The Two COVID19 Vaccines Developed in India Succesful In Seeking DCGI Approval

India's first COVID 19 vaccine launched by Bharat Biotech on 30th June 2020

India’s first potential COVID-19 vaccine has been given approval for Phase I and Phase II clinical trials. Named COVAXIN, the vaccine was developed by Bharat Biotech and has been granted approval from the Drugs Controller General of India (DCGI). Human clinical trials are scheduled to start across India in July 2020.

Bharat Biotech created COVAXIN in coorporation with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV). 

According to the company, the SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech’s facility located in Hyderabad, India.

The DCGI granted permission to initiate Phase I and II human clinical trials after the pharmaceutical submitted results generated from pre-clinical trial studies, demonstrating “promising” and “extensive” safety and immune responses. 

Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech, said that biotech Pharma is proud to announce COVAXIN, India’s first indigenous vaccine against COVID-19. The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO has enabled  them approvals to this project. There R&D and manufacturing teams worked tirelessly to deploy proprietary technologies towards this platform.
Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies.

Mrs Suchitra Ella, Joining to Managing Director of Bharat Biotech added that the company is committed to advancing vaccine development as a matter of national importance to demonstrate India’s strength in handling future pandemics.

This was about the first vaccine which was approved for human studies which was launched by Bharat Biotech Pharma on 30th 0f June 2020.

On 3rd of July Zydus Cadila cleared the DCGI approval  for human trials for potential corona vaccine.

In positive development, another Indian pharmaceutical company,  Zydus Cadila received the approval from The Drug Controller General of India (DGCI) to start phase I and II of their clinical trials on human participants.The pharma compant declared its approval just after India's first homegrown vaccine, Bharat Biotech's COVAXIN received the approvals to start with their clinical trials.

While India is one of the leading vaccine producers and suppliers in the world and it takes a lot of time for a vaccine to pass through stages, trials are being done in a speedy way across the world to meet the surge of the pandemic that has caused widescale destruction.

A report mentioned that Ahmedabad based Zydus Cadila saw satisfactory results in the pre-clinical trials and various animal studies, post which, the regulatory board issued them the go-ahead to start the trials.

India-based pharmaceutical firm Zydus Cadila has launched a fast-tracked research programme to develop a vaccine against the disease caused by the new coronavirus, Covid-19.

The company’s teams in India and Europe will leverage two different methods to develop the vaccine.

1. One approach involves the creation of a DNA vaccine against the viral membrane protein required for the virus’ entry into the cell.

In host cells, the delivered plasmid DNA would translate into the viral protein and trigger an immune response via the cellular and humoral arms of the immune system. These arms are known to help to protect from disease and viral clearance.

2. The second method will see the development of a live attenuated recombinant measles virus (rMV) vectored vaccine to fight the new coronavirus.
 

Codon-optimised proteins of the new coronavirus, expressed by rMV generated, will use reverse genetics to stimulate long-term neutralising antibodies that protect against the infection.

A team at the company’s Vaccine Technology Centre in India is working on the plasmid DNA vaccine, while its research unit at Etna Biotech in Europe is working on measles reverse genetics technology.

Zydus Group chairman Pankaj Patel said that there is an urgent and pressing need to develop a safe and efficacious vaccine that can prevent the spread of this deadly virus. And researchers are working to bring a speedy solution to this most devastating outbreak in recent times.

The company’s manufacturing facilities for recombinant antigens and measles-containing vaccines will allow scale-up both vaccine candidates’ production.

These are the only two vaccine prototypes which have been approved for the testing phase so far. While over seven other candidates are developing their vaccine models, Patanjali group's 'Coronil', marketed as a COVID-19 cure has only been approved by the officials as an immunity booster, after a lot of murky trials.

Apart from this, global candidates like Moderna Inc.'s mRNA 1273, CanSino BioTech's SinoVac and Oxford-Astrazeneca's ChAdOx1 nCoV-19 are currently in advanced stages of human trials.