Bharat Biotech eyes 1B doses of nasal COVID vax in 2022

Covaxin maker Bharat Biotech is targeting to make one billion doses annually of its intranasal vaccine in 2022 that is under clinical trials now.

The Hyderabad-based vaccine maker is also looking for global partners to manufacture and distribute the vaccine overseas.

BBV154, the intranasal vaccine, can be administered as a nasal spray or a drop. It cannot be taken at home though, but needs to be administered in a clinical setting.

The adenovirus vector-based vaccine helps trigger generation of IgA antibodies that line the nasal mucosa.

Bharat Biotech claims that the vaccine helps reduce transmission of the Sars-CoV-2 virus as it attacks the virus at the first points of entry — the nose and the upper respiratory tract. “We are scaling up manufacturing of the intranasal vaccine now. The target is a billion annual doses for the nasal vaccine. The sites, which make Covaxin now (Bengaluru, Hyderabad, Pune), will also have facilities to make the nasal vaccine,” a senior company executive told Business Standard.

“We are looking for global partners both for manufacturing and distribution,” the company added.

It is a live adenovirus vector platform that is similar to the Oxford-AstraZeneca or Johnson & Johnson vaccines. “We have done a lot of work to stabilise the spike protein. The antibodies in the nose are IgA, which are also present in the upper respiratory tract,” the executive added.

Meanwhile, Bharat Biotech has sought permission to start phase 3 clinical trials of the vaccine. The company is testing the vaccine as a booster shot for someone who has had Covid infection or received two shots of any other vaccine.

The phase 3 trial size will be lesser than the Covaxin trial (25,800 participants).

“We are not considering an efficacy trial right now, because many people are either sero-positive or vaccinated. So mostly, we are testing the safety, immunogenicity and specifically as a booster dose (after any vaccine). The trial protocol would be designed accordingly,” the company executive said.

It has conducted phase 2 trials on 650 volunteers. Recruitment for the phase 2 trials was completed by September. The first phase had 175 participants.

The company had conducted three-legged phase 2 clinical trials for its intranasal vaccine. The vaccine was tested in three combinations — two nasal shots, first a Covaxin shot followed by the nasal vaccine, or Covaxin following a nasal shot.

The idea was to see which combination induces better and long-lasting immune response. Therefore, the intranasal vaccine could be used as a combination with the intramuscular Covaxin shot.

Bharat Biotech will first establish the intranasal vaccine for adults and then consider children’s trials.

Experts have said the intranasal vaccine is a good idea. Commenting on the nasal vaccine, Jacob John, former head of Centre for Advanced Research in Virology at the Indian Council of Medical Research said to have a nasal vaccine is a “fantastic idea” for two reasons — firstly, it can potentially create sterile immunity. Secondly, it is easy to administer, and thus, scalable. Buisness Standard