CDSCO panel recommends market nod for Serum Institute qHPV vaccine against cervical cancer
In the application, Singh is learnt to have stated that qHPV vaccine CERVAVAC has demonstrated robust antibody response that is nearly 1,000 times higher than the baseline against all targeted HPV types and in all dose and age groups.;
New Delhi: An expert panel of India's central drug authority on Wednesday recommended granting of market authorisation to Serum Institute of India (SII) to manufacture indigenously-developed India's first Quadrivalent Human Papillomavirus vaccine (qHPV) against cervical cancer, official sources said.
Prakash Kumar Singh, director (government and regulatory affairs) at SII had applied to Drugs Controller General of India (DCGI) on June 8 for market authorisation of qHPV after completing the phase 2/3 clinical trial with support of the Department of Biotechnology to ensure its early availability in the country.
In the application, Singh is learnt to have stated that qHPV vaccine CERVAVAC has demonstrated robust antibody response that is nearly 1,000 times higher than the baseline against all targeted HPV types and in all dose and age groups.
"The Subject Expert Committee (SEC) on COVID-19 of the CDSCO which deliberated on the application on Wednesday recommended granting market authorisation to Serum Institute to manufacture qHPV against cervical cancer," an official source said.
Read also: SEC to review Serum Institute qHPV vaccine trial data today
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.