After Serum’s Covishield, expert panel recommends restricted emergency approval for Bharat Biotech’s Covaxin

India's Central Drugs Standard Control Organization (CDSCO) expert panel on Saturday recommended granting approval for restricted emergency use of Bharat Biotech's indigenous COVID vaccine Covaxin in India, said officials.

The Indian drug regulator DCGI's Subject Expert Committee (SEC) today reviewed the application for emergency use authorisation of Covaxin, which is jointly developed by Hyderabad-based vaccine manufacturer Bharat Biotech and Indian Council of Medical Research (ICMR).

The committee on Saturday again deliberated on the emergency use authorisation (EUA) application of the Hyderabad-based pharmaceutical firm after it submitted additional data, facts and analysis subsequent to Friday's review meeting, PTI reported citing sources.

This is the second Covid-19 vaccine which has been recommended for emergency use approval to DCGI after Serum Institute of India's locally produced Oxford Covid-19 vaccine 'Covishield'.

The government said the final decision on the two vaccines would be made by the chief of the Central Drugs Standards Control Organisation (CDSCO).

Ministry of Health and Family Welfare's statement:

"The Subject Expert Committee of CDSCO met on 1st and 2nd January, 2021 and made the following recommendations for the consideration and final decision of the Drugs Controller General of India:

1) Grant of permission for restricted emergency use of vaccine, subject to multiple regulatory conditionalities, to M/s Serum Institute of India, Pune.

2) Grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains, to M/s Bharat Biotech International Ltd., Hyderabad."

According to a PTI report, the SEC had on Friday recommended 'interim efficacy analysis for Covaxin'.

While considering Bharat Biotech's application, the SEC had noted that the" ongoing clinical trial is a large one with 25,800 subjects of which 22,000 have been enrolled, including subjects with comorbid conditions, which has demonstrated safety till date but efficacy is yet to be demonstrated," PTI reported.

On Friday, the expert panel recommended granting emergency use authorization to Serum Institute of India’s (SII’s) Covishield, according to Mint report, while the government prepared to roll out the shots as early as next week.

SEC gave its recommendations to Drugs Controller General of India (DCGI) V.G. Somani for emergency licence for Covishield subject to certain conditions, the persons said, requesting anonymity. A formal clearance from the DCGI is likely to follow soon.

However, Information and Broadcasting Minister Prakash Javadekar confirmed the new reports and told reporters on Saturday the vaccine had been given the green light on Friday.

Javadekar said at least three more vaccines were waiting to be approved - local company Bharat Biotch's COVAXIN, Zydus Cadila's ZyCoV-D and Russia's Sputnik-V.

"India is perhaps the only country where at least four vaccines are getting ready," he said.

"One was approved yesterday for emergency use, Serum's COVISHIELD." he said, referring to the fact that the AstraZeneca/Oxford shot is being made locally by the Serum Institute of India (SII).

Union Health Minister Harsh Vardhan also stressed that there would be no compromise on any protocol while approving the vaccine. Vardhan appealed to people on Saturday not to be misguided by "rumours" regarding the safety and efficacy of the coronavirus vaccine, and said the most prioritised beneficiaries would be vaccinated for free.

The minister, who visited two mock vaccination sites in Delhi to review the drill, said free vaccines would be provided in the first phase of the inoculation drive to the most prioritised beneficiaries, including one crore healthcare and two crore frontline workers.

SII had applied to the Drugs Controller General of India (DCGI) for EUA for Oxford COVID-19 vaccine on December 6, while the Hyderabad-based Bharat Biotech had sought the nod for its indigenously developed Covaxin on December 7.

With input from PTI