Bharat’s Next-Gen COVID-19 Nasal Vaccine Moving Toward Human Testing
Days after vaccine-maker Bharat Biotech released interim Phase III efficacy data for a COVID-19 vaccine already in use in India, a pulmonary expert is expressing enthusiasm for the company’s next-generation intranasal vaccine on track to enter clinical testing this quarter.
Randeep Guleria, a pulmonologist and Director of the All India Institute of Medical Sciences, New Delhi, said that although children are at less risk for severe COVID-19, they can be infectious, and if approved, a nasal vaccine would boost compliance. “In half-an-hour, you can vaccinate an entire class,” he added.
Nasal vaccines marketed for influenza have been particularly useful for children, although there have been concerns over their efficacy compared to injected vaccines. The new vaccine candidate, BBV154, is delivered with by an engineered chimpanzee adenovirus vector and has been administered in a single dose to rodents and rhesus macaques, but data has not yet been published. The company believes that stimulating a protective effect will be possible given that the nose is the point of entry for SARS-CoV-2.
At least three other companies have launched Phase I trials for intranasal COVID-19 vaccine candidates, the most recent of which is Maryland-based vaccine company Altimmune. Altimmune last month began enrolling up to 180 patients in a Phase I trial for its AdCOVID, also administered with a single dose and delivered via adenovirus.
In January, New York-based Codagenix began testing its COVI-VAC single-dose intranasal candidate in a 48-person Phase I trial in India. The first reported trial was from Chinese company Beijing Wantai Biological Pharmacy Enterprise, which was scheduled to begin enrolling up to 100 patients in November.
Bharat’s whole-virion inactivated intramuscular injection vaccine Covaxin was granted an Emergency Use Authorization by the Drug Controller General of India in January, and people in India have begun receiving the vaccines. India has vaccinated over 15 million people so far with a combination of Cpovaxin and another vaccine from Oxford and AstraZeneca. Earlier this week, the company reported interim data for Covaxin showing it had an 81% efficacy rate in its Phase III clinical trial in India of 25,800 people. No Phase II or III data has yet been published, but safety and tolerability data from a Phase I trial in 375 people was published in The Lancet Infectious Diseases in January.
Bharat has partnered with Pennsylvania-based Ocugen to develop and commercialize the vaccine for the U.S.