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Congressional leaders express concern over the granting of permission for the restricted use of the Covid-19 vaccine | India News

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NEW DELHI: Congressional Senior Leader Anand Sharma on Sunday expressed concern that India’s drug regulator is granting permission for restricted use of Bharat Biotech’s Covid-19 vaccine and asked the government to explain why mandatory protocols and data verification have been dispensed with.
India’s drug regulator DCGI approved Oxford Covishield’s Covid-19 vaccine and Bharat Biotech’s Covaxin vaccine for restricted emergency use on Sunday.
Sharma, who heads the parliamentary panel on Internal Affairs that addressed the issue in depth, said that the issue of granting authorization for the use of the vaccine should be taken with care, as no country has dispensed with mandatory phase 3 trials and the data verification.
According to presentations made to the expert panel, the phase 3 trials have not been completed and therefore the data on safety and efficacy have not been reviewed, which is a mandatory requirement, he said.
“The Ministry of Health needs to give compelling reasons to dispense with the mandatory protocols and requirements in this case, as it is about the health and safety of frontline workers who will be vaccinated in the restricted category,” he told PTI.
“DCGI’s statement is puzzling and the government must disclose final data from global efficacy trials and final trials in the UK, which has been officially shared by the UK MHRA following a signed government-to-government agreement. between the two countries that public domain should be made to avoid confusion about the proven efficacy of the vaccine, “said Sharma as well.
He said the news of the imminent arrival and launch of the nationwide vaccination campaign is “truly encouraging and reassuring” for a country paralyzed by the pandemic.
It is also a tribute to our scientists, researchers and institutions, who have established India as the largest vaccine manufacturer in the world, he said.
A panel of experts from India’s central drug authority recommended on Saturday granting permission for the restricted use of the indigenous Covid-19 vaccine developed by Bharat Biotech, Covaxin, in emergency situations.
The recommendation came a day after the panel approved the Serum Institute of India’s emergency use authorization request for Oxford-AstraZeneca’s Covishield vaccine.
This paves the way for the launch of at least two vaccines in India in the coming days, while two more are in advanced stages of development.
Sharma said there are some concerns raised by the news of the recommendation for restricted-use emergency authorization for a vaccine that is still undergoing phase 3 trials and that it has raised good faith concerns as it would involve problems health safety.
Another congressional leader, Jairam Ramesh, also expressed concern, asking Health Minister Harsh Vardhan to clarify why internationally accepted protocols are being modified in phase 3 trials.
“Bharat Biotech is a top-tier company, but it is puzzling that internationally accepted protocols related to phase 3 trials are being changed for Covaxin. Health Minister Harsh Vardhan should clarify,” he said on Twitter.
The issue was previously discussed in depth by the Permanent Parliamentary Committee on Home Affairs.
The panel recommended to the government that any Covid-19 vaccine should be authorized for emergency use only after proper consideration and conducting its trials on a sufficient sample size.
In its report presented on December 21 to Rajya Sabha President and Vice President M. Venkaiah Naidu, the Parliamentary Standing Committee noted that the CDSCO has not granted any emergency use authorization in the past, and suggested that all necessary requirements and Mandatory procedures must be duly complied with and testing phases completed.

Times of India

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