When Prime Minister Narendra Modi kicks off the 90-day nationwide campaign for HPV vaccination from Ajmer on Saturday, thousands of girls aged 14 will be protected against cervical cancer, the second-most prevalent cancer among women in India.
Interestingly, the government has opted for American-made Gardasil-4 vaccine for the campaign, instead of the indigenously developed Cervavac, which was launched in 2023 in the market. A government source told FE that the reason to opt for Gardasil-4 was that it is a single-dose vaccine, and also approved by the World Health Organization (WHO), whereas the Cervavac vaccine currently available in the market is a double-dose vaccine, and is not approved by the WHO.
Cervavac available, supply-ready; SII eyes UIP tender route
As per a source in Serum Institute of India (SII), which makes Cervavac, “The vaccines are available with SII and ready for supply.” However, when asked if they will be included in the government scheme in the future, they said once a tender process is opened by the government for procurement of vaccines, potentially as part of the Universal Immunisation Programme (as had been announced by the finance minister in the 2023-2024 Budget), SII would also pitch its vaccine. They also told FE that “The SII might start the process for WHO approval (for Cervavac) next year.”
As per industry sources, the SII is also in the process of developing single-dose Cervavac, which is under trial and should be ready for approval by 2027.
Gardasil-4 has been in the market for the past over 15 years, and has been adopted by nearly 80 countries, currently costing between ₹3,000 and ₹4,000 per dose. It will be provided free across states,at Ayushman Arogya Mandir-Primary Health Centres, Community Health Centres, sub-district/district hospitals and government medical colleges and hospitals as well.
Gardasil-4 and Cervavac have the same spectrum, which means they protect against the same strains of Human Papillomavirus (HPV) — 6, 11, 16 and 18 — protecting against 90% of cervical cancers.
Separately, the Gardasil-9 is another HPV vaccine available in the market, with a much larger spectrum, covering HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. However, the government source FE spoke with said, “HPV types 6,11, 16 and 18 are behind 90% of cervical cancers, which Gardasil-4 covers. The other HPV types covered additionally by Gardasil-9 do not pose as much of a risk. Moreover, the price of this vaccine is currently over ₹10,000 per dose, and it is a double-dose vaccine.”
Dr Darshana Rane, consultant, medical oncology, at HCG Cancer Centre in Borivali, affirmed: “This (Gardasil-4) is more suitable for large-scale public health programmes because of its wide coverage. Moreover, Gardasil has a strong safety and efficacy profile worldwide, with the ability to manufacture on a large scale and robust supply chains.”
Adolescent girls prioritised in HPV drive; lower male cancer burden cited
The disbursal group for the free vaccination campaign has been determined as girls aged 14 years and 3 months over, as the intention is to “nip the spread in the bud”, said the government source. This means a target of approximate 12 million adolescent girls annually. HPV in women is most commonly a sexually transmitted virus, which is why the vaccine is being administered at an age before the young girls become sexually active. As for men, the cancers caused by HPV are oral and head cancer, for which the national burden is not as high, they elaborated, explaining why boys are not being included in the scheme.
The government is meant to receive 2.6 crore free doses of Gardasil-4 for two years, in partnership with Gavi, the Vaccine Alliance (a public-private global health partnership working to provide immunisation in poor countries). According to the government source, 15 million of these vaccines have already been received, with the remaining scheduled to be sent by next year. They have also been distributed among states as per requirement.
As far as dissemination is concerned, those who want the vaccine will have to apply on the central government’s U-Win portal, following which they can avail the vaccine at designated health centres, everyday for the first 90 days. After the first 90 days it will be available at the same centres on routine immunisation days. To this, the government source added that the girls will be screened for allergies and other vulnerabilities to the vaccine, which is rare, and will also be kept for observation for 30 minutes post vaccination to ensure no adverse reactions or anaphylactic shock happen.
“If cervical cancer screening is continued along with the above strategy, it will help in a marked reduction in the incidence and mortality rates, and India will be able to achieve the target of eliminating cervical cancer as a public health problem,” added Dr Rane.