With preparations underway for a possible launch of the vaccine in January, the Indian drug regulator is looking into the UK, which sources believe could endorse Oxford COVID-19
vaccine next week, before deciding to give emergency use authorization to the Serum Institute, which is manufacturing the vaccines here.
As soon as the UK drug regulator approves the Oxford vaccine, the committee of experts in COVID-19 at the CDSCO it will hold its meeting and will analyze in detail the safety and immunogenicity data from clinical assessments carried out abroad and in India before granting any emergency authorization for the vaccine here, official sources said.
The emergency use approval granting process for Bharat Biotech’s COVID-19 The ‘Covaxin’ vaccine may take some time, as its phase 3 tests are still in progress, while Pfizer has not yet made a presentation. “Going this way, the Oxford ‘Covishield’ vaccine is likely to be the first to be launched in India,” said a source.
The Serum Institute of India (SII) also presented last week some additional data required by the Drug Controller General of India (DCGI), the sources said. Amid fears about the mutant variant of SARS-CoV-2 detected in the UK, government officials said recently that it will have no impact on the potential of emerging vaccines being developed in India and other countries.
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Bharat Biotech, the Serum Institute of India (SII) and Pfizer have applied to the General Medicines Controller of India (DCGI) for emergency use authorization for their COVID-19 vaccines earlier this month. The subject matter expert committee (SEC) on COVID-19 Central Drugs Standard Control Organization (CDSCO) on December 9 had sought additional safety and efficacy data for COVID-19 SII and Bharat Biotech vaccines after deliberating on their applications.
The request by the Indian arm of the American pharmaceutical company Pfizer was not taken into consideration because the company had sought more time to make a presentation before the commission. The Pfizer vaccine has already been approved by several countries, including the United Kingdom, the United States and Bahrain.
When considering the application of the SII, the SEC recommended that the company present updated safety data from phase 2 and 3 clinical trials in the country, immunogenicity data from the clinical trial in the United Kingdom and India, together with the result of the regulatory agency’s assessment UK Medicines and Health Products (MHRA) for USA grant. As for Bharat Biotech, based in Hyderabad, “after detailed deliberation, the committee recommended that the company present the safety and efficacy data from the phase 3 clinical trial underway in the country for further analysis,” said the SEC.
SII, based in Pune, the world’s largest vaccine manufacturer, collaborated 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 manufacturing and at-risk storage license, officials said recently.