With preparations underway for a possible vaccine launch by January, the Indian Drug Regulatory Authority is looking to the UK, which sources believe could turn a blind eye to Oxford COVID-19
vaccine next week, before deciding on granting emergency use authorization to the Serum Institute, which manufactures the photos here.
Once the UK Medicines Authority approves its Oxford vaccine, the Committee of Experts for COVID-19 at CDSCO will hold its meeting and carefully review safety and immunogenicity data from clinical evaluations conducted abroad and in India before granting any emergency vaccine clearance here, official sources said.
The process for granting emergency use approval for Bharat Biotech COVID-19 The “Covaxin” vaccine may take some time, as phase 3 studies are still ongoing, while Pfizer has not yet made a presentation. “Next, the Oxford ‘Covishield’ vaccine will probably be the first to be launched in India,” a source said.
The Serum Institute of India (SII) last week also presented some additional data requested by the Comptroller General of Drugs of India (DCGI), sources said. Amid fears over the mutant variant of SARS-CoV-2 detected in the UK, government officials recently said it would have no impact on the potential for emerging vaccines to be developed in India and other countries.
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Bharat Biotech, Serum Institute of India (SII) and Pfizer have applied to the Comptroller General of Drugs of India (DCGI) to apply for emergency use authorization for COVID-19 vaccines earlier this month. Subject matter expert committee (SEC) on COVID-19 of the Central Organization for the Control of Drug Standards (CDSCO) of 9 December 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 for deliberation, as the company sought more time to make a presentation to the committee. The Pfizer vaccine has already been approved by several countries, including the United Kingdom, the United States and Bahrain.
While reviewing the SII application, the SEC recommended that the company submit updated safety data from Phase 2 and 3 clinical trials in the country, immunogenicity data from clinical trials in the UK and India, together with the outcome of the Medicines Regulatory Agency assessment. and UK medical products (MHRA) for the award of EUA. As for Hyderabad-based Bharat Biotech, “after detailed deliberation, the committee recommended that the company present safety and efficacy data from the ongoing Phase 3 clinical trial in the country for further analysis,” the SEC said.
SII, based in Pune, the world’s largest vaccine manufacturer, has partnered with Oxford University and AstraZeneca to make the vaccine. SII has already manufactured 40 million doses of the vaccine, under a manufacturing and risk storage license from DCGI, officials said recently.