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Expert panel clears way for more COVID vaccines in Indian market, say sources

healthcare | Aug 27, 2021 4:24 PM IST

Expert panel clears way for more COVID vaccines in Indian market, say sources

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The SEC has accepted the interim report submitted by Bharat Biotech of phase-1 clinical trials of its nasal vaccine for those between 2 and 18 years.

The subject expert committee (SEC) on vaccination has recommended Reliance Life Sciences to begin clinical trials and generate data based on these trials for their COVID-19 vaccine candidate. This will be a protein-based COVID-19 vaccine that they're working on.

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The SEC has also accepted the interim report submitted by Bharat Biotech of phase-1 clinical trials of its nasal vaccine for those between 2 and 18 years. This is very crucial given that the government is looking at the next phase of vaccination for children. It could be one possible candidate that would get approval soon.
According to souces, the committee has found that this vaccine is safe when it comes to the interim data that was submitted by Bharat Biotech. The submission of interim data is to check safety of the vaccines and now they found it safe, and they have allowed Bharat Biotech to begin phase-2 and phase-3 clinical trials for this particular nasal vaccine. That too, for those between the age group of two and 18 years.
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Apart from that, SEC has sought more data from Abbott for re-deliberation of Regdanvimab, which is a substitute developed for Tocilizumab and that needs to be established by Abbott, so more data needs to be given.
Meanwhile, the panel has granted emergency use authorisation (EUA) to Hetero Biopharma for their product Tocilizumab for COVID-19 treatment. This is one of the crucial drugs, which were being used as an experimental drug and now it has got a EUA nod from the government. This is a crucial move coming in for the use of Tocilizumab in the treatment of COVID-19.
Also Biological E has been granted approval to amend the protocol for phase-2 and -3 clinical trials for their vaccine.
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