Centre orders 37 lakh doses of diarrheas vaccine that can withstand heat and requires no refrigeration

Rotasil is first rotavirus vaccine that doesn’t need refrigeration, claims Serum Institute

The Central government has placed an order for 37 lakh doses of a rotavirus vaccine that promises to beat heat issues and requires no refrigeration. The vaccine, set to be launched in the country in August by Pune-based vaccine maker Serum Institute of India, has undergone clinical trials in India and Africa. Its heat-stable attribute will help it reach remote corners of the country without damage due to power outages and lack of cold storage facilities.

Rotavirus, the leading cause of diarrhoea in children under five, kills close to one lakh children of the 3.34 lakh that succumb to diarrhoeal diseases in India every year. The high mortality rate pushed the Centre to finally introduce the rotavirus vaccine in the Universal Immunisation Programme last year.

Adar Poonawalla, CEO, Serum Institute, told

The Hindu , “In most rural areas, storing vaccines is a great challenge as they require a cold chain. Ours is the first-such vaccine that can be stored below 25 degrees Celsius and does not require refrigeration. For a few days, the vaccine is also able to take temperature excursions beyond 30 to 35 degrees Celsius,” Mr. Poonawalla confirmed that the Central government has placed an order for over 30 lakh doses.

Called Rotasil, the formula was being researched by SII scientists for nine years. The oral vaccine will come in a freeze-dried powder form along with 2ml of antacid liquid in the package. At the time of administering, the health workers will simplyhave to mix the powder with the liquid and feed the baby. This should be done at six, 10 and 14 weeks.

No cold storage needed

Under the Expanded Immunisation Programme (EPI), children are administered vaccines for diphtheria, pertussis (whooping cough), tetanus (DPT), hepatitis B, haemophilus influenzae Type B (HIB), bacillus Calmette–Guérin (BCG), measles and polio. The rotavirus vaccine is the seventh to be added to this programme, which has been rolled out in Andhra Pradesh, Haryana, Himachal Pradesh and Odisha. The vaccine currently in use is Barath Biotech’s Rotavac, which has to be stored at -20 degrees Celsius. Two other rotavirus vaccines, Rotarix by GSK and Rotateq by Merck, also require cold storage.

Dr. Rajeev Dhere, executive director, Serum Institute, said, “There are 25 to 30 vaccines availabe, but all require cold storage. Rotasil is the world’s very first thermostable vaccine that can be stored in a cool and dry place like a strip of Crocin or an over-the-counter cough syrup.” He said clinical trials in Africa and India, each with a sample size of 7,000 children, have shown safety and efficacy. The result of the Africa trial, funded by Médecins sans Frontières (Doctors Without Borders), was published in the New England Journal of Medicine in March. The trial showed an efficacy of 66.7% against severe rotavirus gastroenteritis among infants in Niger. The results of the India trial will be published internationally next month.

The government plans to train staff and prepare special labelling that will change colour beyond a certain temperature. They plan to store Rotasil at 2-8 degrees Celsius. “The temperature variations in our country are extreme, so we plan to store the SII’s vaccine in cold storage,” Dr. Pradeep Haldar, Deputy Commissioner (Immunisation), Union Ministry of Health said.