Home News Coronavirus News LIVE Updates: Bharat Biotech recruits 26,000 volunteers for Phase 3 COVAXIN trials which began November 2020 – India News , Firstpost

Coronavirus News LIVE Updates: Bharat Biotech recruits 26,000 volunteers for Phase 3 COVAXIN trials which began November 2020 – India News , Firstpost

SEC recommends Bharat Biotech's COVAXIN for emergency use as India tests its vaccine delivery system

Coronavirus News LIVE Updates: The company’s chairman Dr Krishna Ella called DGCI’s approval for COVAXIN ‘a giant leap for innovation and novel product development in India’

Coronavirus News LATEST Updates: Expressing delight on DGCI’s nod for emergency use of its COVID-19 vaccine on Sunday, the Chairman and Managing Director of Bharat Biotech Dr Krishna Ella in a statement said “The approval of COVAXIN™️ for emergency use is a giant leap for Innovation and novel product development in India.”

Senior Congress leader Anand Sharma on Sunday raised concerns over India’s drugs regulator granting permission for the restricted use of Bharat Biotech’s COVID-19 vaccine and asked the government to explain why mandatory protocols and verification of data has been dispensed with.

Serum Institute of India CEO Adar Poonawalla on Sunday said the Oxford-AstraZeneca COVID-19 vaccine ‘Covishield’ is ready to roll out in the coming weeks. Poonawalla’s remarks came soon after India’s drugs regulator approved Covishield for restricted emergency use.

Prime Minister Narendra Modi called DCGI’s emergency approval for 2 vaccines in India a “decisive turning point” in the country’s fight against the virus and expressed gratitude for all frontline workers in “adverse circumstances.”

The Drugs Controller General of India (DCGI) has granted emergency use authorisation for the Serum Institute of India (SII)’s ‘Covishield’ and Bharat Biotech’s ‘COVAXIN’ vaccines against COVID-19 , the disease caused by the novel coronavirus . This comes after clearances from the Subject Expert Committee (SEC)

The development comes after the subject expert committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) recommended Oxford-AstraZeneca’s vaccine, which is being manufactured by the Serum Institute of India (SII) as Covishield, for emergency use and Covaxin for restricted use.

India recorded 18,177 new COVID-19 cases in a day, while 99,27,310 people have recuperated so far pushing the national recovery rate to 96.15 percent on Sunday, according to the Union Health Ministry data.

The total coronavirus cases mounted to 1,03,23,965 and the toll climbed to 1,49,435 with the novel coronavirus virus claiming 217 lives in a span of 24 hours in the country, the data updated at 8 am showed. The COVID-19 case fatality rate stood at 1.45 percent

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 athorisation application for the Oxford-AstraZeneca vaccine Covishield.

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.

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.

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, 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 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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