An expert body of the Central Drugs Standard Control Organisation (CDSCO) has asked Bharat Biotech to revise the trial protocol for clinical trials of the BBV154 – proposed single-dose intranasal COVID-19 vaccine. Let’s have a look at how the intranasal vaccine can be of use in a pandemic and what are the recommendations made by the subject expert committee of the Drugs Controller General of India (DCGI).
What Is An Intranasal Vaccine?
Unlike the usual process where vaccines are administered as injectable shots into intramuscular or subcutaneous, an intranasal vaccine is sprayed or squirted in each of the nostrils and inhaled. But this way of administering a vaccine is not very common and there are only a few flu shots that are given this way.
How Intranasal Vaccine Can Help During Pandemic?
Intranasal vaccines are not only easier to administer, but they may also be more effective as they can tap an additional set of immune cells that are found in the tissues lining the lungs, mouth, and nose.
Intranasal vaccines also reduce the use of medical consumables such as syringes, needles, and other components. This can also have a significant impact on the overall cost of a vaccination drive. According to Bharat Biotech, intranasal vaccine BBV154 is non-invasive and therefore cut down on needle-associated infection and injuries.
Also, no proper training is required to administer the vaccine. As it is a single-dose vaccine, it is much easier for people to receive it, and also they will not have to schedule revisits for booster shots. In the case of injectable vaccines, booster shots are required for building proper immunity. On the manufacturing front, the company said that such a vaccine is easier to develop. Bharat Biotech said that it is aiming to develop up to 1 billion doses of the intranasal vaccines.
Not So Easy Way Forward
Attempts to develop intranasal vaccines in the past have not been so fruitful. Live and weakened viruses are mostly used to make these vaccines but they failed to clear clinical trials. So far only a live attenuated influenza flu vaccine has been approved to administer through this route. Bharat Biotech’s BBV154 is the first attempt to develop an intranasal COVID-19 vaccine.
The company claims that they found the vaccine showing promising results during animal studies. However, it remains to be seen how effective and safe it will be on humans.
On January 18, after looking at the animal testing data of Bharat Biotech, the subject expert committee recommended that the company must conduct a Phase-I clinical trial on 75 subjects and generate Safety and Immunogenicity data. The committee will go through it and then only the second phase of the trial can begin. Bharat Biotech will now have to revise its protocol according to the recommendations made by the Indian drug regulator.