Another Indian COVID-19 vaccine candidate will soon begin human trials

Dr VK Paul, a member of NITI Aayog, said Tuesday that the Drugs Controller General of India (DCGI) recently granted clearance for an additional Covid-19 vaccine candidate from Gennova Pharmaceuticals Ltd. Gennova, in association with the Department of biotechnology, a research agency under the government of India, developed the vaccine. The technology used to develop this vaccine is the same as that used for the Pfizer vaccine, Paul said.

Previously, a mint report said Pune-based Gennova Pharmaceuticals will begin phase 1 clinical trials of its messenger RNA platform-based indigenous vaccine candidate HGCO19 with enrollment of 120 participants starting early January.

The company received approval from the Drug Controller General of India on Friday to conduct a Phase 1 and 2 clinical trial for safety and immunogenicity.

However, the storage procedure for this vaccine would not be the same as for the Pfizer vaccine or any other vaccine that has been developed so far. If it is produced, it will be kept under normal cold chain conditions, in a normal refrigerator, said NITI member Aayog.

Currently, Indian regulators are considering three vaccines to be authorized in an emergency. These vaccines are developed by AstraZeneca, Bharat Biotech and the third vaccine was created jointly by Pfizer Inc and BioNTech.

“There is hope that it will be possible to obtain an early license for all or some of them,” the Union health ministry said Tuesday. The United States recently approved the Pfizer-BioNTech vaccine, and a nurse from New York was the first to receive it.

In India, six vaccines are in clinical trials and the government is in talks with Moderna, which requires ultra-cold storage, Paul said.

Paul said the government is also in talks with Moderna, which also has cold storage requirements.

There are eight vaccines that are currently in different stages of development in the country. One is Covishield, produced by the Serum Institute of India (SII) in collaboration with AstraZeneca. Bharat Biotech in association with the ICMR is developing another vaccine, Covaxin.

ZyCOV-D, a vaccine from Cadila Healthcare developed jointly with the Department of Biotechnology. Sputnik-V is the fourth candidate vaccine developed by Dr Reddy’s Lab and the Gamaleya National Center in Russia.

NVX-CoV2373 is another vaccine developed by SII and Novavax. The sixth vaccine is a recombinant protein antigen-based vaccine manufactured by Biological E and MIT in the United States.

HGCO 19, the seventh is produced by Genoa in Pune in collaboration with HDT, USA. The eighth vaccine was developed by Bharat Biotech in collaboration with Thomas Jefferson University, USA.

In addition, the health ministry has released guidelines for the cold chain end point, and states have also received the necessary resources for vaccination. Under the multilevel governance mechanism, 36 states and UT concluded meetings of the state steering committee and state task force. Among the District Task Forces, 633 districts have concluded their meetings and 23 ministries or departments under the government have been assigned to vaccine launch roles.

Vaccine training for different staff was provided as part of human resource training and capacity building. Training modules for medical officers, vaccination officers / alternative vaccination officers, cold chain operators, supervisors, data managers, ASHA coordinators and others.

Training for physical and virtual platforms has begun and national and state trainings of trainers (ToT) have also been completed.

The health ministry has asked states to organize at least one adverse event center for immunization (AEFI) in each block. For the AEFI, states have benefited from infection prevention and control practices during vaccination and management of minor, severe and severe AEFI. Any fixed health facility, including PHC, CHC, private health facility with medical officers or paramedics must be AEFI management centers.

For the management of the cold chain, the ministry has issued guidelines for electrical and non-electrical equipment in the cold chain. 29,000 cold chain points, 240 walk-in coolers, 70 walk-in freezers, 45,000 ice-lined fridges, 41,000 freezers and 300 solar refrigerators are to be used.

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