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Foreign diplomats to tour India's COVID-19 vaccine facilities

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It is also home to the Pune-based Serum Institute of India (SII), the world's biggest vaccine producer.

The Union health ministry on Tuesday confirmed that drug manufacturers Serum Institute of India and Bharat Biotech have applied for emergency use approval of their potential coronavirus vaccines, ANI reported.

According to reports, the CDSCO did not consider Pfizer's application because the committee's USA experts could not attend the Wednesday meeting.

The development comes after the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) today reviewed the applications of Pfizer, Serum Institute of India and Bharat Biotech.

However, Pfizer's two-dose vaccine - which has also not undergone trials in India - requires storage at minus 70 C, which could pose a challenge to India for distribution in rural areas.

Phase-two and three clinical trials of the vaccine, Covishield, manufactured by SII in collaboration with AstraZeneca, is underway and the firm has applied for EUA.

SII's COVISHIELD is leading the Covid19 vaccine race in India.

As per the minutes of the SEC meeting, the SII was asked to submit, specifically, safety data on Phase 2/3 clinical trials in India of its vaccine candidate named Covishield, developed by Oxford-AstraZeneca; immunogenicity data from the clinical trial in the United Kingdom and India; as well as the outcome of the United Kingdom regulatory authority's assessment regarding its emergency use authorisation application. "After detailed deliberation, the committee recommended that the firm should present the safety and efficacy data from the ongoing Phase 3 clinical trial in the country for further consideration", the minutes of the meeting showed.

It may be recalled that the Covaxin is now under phase III trials and the Bharat Biotech Chairman Dr Krishna Ella d the delegates about the progress of the Covaxin. During his presentations, Mr Krishna Yella said the results of ongoing third phase clinical trials are satisfactory.

India has bought 1.6 billion doses of Covid-19 vaccines, which is more than any other country, according to a global analysis.

Queries sent to the SII and Pfizer remained unanswered, while Bharat Biotech declined to comment on the meeting.

Bharat Biotech joint managing director Suchitra Ella said, "The development and clinical evaluation of COVAXIN marks a significant milestone for novel vaccinology in India". Last month the vaccine successfully completed Phase 1 and 2 trials and now phase 3 trial, human clinical trial, has begun at AIIMS in New Delhi.

Another said: "The CDSCO just wants more data on efficacy and safety before making a decision".

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