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HomeIndiaBharat Biotech hopes to get regulatory approval for intranasal COVID-19 vaccine

Bharat Biotech hopes to get regulatory approval for intranasal COVID-19 vaccine

Bharat Biotech, which is developing an intranasal COVID-19 vaccine candidate, hopes to get regulatory approval this month, according to Krishna Ella, Chairman, and Managing Director.

Additionally, he has stated that BBIL (Bharat Biotech International Limited), which has a vaccine manufacturing plant in Ankleshwar in Gujarat, is one of only two facilities in the world that can produce vaccines for monkeypox. Another one is in Bavarian Nordic, Germany.

Licenses will be applied for and (they) should arrive soon. We should know by the end of next month (August) if everything goes smoothly. It is easy to plug in any variant of the Coronavirus nasal vaccine and move quickly if any variant arises. So we are optimistic that both injectable and nasal strategies will work in the future, and we can deal with any variants that arise, he said at a recent event.

ALSO READ: Germany Approves Bharat Biotech’s Covaxin

In clinical trials of the nasal vaccine, Ella said, about 4,000 volunteers participated and no adverse reactions or side effects have been reported.

The Drug Controller General of India has approved clinical trials for BBIL’s intranasal vaccine as a booster dose.

Separately, the DCGI authorized the company to conduct a phase-3 clinical trial comparing the immunogenicity and safety of BBV-154 (intranasal) to Covaxin. This trial has been approved for nine different locations.

Justifying the need for a nasal coronavirus vaccine, he stated that any injectable vaccine only protects against the lower levels (of the body). As a result, people who received injectable vaccines may still be RT-PCR positive, whereas the nasal jab protects the entire body.

It is not the same as the delta variant. It is also not the same as omicron. They call it “deltaomicron,” a combination of the two. If that happens, I believe it will be a problem. But we remain vigilant. We are also working on this. We are attempting to reduce risk. We are now well prepared… I believe that if there are BA.5 attacks, hospitalization will rise, Ella said.

 

 

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