Will Rotavac find its place in the National immunization Program in India?

It took 25 years, scores of institutions and 100s of dedicated people to bring Rotavac to the brink of licensing, the place where it stands today. This achievement marks the 25th anniversary of Indo-US Vaccine action Program (VAP). VAP is a collaboration to develop vaccines and immunodiagnostic agents to prevent infectious diseases, with DBT and NIAID (part of NIH) being the presiding organizations.

Rotavac is a live attenuated rotavirus strain 116E.  It was isolated from Indian neonates and went on to be manufactured by Bharat Biotech for use in clinical trials through a technology transfer agreement with NIAID in 1998. The phase III clinical trials began in March 2011 and have been completed with conclusive results a week back. Bharat Biotech will soon submit the paperwork to DCGI for approval.

Rotavirus is the most common cause for diarrhea in children under five years of age. Please be reminded that Rotavirus infection is not only a problem of developing nations and low economic groups. The virus causes a number of hospitalizations and also deaths in children under the age of 5 worldwide. See table 1 below. The severity and incidence of death is higher in countries where access to hospitals and healthcare is limited. Rotavirus caused diarrhea leads to dehydration which in severe cases can only be controlled by intravenous supply of hydrating fluids to the child which requires access to hospitals.

Table1: Rotavirus affliction Statistics

Region

Hospitalizations

Deaths

Worldwide 2 million 475000-580000
India 100000
Africa 200000
US 55000-75000 20-60

 

Bharat Biotech has estimated the cost of Rotavac to be Rs 54/ dose. This is very reasonable as compared to the cost per dose of the two vaccines available in the private market today (see table 2).

Table 2: Rotavirus vaccines available in market:

 

Vaccine

 

Description

 

Inventor

 

Efficacy/ Route

 

Year licensed

Cost per dose/number of doses required

RotarixTM Human monovalent live attenuated RV strain Developed by AVANT Immunotherapeutics then licensed to GSK 70%-85% protective efficacy against severe disease, including that due non-G1 serotypes/ Oral 2006 Rs 1000 per dose; 2 dose series in infants 6 weeks to 24 weeks of age.
RotaTeqTM Pentavalent live bovine-human reassortant vaccine Merck Research Co 74% protection against any G1-G4 RV gastroenteritis/ Oral 2006 Rs 1000 per dose; 3 dose series in infants 6 weeks to 28 weeks
LLR Lamb-derived monovalent live attenuated strain Lanzhou Institute of Biomedical Products, China Induces neutralizing antibody responses in 60% of vaccines/ Oral
Rotavac(not yet approved) Live attenuated 116E rotavirus monovalent vaccine Bharat Biotech, India reduced severe rotavirus diarrhea by 56% during the first year of life vs. placebo in an Indian Phase III trial/ Oral Pending approval Rs 54 per dose; three-dose series at the ages of 6, 10 and 14 weeks

 

WHO in 2009 has recommended that rotavirus vaccine be introduced in the national immunizations programs of every country. As of April 27, 2013, 45 countries—mostly middle-and high-income countries— have introduced rotavirus vaccines in their national immunization programs (www.path.org; see map below). UK got added in the list this year. There have been very encouraging reports from the countries where the vaccine had been introduced. The disease incidence and hospitalizations have considerably reduced (see table 3 below).

http://sites.path.org/rotavirusvaccine/rotavirus-advocacy-and-communications-toolkit/country-introduction-maps-and-list/

 

Table 3: Impact of rotavirus vaccines on hospitalizations for rotavirus gastroenteritis among

children <5 years old

Whether India will include Rotavac in its national immunization program remains to be seen. Indian health ministry has not given any statement yet. Rotavac has shown good prognosis when given concurrently with Polio vaccine. It is heartening to know that lives of 100,000 children annually can be saved with this measure.  But there is a contrary view and some scientists believe that recommendation by WHO for a worldwide vaccination program is based on regional data and cannot be necessarily extrapolated to the Indian situation. They argue that stats of rotavirus as a cause of diarrhea is an overestimate as most often rotavirus is concomitantly found with other diarrhea causing bacteria. Also price of the vaccine was a consideration before Bharat announced its low cost vaccine. With the price factor taken care of and the clinical trial phase III a success, Rotavac might turn up in the compulsory vaccine program.

VAP is continuing its efforts and has recently announced research grants for vaccines for dengue, influenza (including avian influenza), malaria, enteric diseases, HIV/AIDS, and tuberculosis. Hopefully these diseases will find there nemesis soon.

 

References for the article and other resources:

http://www.nih.gov/news/health/may2013/niaid-14.htm

http://www.path.org/news/an130514-rotavac-results.php

 

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