DCGI has deemed Covaxin 'safe' for emergency use.
Bharat Biotech’s coronavirus vaccine Covaxin has reportedly been approved for emergency use in India on January 2, 2021.
The vaccine has been approved by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) of India.
Covaxin is the second vaccine after Serum-AstraZeneca’s Covishield to get marketing approval from the expert panel.
Drugs Controller General of India (DCGI) has also approved the Covaxin vaccine on January 3, 2020.
DCGI has deemed Covaxin ‘safe’ for emergency use.
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 vaccine has not yet completed its phase-3 trials, hence the government has asked Bharat Biotech to submit additional data for Covaxin.
The SEC has also suggested that Bharat Biotech expedite their volunteer recruitment for the ongoing phase-3 clinical trials.
The SEC recommended that the company conduct interim efficacy analysis for further consideration of restricted emergency use approval for Covaxin.
The data from Bharat Biotech’s phase-1 and 2 trials of Covaxin was reportedly submitted in a non-peer-reviewed journal.
The company is, however, yet to disclose the results or study design of phase-3 trials.
Bharat Biotech has claimed that Covaxin can protect against the new mutated Covid-19 strain from the UK as well.
India’s Health Minister, Harsh Vardhan verified:
“Covaxin is more likely to work against newer variants like N501Y Variant (UK variant).
“As well as any other that may arise due to antigenic drift as it contains immunogens (epitopes) from other genes in addition to those from Spike protein.”
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 checks preparedness to deal with adverse events that might arise after vaccination.
Neither Covaxin nor Covishield vaccines were administered during the dry run.
The two vaccines will first be offered to healthcare frontline workers in India.
The Health Ministry of India has said personnel who are considered at highest risk for Covid-19, will be given the vaccine for free.
Covaxin and Covishield rollouts are said to begin in January 2021.