Bharat Biotech's nasal Covid-19 vaccine gets DCGI approval

The Indian drug regulatory authority DCGI on Tuesday approved vaccine major Bharat Biotech's intranasal shot against Covid-19 for primary immunisation for the 18-plus population, providing the government with yet another inoculation option to tame the pandemic.

However, the Central Drugs Standard Control Organisation is still to approve the intra-nasal shot as a precautionary dose though the company last month had submitted clinical trial data for the vaccine use both as primary and as a booster dose.

Two separate and simultaneous clinical trials were conducted to evaluate the vaccine, branded as iNCOVACC, as a primary dose and as heterologous booster dose for subjects, who have previously received two doses of Covishield and Covaxin, the two commonest vaccines used in India.

More than 86 crore Indians have received two doses of the Covid-19 vaccines so far, but the uptake of the precautionary third shot remains low with just about 17 crore population receiving it so far.

India currently has just about 52,000 active Covid-19 cases with more than 4,000 new cases recorded on Monday. The experts, however, have cautioned against a localised periodic spurt in the states as was seen in July.

Union Health Minister Mansukh Mandaviya described the approval as a "big boost" to India's fight against Covid-19; but Bharat Biotech’s chairman and managing director Krishna Ella said that the company went ahead to develop the intranasal vaccine despite a low demand only to prepare such platforms against future infectious diseases.

“Despite the lack of demand for Covid-19 vaccines, we continued product development in intra nasal vaccines to ensure that we are well prepared with platform technologies for future infectious diseases,” Ella said in a statement.

The company claimed iNCOVACC was the world's first intranasal vaccines to receive approvals for a primary-2 dose schedule.

The vaccine has been developed in partnership with Washington University School of Medicine in St. Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy.

Product development related to preclinical safety evaluation, manufacturing scale up, formulation and delivery device development and human clinical trials were conducted by Bharat Biotech.

Being an intranasal vaccine, iNCOVACC (also known as BBV154) produces local antibodies in the upper respiratory tract, providing the vaccine with higher potential to reduce infection and transmission.

The new vaccine has the double benefit of enabling faster development of variant specific vaccines and easy nasal delivery that enables mass immunization to protect from emerging variants of concern. Also it is stable at 2-8 degrees Celsius for easy storage and distribution.

The nasal shot, Bharat Biotech claims, holds promises to become an important tool in mass vaccinations. With the receipt of approval today, the product will be launched and available for use in due course of time.

The CDSCO also granted permission to conduct a phase-3 clinical trial to compare the immunogenicity and safety of iNCOVACC with home grown Covaxin. The trial would be conducted at nine sites.