Bharat Biotech's 'Covaxin' induces immune response, shows no severe adverse effects in Phase I trials

Covaxin - one of the three COVID-19 vaccine candidates in consideration for emergency use authorisation in India, as well the country's first indigenous vaccine - has been found to have no serious adverse effects as per the initial results of its Phase I trials.

Being developed by Bharat Biotech in association with Indian Council of Medical Research (ICMR), Covaxin induced an immune response through a neutralising antibody, which was "well tolerated in all dose groups with no vaccine-related serious adverse events," stated the interim findings.

The trials were conducted on 375 participating volunteers. Post the first jab, the most common adverse event observed was of pain at the injection site, which resolved on its own. Other events were rather mild or moderate in severity and resolved spontaneously as well, without the need of any medication.

As of now, the Hyderabad-based manufacturer is in Phase III of its candidate's clinical trials, having over 25,800 volunteers across 18 sites in the country.

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Bharat Biotech has also applied for emergency use authorisation for Covaxin, which is granted to any vaccine if sufficient evidence to prove the drug's safety and efficacy are in place.

Earlier this month, Covaxin's emergency use request was rejected by a committee of the Central Drugs Standard Control Organisation (CDSCO), which had asked for more data on vaccine efficacy and safety. Although there is some data regarding the potential safety hazards in the form of observed adverse events, the company is yet to come out with the vaccine's efficacy rate.

Even Covishield - the COVID-19 vaccine developed by Oxford University and AstraZeneca - is waiting on approval for emergency use. "It is standard practice for the government to hold several meetings. The process is expected to go on for one or two weeks," sources within the Serum Institute of India (SII) told news agency Reuters. As of 2020, SII is the world's largest vaccine manufacturer, and will be manufacturing Covishield doses as well.

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Owing to previous instances of allergic reactions and adverse events, like that in the UK, the Indian government released guidelines for adverse event management on Tuesday, admitting that there is always "the possibility of an adverse event" after being inoculated.

Covaxin requires storage temperatures in the range of 2-8 degrees Celsius, which is way more feasible than the requirements of Pfizer's vaccine, which has been approved by five countries already. Having said that, if Covaxin receives approval, the indigenous vaccine will have an edge over Pfizer's, which needs to be stored at -70 degrees Celsius. This would make transportation and storage for the latter vaccine much harder in India.

Suchitra Ella, joint Managing Director at Bharat Biotech, had also informed ANI last week about Covaxin's nationwide availability by the first quarter of 2021.

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