With preparations underway for a possible vaccine launch in January, the Indian drug regulator is looking to the UK, which sources believe could endorse the Oxford Covid-19 vaccine next week, before deciding to give authorization to emergency use to the Serum Institute that is manufacturing the photos here.
As soon as the UK drug regulator approves the Oxford vaccine, the Covid-19 committee of experts at CDSCO will hold its meeting and fully analyze the safety and immunogenicity data from clinical assessments conducted abroad and in India before granting any emergency clearance 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 its phase 3 trials 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.
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The Serum Institute of India (SII) last week also presented 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.
Bharat Biotech, the Serum Institute of India (SII) and Pfizer applied to the General Medicines Controller of India (DCGI) for emergency use authorization for their Covid-19 vaccines earlier this month.
The Covid-19 Committee of Subject Matters (SEC) of the Central Drugs Standard Control Organization (CDSCO) on December 9 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.