Picture for representation
Picture for representation

New Delhi: The Drugs Controller General of India will brief the media at 11 am today at the National Media Centre regarding the coronavirus vaccine.

This comes as an expert panel of India's central drug authority on Saturday recommended to the Drugs Controller General of India to grant 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.

Bharat Biotech's vaccine

The recommendation for Bharat Biotech's vaccine came a day after the Subject Expert Committee (SEC) of the Central Drugs Standards Control Organisation cleared the Serum Institute of India's emergency use athorisation application for the Oxford-AstraZeneca vaccine Covishield.

As per an official release, the SEC met on Friday and Saturday and made its recommendations in respect of the accelerated approval process request of the SII, Bharat Biotech International Ltd as well as about phase-III trials of Cadila Healthcare Ltd.

The Subject Expert Committee recommended a grant of permission for restricted emergency use of the vaccine, subject to multiple regulatory conditionalities, to Serum Institute of India, Pune.

"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 Union Health Ministry said.

Restricted use in emergency situation

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 recommendations were made for the consideration and final decision of the Drugs Controller General of India.

Covaxin is an indigenously developed coronavirus vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

This paves the way for the roll-out of at least two vaccines in India in the coming days, while two more are in advance stages of development.

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.

Oxford COVID-19 vaccine emergency use approval

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.

At a press conference in New Delhi, Union minister Prakash Javadekar said India was probably the only country where four vaccines were in the pipeline.

Asked about some religious figures raising doubts over vaccines, Javadekar said "our vaccine is effective" and the rest of the world was also using it. He added that vaccines are introduced after tests and those that would be brought in would be safe.

(With agencies)

(To receive our E-paper on whatsapp daily, please click here. We permit sharing of the paper's PDF on WhatsApp and other social media platforms.)

Free Press Journal

www.freepressjournal.in