Bharat Biotech's iNCOVACC has received Emergency Use approval from the Drugs Controller General of India, making it the world's first intransal vaccine to be used for patients of 18 years or older.
Nearly three years after the novel coronavirus first started spreading among nations, the world's first intranasal Covid-19 vaccine is about to hit the market with medical experts hailing it as a revolutionary step in humanity's fight against the killer virus.
The vaccine, named iNCOVACC (BBV154), will be manufactured by Bharat Biotech International Limited (BBIL) which on Tuesday, September 6, got the nod from the Drugs Controller General of India under Restricted Use in Emergency Situation for ages 18 and above.
Commenting on the significant achievement, Krishna Ella, Chairman and Managing Director at Bharat Biotech, said, "We are proud to announce the approval of iNCOVACC, a global game changer in intranasal vaccines technology and delivery systems. 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."
The emergency use approval means that the vaccine will soon be available for use for Covid-19 cases.
The new iNCOVACC vaccine is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein. This vaccine candidate was evaluated in phase I, II and III clinical trials with successful results, a press release from the vaccine-maker said.
Clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule, as heterologous booster dose for subjects who have previously received two doses of the two commonly administered Covid vaccines in India.
As per the manufacturer, Phase III trials of the vaccine were conducted for safety, and immunogenicity in about 3,100 subjects, in 14 trial sites across India.
Unlike regular vaccines administered through external needles, intranasal or simply nasal vaccines can be administered via the nose or mouth.
These second-generation coronavirus vaccines are basically liquids that can be given as a spray or through a dropper or syringe. The most common nasal vaccine is FluMist, a nasal spray that uses inactivated flu virus to protect against influenza.
An intranasal vaccine could be a weakened live virus similar to FluMist, a nucleic acid vaccine-like mRNA coronavirus vaccine or a protein vaccine-like Hepatitis B vaccine or the CorbeVax coronavirus vaccine.
As these vaccines are put directly into the nose and mouth, they might prevent the virus from taking hold in the mucus membranes and mucosal tissue. If this works well, this would check the overall airborne transmission of coronavirus.
Experts also feel that it will provide longer-lasting protection than current vaccines, which have required booster doses to remain effective.
Nasal vaccines mimic the virus in order to prepare the immune system against a virus, just like any other vaccine. But importantly, they mimic the process of infection, too, and boost protective response within the mucosal immune system of the nose and throat.
In simple terms, intranasal vaccines are like knowing there is going to be a break-in and putting your guards in the right location before the trouble even starts.
In addition, intranasal vaccines are painless, non-invasive and do not require specialised training to use.
In clinical trials, vaccines are primarily divided into four categories: Whole Virus vaccines, Protein Subunit vaccines, Viral vector vaccines, and Nucleic Acid vaccines which include RNA and DNA shots.
Each of them differs in the way they operate upon entering the body. While some vaccines work by trying to smuggle virus killing antigens into the body, others use the body’s own cells to create the antigen. However, all vaccines so far have had to be administered intramuscularly but it isn't the only way. Vaccines can be administered through Intramuscular (IM) jabs or they could be subcutaneous (SC), intradermal (ID) or oral/nasal.
(With inputs from PTI)