Second COVID-19 vaccine cleared for human trials as India crosses 6 lakh cases

New Delhi, July 03: After Bharat Biotech's Covaxin, another potential COVID-19 vaccine indigenously developed by Ahmedabad-based Zydus Cadila Healthcare Ltd has received approval from Indian regulators to begin human studies for its Covid-19 vaccine as the novel coronavirus infections continue to surge in the world's fourth worst-hit nation.

The vaccine showed a "strong immune response" in animal studies, and the antibodies produced were able to completely neutralize the wild type virus, Reuters reported quoting Zydus.

"Zydus has already manufactured clinical good manufacturing practise (GMP) batches of the vaccine candidate and plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1,000 subjects," the company said.

The company is expected to begin human trials this month in over 1,000 subjects in multiple sites in India. It also plans to ramp up its production capacity for the vaccine contender to serve Indian and global demand.

In animal studies the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits.

The antibodies produced by the vaccine were able to completely neutralise the wild type virus in virus neutralisation assay indicating the protective potential of the vaccine candidate, it said.

It further said no safety concerns were observed for the vaccine candidate in repeat dose toxicology studies by both intramuscular and intradermal routes of administration.

In rabbits, up to three times the intended human dose was found to be safe, well tolerated and immunogenic. Zydus said, with its ZyCoV-D, it has successfully established the DNA vaccine platform in India using non-replicating and non-integrating plasmid carrying the gene of interest making it very safe.

The company claimed that the vaccine candidate has no vector response and with absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements.

It is also known to show much improved vaccine stability and lower cold chain requirements making it easy for transportation to remotest parts of the country, it said.

"Furthermore, the platform can be rapidly used to modify the vaccine in couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection," it added.

The company now intends to rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand.

Similar efforts are underway in different countries. Precisely, there are nearly 150 vaccine candidates under development currently, of which 17 are undergoing human trials.

University of Oxford's vaccine is the furthest in the trial, currently in the third phase, while there are various candidates in the second phase. Moderna Inc, Chinese Sinovac Biotech and Oxford-AstraZeneca experimental vaccines are all expected to go into late-stage trials in the coming month.

With over 20,000 COVID-19 cases, India on Friday recorded the highest one-day spike this month.

Coronavirus cases have gone up to 6,25,544 with 20,903 new cases being reported in the past 24 hours. 379 deaths have been reported in a single day taking the death toll to 18,213 in India.