Can Bharat Biotech's single-dose, 'super efficient' nasal vaccine be the game-changer?

Could a new nasal COVID vaccine in the works, a partnership between Washington University in St Louis, USA, and Hyderabad-based Bharat Biotech International Ltd (BBIL), be that wonder solution which Bill Gates, in an interview to an American TV channel last week, said will check the spread of virus?

A paper in scientific journal Cell says that animal studies on nasal vaccine - single dose intranasal ChAd vaccine - protects upper and lower respiratory tracts against SARS-CoV-2. "Intranasal administration of ChAd-SARS-CoV-2-S is a candidate for preventing SARS-CoV-2 infection and transmission, and curtailing pandemic spread", the paper says.

It is this very vaccine that Krishna Ella, chairman and managing director of BBIL says will revolutionise Indian vaccine making capabilities and help the country leapfrog along with Europe, the US and China.

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"We have completed studies on monkeys. It demonstrates 100 per cent sterilising ability. That means when a virus attacks the animal, it doesn't touch even one cell. Sterilising immunity will prevent infection and also transmission. If you want to control COVID-19, you have to stop the infection and the transmission. So while all the first generation vaccines (most coronavirus vaccines that are under various stages of development world over at the moment) can only prevent partial infection and partial transmission, nasal one will prevent both the infection and transmission", says Ella.

In an exclusive interaction with BusinessToday.In, Ella said nasal vaccine may be the best choice for India  because it will be single dose, easy to administer and super efficient. "You put one drop 0.1 ml in one nostril and 0.1 ml in the other one. You are done. Just one dose."

The entire vaccine platform developed in partnership with Washington University has been licensed to BBIL. "We have the global rights excluding the US and Europe. And in US, my partner, who is a faculty there, started Precision Medical. We will supply the Phase 1 clinical trial material from here to the US," Ella says.

According to Ella, vaccines administered through the intramuscular injection route protects the lower lungs but not the upper lung. Hence it can prevent the symptoms, but cannot prevent infection and transmission. Instead, the nasal route can protect the lungs completely and thus stop the transmission and also infection.

Also read: Coronavirus vaccine: Covaxin to be at least 60% effective, says Bharat Biotech

BBIL is getting the vaccine candidate ready for Phase I clinical trials by December. Ella says that if the government can develop a total protocol for (all phases of) clinical trials now itself, the company can get the nasal vaccine into the market by June 2021. "The production is very easy. The facility is in place already. It is a vector based vaccine. If successful, I can make more than 1 billion doses," he says.

Ella says that he is yet to discuss with the government about the advantages of having a nasal vaccine strategy in place.

Only clinical trials in human beings can say how safe and efficacious the vaccine is. Further research will also say how long the efficacy or the protective feature of the vaccine will remain. All that we know is there has been a promising start.

As the scientific paper in Cell says, the studies on monkeys "establish that immunisation with ChAd-SARS-CoV-2-S induces both neutralising antibody and antigen-specific CD8+ T cell responses. While a single intramuscular immunisation of ChAd-SARS-CoV-2-S confers protection against SARS-CoV-2 infection and inflammation in the lungs, intranasal delivery of ChAd-SARS-CoV-2-S induces mucosal immunity, provides superior protection, and possibly promotes sterilising immunity, at least in mice." The paper recommended further studies as "intranasal delivery of ChAd-SARS-CoV-2-S is a promising platform for preventing SARS-CoV-2 infection, disease, and upper airway transmission, and thus warrants clinical evaluation in humans".

Incidentally, Pune based Serum Institute of India, world's largest vaccine maker by volume, is also working on a nasal COVID-19 vaccine, through using a different technology.

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