Bharat Biotech expects regulator’s nod for intranasal COVID-19 vaccine in August
The Drug Controller General of India (DCGI) gave its nod to conduct clinical trials for Bharat Biotech’s intranasal vaccine as booster dose
Bharat Biotech, which is working on an intranasal COVID-19 vaccine candidate, is hopeful of getting regulatory licences this month, if all goes well, Chairman and Managing Director of the company, Krishna Ella, said.
He has also said that Bharat Biotech, which has a vaccine manufacturing plant in Ankleshwar in Gujarat, is one of the two plants in the world to manufacture vaccine for monkeypox. The other one is in Bavarian Nordic, Germany.
“We will be applying for licences and (they) should come. If everything goes well, we know by next month (August), you (people) would rather get the coronavirus nasal vaccine and if any variant comes, it is easy to plug in quickly and move fast. So, we are optimistic that both injectable and nasal strategies will work protecting people’s lives in the future, any variant comes also, we can handle,” he said in a recently held event.
Ella said the firm completed clinical trials of the nasal vaccine with about 4,000 volunteers and there is no single instance of side effect or adverse reaction reported so far.
The Drug Controller General of India (DCGI) gave its nod to conduct clinical trials for Bharat Biotech’s intranasal vaccine as booster dose.
Separately, the DCGI also granted permission to the firm to conduct phase-III clinical trial to compare the immunogenecity and safety of BBV-154 (intranasal) with Covaxin. This trial has been permitted to be conducted at nine sites.
Justifying the reason for a nasal vaccine for coronavirus, he said any injectable vaccine only protects the lower level (of the body). That’s why people who were vaccinated with injectable vaccines may still get RT-PCR positive, whereas the nasal jab gives protection to the whole body.
Replying to a query, he predicted that the country may face higher hospitalisations with the emerging coronavirus variant BA.5 as the new form may “evade the vaccine.”
“It is totally different from Delta variant. It is totally different from Omicron also. They call “Deltaomicron,” a combination of both. I think if that attacks, then it is going to be an issue. But, we keep watching. We are working on that also. Risk mitigation, we are trying to do. We are well prepared now… I think hospitalisation will increase if there are BA.5 attacks,” Ella said.
Edits by EP News Bureau