deadly cholera outbreaks.