A man drives past a parked bus of Indian biotech company Bharat Biotech outside its Hyderabad office, July 2020. Photo: Reuters/Stringer/File Photo.
New Delhi: 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 candidate Covaxin in emergency situation, especially in the context of infection by mutant strains, officials said.
The next step is for the Drug Controller General of India (DCGI) to decide on the final approval.
The recommendation for Bharat Biotech’s vaccine candidate came a day after the panel cleared the Serum Institute of India’s emergency use authorisation application for the Oxford-AstraZeneca vaccine candidate Covishield.
This paves the way for the roll-out of at least two vaccine candidates in India in the coming days, while two more are in advance stages of development.
At a press conference in New Delhi, Union minister Prakash Javadekar said India was probably the only country where four vaccine candidates were in the pipeline.
Asked about some religious figures raising doubts over vaccines, Javadekar said “our vaccine is effective” and that vaccines are introduced after tests, and those that would be brought in would be safe.
Union health minister Harsh Vardhan appealed to people on Saturday not to be misguided by “rumours” regarding the safety and efficacy of the coronavirus vaccine candidates, and said, “We will not compromise on any protocol before approving a vaccine.”
The Union health ministry on Saturday said 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 restricted use authorisation (RUA) 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.
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The committee noted that the vaccine is an inactivated whole-virion candidate with the potential to target new strains of the novel coronavirus as well, according to a source. The data generated thus 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 candidate on Friday, the panel had imposed certain regulatory provisions – including that the shot be indicated for active immunisation in individuals of 18 years or more to prevent disease and that SII 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 is to submit safety data, including 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, until the clinical trials in the country end, according to the recommendations.
After that, the firm is to submit safety data according to provisions and standard procedures.
According to sources, the recommendations stated that the vaccine candidate should be supplied along with a fact-sheet and separate leaflet for the guidance of healthcare providers.
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 DCGI for RUA for the Oxford COVID-19 vaccine candidate 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 candidate on December 4 and has not yet turned for deliberation.
After detailed discussions, the SEC has also recommended grant of permission to Cadila Healthcare Ltd. in Ahmedabad to conduct its phase-3 clinical trials for its vaccine candidate according to predetermined protocols.
(PTI)