Serum Institute of India designed CERVAVAC®, India's first indigenously developed gender-neutral Quadrivalent Human Papillomavirus vaccine (qHPV) & further received prequalification by the World Health Organization (WHO).
This regulatory landmark reflects the 32nd WHO prequalification for products/biologicals received by Serum Institute of India. Moreover, this inclusion on the WHO List of Prequalified Vaccines enables procurement by United Nations agencies. However, key indications of this indigenous recombinant quadrivalent HPV vaccine aim at HPV types 6, 11, 16 and 18, specifically for girls and boys aged 9 through 26 years.
Mr. Adar Poonawalla, Chief Executive Officer, Serum Institute of India, said: "WHO prequalification of CERVAVAC® is an important step in strengthening the global response to HPV. This milestone reflects the effectiveness of the vaccine and creates the opportunity for countries to prevent HPV-related risks. We are pleased to see this indigenously developed vaccine reach this achievement, and look forward to contributing to immunisation coverage, advancing global healthcare."
In earlier days, the Drugs Controller General of India (DCGI) authenticated the significant application of CERVAVAC in India to prevent diverse diseases caused by the four HPV types. Furthermore, indications of this vaccine encompass mitigation of anal cancer in boys and young men, and cervical, vulvar, vaginal, and anal cancers in girls and young women. Subsidiary use also supports preventing genital warts, as applicable to the mentioned or allotted population.
About CERVAVAC®
Quadrivalent Human Papillomavirus vaccine (qHPV) called CERVAVAC was developed under an alliance with the Department of Biotechnology (DBT) and the Biotechnology Industry Research Assistance Council (BIRAC). Alongside this, SII also joined with the WHO-IARC (International Agency for Research on Cancer) and the Gates Foundation & executed CERVAVAC® as a recombinant quadrivalent HPV vaccine that targets HPV types 6, 11, 16 and 18.
In terms of demographics, qHPV CERVAVAC is approved for use in girls and women 9 through 26 years of age for the prevention of cervical, vulvar, vaginal and anal cancer due to HPV types 16 and 18, and genital warts caused by HPV types 6 and 11. Additionally, for men, this vaccine is recommended for boys and men 9 through 26 years of age to mitigate anal cancer caused by HPV types 16 and 18, and genital warts caused by HPV types 6 and 11.
Meanwhile, the population from 9 to 14 years of age can employ CERVAVAC® as per a 2-dose schedule, i.e. 0.5 mL at 0 and 6 months. On the other hand, people aged 15 to 26 years receive a 3-dose schedule, i.e. 0.5 mL at 0, 2, and 6 months. Moreover, its route of administration is intramuscular. Specific exploration of dose availability of CERVAVAC® consists of 1-dose vials of 0.5 ml and 2-dose vials of 1.0 ml presentations.
As a part of Cyrus Poonawalla Group, Serum Institute of India Pvt. Ltd. is also known as a global, eminent player in vaccine production. This firm widely emphasises facilitating inexpensive vaccines across the world. This has been done mainly across 170+ nations, such as the US, UK, and Europe, while SII positions itself as different as the world's largest vaccine developer.
One of the highlighted insights of Serum Institute of India Pvt. Ltd. is that it is a versatile or multi-purpose manufacturing facility. Over the last many years, SII has saved nearly 30 million lives. This multifunction production approach is considered one of the giants in Hadapsar & Manjari, Pune, with an annual capacity of 4 billion doses.
SII was established in 1966, and its prominent mission is to develop or manufacture life-saving immunobiological drugs, coupled with a key focus on cost-effectiveness and accessibility. Furthermore, it is driven by a robust dedication to enhancing global health. Besides this, SII has acted as an important force in lowering the costs of necessary vaccines, including Diphtheria, Tetanus, Pertussis, HIB, BCG, r-Hepatitis B, Measles, Mumps, and Rubella.
Significantly, they are the developers of 'Pneumosil,' i.e. the world's highly inexpensive PCV; 'Cervavac', the first indigenous qHPV vaccine in India, along with R21/Matrix-M™, the second Malaria vaccine to be authenticated for use in children in malaria-endemic regions. Alongside this, they have made 'MenFive', the first in the world Pentavalent (ACYWX) Meningococcal Polysaccharide Conjugate Vaccine, with approval & WHO-prequalification allowed to be used primarily in the pediatric and adult population. Recently, in the COVID-19 era, SIIPL has stepped up as a leader in the global fight against COVID-19 and has provided roughly 2 billion doses of the COVID-19 vaccine globally.
To elevate SII's global dominance and confirm broader vaccine accessibility, they have discovered Serum Life Sciences Ltd, a subsidiary in the UK and Serum Inc., a subsidiary in the US. With an emphasis on substantial innovations, SII is consistently leading because of its commitment to affordable vaccines, which has a positive effect on the lives of millions around the world.
Source- https://www.seruminstitute.com/sii-HPV-Vaccine-Cervavac-receives-WHO-prequalification.php
