With preparations underway for a possible launch of the vaccine in January, India’s drug regulator is looking to the UK, which sources say may give Oxford its go-ahead. COVID-19
vaccine next week, before deciding to give emergency use authorization to the Serum Institute that makes the injections here.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the CDSCO it will hold its meeting and thoroughly review the safety and immunogenicity data from clinical evaluations conducted abroad and in India before granting any emergency authorization for the vaccine here, official sources said.
The Emergency Use Approval Grant Process for Bharat Biotech COVID-19 The ‘Covaxin’ vaccine may take time as its phase 3 trials are still ongoing, while Pfizer has yet to make a presentation. “Based on this, the Oxford ‘Covishield’ vaccine is likely to be the first to be implemented in India,” said a source.
The Serum Institute of India (SII) also released some additional data required by the Comptroller General of Drugs of India (DCGI) last week, the sources said. Amid fears over the mutated variant of SARS-CoV-2 detected in the UK, government officials recently said it will have no impact on 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 Comptroller General of Drugs of India (DCGI) for an emergency use authorization for their COVID-19 vaccinations earlier this month. The subject matter expert committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on December 9 had sought additional safety and efficacy data to COVID-19 IBS and Bharat Biotech vaccines after deliberating on their applications.
The application from the Indian branch of the US pharmaceutical company Pfizer was not discussed, as the company had sought more time to make a presentation to the committee. The Pfizer vaccine has already been approved by several countries, including the UK, the US, and Bahrain.
In considering the SII application, the SEC had recommended that the company submit updated safety data from phase 2 and 3 clinical trials in the country, immunogenicity data from the clinical trial in the UK and India, along with the result from the UK Medicines and Health Products Regulatory Agency (MHRA) assessment for the US concession. Regarding Hyderabad-based Bharat Biotech, “after detailed deliberation, the committee recommended that the company submit the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration,” said the SEC.
Pune-based IBS, the world’s largest vaccine manufacturer, has partnered with Oxford University and AstraZeneca to manufacture the vaccine. IBS has already manufactured 40 million doses of the vaccine, under the DCGI’s manufacturing and storage-at-risk license, officials said recently.
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