World's First Intranasal Covid Vaccine From Bharat Biotech Gets Approval, No Efficacy Data Released

Working towards the prevention of contracting COVID-19, makers of India's first covid vaccine Covaxin, have launched the world's first intranasal vaccine – iNCOVACC (BBV154). The Hyderabad-based company – Bharat Biotech – has received approval for both primary series and heterologous boosters from the Central Drugs Standard Control Organisation (CDSCO) for restricted use in emergencies for ages 18 and above, in India.

However, just like Covaxin, Bharat Biotech has not released any efficacy data for the nasal vaccine yet.

What Is The New Vaccine?

The iNCOVACC (BBV154) is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein. It can be administered as both a primary dose or heterologous booster (for those who were already administered two doses of a different vaccine before). The vaccine triggers immune responses at the site of the infection in the nasal tract, which is essential for blocking the infection and transmission of COVID-19.

The specific formulation of the vaccine allows it to be administered as nasal drops without the help of healthcare workers, thus making it cost-effective in low and middle-income countries. Developed in partnership with Washington University, St Louis, the vaccine has cleared the phase I, II, and III trials reported The Mint.

The university designed and developed the recombinant adenoviral vectored construct and assessed it in preclinical studies to derive its efficacy. Bharat Biotech took charge of the product development following the preclinical safety evaluation, manufacturing and formulation. It was also in charge of conducting human trials.

Speaking on the recent development, Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech, said, "This is a great achievement for us and the global scientific community to enable nasal administration of COVID vaccines. Despite the lack of demand for COVID vaccines, we continued product development in intranasal vaccines to ensure that we are well-prepared with platform technologies for future infectious diseases."

No Efficacy Data Released

Every vaccine goes through at least three stages of trials to determine its use and impact on the target group. At the end of the trials and once the efficacy of the vaccine is determined, the data is released to the public, reports NDTV.

After the first two trials were cleared for iNCOVACC, Bharat Biotech conducted the phase III trials for safety and immunogenicity. The trial saw around 3,100 subjects at 14 trial sites across the country. For the heterologous booster dose, trials were conducted for safety and immunogenicity in around 875 subjects across nine trial sites in the country, where the nasal vaccine was administered to those who had already taken two jabs of Covishield or Covaxin vaccines.

However, no efficacy data proving the successful use and impact of the nasal vaccine has been released yet. Earlier, too, the company had not released Covaxin without revealing any efficacy data, and the vaccine was approved even before the third phase of trials had commenced, thus raising concerns about its authenticity.

Also Read: Needle Free! India Gets First Intranasal Vaccine Against COVID-19; All You Need To Know