From Vietnam to the world: How PATH helped ready locally-made influenza vaccine for global use

Dr. Vu Minh Huong talks about influenza vaccines with the same type of excitement one might discuss an upcoming dream vacation. His eyes are bright, his hands are moving, and his voice is buoyant. Now PATH’s Mekong Regional Technical Director, he has been working on vaccination and immunization projects for 20 years. He firmly believes vaccines are one of public health’s most important success stories; he champions vaccine access and acceptability; and he even recalls vaccination clinics—and the frightened children who make up a large portion of the attendees—with a whimsical fondness.

“Not many other people feel happy when they see children crying, but I do—when it’s from a vaccine!” he admits with a laugh. “Their cries mean they are protected. That they are safe.”

And when he talks about influenza vaccine production in Vietnam? He’s almost giddy.

“There is confidence in Vietnam now,” he says. “In the beginning, not a single dose of influenza vaccine could be produced here. But now, we are on the verge of being able to protect millions of people. Of being able to respond to significant outbreaks. This will be our legacy.”

Dr. Huong has been a member of PATH’s influenza vaccine development project since it began in 2009. The project is a collaboration with the World Health Organization (WHO) and the Biomedical Advanced Research and Development Authority, within the US Department of Health and Human Services, to provide technical assistance to vaccine manufacturers in low-resource countries as they strengthen development capacity and usher locally-made influenza vaccines toward licensure. The project also builds on the WHO’s Global Action Plan for Influenza Vaccines (GAP), a comprehensive strategy to reduce the global shortage of seasonal and pandemic influenza vaccines.

A key component of that strategy is to bolster seasonal influenza vaccine production.

Why? Because seasonal production is the backbone of pandemic preparedness; by maintaining manufacturing capacity on an ongoing basis, producers are able to smoothly transition between products in the case of a pandemic.

The next influenza pandemic is not a case of “if,” but “when.” And in Vietnam, a country of more than 92 million people without a steady supply of influenza vaccine, that’s a chilling thought.

“It is a very dangerous position,” Dr. Huong warns. “We’ve seen A/H5N1 here on small scales; it could so easily get bigger.”

Vietnam is uniquely vulnerable to A/H5N1. A highly pathogenic avian strain that spreads widely among poultry, and sometimes infects humans, A/H5N1 causes fast-acting, severe illness and has a high mortality rate. In an agricultural country like Vietnam, where people often live in close quarters with poultry, it’s not hard for the disease to pass to humans. It has done so sporadically, most severely in 2003, when more than 60 people died. Vietnam is also located near China, which itself has experienced outbreaks of A/H5N1 and A/H7N9. A/H5N1 does not currently pass easily between humans, but with just minor mutations that could all change, and health security in Vietnam—and the surrounding region, and even the world—could crumble.

But Dr. Huong is reassured by the significant progress he has seen. PATH and its partners have been working diligently to ensure Vietnam is able to protect itself, and the surrounding region, when the next pandemic comes.

Affordable influenza vaccines can be hard to produce in large quantities, and production is mostly concentrated in the industrialized world—meaning, low- and middle-income countries are often the last to receive vaccines, if they can afford them at all. We can reverse those trends, though, by increasing manufacturing capacity in those same low-resource countries. Which is exactly why state owned vaccine manufacturer the Institute of Vaccines and Medical Biologicals (IVAC) has been working on influenza vaccine development for more than a decade. It has racked up quite a list of achievements, including vaccines against the pandemic strain A/H1N1, the pre-pandemic strains A/H5N1, and A/H7N9, and a trivalent seasonal influenza vaccine. The pre-pandemic A/H5N1 and seasonal vaccines are expected to be licensed for use by early 2019.

It took a lot of work. IVAC has been successfully producing vaccines for decades, but influenza vaccine was a new challenge; and, in order for the eventual vaccine to be made available on the global market, it needed to be developed according to international standards. This required IVAC to make changes that ranged from building a new manufacturing facility to adopting new laboratory practices to learning how to raise chickens (influenza viruses for vaccines are grown in chicken eggs) and conducting clinical trials.

PATH provided technical assistance throughout. We helped operationalize the manufacturing facility, provided support during clinical trials, and conducted numerous trainings and workshops. But importantly, IVAC’s need for support has lessened over the years as its expertise has grown.

“IVAC is almost a different institute now, with how much they’ve changed,” says Dr. Huong. “In the beginning we provided quite a bit of support, but now they are so independent. They are a very committed manufacturer and we have such confidence in them to move forward successfully.”

IVAC’s success is the linchpin in Vietnam’s pandemic preparedness efforts, but its vaccines could have an impact far beyond the country’s borders. IVAC has a commitment with the WHO as part of the GAP program: in the case of a global influenza pandemic, IVAC will provide WHO with pandemic vaccine for use anywhere it is needed globally. This project isn’t just about protecting one’s own borders; it is about extending health security to everyone.

Now, the project is coming to an end; and, while there is still work to be done in terms of manufacturing processes, much of the conceptual challenges—changing minds, changing behaviors, changing perceptions—are over. The mental roadblocks that can impede success are gone and Vietnam’s vaccine manufacturers have set a new standard for what a quality vaccine looks like—an achievement that goes far beyond flu.

“We are in such a better position than we used to be,” says Dr. Huong. “We are stronger against flu and we are better manufacturers. Influenza vaccine is our success story, but increased capacity is our legacy. Now Vietnam has the tools to fight many more diseases.”

Vietnam now looks forward to vaccine licensure, and introduction. Dr. Huong is confident that IVAC’s vaccine will lead to increased demand—which in turn will lead to increased awareness of the dangers of influenza and a better protected public. And, ultimately, a weapon in the fight against pandemic flu.

Dr. Huong is also excited to begin thinking about influenza disease in a new way.

“Before you introduce a new vaccine, you have to determine disease burden and strengthen disease surveillance, so you know, to the numbers, how many people are affected by a disease,” Dr. Huong says. “After introduction you continue to monitor, but the change is so striking. You’re no longer counting how many people are dying, you’re counting how many people are living.”

Vietnam is finally ready to change its count.

• Defending the world from influenza: As a nine-year project to build vaccine development capacity worldwide comes to an end, PATH and partners reflect on how far we've come
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• Vietnam’s vaccine champion: Why Dr. Le Van Be fights influenza
• Building a new influenza vaccine: A longtime vaccine manufacturer conducts its first clinical trial
• The power of local: Can a domestically produced vaccine increase uptake?

• Vietnam welcomes two locally produced vaccines for seasonal and pandemic use press release
• Enhancing Influenza Vaccine Development in Low-resource Countries: Pandemic Preparedness Through Seasonal Sustainability report
• Supporting Influenza Vaccine Production in Vietnam fact sheet
• Moving the Needle e-newsletter
• Immunization Matters e-newsletter