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Expert panel recommends granting approval for restricted emergency use of Bharat Biotech’s Covaxin

Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

By: PTI | New Delhi |
Updated: January 2, 2021 9:06:08 pm
Dry Run of Covid 19 Vaccination being held at Chandigarh (Express Photo by Kamleshwar Singh)

An expert panel of India’s central drug authority on Saturday recommended granting permission for restricted use of Bharat Biotech-developed indigenous COVID-19 vaccine Covaxin in emergency situation, especially in the context of infection by mutant strains, officials said.

The recommendation for Bharat Biotech’s vaccine came a day after the panel cleared the Serum Institute of India’s emergency use authorisation application for the Oxford-AstraZeneca vaccine Covishield, paving the way for the roll-out of COVID-19 shots in the country in the next few days.

The Union Health Ministry on Saturday also confirmed that the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to the Serum Institute of Institute (SII) for restricted emergency use of Covishield in India, subject to multiple regulatory conditionalities.

“The SEC of CDSCO met on January 1 and 2 and made the recommendations for the consideration and final decision of the Drugs Controller General of India (DCGI),” the ministry said.

Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

The SEC again deliberated on the emergency use authorisation (EUA) application of Bharat Biotech on Saturday after it presented the updated data, justification and requested for consideration of their proposal in the wake of incidence of new mutated coronavirus infection.

It recommended “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 Bharat Biotech,” the health ministry stated.

According to sources, the committee, however, stated that the firm shall continue the ongoing phase 3 clinical trial and submit data emerging from the trial as and when available.

The committee noted that the vaccine is an inactivated whole virion, coronavirus vaccine, having potential to target mutated coronavirus strains, a source said. The data generated so far demonstrates a strong immune response (both antibody as well as T cell) and in-vitro viral neutralisation.

While granting the restricted emergency use approval for the Oxford COVID-19 vaccine on Friday, the panel had imposed certain regulatory provisions, including that the shot is indicated for active immunisation in individuals of 18 years or more to prevent the disease and that SII should submit safety, efficacy and immunogenicity data from the ongoing clinical trials in the country and across the globe for review at the earliest.

Also, the Pune-based firm should submit the safety data including the data on adverse events following immunisation (AEFI) and adverse event of special interest (AESI) with due analysis every 15 days for the first two months and monthly thereafter till the completion of the ongoing clinical trial in the country, according to the recommendations.
Thereafter, the firm should submit the safety data as per the provisions and standard procedures.

According to sources, the recommendations stated that the vaccine should be supplied along with fact-sheet and separate leaflet for the guidance of the healthcare provider. The Serum Institute of India, the world’s largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield.

According to sources, the firm had presented the details of the conditions and restrictions under which AstraZeneca was granted emergency use authorisation in the UK and the revised fact sheet and prescribing information in Indian context as required by the committee.

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.

Pfizer had applied for regulatory approval for its vaccine on December 4 has not yet turned for deliberation. After detailed deliberations, the SEC has also recommended for grant of permission to Cadila Healthcare Ltd in Ahmedabad for conduct of phase-3 clinical trial protocol for its vaccine candidate.

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