Emerging Rotavirus Vaccines in Asia: ROTA Council Workshop Summary

The ROTA Council, the Vietnam National Institute of Hygiene and Epidemiology, POLYVAC and the U.S. Centers for Disease Control and Prevention convened global health experts at the 5th Asian Vaccine Conference in Hanoi, Vietnam on June 11, 2015 for a workshop to discuss emerging rotavirus vaccines for Asia.

This meeting was crucial because a healthy vaccine market—one with sufficient supply and competitive pricing—requires three to five globally licensed manufacturers, and currently there are only two for rotavirus vaccines, and there is a current global supply shortfall, which is affecting country introductions.

Highlights from the workshop include:

  1. The health burden and economic burden of rotavirus in Asia are high.
    Though rotavirus diarrhea mortality rates are lower in Asia than in Africa, the overall burden is serious.

    • Rotavirus accounts for 42 percent of diarrheal hospital admissions in Asia, according to the WHO-coordinated Asian Rotavirus Surveillance Network.
    • Though oral rehydration therapy (ORT) can treat mild and moderate cases of rotavirus diarrhea, severe rotavirus requires hospitalization. Not all children have access to ORT or hospital care.
    • Rotavirus strikes at earlier ages in lower-income countries, and many children become infected multiple times.
    • Preventing rotavirus in the first place is better than treating children when they become sick. Approximately one in five children under 2 years of age suffer from an episode of moderate to severe diarrhea each year, and these children are 8.5 times more likely to die within two months of this diarrheal episode after leaving the hospital. If they survive, they are more likely to have developmental delays.
    • There is a steep economic cost to governments and to families for treating rotavirus diarrhea. In addition to the direct medical costs to governments of outpatient visits and treatment, and hospitalization costs, families often pay for care, parents endure opportunity costs such as forgone income and sometimes pay high transportation costs to and from the hospital.
  2. Vaccine pricing remains a barrier, and more consistent or transparent pricing mechanisms are needed.
    Decision makers need accurate information on rotavirus vaccine pricing to evaluate and introduce rotavirus vaccines. Unfortunately, lack of transparency around true vaccine pricing, or lack of mechanisms to negotiate price prior to tendering, causes countries to use the private sector price in economic evaluation, leading to the possibly inaccurate conclusion that the vaccine is too high. For more detail, please see the past work of ROTA Council member Tony Nelson here and here.
  3. Manufacturers should think about the WHO prequalification process early.
    Communicating with WHO early in the vaccine development process and incorporating their feedback can help avoid a situation where a second-generation product is needed to obtain WHO prequalification. Guidelines can be found on the WHO website here. Connecting with key personnel at WHO by sending a list of questions and meeting participants in advance will help secure a meeting to discuss prequalification. Information about expediting prequalification can also be found on the WHO website.
  4. Manufacturers must keep in mind the settings in which their vaccines will be used.
    Packaging size and cold chain requirements can impact the decision to introduce—or not—a vaccine into a country’s national immunization program.