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India approves AstraZeneca local COVID vaccine

On January 2, 2021, a man finished a graffiti representing a vaccine as coronavirus disease 2019 (COVID-19) spread in Kolkata, India. — REUTERS / RUPAK DE CHOWDHURI

New Delhi — On Sunday, Indian drug regulators finally approved the emergency use of two coronavirus vaccines. One was developed by AstraZeneca and the University of Oxford, and the other was developed by local companies Bharat Biotech and the State Institute.

This decision marks the first vaccine approval for the second most populous country in the world, the country with the highest number of coronavirus diseases after the United States.

According to government officials, a large-scale vaccination program is currently scheduled to start within about a week, and 300 million out of 1.35 billion people will be vaccinated free of charge in the first 6-8 months of this year. I want to do it.

With AstraZeneca / Oxford shots already approved in the UK, Argentina and El Salvador taking the lead and no efficacy data released, Bharat Biotech’s COVAXIN will be administered under more stringent conditions.

“It’s time to take advantage of the robust supply chain infrastructure we have implemented to distribute vaccines quickly and equitably,” said Hirsch, India’s Health Minister, the world’s largest producer and exporter of vaccines. Baldan says.

“Encourage all citizens to outsource rigorous protocols to ensure the safety, efficacy and immunogenicity of approved vaccines.”

Indian drug controller General V Somani said the overall efficacy of the AstraZeneca / Oxford vaccine was 70.42%, and Barrat Biotech’s COVAXIN “provides a safe and powerful immune response.”

Developed in the United Kingdom, AstraZeneca / Oxford Shot is locally created by the Serum Institute of India (SII) and becomes the COVISHIELD brand. Meanwhile, Bharat Biotech is affiliated with the Government-run Indian Medical Research Council.

Prime Minister Narendra Modi’s nationalist party lawmakers had previously complained about the apparent preference for foreign-made vaccines over local vaccines. The approval also raised questions about the lack of transparency in the process.

“M / s serum and M / s varato biotechnology vaccines have been approved for limited use in emergencies,” said Somani, head of the Central Pharmaceutical Standards Control Organization, in writing at a press conference. Read and stated the statement by. Somani didn’t ask any questions.

Both vaccines are given twice and stored at 2-8 degrees Celsius (36-48 degrees Fahrenheit), but it is not clear if shot spacing is recommended. Sources said on Saturday the dose should be given at 4-week intervals.

The Bharat Biotech vaccine has been “approved in the public interest in clinical trial mode as a rich precaution to increase vaccination options, especially in the case of infection with mutant strains,” Somani said.

Prime Minister Narendra Modi welcomed the approval.

“All Indians will be proud that two vaccines with an emergency use authorization are made in India!” He said on Twitter, calling it a sign of an “independent” country. It was.

SII, the world’s largest producer of vaccines, has already stockpiled more than 50 million AstraZeneca / Oxford vaccines before signing a formal supply contract with the government.

“@SerumInstIndia has finally paid off all the risks associated with vaccine stockpiling,” CEO Adar Poonawalla said on Twitter. “India’s first COVID-19 vaccine, COVISHIELD, has been approved, safe, effective and ready to be rolled out in the coming weeks.”

Controversy
The AstraZeneca / Oxford vaccine, first approved by the UK last week, is cheaper and easier to use than rival shots such as Pfizer — a major advantage in tackling a pandemic that killed more than 1.8 million people worldwide.

However, the UK shot is the most effective dose since the data released in November showed a 90% success rate for the half dose and the subsequent full dose, with two full shots showing a 62% effect. I have been plagued by uncertainties about.

The effectiveness of Indian vaccines can be “much higher” by more than 60% after two doses, sources familiar with the matter told Reuters. Bharat Biotech previously stated that up to 300 million doses can be administered annually.

“This vaccine addresses the unmet medical needs during this pandemic, but our goal is to provide global access to those who need it most,” said Krishnaela. The chairman said. “COVAXIN has generated excellent safety data with a strong immune response.”

However, opposition lawmakers and former ministers questioned the COVAXIN approval process.

“Bharat Biotech is a leading company, but it’s puzzling that the internationally recognized protocol associated with Phase 3 trials has been modified for Covaxin,” Jairam Ramesh wrote on Twitter.

Indian regulators have also received an emergency use application for the COVID-19 vaccine prepared by Pfizer and BioNTech in Germany. This is the first shot to secure regulatory approval in the West.

In India, more than 10.3 million COVID-19 cases and approximately 150,000 deaths have been reported, although infection rates have dropped significantly since their peak in mid-September.

SII plans to sell the AstraZeneca / Oxford vaccine to the Government of India for approximately 250 rupees ($ 3.42) per dose and 1,000 rupees on the private market.

Regulators on Sunday also allowed Cadila Healthcare Ltd. to conduct a Phase III clinical trial of 26,000 Indian participants on its DNA platform vaccine candidate, with interim study data indicating that it is “safe.” A three-dose regimen. — — Reuters



India approves AstraZeneca local COVID vaccine

https://www.bworldonline.com/india-approves-astrazeneca-local-covid-vaccines/ India approves AstraZeneca local COVID vaccine

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