The relaxation of prescribed doses and ‘free’ doses of human papilloma virus (HPV) vaccine by the World Health Organization (WHO) has pushed back the inclusion of the India-made vaccine in the national program to vaccinate children against HPV.
Publicly available documents show that the Health Ministry had committed to produce an India-made vaccine for inclusion in the Universal Immunization Program (UIP) in 2023.
Prime Minister Narendra Modi on 28 February… Launched a campaign in Ajmer, Rajasthan1.15 crore 14 year old girls will be vaccinated Gardasil-4, developed by Merck And available in India since 2009. It is one of the most well-tested HPV vaccines and is part of vaccination programs in many countries. In 2023, India received a US$250 million grant from the Global Alliance for Vaccines and Immunization (GAVI) to, among other things, roll out HPV vaccine and Typhoid Conjugate Vaccine (TCV) as well as strengthen routine immunization systems. Will be included in this, Health Ministry sources said The HinduUp to 20 million HPV vaccines “free”, which India can use in its vaccination programme.
However, the inclusion of Gardasil-4 pushed it back CervaVac, an indigenously developed quadrivalent HPV vaccineWhich resulted from Grand Challenges India (GCI), a partnership of the Department of Biotechnology (DBT), BIRAC (Biotechnology Industry Research Assistance Council, a DBT public enterprise), the Bill & Melinda Gates Foundation (BMGF), and vaccine manufacturer Serum Institute of India (SII). After phase ⅔ trials of the vaccine it was revealed that it was “Non inferior” to Gardasi.l, it was officially launched in September 2022, where the Science Minister, Jitendra Singh, lauded it as an example of the private sector and government coming together to create an affordable product. SII CEO Adar Poonawalla had then said that if government procurement is part of the process, the vaccine could be available for as low as ₹200-400 per dose, which is one-tenth of the retail cost.
What did the government say first?
Reports in January 2023 said that the Health Ministry was planning to issue a global tender for 16.02 crore doses of HPV vaccine in April to begin the vaccination program in 2026.
The minutes of the July 2023 meeting of the National Technical Advisory Group on Immunization (NTAGI), India’s highest advisory body on vaccination, said that “…indigenously developed qHPV vaccine (SurvaVac) might consider For introduction into UIP as a two-dose regimen.”
In the same meeting, the Ministry of Health and Family Welfare (MoHFW) had also said, “..the introduction of the vaccine has been approved, and MoHFW is currently working on its implementation in UIP.” However, no such tender came.
The absence of CervaVac from India’s current universal vaccination program is due to an ongoing study led by the Indian Council of Medical Research (ICMR), which is testing whether a single dose of CervaVac generates sufficient protective antibodies and a stable immune response compared to the single-dose Gardasil vaccine. This would be an important step to officially recommend the vaccine as a single-dose regimen. NTAGI member NK Arora said that the results of this study are expected in 2027. The Hindu.
Two doses vs. single dose
By early 2022, WHO recommends a two-dose schedule for administering HPV vaccines to girls aged 9-15 for maximum generation of antibodies. Sikkim, India’s first stateIn 2018, as part of a state-wide program to begin administration of the HPV vaccine, approximately 25,000 girls aged 9–14 years were given 2 doses of the vaccine at an interval of 6 months.
However, it faced “…stagnant pace of progress, low HPV vaccine coverage in many countries, and gaps with the 2030 target of 90% coverage needed for elimination..” A Strategic Advisory Group of Experts (SAGE) on Immunization of the World Health Organization (WHO) – after analyzing efficacy and clinical data on HPV vaccines globally – recommended in March 2022 that national vaccination programs had the option of using either a two-dose or a single-dose vaccination schedule.
A major factor was the limited global availability of HPV vaccines and more girls (and later boys) could get at least one dose of the vaccine to provide more coverage and improve the chances of herd immunity.
NTAGI’s expert members were aware of the loose dosing schedule of HPV vaccines when they met in June 2022, records show, and supported the decision to move forward with CervaVac’s 2-dose schedule along with collecting data on immunogenicity, persistence of adequate antibody levels and protection from infection after two years of a single dose. “At UIP, a mechanism can be developed to follow-up those girls who have received only one dose in the program and do not return for the second dose as recommended. Their samples can be collected after two years and real-world immunogenicity and effectiveness data of the single dose can be generated,” the note said.
However, at the NTAGI meeting in July 2023, NTAGI co-chairman Rajeev Bahl, director general of the Indian Council of Medical Research, said that the SII as well as a subject expert committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) – the apex regulatory body to allow the release of drugs and vaccines in India – had questioned the “relevance and necessity of these studies”. Suggestions for a phase-3 efficacy trial of a single dose of the vaccine were considered, but it would take “substantial time” given the age groups of potential vaccine recipients. Records show that Dr Bahl said that “..ICMR is ready to start the single dose antibody persistence study to avoid further delays.” The one-dose recommendation by WHO is entirely off-label and intended for public health programs The HinduDr Arora said it “may be possible” to use CervaVac following the results of the ICMR study. “The system of using a one-dose vaccine is better because these are teenage girls and may not always come for the second dose,” she said.
Limited, free doses
Another expert, who was part of the NTAGI meeting but who requested anonymity, said that while the supply of vaccines from SII was not yet assured, funding from GAVI was available for a limited period and hence the government had taken a “pragmatic” call on using Gardasil-4 until the Cervavac results were available. “It all depends on whether two doses of Cervavac will be more economical than one dose of Gardasil, as current batches of vaccines may not be available in the future at the current price.”
In a policy statement available on its website, GAVI said it would not provide vaccines for free after 2027. In her 2024 interim budget speech, Finance Minister, Nirmala Sitharaman Committed to making HPV vaccines available For all girls aged 9-14 in India. “This is about 4-5 times the number of vaccines provided to India by GAVI. The government has not issued a procurement tender for vaccines all these years, which determines how many vaccines a company will manufacture,” said a person associated with the HPV vaccine industry. The HinduRefusing to be recognized. “The difference is that Gardasil has WHO-prequalification for a single dose, but Cervavac does not. A single dose of Gardasil is around ₹4,000 and Cervavac is around ₹1800-2000. Otherwise these vaccines are similar in all respects.” There is also a version of the Gardasil vaccine that protects against 9 strains of HPV, although for programmatic purposes it is strains 16 and 18 that are associated with the most serious infection.
SII declined to officially respond to The Hindu’s questions.
burden in india
According to estimates from India’s National Family Health Survey (NFHS) – which conducts periodic health surveys and is representative of India’s population numbers – there are likely to be 8–10 crore girls in the 9–15 age group (the recommended target group for the HPV vaccine). This is an extrapolation of 2011 census numbers.
Cervical cancer is the second most common cancer among women in India, with approximately 80,000 new cases reported every year and more than 42,000 women dying every year. India accounts for almost one-fifth of global cervical cancer cases.
published – March 05, 2026 03:42 PM IST
