Another Indian candidate for the COVID-19 vaccine will soon begin human studies

Dr. VK Paul, a member of NITI Aayog, said on Tuesday that the Comptroller General of Medicines of India (DCGI) recently approved the approval of an additional candidate for the Covid-19 vaccine from Gennova Pharmaceuticals Ltd. Gennova, in association with the Department of Biotechnology, an agency study 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.

Earlier, a Mint The report stated that Gennova Pharmaceuticals, based on Pune, will begin Phase 1 of the clinical trial of its indigenous HGCO19 vaccine candidate based on the messenger RNA platform with the registration of 120 participants starting in early January.

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

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

Indian regulators are currently considering three vaccines for emergency authorization. These vaccines are developed by AstraZeneca, Bharat Biotech, and the third vaccine was created jointly by Pfizer Inc. and BioNTech.

“There is hope that early licensing is possible for all or any of them,” the Union’s health ministry said on Tuesday. The United States recently approved the Pfizer-BioNTech vaccine, and a nurse in New York was the first to receive it.

In India, six vaccines are undergoing 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 requirements for ultra-cold storage.

There are eight vaccines that are currently in various stages of development in the country. One is Covishield, manufactured by the Serum Institute of India (SII) in collaboration with AstraZeneca. Bharat Biotech, in association with 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 vaccine candidate developed by Dr. Reddy Laboratory 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 vaccine manufactured by Biological E and MIT in the United States.

HGCO 19, the seventh is manufactured by Genoa 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 Ministry of Health has published guidelines for the end point of the cold chain, and states have also received the resources needed for vaccination. Under the multi-level governance mechanism, 36 states and TUs held meetings of the State Steering Committee as well as the State Task Force. Of the district task forces, 633 districts ended their meetings and 23 ministries or departments under government were given the task of launching the vaccine.

Vaccine training for different staff was provided in Human Resource Training and Capacity Development Training modules for medical officers, vaccination officers / alternative vaccination officers, cold chain managers, supervisors, data managers, ASHA coordinators and others.

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

The Ministry of Health has asked states to have at least one adverse event after the installation of the immunization center (AEFI) in each block. For EFSA, states received guidance on infection prevention and control practices during vaccination and management of minor, severe and severe EFSA. Any fixed health unit, including PHC, CHC, private health units with medical officers or medical staff, must be AEFI management centers.

For the management of the cold chain, the ministry issued guidelines for the electrical and non-electrical equipment of the cold chain. 29,000 points for the cold chain, 240 coolers, 70 freezers, 45,000 ice refrigerators, 41,000 freezers and 300 solar refrigerators.

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