For the first time, India is going to have its own vaccine to prevent cervical cancer, which ranks as the second most frequent cancer in women in the country.
The announcement came on Tuesday evening when Adar Poonawalla, head of India’s largest vaccine manufacturing company, SII, said the vaccine is going to be “both” – accessible and affordable.
For the first time, there will be an Indian HPV vaccine that is both affordable and accessible to treat cervical cancer in women. We look forward to launching it later this year and we thank #dcgi @MoHFW_INDIA Regarding approval today.
— Adar Poonawalla (@adarpoonawalla) 12 July 2022
Soumya Swaminathan, Chief Scientist of the World Health Organization, responded to the tweet, writing that it was “good news”.
Good News. #cervical cancer Can be terminated if given to all pre-pubertal girls #hpv vaccinations globally
— Soumya Swaminathan (@doctorsoumya) 12 July 2022
Serum Institute of India’s (SII) Survvac – a quadrivalent human papillomavirus (qHPV) vaccine – is expected to cost less and, therefore, will be more affordable for Indian households as the available alternatives manufactured by foreign drug makers are much more expensive.
“The cost of the HPV regimen is expected to be at least half as much as India’s own vaccine product prepares to enter the market,” said a government official with knowledge of vaccine development and approval. “The product was expected to hit the shelves by November this year. However, according to our latest buzz, it looks like it might be rolled out by September.
Experts told News18.com that a complete regimen of HPV vaccines currently approved in India requires an individual to spend at least Rs 5,000 to Rs 8,000. Two options are available: Merck Sharp & Dohm’s Gardasil (qHPV vaccine) and GSK’s Cervarix (bivalent HPV vaccine).
The cost of one vial of Gardasil is Rs 3,927 and Rs 2,640 for Cervarix. Injections have to be given in two or three doses at intervals of several months. If the dosage regimen is not followed, the person will not be completely protected from HPV.
Developing India’s own HPV vaccine
Human papillomavirus (HPV) infection is now a well-established cause of cervical cancer and HPV types 16 and 18 are the most frequent and responsible for approximately 70% of all cervical cancer cases worldwide.
Cervavac is an indigenously developed quadrivalent prophylactic (preventive) HPV vaccine indicated in girls and boys aged 9 to 26 years.
It is a VLP (virus-like particle) based vaccine similar to the hepatitis B vaccine, and provides protection by generating antibodies against the HPV virus L1 protein.
In India, the SII vaccine trial was started in 2019 and involved over 2,000 participants in the age group of 9-26 years at 12 sites including All India Institute of Medical Sciences, New Delhi, Christian Medical College, Vellore. went away. , and Tata Memorial Hospital and Cancer Research Institute in Maharashtra.
“The Phase III results show a strong immune response in 100% of vaccine recipients with an excellent safety record,” the official quoted above said.
SII Phase II/III multicenter study with a two-dose schedule (0 and 6 months) for Group 1 (ages 9-14) and a three-dose schedule (0, 2, and 6 months) for Group 1 . 2 (ages 15–26 years) with three treatment arms in each group.
A total of 600 subjects were enrolled, such as 200 girls or women receiving either qHPV vaccine of SII or Gardasil vaccine of MSD in a 1:1 ratio in a randomized and blinded manner and 100 boys/men in a randomized and blinded manner was. was enrolled in non-randomised. Indiscriminately receiving qHPV vaccine of SII in each age group.
Reactivity and safety data were collected over seven months for all 600 subjects analyzed, whereas long-term follow-up data were obtained for up to 36 months.
Cervical cancer status in India
About 5% of women in the general population are estimated to have cervical HPV infection at a given time, and 83.2% of invasive cervical cancers are caused by HPV (16 or 18).
According to WHO statistics, 1 in 10 women have been screened for cervical cancer in the last 5 years. In 2019, more than 45,000 women died due to this type of cancer.
The data also shows that the age-standard cervical cancer incidence per 100 000 women in 2020 was 18 years, while the crude cervical cancer incidence per 100,000 women was 18.7.
According to the WHO’s Cervical Cancer Eradication Strategy target for 2030, 90% of girls should be fully immunized with the HPV vaccine by the age of 15.
Also, 70% of women should be screened with a high-performance test by age 35 and again by age 45. It also states that 90% of women with cervical disease receive treatment.
The data also shows that India lacks the infrastructure to handle such patients.
For example, it shows that in 2019, there were only 3 radiation oncologists per 10,000 cancer patients.
“The new vaccine by an Indian manufacturer will go a long way in reducing the burden of cervical cancer in India,” said Dr Shweta Goswami, Gynecologist and Director, IVF chain Jiva Fertility. “Because it is affordable, it will increase coverage and there is a high chance that the vaccine will be included in the national immunization program.”
However, experts pointed out that it is extremely important to create awareness about this vaccine among young girls and their parents so that adolescent girls can be vaccinated, which can later protect them from cervical cancer.
“Cervical cancer is a preventable cancer and 99.99% is related to HPV infection. This vaccine is very effective and will save a large number of women from cervical cancer,” Dr. Goswami said.
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