Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has given permission to Bharat Biotech to conduct phase 1 clinical trials of their intranasal COVID vaccine, denying their request for simultaneous phase 1 & 2 trials.
On 23 September, Hyderabad-based vaccine developer Bharat Biotech announced a licensing agreement with Washington University School of Medicine for ‘BBV154’ 0 a novel chimp-adenovirus, single-dose intranasal COVID-19 vaccine.
As per IANS reports, the clinical trials will be conducted at various locations.
So far, the COVID vaccines in India are intramuscular which means they are delivered by injections to the muscles. But there are many ways you can get a vaccine, for example, as an injection which is subcutaneous meaning it goes into the tissue between the skin and muscles or orally via a liquid solution instead. Intranasal vaccines are especially helpful for infants where the vaccine is sprayed into the nostrils and inhaled.
Why could they be a game-changer for COVID-19? Let’s break it down.
Firstly, they just require one dose and save a lot of logistical hassle. Second, they are easier to administer and can be given to more people, such as children. Not relying on skilled healthcare workers and instead being able to self-administer the vaccine will be a huge bonus especially in crunch situations like pandemics where organising resources is difficult.
Virologist Dr Gagandeep Kang told The Indian Express,
“The ability to accomplish effective immunization with a single nasal dose is a major advantage, offering broader reach and easier administration. An effective nasal dose not only protects against COVID-19, but it also prevents the spread of the disease by offering another kind of immunity that occurs primarily in the cells that line the nose and throat. Most other vaccine candidates currently under development can’t do that,” added Dr. David T. Curiel, MD, Ph.D., Director of Biologic Therapeutics Center and Professor of Radiation Oncology at Washington University School of Medicine in St. Louis and Precision Virologics Interim CEO.
One of the big advantages of the nasal vaccine is that it is non-invasive and needle-free and thus eliminates needle-based risks. It also doesn't require trained healthcare workers to help administer the vaccine. It can also be manufactured more easily.
It can also be given to children safely which is quite useful.
As per WebMD, the spray “causes your immune system to make proteins in your blood and in your nose that help you fight the virus.” This works in the cause of the coronavirus, as your nose is one of the most common ways the virus enters your body.
The animal trials of this intranasal vaccine candidate has shown “unprecedented levels of protection in mice studies.” The data has recently been published in the prestigious scientific journal Cell and the Journal Nature.
Only 5 out of 187 COVID vaccines being developed worldwide as per the World Health Organisation, are listed as intranasal.
One main reason for this is that the practical effectiveness of this mode of delivery. Experts suggest that most attempts to deliver nasal vaccines have been unsuccessful - except for some flu vaccines.
Another issue is that only very small volumes around 0.1 ml, can be administered in each nostril, which means the vaccine antigens should be there in high concentrations.
Despite not requiring healthcare workers to administer these, it is important to be educated on the proper way to give and take this type of vaccine.