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SEC asks SII to submit revised phase III trial protocol for consideration of its cervical cancer vaccine Cervavac

Gireesh Babu, New Delhi
Monday, May 29, 2023, 08:00 Hrs  [IST]

The Subject Expert Committee (SEC) - Vaccines, which advises the nation’s drug regulator in the matters for biologicals, has recommended the Pune-based Serum Institute of India (SII) to submit revised phase III clinical trial protocol for further consideration for its single dose vaccine Cervavac, the first indigenously developed vaccine for cervical cancer.

The recommendation comes against the company’s proposal for grant of permission to conduct phase IV clinical trial of single dose quadrivalent human papilloma virus (serotypes 6, 11, 16 and 18) recombinant vaccine in girls or women of age group 9-14 years and 15-20 years.

After detailed deliberation on the proposal, the Expect Committee meeting held on May 16, recommended that the trial design should be phase III clinical trial with certain changes.

The changes it recommended include that the design should have efficacy endpoint and one, six and 12 months blinded analysis may be used to decide on continuation of trial, based on any infection findings etc., in addition to Data and Safety Monitoring Board (DSMB) review. Further trial stoppage criteria should also be described in the protocol, it advised.

Besides, 18 months interim un-blinded immunogenicity or efficacy analysis should be included in the protocol.

“As proposed by the firm, urine samples will be collected from all enrolled participants and additionally cervical swab will be collected from all consented participants of 18 years and above at the baseline and every six months upto five years,” it recommended.

“Accordingly, the firm should submit revised phase III clinical trial protocol for further deliberation,” it added.

It may be noted that the company has launched the first made-in-India qHPV vaccine Cervavac on January 24, 2023. The vaccine was launched by the Home Minister Amit Shah at New Delhi. The launch was of an affordable cervical cancer vaccine, according to reports, at a maximum retail price of Rs. 2,000 per vial of two vaccines.

India’s first indigenously developed Quadrivalent Human Papillomavirus vaccine (qHPV) ‘Cervavac’ is an outcome of a partnership between Serum Institute Of India (SII), Department of Biotechnology (DBT) and the Biotechnology Industry Research Assistance Council (BIRAC) along with the Bill and Melinda Gates Foundation.

Announcing the development of the vaccine in September, 2022, Union Minister of State for Science and Technology, Dr Jitendra Singh pointed out that cervical cancer ranks as the 2nd most prevalent cancers in India and accounts for nearly one-fourth of the world’s cervical cancer deaths despite being largely preventable.

He said, current estimates indicate that every year approximately 1.25 lakhs women are diagnosed with cervical cancer, and over 75 thousand die from the disease in India, and 83% of invasive cervical cancers are attributed to HPVs 16 or 18 in India, and 70% of cases worldwide. The minister said, the most promising intervention for preventing cervical cancer is vaccination against human papillomavirus (HPV). It is estimated that HPV types 16 and 18 (HPV-16 and HPV-18) together contribute to approximately 70% of all invasive cervical cancer cases worldwide.

According to a recent International Agency for Research on Cancer (IARC) Evidence Summary Brief, the vaccine was found to be highly immunogenic, and immunogenic non-inferiority compared to women aged 15-26 years who received Gardasil was demonstrated in both girls and boys against the target HPV types. The safety profile was also comparable to that of Gardasil.

“The introduction of the new HPV vaccines that have recently been developed (Cervavac, Cecolin and Walrinvax) will be a huge step to accelerate cervical cancer elimination in India and globally, and an option to improve access and affordability,” it said. IARC was part of the collaboration between the Serum Insitute of India, the Department of Biotechnology and the Bill & Melinda Gates Foundation to design phase II/III randomised trials to evaluate the new vaccine, it said.


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