National Immunisation Mission: How indigenous vaccines can go a long way

The locally developed Ceravac can play a critical role in the efficacy of the National Immunisation Mission

The first doses of smallpox vaccine lymph arrived in India in May 1802. A three-year-old child from Bombay (now Mumbai) – Anna Dusthall became the first person in India to receive the smallpox vaccine on May 14, 1802.

Till 1850 India was using vaccines imported from Britain until Dr Waldemar Haffkine developed cholera and plague vaccines through clinical trials in India in the late 19th century.

India’s National Immunisation Mission has come a long way since then. But it still needs a sustained supply of indigenously developed vaccines to run the world’s largest universal immunisation programme.

For example, vaccines for human-papillomavirus (HPV) that is known to cause cervical cancer and rotavirus that causes potentially lethal diarrhoea in children could be included in the NIM only after local players developed them at affordable rates.

This July, after over a decade’s hard work, the first indigenously developed HPV vaccine Ceravac received approval from the country’s drug regulator. The vaccine has a two-dose and a three-dose regimen depending on the age of the person.

Co-developed by the Department of Biotechnology and Pune-based vaccine maker Serum Institute of India (SII), the vaccine is expected to cost between Rs 200 and Rs 400 per dose as against the currently available vaccines Gardasil (Merck) and Cervarix (GlaxoSmithKline) that cost Rs 2,000-3,500 per dose.

Affordability is going to be the driver.

“Although there has always been a considerable demand for multinational vaccines, the cost of these has always been a concern. Now with an affordable HPV vaccine available for cervical cancer, a much larger population will have access to the vaccine, which might reduce the incidences of cervical cancer,” Dr Sonal Kumta, Senior Consultant-Obstetrician & Gynaecologist, Fortis Hospital, Mulund, Mumbai.

The government vaccine policy think tank, National Technical Advisory Group on Immunisation (NTAGI), has wanted to include the HPV vaccine in the list of vaccines that are part of the NIM for a while. India was, however, waiting for an indigenously developed affordable vaccine to be able to do so.

The concerns stem from the fact that cervical cancer ranks as the second most frequent cancer among women in India. About 5 per cent of women in the general population are estimated to harbour cervical HPV‐16/18 infection at a given time, and 83.2 per cent of invasive cervical cancers are attributed to HPVs 16 or 18. HPV infection is now a well‐established cause of cervical cancer and HPV types 16 and 18 are types most frequent and responsible for about 70 per cent of all cervical cancer cases worldwide.

India has a population of 483.5 million women aged 15 years and older who are at risk of developing cervical cancer. Current estimates indicate that every year 123,907 women are diagnosed with cervical cancer and 77,348 die from the disease. Cervical cancer ranks as the second most frequent cancer among women in India and the second most frequent cancer among women between 15 and 44 years of age.

Doctors say that having an India-made low-cost vaccine would help spread the coverage.

“As gynaecologists, we get this demand for the vaccine, especially in females, who had cervical cancer history in their families. The low socio-economic strata are still not very much aware of the vaccine. If this vaccine comes and it is launched, which is expected in December, at a rate of Rs 200-400, it's definitely going to be a boon and the number of people who will go in for vaccination is also going to increase,” said Dr Anjana Singh, director and head of department, obstetrics and gynaecology, Fortis Hospital Noida.

The Ceravac project was conceptualised in September 2011 and there have been 30 meetings of the scientific bodies, and the industry partners since then to discuss the scientific development of this vaccine.

Bharat Biotech developed Rotavac 5D’s story is similar — the vaccine originated from a new strain of rotavirus 116E, isolated from an Indian asymptomatic infant at the All India Institute of Medical Sciences in New Delhi in 1986. In India alone, around 113,000 infants die every year due to rotavirus diarrhoea (309 infant deaths a month) and 450,000 infants succumb to the disease globally. Rotavac is a three-dose orally administered vaccine given to infants.

Almost two decades of work went into developing the Rotavac 5D. The Government of India’s Department of Biotechnology (DBT), along with several public sector scientific institutions, Stanford University School of Medicine, the US National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), and the non-profit organisation PATH have all worked as a team to develop Rotavac 5D.

Bharat Biotech’s Rotavac became a part of India’s NIM around 2016. The company supplied the vaccine at Rs 70 per dose to the government. In 2019, it upgraded the vaccine further to Rotavac 5D, which entailed a smaller dose of 0.5 ml as against its competitors 2-2.5 ml per dose.

The company had then said that trials had revealed that many infants could not swallow a 2.5 ml dose and would spit it out. This oral vaccine was being supplied to the government at around Rs 100-110 per dose. Merck (RotaTeqO) and GlaxoSmithKline (RotarixO) have two approved rotavirus vaccines here which cost between Rs 900 and Rs 1,000 per dose.

In a country where good healthcare comes at a premium, such indigenous initiatives could go a long way towards improving health outcomes for the average Indian.

Immunisation journey

1978: Expanded Programme of immunisation (EPI)

Limited reach — mostly urban

1985: Universal Immunisation Programme (UIP)

Indigenous vaccine production capacity enhanced

Cold chain established

1986: Technology Mission On Immunisation

Coverage in infants (0 – 12 months) monitored

1992: Child Survival and Safe Motherhood (CSSM)

Included both UIP and safe motherhood program

1997: Reproductive Child Health (RCH 1)

2005: National Rural Health Mission (NRHM)

2012: Government of India declares 2012 as “Year of Intensification of Routine Immunisation

2013: India, along with other South-East Asia Region, declares commitment towards measles elimination and rubella/congenital rubella syndrome (CRS) control by 2020

2014: India is certified “polio free country”