Indian Vaccine

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India has formally approved the emergency use of two coronavirus vaccines as it prepares for one of the world's biggest inoculation drives.

The drugs regulatory authority gave the green light to the jabs developed by AstraZeneca with Oxford University and by local firm Bharat Biotech.
Prime Minister Narendra Modi called it "a decisive turning point".
India plans to inoculate some 300 million people on a priority list this year.
It has recorded the second-highest number of infections in the world, with more than 10.3 million confirmed cases to date. Nearly 150,000 people have died.

On Saturday India held nationwide drills to prepare more than 90,000 health care workers to administer vaccines across the country, which has a population of 1.3 billion people.

The Drugs Controller General of India said both manufacturers had submitted data showing their vaccines were safe to use.

However, opposition politicians and some doctors have criticised a lack of transparency in the approval process.
Dr Swapneil Parikh, an infectious diseases researcher based in Mumbai, told the BBC doctors were in a difficult position.
"I understand there is a need to go through the process quickly, remove regulatory hurdles," he said. "However... [governments and regulators] have a duty to be transparent about the data they have reviewed and the process involved in making the decision to authorise a vaccine, because if they don't do this, it can affect the public's faith in the process."
The Oxford/AstraZeneca vaccine is being manufactured locally by the Serum Institute of India, the world's largest vaccine manufacturer. It says it is producing more than 50 million doses a month.
Adar Poonawalla, the company's CEO, told the BBC in November that he aimed to ramp up production to 100 million doses a month after receiving regulatory approval.
The jab, which is known as Covishield in India, is administered in two doses given between four and 12 weeks apart. It can be safely stored at temperatures of 2C to 8C, about the same as a domestic fridge, and can be delivered in existing health care settings such as doctors' surgeries.
This makes it easier to distribute than some of the other vaccines. The jab developed by Pfizer/BioNTech - which is currently being administered in several countries - must be stored at -70C and can only be moved a limited number of times - a particular challenge in

Scientists criticize ‘rushed’ approval of Indian COVID-19 vaccine without efficacy data​

By Priyanka PullaJan. 5, 2021 , 4:40 AM

Reporting for this story was supported by a journalism grant from the Thakur Family Foundation, which has not influenced the contents of this report.

India’s drug regulator approved two COVID-19 vaccines on 3 January, a decision Prime Minister Narendra Modi hailed on Twitter as “a decisive turning point to strengthen a spirited fight!” against the pandemic and a testament to the Indian scientific community’s self reliance. But some scientists and patient advocates are sharply critical of the move—in particular, the decision to greenlight Covaxin, a vaccine developed in India by Bharat Biotech, without awaiting the results of a phase III trial to determine efficacy and safety.

At a Sunday press conference, the drugs controller general of India, V. G. Somani, said that even though Covaxin’s efficacy study is still recruiting participants, he was approving the vaccine as an “abundant precaution,” in case it was needed to curb the spread of a highly transmissible variant of SARS-CoV-2 first found in the United Kingdom. Somani said it and the other vaccine, the Indian version of a vaccine developed by the University of Oxford and AstraZeneca, were approved for “restricted use” in an emergency situation and that their manufacturers would have to continue the clinical trials that have begun.

 

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