The Drug Controller General of India (DCGI) approved Bharat Biotech's vaccine candidate Covaxin for restricted usage in emergency situations in India, a day after Serum Institute of India's vaccine candidate got the approval for emergency use.
The decision comes after the Subject Expert Committee of CDSCO had recommended the DCGI to grant permission for restricted emergency use of the Serum Institute of India's Covid-19 vaccine, subject to multiple regulatory conditionalities as well as Bharat Biotech's vaccine for restricted use in emergency situation in the public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains.
Here are the key takeaways from the briefing:
1. India's drugs regulator approved Oxford's Covid-19 vaccine Covishield and Bharat Biotech's Covaxin for restricted emergency use.
2. The vaccines have to be administered in two doses.
3. Cadila Healthcare has also sought permission to conduct Phase-III clinical trial in 26,000 Indian participants, which has been recommended by the Subject Expert Committee.
4. All three vaccines have to be stored at 2-8° C.
5. Phase III efficacy data on the Bharat Biotech vaccine is not out yet. The DCGI has granted permission for conduct of Phase-III Clinical Trial Protocol.
6. Vaccine candidate by Cadila Healthcare has initiated Phase-I/II clinical trials in India in more than 1000 participants which are ongoing. The interim data suggest that the vaccine is safe, the DCGI said.
7. DCGI chief VG Somani said that the vaccines are 100 per cent safe. "Some side effects like mild fever, pain & allergy are common for every vaccine," he said, rubbishing the claims made by Samajwadi Party MLC who said that people might become impotent after taking Covid-19 vaccine.