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The SEC has recommended Covaxin for emergency use authorisation (EUA), reported news agency ANI quoting government sources. The recommendation, together with rollout modalities, will be taken up from the Drug Controller General of India (DCGI) to get a final decision on the issue.
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 its the second vaccine following Serum-AstraZeneca’s Covishield to get marketing approval from the expert panel.
Expert panel recommends granting permission for restricted emergency use authorisation for Bharat Biotech’s indigenously developed COVID-19 vaccine — (Covaxin): Govt Sources— ANI (@ANI) January 2, 2021
Expert panel recommends granting permission for restricted emergency use authorisation for Bharat Biotech’s indigenously developed COVID-19 vaccine — (Covaxin): Govt Sources
— ANI (@ANI) January 2, 2021
The SEC has recommended Covaxin for emergency use authorisation (EUA), reported news agency ANI quoting government sources. The recommendation, along with rollout modalities, will 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 to the ongoing Phase 3 clinical trials. The SEC had also suggested that the firm may conduct interim efficacy analysis for additional consideration of restricted emergency use approval for Covaxin.
According to reports, Bharat Biotech submitted interim efficacy data from Phase 1 and 2 trials, along with safety and immunogenicity data printed in a non-peer-reviewed journal. The organization, however, is yet to disclose the results or research design of Phase 3 trials.
Bharat Biotech has promised that Covaxin can protect against the mutated COVID-19 strain that surfaced in the United Kingdom last month.The new breed was found to be extremely contagious. Aside from the UK, it has been found 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 this (mutated) virus because of two hypotheses… So you’ve got these two components from the inactivated vaccine. Additionally, it will look after these mutations,” Bharat Biotech Chairman Krihsna Ella said.
India currently has two COVID-19 vaccines ready for rollout as the country conducted a nationwide dry run of its own vaccination drive. The mock exercise was meant to test the vaccine delivery network and Co-WIN, the electronic platform developed to help with this. The dry run also assess preparedness to take care of adverse events which may rise after vaccination. No fingerprints were administered during the long term.
