Why we love vaccine prequalification

Close-up portratit of four young children, smiling.

Prequalification of an affordable Japanese encephalitis vaccine means protection for millions of children. Photo: PATH/Lesley Reed.

At PATH, we’ve long known that vaccines protect children from early death and devastating disability, but they only work if they are safe, effective, affordable, and available.

That’s why we’re so enthusiastic about this week’s World Health Organization (WHO) prequalification of a vaccine against Japanese encephalitis (JE). It’s a milestone we and our partners have been working toward for more than a decade, and it means millions of children may be spared the heartbreaking effects of a disease that severely disables when it doesn’t kill. (For the details, see the fascinating story behind the quest for this vaccine.)

What it means now

Young boy gazes at camera, with the words, "Japanese encephalitis vaccine: approved by WHO for lifesaving use across Asia. Learn more."

Photo: PATH/Gabe Bienczycki.

In the vaccine world, WHO prequalification is essential to protecting children from diseases like Japanese encephalitis. The prequalification process promotes international standards for vaccine production. When a vaccine earns prequalification, countries that run immunization programs and groups that buy vaccine or fund purchases, such as the GAVI Alliance, have the assurance they need that a vaccine is safe, effective, and suited for use in poor countries.

The numbers, though, really illustrate the importance of prequalification to a vaccine’s success: two-thirds of all babies—that’s all babies, worldwide—are immunized using WHO prequalified vaccines.

What it means for the future

Clearly, this is a hopeful and heartening win for global health, and for the four billion people who live in regions, mostly in Southeast Asia and the Western Pacific, where Japanese encephalitis is still unchecked. In addition, it signals encouraging changes ahead for collaborative partnerships, for the global health marketplace, and for China’s potential for further contributions to solving the world’s biggest challenges.

The vaccine is manufactured by Chengdu Institute of Biological Products Co., Ltd., a subsidiary of the leading vaccine manufacturer in China, China National Biotec Group, Ltd. That makes it the first vaccine made in China to receive WHO prequalification—a first that was noted by many of our leaders and partners when we asked them about the significance of this milestone. Their thoughts follow.

An “audacious goal” in reach

“This milestone brings the world within reach of an audacious goal: the elimination of a devastating disease through expanded access to an affordable and lifesaving vaccine. Our groundbreaking collaboration with leading Chinese partners also helped lay the foundation for reshaping global vaccine supply, pricing, and accessibility through increased competition. This milestone signals China’s rising importance as a global supplier of high-quality vaccines for the most vulnerable children in the world.”

—Steve Davis, PATH president and CEO

“A victory for millions of children”

“China’s emergence as a supplier of high-quality, low-cost vaccines for developing countries is a victory for millions of children in Asia who will no longer be vulnerable to a deadly and disabling disease. Vaccines work to save and improve lives and protect children for a lifetime.”

—Bill Gates, cochair of the Bill & Melinda Gates Foundation, a funder of the Japanese encephalitis vaccine

Access to “a safe, affordable vaccine”

“Today’s prequalification means that all communities in JE regions will have access to a safe, affordable vaccine. We’ll now work with our global health and in-country partners to accelerate the delivery of this vaccine to children in low-resource settings who are most vulnerable to the disease and its severe consequences.”

—Dr. Kathleen Neuzil, director of PATH’s Vaccine Access and Delivery Program

“Proud to be the first”

“We have reached two major milestones today. In addition to achieving WHO prequalification of our JE vaccine, we are proud to be the first Chinese manufacturer to produce a WHO-prequalified vaccine. As one of the largest vaccine manufacturers in the world, we take our mission of providing safe, effective, and affordable vaccines very seriously. With PATH’s support and WHO’s prequalification, we’re proud to bring China onto the global stage as an important vaccine supplier serving GAVI-eligible countries.”

—Dr. YANG Xiaoming, CEO of China National Biotec Group, Ltd.

More information

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