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

Dr. VK Paul, a member of NITI Aayog, said Tuesday the Drugs Controller General of India (DCGI) recently received approval for an additional Covid-19 vaccine candidate from Gennova Pharmaceuticals Ltd. Gennova, in collaboration with the Department of Biotechnology granted agency under the Government of India, has 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 A report said that Pune-based Gennova Pharmaceuticals will start the Phase 1 clinical trial of its domestic vaccine candidate HGCO19 based on a messenger RNA platform with 120 participants from early January.

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

However, the storage procedure for this vaccine would not be the same as for the Pfizer vaccine or any other vaccine developed to date. When it does arise, it will be kept in a regular refrigerator under normal cold chain conditions, said the NITI Aayog member.

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

“There is hope that early licensing will be possible for all or one of them,” the Union Health Ministry said Tuesday. The US recently approved the Pfizer BioNTech vaccine, and a nurse in New York was the first to receive it.

Six vaccines are currently being clinically tested in India and the government is in talks with Moderna, which require ultra-cold storage, Paul said.

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

There are eight vaccines that are currently in various stages of development in the country. One of them is Covishield, made by the Serum Institute of India (SII) in partnership with AstraZeneca. Bharat Biotech is working with the ICMR to develop another vaccine, Covaxin.

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

NVX-CoV2373 is another vaccine being 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 manufactured by Genova in Pune in collaboration with HDT, USA. The eighth vaccine is being developed by Bharat Biotech in collaboration with Thomas Jefferson University, USA.

In addition, the Department of Health has published guidelines for the cold chain endpoint, and states have also received the necessary inoculants. As part of the multilevel governance mechanism, 36 states and UT completed the state steering committee and state task force meetings. Under the district task forces, 633 districts have completed their meetings and 23 ministries or departments under the government have been assigned roles for the introduction of the vaccine.

As part of staff training and capacity building, vaccine training sessions were held for the various employees. Training modules for doctors, vaccination officers / alternate vaccination officers, cold chain leaders, supervisors, data managers, ASHA coordinators and others.

Physical and virtual platform training has started and national and state trainer training (ToTs) has also been completed.

The Department of Health has asked states to establish at least one Post-Immunization Adverse Event Center (AEFI) in each block. For the AEFI, states have received instructions on how to prevent and control infections during vaccination and treatment of small, severe, and severe AEFIs. All permanent health facilities, including PHC, CHC, private health facilities with doctors or paramedical staff, are AEFI management centers.

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

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