COVID-19 vaccine Covaxin: Bharat Biotech to begin Phase II trials soon

• Bharat Biotech is all set to begin the Phase II trials of its potential coronavirus vaccine candidate, Covaxin, in the coming week.
  
• The Hyderabad-based vaccine maker received approval from Central Drugs Standard Control Organisation under the Directorate General of Health Services to conduct the phase II trials on September 6.
  
• These trials of the BBV152 coronavirus vaccine or Covaxin will be conducted on 380 participants, who will have to be screened for four days after they receive the vaccine shots.

Bharat Biotech is all set to begin the Phase II trials of its potential coronavirus vaccine candidate, Covaxin, in the coming week. The Hyderabad-based vaccine maker received approval from Central Drugs Standard Control Organisation under the Directorate General of Health Services to conduct the phase II trials.

These trials of the BBV152 coronavirus vaccine or Covaxin will be conducted on 380 participants, who will have to be screened for four days after they receive the vaccine shots.

"This is to inform you that the subject proposal was examined in consultation with SEC (COVID-19) experts held through virtual meeting on 03-09-2020, wherein the committee recommended for the conduct of Phase II part of clinical trials with 380 participants subject to the condition that time for screening the participants should be revised to 4 days," reads the letter Joint Drugs Controller Dr S. Eswara Reddy wrote to Bharat Biotech International.

Bharat Biotech began Phase I clinical trials of the vaccine July 15 at 12 centres across the country where healthy volunteers were administered two doses of vaccination shots with a gap of 14 days. These trials on 375 volunteers are still continuing. The subjects were monitored at the respective centres for two days after they were administered the vaccine shots.

In the phase II clinical trials, this period has been revised to four days.

Previously, Bharat Biotech had announced on June 29 that it had successfully developed Covaxin in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).

The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The 'indigenous, inactivated vaccine candidate' has been developed and manufactured in Bharat Biotech's high containment facility located in Genome Valley, Hyderabad.

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