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Bharat Biotech Requests Authorization For Its Intra-Nasal Covid Vaccine For Booster Dose

India has reported 6,563 new cases, 132 deaths, and 8,077 recoveries in the last 24 hours. According to the Ministry of Health and Family Welfare, the active caseload is at 82,267, the lowest in 572 days.

As the Omicron coronavirus variety causes a new wave of infections around the world, top US pandemic expert Anthony Fauci warned of a dismal winter ahead, citing constraints and concerns about overburdened healthcare systems.

Official sources said on Monday that Bharat Biotech has requested authorization from India’s pharma authority to undertake a phase-3 study for its intra-nasal COVID-19 vaccine as a booster dose on participants who had previously received Covishield or Covaxin. India has yet to approve the use of the Hyderabad-based company’s intranasal vaccination BBV154. In August, the business gained approval from the Drug Controller General of India (DCGI) to commence phase 2 clinical trials of the nasal vaccination. “Bharat Biotech has filed an application to undertake a Phase 3 study to evaluate the safety and immunogenicity of BBV154 and BBV152 as a third dose (booster) to individuals previously immunised with SARS-CoV-2 vaccines,” an official said.

Bharat Biotech has applied to the DCGI for authorization to undertake Phase 3 clinical trials for its nasal vaccine, which will be administered as a booster dosage for those who have already been vaccinated with Covaxin and Covishield. According to insiders, the corporation has also requested authorization to undertake studies with 5,000 people that will be completed in three months.

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