A syringe and vaccine vials. Photo by: Dawn / CC BY

KATHMANDU, Nepal — A new vaccine against rotavirus made by the Serum Institute of India — the world’s largest vaccine manufacturer — and tested in Niger by Médecins Sans Frontières, is being hailed as a major public health breakthrough for children.

The vaccine, called Rotasil, or BRV-PV, is 67 percent effective in preventing severe episodes of rotavirus-related diarrhea, according to results of its trial published in the New England Journal of Medicine earlier this year. That could put it ahead of existing oral vaccines, GSK’s Rotarix or Merck’s RotaTeq, which showed 49 percent efficacy in Malawi and 42 percent in Bangladesh.

Rotasil will likely be cheaper than the two available vaccines, and it will fill a key supply gap; there is a global shortage of both these options. Also, unlike its peers, Rotasil can last up to six months in extreme heat without refrigeration.

The vaccine, which is currently under examination for acceptability by the World Health Organization, could make a significant impact in efforts to combat preventable pediatric diarrhea. Rotasil is expected to be qualified by the WHO by the end of the year, meaning it can be purchased in bulk by agencies such as UNICEF and Gavi, The Vaccine Alliance. The prequalification assessment is intended to provide assurance that vaccines meet the WHO’s recommendations on quality, safety and efficacy.

The development of Rotasil is also evidence of a growing drug development sector in India, a country previously known for remaking existing drugs in generic form. With its expertise in economical production, India’s drug industry could provide a significant boon to research on diseases that primarily affect the developing world.

“India’s vaccine and drug development industry is becoming a big player in the world,” Heidi Larson, director of the Vaccine Confidence Project at the London School of Hygiene and Tropical Medicine, told Devex. “While the research and development end is growing, India will continue to be an important producer.”

In addition to Rotasil, India-made vaccine Rotavac is also in the pipeline to be prequalified by the WHO. Manufactured by Bharat Biotech International Ltd., it was licensed for use in India in 2014. Clinical trials in India show that it is 56.4 percent effective.

“We anticipate that both new vaccines will contribute to the global supply which will then increase the number of children vaccinated,” said Dr. Duncan Steele, deputy director of the Bill & Melinda Gates’ Enteric Diarrheal Diseases team.

Passing the trial

The 2015 trial in Niger was a huge undertaking involving 300 medical personnel. A health worker spent 24 hours a day in each of the 132 villages that the 3,508 children lived in, according to Rebecca Grais, director of research at Epicentre, an association created by MSF to provide epidemiological expertise to the organization.

“All these people worked really hard. People who worked on this trial were dedicated on a personal level—it’s important to them and their communities,” she said.

Niger, with its extreme poverty and heat, was selected for those two reasons: researchers and scientists knew that if the vaccine showed promising results in such a challenging environment then the same or even better results could be replicated elsewhere.

The trial was carried out by MSF in collaboration with the Nigerien Ministry of Health, the Serum Institute of India, and other partners.

Healthy infants received three doses of Rotasil or the placebo at 6, 10 and 14 weeks of age. Among the 1,780 children who received three doses of the vaccine, there were 31 cases of severe rotavirus compared to three times that number among those treated with a placebo.

“Of course 100 percent vaccine efficacy is the dream but nothing in life is 100 percent except death,” said Grais. “This is probably the best oral vaccine you’re going to get.”

The threat

Diarrheal disease, which is both preventable and treatable, is the second leading cause of death among children under 5 years of age. Globally, diarrhea kills more than 2,000 children every day—more than AIDS, malaria and measles combined. Rotavirus is the most common cause of severe diarrhea and kills more than 200,000 children every year.

While child deaths from rotavirus have more than halved since 2000, almost half of the 215,000 deaths each year occur in just four countries: India, Pakistan, Nigeria and the Democratic Republic of Congo, according to the WHO.

Even if it doesn’t kill, rotavirus can leave children permanently stunted.

“It’s like a lawnmower over the intestines,” said Steele. “It shaves off all the microvilli used to absorb nutrients and water.”

Existing vaccines are currently in short supply. GSK and Merck would require new facilities to ramp up existing production.

“They are operating on a for-profit model,” said Steele. “Without trying to belittle them, they produce what they think they can sell.”

Rollout of Rotasil

Before the vaccine can be rolled out, and the United Nations and Gavi can buy it in bulk, Rotasil must be prequalified by the WHO. Rotasil was licensed in India last year and is expected to be prequalified by the end of 2017. Then, ideally, its price will drop below that of existing vaccines.

Forty poor and low-income countries have so far introduced the existing rotavirus vaccines into their national immunization programs with the support of Gavi. This has translated into 54 million children vaccinated against rotavirus.

Rotasil could be particularly in demand in Nigeria and the Democratic Republic of Congo, which have yet to begin immunization programs. Dr Steele said other countries with ongoing immunization programs may also switch the new vaccine. If that is the case, thousands of vaccinators would have to be retrained on the new protocol.

Meanwhile, Rotasil is among a growing range of vital vaccines being produced in India. The Serum Institute also manufactures the MenAfriVac, a vaccine for meningococcal A, developed for use in sub-Saharan Africa. The vaccine has led to the control and near elimination of the deadly disease in the “meningitis belt”.

The Serum Institute of India says it is ready to produce 60 million doses of Rotasil each year.

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