The phase 1 clinical trial for Bharat Biotech’s nasal COVID-19 vaccine began on Friday. The vaccine, called BBV154, was administered to two people who are among the 10 shortlisted volunteers. According to a source, both the patients are doing fine after being administered the vaccine.
A hospital in Hyderabad is one of the four facilities shortlisted for the trials across the nation. As part of the first phase, the company will test the vaccine on 175 candidates at four health centres located in Patna, Chennai, Nagpur and Hyderabad. Though the company has approached the Drugs Controller General of India (DGCI) for permission for clinical trials in January, it was on Tuesday that Bharat Biotech received clearance to start clinical trials of their intranasal COVID-19 vaccine. Though there were reports saying the nasal vaccine will be called Coroflu or Flugen, Bharat Biotech has not confirmed this information.
Earlier in September 2020, Bharat Biotech had signed a licensing agreement with Washington University School of Medicine in St Louis for a novel chimp adenovirus single dose intranasal vaccine for COVID-19. Back then, it was revealed that phase 1 trials of the nasal vaccine would take place at the Saint Louis University’s Vaccine and Treatment Evaluation Unit and that after receiving the required regulatory approval, Bharat Biotech would pursue further stages of clinical trials in India. They had also mentioned that after the clinical trials, the large-scale manufacture of the vaccine will take place in Hyderabad’s Genome Valley.
According to the company, an intranasal vaccine will not only be simple to administer but will also reduce the use of medical consumables such as needles, syringes, etc. This can thereby help reduce the overall cost of a vaccination drive.
Commenting on Bharat Biotech’s efforts to develop an intranasal vaccine, Dr David T Curiel, Director of Biologic Therapeutics Center and Professor of Radiation Oncology at Washington University School of Medicine, had earlier said, “The ability to accomplish effective immunization with a single nasal dose is a major advantage, offering broader reach and easier administration. An effective nasal dose not only protects against COVID-19, but it also prevents the spread of the disease by offering another kind of immunity that occurs primarily in the cells that line the nose and throat. Most other vaccine candidates currently under development can’t do that.”