Bharat Biotech completes third-phase of intranasal COVID-19 vaccine trials
The manufacturing body of the made-in-India Covaxin is only steps away from releasing its intranasal vaccine for the virus. Bharat Biotech International Limited (BBIL) on Monday announced that they have completed phase III trials for the BBV154 COVID-19 vaccine as a primary and booster dose. Data from the trials has now been sent to the National Regulatory Authorities.
- As one of the first responders to the crisis of COVID-19 in India, Bharat Biotech stepped up to produce Covaxin, which immunizes one against the virus with 78% efficacy.
- While the worst of COVID-19 is behind us, it continues to infect and kill citizens across the nation.
- The intranasal vaccine, if approved, will be the newest addition to India's vaccine kitty.
BBIL conducted two separate and simultaneous clinical trials to evaluate BBV154 as a primary dose and a booster dose. Phase III trials for primary dose were conducted for 'safety and immunogenicity' in 3100 citizens across 14 trial sites, while 875 people were tested in the booster dose trials The trials for booster dose were conducted among citizens previously vaccinated with two doses.
The trial results state BBV154 to be "safe and well-tolerated." According to Bharat Biotech, "Being an intranasal vaccine, BBV154 may produce local antibodies [against COVID-19] in the upper respiratory tract." This can provide potential protection from infection and transmission of coronavirus. Additionally, it has been specifically formulated for intranasal delivery which has proven to be cost-effective in many countries.
Trial results have been submitted for approval to National Regulatory Authorities, BBIL said. As per Suchitra Ella, Joint MD, Bharat Biotech, the vaccine can make it easier to deploy in mass immunization campaigns with an easy-to-administer formulation and delivery device. "BBV154 can enable faster development of variant-specific vaccines and easy nasal delivery...It promises to become an important tool in mass vaccinations," she said.
The BBV154 stimulates an immune response by neutralizing IgG, T cell responses, and mucosal IgA. It is needle-free, non-evasive, and can easily be administered by non-medical professionals also. It also removes the risk of injuries and infections with injection and can be administered with ease in children and older adults. Additionally, it generates an immune response at the site of the infection.
Meanwhile, the United Kingdom approved an updated Moderna vaccine that targets the Omicron variant. The vaccine was approved for booster doses by the UK drug regulator and is the first 'bivalent' vaccine to be approved. "The vaccine prompted a strong immune response against the original form and Omicron, and would prove to be a sharpened tool in our armory," UK officials said.