The government needs to quash fears about safety of the rubella vaccine and establish its efficacy to achieve its goal of eliminating the disease by 2020
The Union Health Ministry is leaving no stone unturned to eliminate and control congenital rubella syndrome (CRS) by 2020, a disease that causes birth defects such as irreversible deafness and blindness in nearly 40,000 children every year. In a bid to eradicate the rubella virus and achieve success as in the case of polio and maternal and neonatal tetanus, the health ministry has launched a concerted, nation-wide measles-rubella vaccination (MR-VAC) campaign for children aged between nine months and 15 years.
However, phase-1 of the campaign which covers Karnataka, Tamil Nadu, Goa, Puducherry and Lakshadweep has encountered a roadblock in the form of a controversy. There is a rumour going around through Whatsapp messages, SMS alerts, text and AV clips on social media forums that the vaccine is banned in the US as it causes serious side effects which include damaging a child’s immunity and memory. It is being pushed in India by the global pharma industry which is looking for a market to dump substandard products.
However, the Ministry remains undeterred in its course. Claiming that the government faces these hurdles each time a new vaccination campaign is launched, Dr Pradeep Haldar, Deputy Commissioner (Immunisation), Union Ministry of Health says, “During the polio vaccine campaign, we faced a similar kind of situation where people had a mistrust on the immunisation programme. Whenever the government has a targeted eradication campaign and tries to reach the last mile on a targeted time frame such an issue arises. But the government is well prepared to overcome these challenges. However, now they are bigger as the size of the number of children to be covered is three times more than what we did for polio programme. We are covering from children aged from nine months to 15 years.”
Haldar gives further clarity on the action plan against the disease and says that the government included the rubella vaccine in the Universal Immunisation Programme in 2014. Until then, only private hospitals and clinics offered immunisation against rubella through the MMR vaccine. The government is now introducing the MR-VAC against measles and rubella, which will replace the measles vaccine that only protects against measles, in a phased manner across several states.
T Jacob John, Chairman of India Expert Advisory Group on Measles and Rubella Elimination explains the rationale behind the move and says, “Elimination means absence of indigenous transmission of the causative virus in a large defined population, such as a country. Eradication is global level elimination. India’s measles elimination goal is part of the goal of global measles eradication. Measles elimination requires the tactical use of immunisation to achieve near-100 per cent immunity in all children. When measles vaccine is given, the opportunity to piggyback rubella vaccine is obvious. Therefore, measles-rubella (MR) vaccine is being rolled out by the Universal Immunisation Programme.”
A noteworthy effort
Fortunately, the programme has garnered support as well from various quarters. Terming that India’s measles-rubella vaccination campaign is a big step towards reducing childhood mortality and addressing birth defects, Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia says, “The first phase of the campaign is significant as it is expected to accelerate the country’s efforts to eliminate measles also marks the introduction of rubella vaccine in India’s childhood immunisation programme to address CRS which causes birth defects such as irreversible deafness and blindness in nearly 40000 children every year. The campaign covering a total of 410 million children across the country over the next two years, is a truly remarkable, world-beating effort. Apart from improving the life-chances of millions of children in India, the campaign is expected to have a substantial effect on global measles mortality.”
“The first phase of the campaign vaccinating more than 35 million children in the age group of nine months to 15 years with MR (measles and rubella) vaccine once again demonstrates India’s commitment to improve health and well-being of its people by protecting children against vaccine preventable diseases,” states Dr Khetrapal Singh.
According to experts, most of the parents from the middle class who are reluctant to administer the vaccine into their children should know that a single dose of the vaccination gives more than 95 per cent long-lasting immunity, which is similar to that induced by natural infection.
Allaying fears
However, the rumours about the vaccine’s safety can derail the campaign and hence the government is taking measures to negate them. It informs that the vaccine is manufactured by the Serum Institute of India, the world’s largest producer of the vaccines. The health ministry also claims that MR-VAC is highly safe, immunogenic, efficacious and widely used across the globe.
Haldar explains, “There is a group of people against this vaccine and they have sent a negative message that it is a propaganda of sterilisation, which is false. The public should know that this vaccine is manufactured in India and in use since 40 years.” He also said that 47000 children die due to complications caused by measles. CRS affect nearly 40,000 children in the country and these complications can be curbed through vaccination.
Ridding Rubella: The story so far
Rubella, also called as German measles, is an acute, contagious viral infection which has been neglected in India, and its prevalence is less known. According to World Health Organization (WHO), children with CRS are likely to suffer from hearing impairments, eye and heart defects and other lifelong disabilities, including autism, diabetes mellitus and thyroid dysfunction – many of which require costly therapy, surgeries and other expensive care. The highest risk of CRS is in countries where women of childbearing age do not have immunity to the disease (either through vaccination or from having had rubella). Before the introduction of the vaccine, up to four babies in every 1,000 live births were born with CRS globally.
The annual incidence of CRS in developing countries ranges from 0.4 to 4.3 per 1,000 live births. Globally, only Australia and four European countries — the Czech Republic, Slovakia, Slovenia and Sweden — have achieved a protective immunity of less than five per cent among women of childbearing age. CRS rates are highest in the WHO African and South-East Asian regions where vaccine coverage is lowest.
However, there are several global instances where immunisation programmes against rubella have been quite successful. Large-scale rubella vaccination during the past decade has practically eliminated rubella and CRS in many developed and in some developing countries. Cuba declared the disease eliminated in the 1990s, and in 2004 the Centers for Disease Control and Prevention announced that both the congenital and acquired forms of rubella had been eliminated from the US. In April 2015, the WHO Region of the Americas became the first in the world to be declared free of endemic transmission of rubella.
Trying to allay fears abut the vaccine’s safety, Sunil Bahl, Director, Business and Regulatory Affairs, Serum Institute of India clarifies, “The vaccine has been licensed since 1989 and WHO Geneva prequalifies a vaccine only after they do a quality assessment on the production and checking all the critical parameters. Since 2000, that is almost 17 years back, the vaccine has been pre-qualified by WHO for supplies to UN agencies. This vaccine is part of Routine Immunization (RI) in 50 countries in the world, which includes Africa, America, Europe, Western Mediterranean, South East Asia, Western Pacific and we have supplied the vaccine to 100 countries in the world for the past 10 years. From 1996 to 2016, one billion doses have been distributed globally till now.”
“We are the only manufacturer of this vaccine and we have been supplying the vaccine for a long time. The quality of vaccines which we supplied helped to eradicate the measles and rubella globally which ever country which has introduced it. For example, South America has totally eliminated the viral infection,” says Bahl. The Serum Institute of India has already supplied 45 million doses required by the government for phase I in Tamil Nadu, Karnataka on time. The institute will be supplying nearly 150 million doses for the second phase, informs Bahl.
Thus, the central and the state government in India, global health agencies and renowned doctors are trying to dispel the myths over MR-VAC shots and help expand immunisation coverage.
Strides to progress
Giving a rundown on the project’s progress so far, Haldar informs, “We have covered 2.96 crore children out of our target of 3.48 crore. In Tamil Nadu, we have covered 1.35 crore out of 1.76 crore children, i.e. 77 per cent. In Karnataka, we have covered 1.55 crore children out of 1.65 crore children i.e. 94 per cent. In Goa, we have covered 3.08 crore children out of children 3.13 crore, i.e. 98 per cent. In Lakshadweep out of 15000 children we have vaccinated 10,700 children, which is 69 per cent. Also, Puducherry out of three lakh children we have vaccinated 2. 37 children, i.e. 78 per cent. Overall, our vaccination coverage has been 55 per cent, we aim to cover atleast 95 per cent.”
Experts recommend that state health departments should address parental concerns about the vaccination though concerted efforts. They also emphasise on spreading awareness about the need to vaccinate children against rubella to protect them against complications which could be easily avoided. It is to be hoped that the government would be able to squash the rumours about the vaccine which is harming the campaign and make further strides in its goal to eliminate this health menace from the country.