Bharat Biotech recruits 23,000 volunteers for COVID-19 vaccine trials


January 2: Experts at India's drug regulator approve the vaccine "for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains".

The "Covishield" vaccine, developed by University of Oxford and pharmaceutical giant AstraZeneca, is being produced in the country by the Serum Institute.

Suchitra Ella, Joint Managing Director of Bharat Biotech said, "We thank every volunteer who has taken the time to participate in this trial".

Bharat Biotech has successfully recruited 23,000 volunteers, and continued progress towards achieving the goal of 26,000 participants for Phase-3 clinical trial of its COVID-19 vaccine Covaxin across multiple sites in India, it said.

Pfizer's vaccine requires subzero conditions for transportation and storage, while AstraZeneca's can be stored at refrigerator temperatures and is also expected to be cheaper.

"Last year began with corona, but this year is beginning with a vaccine", Information and Broadcasting Minister Prakash Javadekar told reporters Saturday.

A United States trial that aims to evaluate the shot in 40,000 people is ongoing and should clarify some of these questions, with results expected early in 2021.

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Asked about some religious figures raising doubts over vaccines, Javadekar said "our vaccine is effective" and the rest of the world was also using it. SII had applied for a two full-dose regime about 28 days apart.

Prime Minister Narendra Modi welcomed the approvals.

Britain and Argentina this week authorised the AstraZeneca vaccine while the World Health Organization on Thursday granted emergency validation to the rival Pfizer-BioNTech vaccine.

However, it has been plagued by uncertainty about its most effective dosage ever since data published in November showed a half dose followed by a full dose had a 90% success rate while two full shots were 62% effective.

Not much is known about the safety and efficacy of COVAXIN. The SEC again deliberated on the emergency use authorisation (EUA) application of Bharat Biotech on Saturday after it presented the updated data, justification and requested for consideration of their proposal in the wake of incidence of new mutated coronavirus infection. India has more than 10 million reported coronavirus infections and almost 150,000 fatalities, according to Johns Hopkins University - the third-highest after the US and Brazil.

The country hopes to inoculate 300 million of its 1.35 billion people in the first six to eight months of 2021.

SII, the world's biggest producer of vaccines, has already stockpiled about 50 million doses of the AstraZeneca/Oxford shot, which will be sold to the government at about 250 rupees ($3.42) per dose and 1,000 rupees on the private market.