Wednesday, October 22, 2014

A New Indian Vaccine for Rotavirus enters final stage of trials

LYON, France: A new made-in-India vaccine against Rotavirus, the most common cause of severe dehydrating diarrhoea in Indian infants, has entered a crucial final stage of trials. 

Hyderabad-based Shantha Biotechnics' investigational Rotavirus vaccine has entered Phase III clinical trials across 12 different sites in India. 

In an interview to TOI, Sanofi Pasteur's associate vice-president of research and development sites and hubs Jacques Volckmann said, "It is a vaccine which is being developed in India for Indians. Close to 1,200 volunteers are being sought at the trial sites to test the safety and efficacy of the vaccine that will specifically protect Indian children against the strains G1, G2, G3 and G4 that circulate extensively across the country". 

Among children under five, Rotavirus has been estimated to be responsible for two million hospitalizations and 500,000 deaths worldwide each year, the majority of which occur in the Indian subcontinent, sub-Saharan Africa and South America. 

It is estimated that one of every 260 children born each year will die from diarrhea caused by rotavirus infection by their fifth birthday. 

Recent studies indicate that rotavirus causes approximately 40% of childhood diarrheal hospitalizations worldwide, 40.7% in Sub Saharan African countries, 33% in Nepal, 34% in Pakistan ,40-50% in Japan and around 39% in India in children less than 5 years of age. 

India, with more than 1 billion people, 11% of whom are less than 5 years of age, has an especially large population at risk of clinically significant infection. 

There is no specific drug approved to cure rotavirus gastroenteritis. Since virtually all infants and young children will suffer at least one rotavirus infection and many will become infected two or more times, even in settings where good hygiene is practiced, universal immunization of infants with a vaccine is clearly the way to reduce rotavirus related morbidity, mortality, and associated medical costs. 

Shantha's investigational vaccine is designed to prevent severe rotavirus gastroenteritis in infants and children when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. 

Each dose is an all-in-one formulation containing an antacid. The vaccine is a live-attenuated bovine-human reassortant comprising four serotypes, G1, G2, G3 and G4, and is targeted to be safe, confer non-inferior immunogenicity to already licensed vaccines and have the ability to prevent rotavirus gastroenteritis. 

The trial is designed to show non-inferiority against a currently licensed vaccine with the use of three, ready-to-use liquid doses administered orally, starting from six-to-eight weeks of age, with the subsequent doses administered at 4 weeks intervals. 

A phase I/II study was carried out with the long-term aim to produce a locally licensed vaccine that is safe and able to protect children against rotavirus gastroenteritis. 

Overall, the results showed that all three doses of the vaccine evaluated in the study were safe, well tolerated and displayed good immunogenicity (dose-response) in healthy Indian infants. 

"We aim to provide an affordable vaccine to meet the still significant medical need in emerging markets, like India, and through partnerships with organizations like Gavi, the Vaccine Alliance," said Olivier Charmeil, Sanofi Pasteur's President & CEO. 

The World Health Organization (WHO) recommends that vaccination with rotavirus vaccines should be included in all national immunization programs. Gavi, has established an accelerated vaccine introduction initiative with the objective of driving the sustainable introduction of rotavirus vaccine in 30 Gavi-eligible countries by 2015. 

In addition, PATH, an international, non-profit organization to improve public health, is working to accelerate access to rotavirus vaccines and sustain their implementation and use in countries where children need them most urgently. 

Rotavirus infections are prevalent in human populations worldwide. Although the virus can and does infect older individuals, illness caused by rotavirus can be quite severe in infants and young children. In low income countries, the median age at the primary rotavirus infection ranges from 6 to 9 months (80% occur among infants less than 1 year old) whereas in high income countries the first episode may occasionally be delayed until the age of 2-5 years, though the majority still occur in infancy (65% occur among infants less than 1 year old). 

The WHO estimates that in 2008 approximately 453,000 rotavirus gastroenteritis (RVGE) -associated child deaths occurred worldwide. These fatalities accounted for about 5% of all child deaths and a cause-specific mortality rate of 86 deaths per 100,000 population aged less than 5 years. About 90% of all rotavirus-associated fatalities occur in low income countries in Africa and Asia and are related to poor healthcare.


Comment: This is interesting news, since the Bharat Biotech vaccine for Rotavirus (116 E) made in India has already undergone the necessary testing & is likely to be launched in the next couple of months (possibly Jan 2015). Among all the newer vaccines, rotavirus is the only one where we have large amount of Indian data available regarding the disease from India through the IRSN - Indian Rotavirus Surveillance Network. This is probably one of the reasons why we are getting India specific vaccines for this disease. It is important to start vaccinating children early against this disease so as to prevent significant disease burden, since almost EVERY child will suffer from Rotavirus diarrhea if they are not vaccinated, probably by the age of 2 years.

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