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Zydus Cadila Gets Drugs Controller General’s Nod For Phase-3 Clinical Trials For COVID-19 Vaccine

The vaccine candidate has been supported by the National Biopharma Mission (NBM) under the aegis of Biotechnology Industry Research Assistance Council (BIRAC), a PSU under the DBT

Zydus Cadila Gets Drugs Controller General’s Nod For Phase-3 Clinical Trials For COVID-19 Vaccine
Highlights
  • The vaccine candidate has been supported by the National Biopharma Mission
  • Phase-3 trial of COVID-19 vaccine will be done on 26,000 participants
  • Country's first DNA vaccine platform is an important achievement: Official

New Delhi: The drug regulatory body Drugs Controller General of India (DCGI) has approved Ahmedabad based drug firm Zydus Cadila to initiate Phase III clinical trials of its Covid-19 vaccine ZyCoV-D. “The Nation’s first indigenously developed DNA vaccine candidate against COVID-19, ZyCoV-D, by M/s Zydus Cadila has been approved by Drugs Controller General of India (DCGI), for the conduct of the Phase III clinical trials,” Ministry of Science and Technology said in a release on Sunday.

Also Read: Dry Run For COVID-19 Vaccination In All States, Union Territories On January 2

The Ministry said that Zydus Cadila completed Phase-I/II clinical trials of this DNA Vaccine candidate, in India, in more than 1,000 participants and interim data indicated that the vaccine is safe and immunogenic when three doses were administered intradermally.

Based on the recommendations of the Subject Expert Committee, which reviewed the interim data, the DCGI has accorded permission for conducting Phase-III clinical trial in 26,000 Indian participants, the Ministry said.

According to Ministry, the candidate has been supported by the National Biopharma Mission (NBM) under the aegis of Biotechnology Industry Research Assistance Council (BIRAC) and the Department of Biotechnology, Ministry of Science and Technology, Government of India.

Dr. Renu Swarup, Secretary, DBT and Chairperson, BIRAC expressed happiness and hoped that the candidate vaccine continues to show positive outcomes. Speaking on the occasion, she said,

The establishment of the Nation’s first DNA vaccine platform is an important milestone for Atma Nirbhar Bharat and a big leap forward for Indian scientific research.

The DCGI had on Sunday said that COVID-19 vaccines of Serum Institute of India’s Covishield and Bharat Biotech’s COVAXIN have been granted permission for restricted use in an emergency situation.

Also Read: Health Ministry Releases Communication Strategy To Support COVID-19 Vaccine Rollout

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

NDTV – Dettol Banega Swasth India campaign is an extension of the five-year-old Banega Swachh India initiative helmed by Campaign Ambassador Amitabh Bachchan. It aims to spread awareness about critical health issues facing the country. In wake of the current COVID-19 pandemic, the need for WASH (WaterSanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign highlights the importance of nutrition and healthcare for women and children to prevent maternal and child mortality, fight malnutrition, stunting, wasting, anaemia and disease prevention through vaccines. Importance of programmes like Public Distribution System (PDS), Mid-day Meal Scheme, POSHAN Abhiyan and the role of Aganwadis and ASHA workers are also covered. Only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and become a Swasth or healthy India. The campaign will continue to cover issues like air pollutionwaste managementplastic banmanual scavenging and sanitation workers and menstrual hygiene

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