New Delhi: 6.16 lakh. That is the estimated number of Indian women that would have lost their lives to cervical cancer between 2018 – when the path was cleared for the rollout of the Human Papilloma Virus (HPV) vaccine in the Universal Immunisation Programme (UIP) – and 2026, when the programme was finally launched. HPV infection is the commonest cause of cervical cancer, a disease that kills an estimated 77000 Indian women every year.These deaths would not have been prevented had the vaccine rolled out in 2018, but girls who were of vaccination age then but are no longer so now, could have been protected. The primary concern then, say top government officials associated with the decision at that point, had been the cost of the vaccines manufactured by multinational companies. “It was prudent, we thought, to wait for an indigenous vaccine to come in which would significantly reduce the costs,” says a retired government official speaking on the condition of anonymity. The hopes were not unfounded. India indeed saw the launch of indigenous vaccine Cervavac in 2022, then celebrated as a Made in India triumph. But the UIP rollout, ironically, has now started not with the vaccine manufactured by Serum Institute of India but with 2.6 crore doses of Gardasil, manufactured by MSD, whose procurement is being supported by GAVI, the Vaccine Alliance. So, while India advocates “swadeshi” in all spheres, the India-made vaccine has been elbowed out by one that was being used globally and in India in 2018 too, leaving question marks on the long gestation period.The beginning, and the pushbackIt was in January 2018 that the National Technical Advisory Group on Immunisation (NTAGI) – the highest technical body that evaluates and makes recommendations about vaccines – first recommended that India should include HPV in the UIP, using the highest valency (number of virus strains covered). ”At that point there were two primary concerns. We had felt that the evidence was not strong enough to support a national rollout. The second concern was the price of the vaccine and the logistical difficulty of giving two doses to young girls. We were concerned that many girls would not be available for the second dose. The GAVI offer for vaccines was not there then. We would have taken it if it was. We had thought in some years there would be an India-made vaccine which would be more affordable. I feel bad for them (SII) now,” says a former top official of the Ministry of Health who was part of the NTAGI discussions. A person associated with SII, speaking on the condition of anonymity, said: “Our vaccine is now useless. We will just have to dispose of it.”India’s tryst with HPV has been complicated ever since the deaths of nine girls during a trial of the vaccine in Andhra Pradesh that started in 2009. Subsequent investigations found most of the deaths unrelated to the vaccine but the stigma persisted, adding to the already existing social inhibitions about vaccinating young girls against a virus that spreads primarily through sexual activity.In 2018, the face of that opposition became Ashwini Mahajan, head of the Swadeshi Jagran Manch (SJM), the economic wing of the Rashtriya Swayamsewak Sangh (RSS). He gave copious interviews decrying HPV inclusion in the UIP and even wrote to the prime minister expressing concerns that the vaccine of “doubtful utility” would divert “scarce resources from more worthwhile health initiatives” and its “adverse effects will erode confidence in the national immunization programme and thereby expose children unnecessarily to the risk of more serious vaccine-preventable disease”.As the HPV decision was inexplicably kept in abeyance, senior health ministry officials laboured to explain in off-the-record conversations that SJM’s uncharacteristic detour into health policy had nothing to do with the decision but was a function of the financial commitment that HPV inclusion in UIP would require of the government. Interestingly, as early as 2015 which was even before HPV had been cleared by NTAGI, India had received a $500 million support from GAVI for rolling out a range of vaccines including HPV. It was at that point described as a rare instance of the alliance giving monetary rather than material support.Single dose of a 2-dose regimenAccording to people long associated with the health decision making process in India, the wait all along had been for a single dose vaccine. Intriguingly, 14-year-old girls in India will get one shot of a vaccine that is also marketed as a two-dose regimen. There is in fact no HPV vaccine anywhere that is marketed as a single dose option. Indian Council of Medical Research (ICMR) is currently studying the efficacy of the single dose vaccine but the results are a few years away. This was also flagged in a meeting of the NTAGI in September 2023.According to the minutes of that meeting: “Dr. N.K Arora stated that there is an inherent conflict of interest on the part of the vaccine manufacturer in conducting a single dose trial of a vaccine that has been developed as a 2-dose series. He also mentioned that none of the approved/licensed HPV vaccines elsewhere.” That conflict of interest is why the single dose study is being conducted by ICMR. India, in rolling out the single dose vaccine, cited the WHO, a global body that it has chosen to disregard on multiple occasions in the past, including on the matter of the COVID-19 death toll.“In June 2022, the Strategic Advisory Group of Experts (SAGE) on ImmuniSation of the World Health Organisation concluded that a single-dose schedule provides protection comparable to two-dose schedules. The December 2022 WHO Position Paper further endorsed single-dose schedules as an effective and programmatically advantageous option for girls aged 9–20 years,” reads the health ministry statement in February this year.Mahajan continues to oppose the decision citing various real or imagined “conflicts of interest”. On March 10 he posted on X a media report raising questions about Gardasil – the vaccine being used by India for the programme – and quoted from it: “The alternative to reducing the risk of getting cervical cancer by vaccination is to attend screening. Screening with the Papanicolaou test (Pap smear) or an HPV test is close to 100 percent effective. Cervical cancer grows so slowly that screening can prevent virtually all cancer deaths, as cell changes can be removed long before some of them would have developed into cancer many years later.” But there are few takers now for his opposition. Pseudo science proponents and known anti-vaxxers have become the biggest critics of India’s HPV programme on social media. What really changed in these eight years?A senior government functionary who is closely associated with the rollout of the vaccination programme, explains the rationale. “The single dose trials are on but there is a two-year follow up period during which antibody titers will need to be monitored in the subjects. We are starting now with the 2.6 crore GAVI vaccine doses and the way we have planned the programme is that every year girls that turn 14 will be vaccinated with one dose. This cohort is about 1.12 crore which means (assuming all the targeted girls will not be reached every year) we can continue the programme for three years with the GAVI vaccines. Since the vaccines were available, it was an opportunity and it did not seem right not to take it. GAVI is a multilateral organisation where we donate and we also take from it. There is no doubt that we will ultimately have to move to the indigenous vaccine but this was the practical path to start the programme,” says the official. “When the indigenous single dose is ready after 2.5-3 years we will think about the next stage,” the official added. Abantika Ghosh is a journalist and public policy professional.