CervaVac HPV Vaccine 2024
Serum Institute of India (SII) CERVAVAC® is India's first quadrivalent human papillomavirus (qHPV) vaccine, protecting people against HPV types 6, 11, 16, and 18. Cervavac efficacy was studied in HPV vaccine clinical trials that started in September 2018. The Drugs Controller General of India (DCGI) granted market authorization to the Pune-based SII to manufacture the CervaVac vaccine in 2021. In the application to the DCGI, SII stated that Cervavac had demonstrated a robust antibody response higher than the baseline against targeted HPV types and in doses and age groups. Cervavac is an outcome of a partnership between SII, the Department of Biotechnology (DBT), the Biotechnology Industry Research Assistance Council (BIRAC), and the Bill and Melinda Gates Foundation.
The Lancet Oncology published an Editorial on October 1, 2022, HPV vaccination in South Asia: new progress, old challenges. A myriad of factors, including poor awareness of cervical cancer, low screening uptake, insufficient availability of and access to vaccines, and screening and vaccine reluctance, all contribute to the high burden of disease in the region, as we highlighted in a 2019 Editorial. Cervavac should be welcomed in India, where the incidence of cervical cancer accounts for a fifth of the global burden, with more than 124,000 cases and 75,000 deaths annually. On November 7, 2023, The Lancet Oncology published an article that reported Cervavac's efficacy has significant implications for future vaccine uptake and HPV-associated cancer prevention in young people in India. The journal Nature Medicine published a Research Highlight on November 13, 2023, indicating that Cervavac is an affordable, noninferior HPV vaccine.
Pune-based Serum Institute of India is now the world's largest vaccine manufacturer by the number of doses produced and sold globally (more than 1.5 billion doses).
Cervavac Vaccine Price
According to a source, the MRP of Cervavac's 2-dose vaccine would be 200–400 rupees (€5) per dose, making it an affordable HPV vaccine. On December 31, 2023, local media reported that Cervavac is priced at a moderate ₹1,400-1,600, available in hospitals.
Cervavac Vaccine Availability
Over 100 countries marked the third Cervical Cancer Elimination Day of Action in 2023 with renewed commitments, mass screening, and awareness campaigns. The Cervavac vaccine became available in India on January 24, 2023, and is scheduled to be launched internationally in 2024.
Cervavac Indication
CERVAVAC® is indicated in females 9 through 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by human papillomavirus (HPV) types 16, 18; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18; and genital warts caused by HPV types 6 and 11. CERVAVAC® is indicated in males 9 through 26 years of age for the prevention of anal cancer caused by HPV types 16, 18; anal precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18; and genital warts caused by HPV types 6 and 11.
Cervical cancer is the most common HPV-related disease in women. In India, cervical cancer is the second-most common cancer, especially among women between 15 and 44 years of age. Every year, 122,844 Indian women are diagnosed with cervical cancer, and 67,477 die from the disease, according to figures from 2012, says NHP. In 2021, the International Taskforce on Cervical Cancer Elimination in the Commonwealth was launched by the Commonwealth Secretariat (May/2021) and the Union for International Cancer Control to step up efforts towards preventing and treating cervical cancer to align with WHO's Global Strategy (Nov/2020) to accelerate the elimination of cervical cancer as a public health problem.
Cervavac Administration
CERVAVAC® should be administered with a 2-dose schedule (0.5 ml at 0, 6 months). For individuals 15 to 26 years of age, CERVAVAC® should be administered according to a 3-dose (0.5 ml at 0, 2, 6 months) schedule. The second dose should be administered at least one month after the first dose, and the third dose should be administered at least three months after the second dose. All three doses should be given within one year. CERVAVAC® should be administered intramuscularly in the upper arm's deltoid region or the thigh's higher anterolateral area and must not be injected intravascularly, subcutaneously, or intradermally. The safety and efficacy of CERVAVAC® in children below nine years of age have not been established.
Cervavac Vaccine News
November 7, 2023 - The Lancet Oncology published "An HPV vaccine from India: broadening possibilities for cervical cancer control."
January 24, 2023 - The SII launched the first indigenously developed HPV vaccine against cervical cancer in women.
October 21, 2022 - Serum Institute of India will start supplying the government with small quantities of the CervaVac vaccine in early 2023.
October 1, 2022 - The peer-reviewed journal The Lancet published an Editorial - HPV vaccination in South Asia: new progress, old challenges.
September 1, 2022 - News article: Serum Institute's qHPV vaccine is a game changer.
September 1, 2022 - Announcing the scientific completion of the quadrivalent Human Papilloma Virus (qHPV) vaccine in the presence of Mr. Adar C. Poonawalla, CEO, Serum Institute of India, Pune, and other prominent scientists and dignitaries, Dr. Jitendra Singh said, this affordable and cost-effective vaccine marks an essential day for DBT and BIRAC as it takes India a step closer to PM Modi's vision of Atmanirbhar Bharat.
July 18, 2022 - The Serum Institute of India received regulatory approval to sell an indigenously developed HPV vaccine that can prevent cervical cancer. The Drugs Controller General of India granted market authorization for the Quadrivalent Human Papillomavirus vaccine (qHPV).
June 15, 2022 - ANI reported the Drugs Controller General of India's Subject Expert Committee recommended granting market authorization to the Serum Institute of India to manufacture India's indigenously-developed CERVAVAC Quadrivalent Human Papillomavirus vaccine (qHPV).
Cervavac Vaccine Clinical Trials
Serum Institute of India applied for market authorization after completing the phase 2/3 clinical trial with the support of the Department of Biotechnology to ensure its early availability in the country," said the sources.
Findings: Between Sept 20, 2018, and Feb 9, 2021, 2341 individuals were screened, of whom 2307 eligible individuals were enrolled and vaccinated: 1107 (738 girls and 369 boys) in the cohort aged 9-14 years and 1200 (819 women and 381 men) in the cohort aged 15-26 years. No race or ethnicity data were collected. Three hundred fifty girls and 349 boys in the SIIPL quadrivalent HPV vaccine group and 338 women in the comparator vaccine group were included in the modified per-protocol population for the primary endpoint analysis. The median follow-up for the analyses was 221 days (IQR 215-231) for girls and 222 days (217-230) for boys in the SIIPL quadrivalent HPV vaccine group, 223 days (216-232) for girls in the comparator vaccine group, and 222 days (216-230) for women in the comparator vaccine group. GMT ratios were non-inferior in girls and boys receiving the SIIPL quadrivalent HPV vaccine compared with women receiving the comparator vaccine: GMT ratios for girls were 1·97 (98·75% CI 1·67-2·32) for HPV type 6, 1·63 (1·38-1·91) for HPV type 11, 1·90 (1·60-2·25) for HPV type 16, and 2·16 (1·79-2·61) for HPV type 18. For boys, the GMT ratios were 1·86 (1·57-2·21) for HPV type 6, 1·46 (1·23-1·73) for HPV type 11, 1·62 (1·36-1·94) for HPV type 16, and 1·80 (1·48-2·18) for HPV type 18. The safety population comprised all 1107 participants (369 girls and 369 boys in the SIIPL quadrivalent HPV vaccine group and 369 girls in the comparator group). Solicited adverse events occurred in 176 (48%) of 369 girls and, 124 (34%) of 369 boys in the SIIPL vaccine group, and 179 (49%) of 369 girls in the comparator vaccine group. No grade 3-4 solicited adverse events occurred within seven days of each dose. Unsolicited adverse events occurred in 143 (39%) girls and, 147 (40%) boys in the SIIPL vaccine group, and 143 (39%) girls in the comparator vaccine group. The most common grade 3 unsolicited adverse event was dengue fever in one (<1%) girl in the SIIPL vaccine group and three (1%) girls in the comparator group. There were no grade 4 or 5 adverse events. Serious adverse events occurred in three (1%) girls and three (1%) boys in the SIIPL vaccine group and five (1%) girls in the comparator vaccine group. No vaccine-related serious adverse events were reported. There were no treatment-related deaths.
