Drug Controller Likely to Take AstraZeneca Emergency Use Call, Pfizer’s COVID-19
Vaccinations in 2 weeks
The Comptroller General of Drugs of India has started to process applications submitted by Pfizer Inc and Serum Institute of India to grant emergency use authorization to their COVID-19 vaccinations and is likely to make a decision in the next two weeks, sources told CNBC-TV18.
The Committee of Experts on the Matter to review both vaccines is expected to be formed this week, as the government speeds up the process in hopes of containing the novel’s outbreak. coronavirus.
The Indian government is pinning its hopes of mass supply of the vaccine to the Serum Institute of India, the world’s largest vaccine producer by volume, which on Monday submitted the first formal application for emergency use approval to AstraZeneca Plc. COVID-19 vaccine.
Pfizer Inc had already applied for emergency use approval for its vaccine in India over the weekend, said the official, who did not want to be named.
“We are in the review process. It is an expedited review process, which is also there for Serum,” said a government official. “It is the need of the moment. We have to review as soon as possible.”
The second most populous country in the world with more than 1.3 billion people has 9.68 million infections, while more than 140,000 people have died of COVID-19. The lockdowns imposed to contain the spread of the virus have plunged the economy into one of its worst recessions in decades.
Serum Institute CEO Adar Poonawalla tweeted that the decision to request emergency use “will save countless lives,” but did not elaborate.
The company declined to respond to follow-up questions from Reuters about the process.
AstraZeneca, Pfizer and Moderna Inc are among drug makers seeking advanced approvals for their vaccines, which governments increasingly see as the only way to stop a pandemic that will soon be a year old since it was first reported in China. .
AstraZeneca’s vaccine, called “Covishield” by the Serum Institute, has less stringent storage requirements and is expected to be easier to distribute and faster to scale in low-income countries.
But he also faces inquiries from scientists about his trial data, which showed that a 1.5-dose regimen delivered more than 90% efficacy and a full two-dose regimen only 62%, both administered in two stages. .
Britain and some other nations have gone ahead with their plans to roll out the AstraZeneca vaccine, while the Philippines and Thailand secured millions of doses, giving the injection a vote of confidence after experts raised questions about the data from the test.
AstraZeneca said two weeks ago that it could launch an additional trial to evaluate the lower dose regimen, but the Serum Institute has said it will continue to test only the two full doses as it would delay testing.
Poonawalla has said that the company will focus first on supplying the vaccine in India before distributing it to other countries, priced at Rs 1,000 per dose ($ 13.50) for private markets. The Serum Institute has also said that an emergency use approval could precede a full rollout in February or March.
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