With preparations for a possible vaccine rollout by January, Indian drug regulator looks to UK, which sources think may be a nod to the Oxford COVID-19
next week before we decide to give emergency permission to the Serum Institute that manufactures the injections here.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee will be lifted COVID-19 The CDSCO will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting an emergency authorization for the vaccine here, official sources said.
The Process for Granting Emergency Use Approval for Bharat Biotech’s COVID-19 vaccine ‘Covaxin’ may take some time as the phase 3 studies are still ongoing, while Pfizer has yet to present. “In this way, the Oxford vaccine ‘Covishield’ will likely be the first to be introduced in India,” said a source.
Serum Institute of India (SII) had also submitted some additional data last week required by the Drug Controller General of India (DCGI), the sources said. Amid fears of the mutated variant of SARS-CoV-2 being detected in the UK, government officials recently said it will not affect the potential of emerging vaccines being developed in India and other countries.
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Bharat Biotech, Serum Institute of India (SII) and Pfizer had applied to the Drugs Controller General of India (DCGI) for emergency use authorization for their COVID-19 vaccines early this month. The Professional Expert Committee (SEC) COVID-19 of the Central Drugs Standard Control Organization (CDSCO) had sought additional safety and efficacy data on Dec. 9 COVID-19 vaccines from SII and Bharat Biotech after discussing their uses.
The application from the Indian arm of the American pharmaceutical company Pfizer was not considered as the company had sought more time to make a presentation before the committee. The Pfizer vaccine has already been approved by several countries, including the UK, the US and Bahrain.
When considering SII’s filing, the SEC recommended that the company provide updated safety data from Phase 2 and 3 clinical trials in the country, immunogenicity data from the UK and India clinical trial, along with the outcome of the UK Medicines review. and Healthcare products Regulatory Agency (MHRA) for award of EUA. As for Hyderabad-based Bharat Biotech, “the committee, after extensive deliberation, recommended that the company present the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration,” the SEC had said.
Pune-based SII, the world’s largest vaccine manufacturer, has partnered with the University of Oxford and AstraZeneca to manufacture the vaccine. The SII has already manufactured 40 million doses of the vaccine, under the DCGI’s high-risk manufacturing and storage permit, officials recently said.