Cervavac, a vaccine developed by the Serum Institute of India (SII), has recently received market authorisation from the Drugs Controller General of India (DGCI).
What is it?
- Cervavac is India’s first quadrivalent human papillomavirus vaccine (qHPV) designed to protect women from cervical cancer.
- A quadrivalent vaccine is a vaccine that stimulates an immune response against 4 different antigens – viruses or other microorganisms.
What is ‘cervical cancer’?
- Cervical cancer is a common sexually transmitted long-lasting infection with certain types of human papillomavirus (HPV) is the main cause of cervical cancer.
- It is preventable as long as it is detected early and managed effectively.
- Cervical cancer is the second most common cancer type and the second leading cause of cancer death in women of reproductive age (15-44) worldwide.
- According to the World Health Organization’s International Agency for Research on Cancer (IARC-WHO), India accounts for approximately one-fifth of the global burden. India witnesses 1.23 lakh cases and approximately 67,000 deaths each year (one woman every eight minutes).
- Cervical cancer screening and vaccination are two effective preventive measures.
- There is still little awareness among women about this cancer prevention, and less than 10% of Indian women are screened.
- All women aged 30-49, regardless of symptoms, should be screened for cervical cancer and their adolescent daughters vaccinated against HPV.
Existing vaccines –
- Two vaccines licensed globally are available in India – a quadrivalent vaccine (Gardasil, from Merck) and a bivalent vaccine (Cervarix, from GlaxoSmithKline).
- Each dose costs Rs 2,800 per dose (Gardasil) or Rs 3,299 (Cervarix).
- Although HPV vaccination was introduced in 2008, it has yet to be included in the national immunisation programme.
- According to a report, a vaccine delivery and demonstration project led by the international NGO began in 2009 in Andhra Pradesh and Gujarat but was forced to halt soon due to public outrage over the deaths of seven girls who received the vaccine.
- In 2016, the Indian Council of Medical Research (ICMR) reviewed available evidence on the efficacy, adverse effects and cost effectiveness of HPV vaccines and recommended that adolescent girls be vaccinated with two doses.
About Cervavac –
- Cervavac is based on VLP (virus-like particles), similar to the hepatitis B vaccine, and provides protection by generating antibodies against the HPV protein.
- Clinical trials for the new vaccine commenced in early 2019, involving thousands of participants across 12 sites in the country.
- According to the IARC—WHO, a model of public–private partnership involving scientists from IARC, Indian government’s Department of Biotechnology, US States National Institutes of Health and the Bill & Melinda Gates Foundation supported the evaluation of the vaccine in females and males aged 9-26.
- This resulted in completion of phase II and phase III trials, despite the pandemic.
- According to SII officials, Phase III trials show a robust immune response in 100% of the vaccine recipients with excellent safety records.
- Vaccination can be started at the relatively young age of nine and SII plans to launch the vaccine by the end of the year.
- This will allow the Government of India to procure enough HPV vaccines at a special price to vaccinate nearly 50 million girls aged 9-14 years in India.
- This will be a huge step to accelerate cervical cancer elimination in India and globally.