- The technology used to develop this vaccine is same as the one used for the Pfizer vaccine, said VK Paul
- Currently, the Indian regulators are considering three vaccines to authorise under emergency use
Dr VK Paul, Member of NITI Aayog, on Tuesday said the Drugs Controller General of India (DCGI) had 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, has developed the vaccine. The technology used to develop this vaccine is same as the one used for the Pfizer vaccine, said Paul.
Earlier, a Mint report stated that Pune-based Gennova Pharmaceuticals will start the phase 1 clinical trial of its indigenous vaccine candidate HGCO19 based on messenger RNA platform with enrolment of 120 participants starting from early January.
The company had on Friday received approval from the Drug Controller General of India for conducting a phase 1 and 2 clinical trial for 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 that has been developed so far. If it comes into existence, it will be maintained at normal cold chain conditions, in a normal fridge, said the NITI Aayog member.
Currently, the Indian regulators are considering three vaccines to authorise under emergency use. These vaccines are developed by AstraZeneca, Bharat Biotech and the third vaccine was jointly created by Pfizer Inc and BioNTech.
“There is hope that early licensure is possible for all or any of them”, the Union health ministry said on Tuesday. The USA has 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 an 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 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 the ICMR is developing another vaccine, Covaxin.
ZyCOV-D, a vaccine by Cadila Healthcare jointly developed with the Department of Biotechnology. Sputnik-V is the fourth vaccine candidate developed by Dr Reddy’s Lab and Gamaleya National Centre 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 USA.
HGCO 19, the seventh one is being 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.
Additionally, the health ministry has released guidelines for the end point of the cold chain and the states have also received the necessary resources of vaccination. Under the multi-level governance mechanism, 36 states and UTs have concluded meetings of the State Steering Committee as well as State Task Force. Among the District Task Forces, 633 districts have concluded their their meetings and 23 ministries or departments under the government have been assigned roles to roll out the vaccine.
Vaccine training to the different personnel has been given under the Human Resource Training and Capacity Building. Training modules for medical officers, vaccinator officers/alternative vaccinator officers, cold chain handlers, supervisors, data managers, ASHA coordinators and others.
Training for physical and virtual platforms have begun and national and state Training of Trainers (ToTs) have also completed.
The health ministry has asked the states to have atleast one Adverse Events Following Immunizaton (AEFI) centre setup in each block. For the AEFI, states have bene instructed on infection prevention and control practices during vaccination and management of minor, severe and serious AEFIs. Any fixed health facility including PHC, CHC, private health facilities with medical officers or para medical staff are to be AEFI Management Centres.
For cold chain management, the ministry has issued guidelines for electrical and non-electrical cold chain equipment. 29,000 cold chain points, 240 walk-in coolers, 70 walk-in freezers, 45,000 ice-lined refrigerators, 41,000 deep freezers and 300 solar refrigerators are to be used.
