CSDCO expert panel will meet soon to examine Oxford-AstraZeneca's COVID-19 vaccine approvals: Reports

28-12-2020

As India gears up for dry runs of COVID-19 vaccine distribution, and an anticipated rollout of vaccine by early January 2021, all eyes are set at the drug regulators, who are yet to approve any vaccine candidate for public use in the country. Experts are of the view that the Oxford-AstraZeneca COVID vaccine, being tested and produced by the Serum Institute of India is likely to be the first vaccine to receive emergency use approval in India. The approvals of the Oxford vaccine are already pending in the UK, and the regulatory body of the country is likely to approve it soon. According to reports, the expert committee on COVID-19 at the CDSCO is awaiting the approval and is likely to meet and thoroughly examine the safety and efficacy data for clinical trials conducted in India and abroad, before granted the approval. Reports further suggest that emergency use approvals of Bharat Biotech's Covaxin may take time, as phase 3 trials of the vaccine candidate are still underway in the country. Both Bharat Biotech and SII had filed for emergency use approval in India, back to back. The Indian arm of Pfizer, the vaccine candidate that has received approvals from many countries including the US and UK had also filed for emergency use approval in India. The application by the Indian arm of US pharmaceutical firm Pfizer was not taken up for deliberation as the company had sought more time for making a presentation before the committee, news agency PTI reported. The committee is likely to meet this week to go through the emergency use approval applications filed by different firms, as per a report in HT. The subject expert committee is likely to be convened this week to go through the application. Since Pfizer had also sought a fresh date to present its case on its EUA application of its anti-Covid-19 vaccine, the committee is likely to give them time the same date,� said an official from the government, the daily reported. The SII has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling licence from the DCGI, officials recently had said.