‘Covishield’ may receive Emergency Use Authorization across India

With the world preparing for an effective COVID-19 vaccine rollout, speculations are made that the Indian drug regulator is likely to grant approval for the use of Oxford’s coronavirus vaccine (Covishield), providing authorization rights to Serum Institute of India to produce the shots in the country.

Reportedly, after the UK drug regulator signals the use of the Oxford vaccine, the COVID-19 expert committee at CDSCO (Central Drugs Standard Control Organisation) is expected to hold a meeting to thoroughly review the safety and immunogenicity of the vaccine and study the clinical evaluations that were conducted both in India and abroad before permitting its emergency use.

However, Bharat Biotech’s coronavirus vaccine- ‘Covaxin’ may take time to receive approval as its Phase-III clinical study is underway, while Pfizer is yet to submit a presentation.

It is evident from the above that, the Oxford vaccine ‘Covishield’ is ahead of the race and is likely to be the first vaccine candidate to be rolled out across India.

With the recent discovery of the mutated variant of SARS-CoV-2 detected in the Southeast UK, the government officials have clarified that this highly transmissible coronavirus strain will not affect the credibility of the vaccine candidates that are being developed in India and other nations.

For the record, Pfizer, Bharat Biotech, and Serum Institute of India had recently applied to the Drug Controller General of India seeking the application of their coronavirus vaccines for “emergency-use”.

In a statement by SII, the company has manufactured nearly 40 million doses of the vaccine to date, under the at-risk manufacturing and stockpiling license granted by the DCGI.

As per reliable sources, on the 9th of December, CDSCO’s expert committee on coronavirus had sought additional safety, reliability, and efficiency data for COVID-19 vaccines of Bharat Biotech and SII after considering their applications.

The committee has requested SII to furnish an updated safety data of Phase II and III clinical trials across the country, immunogenicity data from the study carried out in the UK and India, and the assessment of the UK MHRA (Medicine and Healthcare products Regulatory Agency) for Emergency Use Authorization (EUA).

Source Credit: https://www.businesstoday.in/sectors/pharma/india-may-give-nod-to-oxford-astrazeneca-covid-19-vaccine-for-emergency-use-next-week/story/426145.html