Bharat Biotech is likely to conduct clinical trials for an intranasal Covid-19 vaccine candidate, called BBV154, next week. The COVID-19 vaccine-making firm will conduct trials in Patna, Chennai, Hyderabad, and Nagpur. According to the Central Trail Registry of India (CTRI), these trials will be conducted on 175 participants.
The Hyderabad-based firm has started the recruitment process for the clinical trial and the ethics committees of these trial sites are yet to grant approval for trials, India Today reported. This year, on January 8, Bharat Biotech approached the Drugs Controller General of India (DGCI) and sought permission to conduct Phase 1 and Phase 2 clinical trials of the intranasal vaccine. The subject expert committee deliberated on the application and recommended granting permission for Phase 1 trials on Tuesday.
Until now, all the vaccines against coronavirus across the world are intramuscular. Krishna Ella, Chairman of Bharat Biotech had earlier said the company is focusing on the intranasal vaccine as the existing vaccines require two-dose intramuscular injections and a country like India needs 2.6 billion syringes and needles which may add up to pollution.
An intranasal vaccine will not only be simple to administer but reduce the use of medical consumables such as needles, syringes, etc, significantly impacting the overall cost of a vaccination drive, he had said.
“One drop of vaccine in each of the nostrils is sufficient,” he had said. Bharat Biotech’s BBV154 is the first publicised attempt at getting an intranasal vaccine against coronavirus. The company has tied up with the Washington University School of Medicine in St Louis to develop an intranasal vaccine for COVID-19.
What is an intranasal vaccine?
Vaccines are usually administered as injectable shots but with intranasal vaccines, the solution is squirted or sprayed into the nostrils.
Benefits to an intranasal vaccine
According to Bharat Biotech, BBV154 is non-invasive, eliminates needle-associated injuries and infections, and is easy to administer, as it also does not require trained healthcare workers. It also is easier to scale up manufacturing of such a vaccine, the company added.
However, past attempts to develop such intranasal vaccines, including for measles flu, have remained unsuccessful. These vaccines have mostly been made using weakened viruses but have never cleared clinical trials. Only a live attenuated influenza flu vaccine has been licenced through this route of delivery.