Intranasal vaccine, though not much data on its clinical efficacy yet available in the public domain, could prove to be an easy and effective tool to enhance the immunity against Coronavirus infection that is again on the surge globally. For India, it could also help lift the much lagged immune booster programme.
The vaccine is new in terms of technology and use in terms of real world experience. So there is limited data available to compare and qualify the product on the basis of clinical experience in a large and vivid population. However, considering its ease of use and the price point (in India), the vaccine can go a long way in the fight against Covid pandemic.
Since the vaccine does not require an injection, it can cut into vaccine hesitancy that had come into place after the Covid curve became almost flat. The vaccine, to be launched in India by Bharat Biotech as it has been approved by the drug control authority, is priced at Rs 800 for private markets and Rs 325 for the government.
According to Bharat Biotech, the vaccine will be rolled out in the fourth week of January and will serve as a booster dose for those above 18 years of age.
Easy delivery, Needle free
Several mucosal COVID-19 vaccines are in development globally. The nasally inhaled vaccine is designed to induce immunity in the airways and block virus transmission. The main advantage of this vaccine is that it will provide a broad spectrum of immunity. The nasal route has an advantage for delivery as they do not require injections. All the other risks of injection like infection and soreness are also eliminated. The health care workers also need not be as skilled in this case as the administration is easy.
Bharat Biotech’s nasal vaccine is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised SARS-CoV-2 spike protein. This vaccine candidate was evaluated in phases I, II and III clinical trials with successful results. It has been specifically formulated to allow intranasal delivery through nasal drops. The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries.
The vaccine that is stable at 2-8C for easy storage and distribution also has the benefit of enabling faster development of variant specific vaccines and easy nasal delivery that enables mass immunisation to protect from emerging virus variants of concern.
Challenging canvas, No data
Delivering vaccines to the nose is one of the most efficient and easy ways to achieve immunity. It can be easily administered and is especially helpful for those who have a fear of needles. Old people who have difficulties in getting an injection will benefit from them.
But despite the several merits there are many challenges. Experts are not sure on how well they will work and how long they will work. There is no available data in the public domain that shows their efficiency and durability. There has to be a robust clinical study on these vaccines to establish their efficacy. In the absence of proper data, their durability cannot be known.
Researchers from the University of Oxford recently published new findings from a Phase 1 clinical trial studying the safety and immune response of an intranasally-administered vaccine against COVID-19. The study was performed in collaboration with AstraZeneca.
The researchers reported mucosal antibody responses were seen in a ‘minority’ of participants. Systemic immune responses to intranasal vaccination were also weaker compared with intramuscular vaccination. The researchers said that the vaccine did not generate a consistent mucosal antibody nor a strong systemic immune response.
Apart from the data constraints, manufacturing of the nasal vaccine needs to be spruced urgently to meet the growing demand. It is not sure whether the current production will be able to meet the demand. The government must help in whatever way possible to ensure that there is no gap in production and demand.
The supply chains that had weakened after the dip in case numbers needed to be activated. The cold storage systems should also be re-looked at to plug any loopholes that have developed. There is also a need to establish a strong pharmacovigilance system to identify any safety concerns.
But despite the challenges, the new vaccine platform can act as a powerful tool in reducing the transmission. The government must ensure that the programme does not lose its steam.
— The author Dr Vanita Srivastava is an independent science and health writer
Read her previous articles here
(Edited by : CH Unnikrishnan)
First Published: Dec 28, 2022 11:48 AM IST
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