Coronavirus vaccine: Bharat Biotech's COVAXIN gets expert panel nod
A government-appointed panel on Saturday recommended emergency-use authorization (EUA) to the COVID-19 vaccine developed by Hyderabad-based Bharat Biotech. The panel submitted its findings to the Drugs Controller General of India (DCGI), who will take a final call on the issuance of EUA. Covishield—the vaccine developed by AstraZeneca and Oxford University, and manufactured by Pune-based Serum Institute of India—has also received the panel's nod.
The Subject Expert Committee (SEC) of Central Drugs Standards Control Organisation (CDSCO) had on Saturday recommended the "grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains, to M/s Bharat Biotech International Ltd, Hyderabad," the Union Health Ministry said.
Notably, the panel's recommendation comes despite a lack of trial data indicating the vaccine's efficacy. COVAXIN has completed two out of three clinical trials so far. The third trial—which had started in November—tests for vaccine efficacy. Bharat Biotech said it has successfully recruited 23,000 out of 26,000 Phase III trial volunteers. Phase I and II trials had shown positive safety and immunogenicity results.
Dr. Savita Verma—a pharmacology professor from Haryana's PGIMS working on the vaccine—told NDTV, "We have very robust Phase I and II results, in which good efficacy was shown." Dr. Verma also said that around 10 million doses of COVAXIN are ready.
Earlier on Friday, the CDSCO panel had recommended Covshield for approval as well. The vaccine will "protect 95% of (its) patients," AstraZeneca CEO Pascal Soriot had said last week. Serum Institute CEO Adar Poonawalla has said that roughly 50 million doses, most of which will go to India, are already stockpiled. India will also be contributing doses to the global COVAX facility.
The vaccine developed by Pfizer and BioNTech, Tozinameran or BNT162b2, is also under review by the CDSCO panel for emergency approval in India. The company is reportedly yet to present its data before the panel. The vaccine has notably been approved in several countries.
The government had on Saturday conducted a day-long trial run of the vaccine delivery system to check for potential challenges. The exercise was conducted in 116 districts and nearly one lakh personnel had undergone the necessary training, the Health Ministry said. Health Minister Dr. Harsh Vardhan said Sunday morning that there should be no misconceptions about vaccines approved in India.
