Bharat Biotech’s Covaxin gets SEC approval for emergency use

The Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation (CDSCO) has reportedly given its approval to Bharat Biotech’s Covaxin coronavirus vaccine for emergency use. This makes it the second vaccine after Serum-AstraZeneca’s Covishield to get marketing approval from the expert panel.

The SEC has recommended Covaxin for emergency use authorisation (EUA), reported news agency ANI quoting government sources. The recommendation, along with rollout modalities, will now be taken up by the Drug Controller General of India (DCGI) for a final decision on the matter.

Covaxin is the first indigenous coronavirus vaccine being developed in India. Hyderabad-based Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV) is working on the jab.

The development comes a day after the SEC granted emergency use authorisation for Covishield. The panel had asked Bharat Biotech to submit for data for Covaxin, and suggested expediting volunteer recruitment for the ongoing Phase 3 clinical trials. The SEC had also recommended that the firm may conduct interim efficacy analysis for further consideration of restricted emergency use approval for Covaxin.

As per reports, Bharat Biotech submitted interim efficacy data from Phase 1 and 2 trials, along with safety and immunogenicity data published in a non-peer-reviewed journal. The company, however, is yet to disclose the results or study design of Phase 3 trials.

Bharat Biotech has claimed that Covaxin can protect against the mutated COVID-19 strain that surfaced in the United Kingdom last month.The new strain has been found to be extremely contagious. Apart from the UK, it has been detected in India, Denmark, the Netherlands, Australia, Italy, Sweden, France, Spain, Switzerland, Germany, Canada, Japan, Lebanon and Singapore so far.

“It (coronavirus) is expected to have a lot of mutation and you can be rest assured this vaccine will also protect against that (mutated) virus because of two hypotheses… So you have these two components in the inactivated vaccine. It will also take care of those mutations,” Bharat Biotech Chairman Krihsna Ella said.

India now has two COVID-19 vaccines ready for rollout as the country conducted a nationwide dry run of its vaccination drive. The mock exercise was meant to test the vaccine delivery network and Co-WIN, the digital platform developed to help with this. The dry run also check preparedness to deal with adverse events that might rise after vaccination. No vaccines were administered during the dry run.

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