An expert panel of the Drugs Controller General of India has said that Hyderabad-based Bharat Biotech can move ahead with its intranasal vaccine for COVID and conduct phase-3 trials of the product. According to media reports citing the pharmaceutical organisation, the nasal vaccine is being planned to use a booster dose.
While seeking approval from the Subject Expert Committee to use the intranasal vaccine as a booster, Bharat Biotech was asked to submit a revised protocol. The company was asked to conduct standalone trials in the third phase.
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The expert panel “made some suggestions on the basis of which the company will come with a revised proposal”, ET reported citing a senior government official.
According to media reports, the third phase for the intranasal COVID vaccine will be conducted on 5,000 healthy individuals. The pharmaceutical giant said they plan to use it on people fully vaccinated with Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin.
The nasal booster dose will be administered after an interval of six months, ET reported.
Krishna Ella, the chairperson of Bharat Biotech, said in a statement, “This vaccine can be given to two-month-old babies as well and a nasal vaccine can be administered to the entire population except for cancer patients and pregnant women”, according to reports from ET.
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Indian health regulators recently expanded the country’s options for COVID-19 vaccines and other medications. Approval was recently granted to anti-COVID pill Molnupiravir, Serum Institute of India’s vaccine Covovax and Biological E’s jab Corbevax.
So far, six COVID vaccines have been given emergency authorisation in India. These include Bharat Biotech’s Covaxin, Serum Institute’s Covishield, Russia’s Sputnik V, Zydus Cadila’s ZyCoV-D and two developed in the United States– Johnson & Johnson and Moderna.