The decision paves the way for the vaccine’s rollout in the world’s second-most populous country which, after the United States, has the highest number of Covid-19 infections in the world. The health ministry, meanwhile, said four more people tested positive for the UK strain of the virus, taking the total number affected by the more infectious variant to 29.
The CDSCO experts are currently meeting, for the second time this week, and could also approve a vaccine locally developed by Hyderabad-based Bharat Biotech, the report added. “Both AstraZeneca and Bharat Biotech will get approval today,” said one of the sources. “All preparations are on with today’s date in mind.”
The Subject Expert Committee (SEC) on Covid-19 had on Wednesday deliberated and analysed the additional data and information submitted by the SII and Bharat Biotech. The SII, Bharat Biotech and Pfizer have applied to the DCGI seeking emergency use authorisation for their Covid-19 vaccine candidates and are awaiting approval.
Six vaccines are at various stages of clinical trials, of which four are being indigenously developed. The clinical trials by Bharat Biotech are in phase 3, while the one which is being developed by Zydus Cadila is in phase 2 clinical trial. SII is also conducting phase 2 and 3 clinical trials of the Oxford-Astrazeneca vaccine. Similarly, Dr Reddy’s Laboratories is conducting phase 2 and 3 clinical trials for Russian vaccine Sputnik V.
The World Health Organization, meanwhile, granted emergency validation to the Pfizer-BioNTech vaccine, paving the way for countries worldwide to quickly approve its import and distribution. Britain launched its inoculation drive with the US-German vaccine on December 8, with the United States, Canada and EU countries following suit.
WHO said the Pfizer/BioNTech vaccine was the first to receive its “emergency validation” since the novel coronavirus first broke out in China a year ago. “This is a very positive step towards ensuring global access to COVID-19 vaccines,” said Mariangela Simao, a top WHO official tasked with ensuring access to medicines. “But I want to emphasise the need for an even greater global effort to achieve enough vaccine supply to meet the needs of priority populations everywhere,” she said in a statement.
WHO said its emergency use listing opens the way for regulators in different countries to approve the import and distribution of the vaccine. It said it also enables UNICEF, which plays a key logistical role in distributing anti-Covid vaccines, and the Pan-American Health Organization to procure the vaccine for countries that need it.
WHO convened its own experts and those from around the world to review the data on the Pfizer/BioNTech vaccine’s “safety, efficacy and quality,” weighing the benefits against the risks. “The review found that the vaccine met the must-have criteria for safety and efficacy set out by WHO, and that the benefits of using the vaccine to address COVID-19 offset potential risks,” it said.
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