Hetero gets CDSCO panel nod to manufacture Sputnik V for restricted emergency use

New Delhi: In a significant development, drug firm Hetero has got the green signal from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) to manufacture the Sputnik V vaccine for restricted use in emergency situations.

This nod, however, is conditional on a number of factors. The expert panel has decided that the vaccine should be used for active vaccination to prevent COVID-19 disease in individuals of ≥ 18 years of age.

The committee has also directed the vaccine be administered intramuscularly in two doses of 0.5 mL each at an interval of 21 days. (Day 0: Component I & Day 21: Component II). The vaccine has to be stored at -18°C.

The approval came in the wake of a proposal moved by the Hetero for grant of Permission to Manufacture Gam COVID Vector vaccine (Sputnik V) along with interim safety and immunogenicity results from the Phase III clinical trial.

Sputnik V, also known as Gam-COVID-Vac, is a viral two vector vaccine made up of two adenovirus vectors, Ad5 and Ad26, into which the SARS-CoV-2 full-length glycoprotein S gene was inserted. It was developed by the Gamaleya Research Institute of Epidemiological and Microbiology.

India's drug regulator approved the restricted emergency use of the Russian COVID-19 vaccine 'Sputnik V' on April 12, 2021, subject to specified circumstances. Further, Russian Direct Investment Fund (RDIF) also inked agreements with large pharmaceutical companies in the region, including Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech, and Shilpa, to produce over 850 million doses per year, enough to vaccinate over 425 million people.

Medical Dialogues team had earlier reported that this year in April, Hetero Biopharma had sought DCGI permission to conduct a Phase III clinical trial of Russian Sputnik V, COVID-Vac Combined Vector Vaccine, manufactured by Hetero Biopharma. In response, the CDSCO committee had granted permission to conduct a Phase III clinical trial under the following conditions: immunogenicity samples should be collected at Day 21, 28, and 42, and neutralizing antibodies and gamma interferon should be measured throughout the study.

In continuation with the above, at the 183rd SEC meeting for examining COVID-19 related proposals under the accelerated approval process, held on September 16, 2021 at CDSCO, the committee thoroughly evaluated the drug-maker Hetero Biopharma's proposal for the grant of Permission to Manufacture Gamma COVID Vector vaccine (Sputnik V), as well as interim safety and immunogenicity results from the Phase III clinical trial.

After detailed deliberation, the committee recommended the grant of permission to manufacture the Sputnik V vaccine for restricted use in emergency situations, subject to various regulatory provisions, including the following:

1. The vaccine is indicated for active immunization to prevent COVID-19 disease in individuals of ≥ 18 years of age.

2. The vaccine should be administered intramuscularly in two doses of 0.5 mL each at an interval of 21 days. (Day 0: Component I & Day 21: Component II).  The  vaccine has to be stored at -18°C.

3. The firm should submit the PI, SmPC & Factsheet to CDSCO after incorporating the latest safety and immunogenicity data.

4. The vaccine should be supplied along with factsheet & separate leaflet for guidance of the healthcare provider

5. The firm should ensure that factsheet for the vaccine recipient/attendant is provided prior to administration of the vaccine.

6. The firm should disseminate the instructions & educational material including factsheet, PI, SmPC, storage instructions etc. in their website.

7. The firm should submit safety & immunogenicity data from the ongoing clinical trial in the country for review as and when available.

8. The firm should submit safety data including the data on AEFI and AESI with due analysis every 15 days for the first two months & monthly thereafter till the completion of the ongoing clinical trial in the country. Thereafter, the firm should submit the safety data as per the provisions and standard procedures.

9. The firm should submit India specific Risk management plan.

Earlier this week, CDSCO released a list of eight pharmaceutical companies that have secured approval for COVID-19 vaccines for Restricted Use in Emergencies in the country. SPUTNIK-V  imported by Dr Reddy's, and SPUTNIK-V (component I & II), manufactured by Panacea Biotech, are on the list.