Another Indian vaccine candidate COVID-19 will soon start human testing

Dr VK Paul, a member of NITI Aayog, said on Tuesday that the General Controller of Medicines in India (DCGI) had recently granted authorization for an additional vaccine candidate Covid-19 from Gennova Pharmaceuticals Ltd. Gennova, in conjunction with the Department of Biotechnology, a research 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 stated that Pune-based Gennova Pharmaceuticals will begin the phase 1 clinical trial of its native vaccine candidate HGCO19 based on a messaging RNA platform with enrollment of 120 participants starting in early January.

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

However the storage procedure for this vaccine would not be the same as followed for the Pfizer vaccine or any other vaccine developed to date. If it does come into existence, it will stay at normal cold chain conditions, in a normal refrigerator, NITI member Aayog said.

Currently the Indian regulators are considering three vaccines to authorize under emergency use. These vaccines are developed by AstraZeneca, Bharat Biotech and the third vaccine was created jointly by Pfizer Inc and BioNTech.

“It is hoped that early authorization is possible for all or some of them,” the Union’s ministry ministry said on Tuesday. The United States recently approved the Pfizer-BioNTech vaccine and a nurse in New York City first received it.

In India, six vaccines are undergoing clinical trials and the government is talking to Moderna, which requires very cold storage, Paul said.

Paul said the government is also chatting with Moderna, which also has requirements for very cold storage.

There are eight vaccines that are currently being found at different stages of development in the country. One is Covishield, manufactured by 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 jointly developed with the Department of Biotechnology. Sputnik-V is the fourth vaccine candidate developed by Dr. Reddy’s Laboratory and 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 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.

Additionally, the health ministry has published guidelines for the end point of the cold chain and the states have also received the necessary resources to vaccinate. Under the multilevel governance mechanism, 36 states and UTs concluded meetings of the State Steering Committee as well as of State Task Force. Among the District Task Forces, 633 districts ended their meetings and 23 ministries or departments under the government were given roles to develop the vaccine.

Vaccine training to the various persons was given under the Human Resources Training and Capacity Building. Training modules for physicians, vaccine officers / alternative vaccine officers, cold chain administrators, supervisors, data managers, ASHA coordinators and others.

Training for physical and virtual platforms began and also ended national and state Training of Trainers (ToTs).

The health ministry has asked the states to have at least one Center for Bad Events After Immunization (AEFI) in each block. For the AEFI, states have good instructions on infection prevention and control practices during vaccination and administration of mild, severe, and serious AEFI. Every fixed health facility including PHC, CHC, private health facilities with doctors or even medical staff must be AEFI Management Centers.

For cold chain management, the ministry has published guidelines for electrical and non-electric cold chain equipment. 29,000 cold chain points, 240 inlet refrigerators, 70 inlets, 45,000 ice-cold refrigerators, 41,000 refrigerators and 300 solar refrigerators are to be used.

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