India’s first nasal COVID vaccine – iNCOVACC
On the occasion of 74th Republic Day Union Health Minister Mansukh mandviya and Science and Technology Minister Jitendra Singh launched India first ever intranasal covid vaccine iNCOVACC
We all know how our lives got upside down when Covid-19 hitted us and left us with no option than to stay at our homes and not to do anything at all or even step outside of our homes. In this pandemic, we had only one thing which could prevent us from getting affected by this virus apart from masks and gloves, vaccines.
But we all are somehow afraid of needles and this fear is the main reason for our vaccine hesitancy, so this Covid vaccine “INCOVACC” might be a relief for us.
World’s first intranasal vaccine for covid “INCOVACC”developed by Bharat Biotech has got approval from the Central Drugs Standard Control Organisation (CDSCO) and Union Government for restricted use in emergency situations in the age group of 18 and above for primary 2 dose schedule, homologous booster doses.
Bharat Biotech’s Chairman and Managing Director, Krishna Ella, stated: In spite of the fact that there is not much demand for COVID vaccines, we have continued the development of intranasal vaccines to ensure that we are well-prepared with platform technologies for future infectious diseases. We have also begun the development of COVID variant-specific vaccines to be ready for the future.”
The recombinant adenoviral vectored construct that was tested for efficacy in preclinical studies was developed by Washington University in St. Louis in collaboration with iNCOVACC.
Rajesh S Gokhale, Secretary, DBT, and Chairperson, BIRAC, said, “The DCGI’s approval of Bharat Biotech’s intranasal vaccine iNCOVACC (BBV154) to be used as a heterologous booster dose against currently available COVID-19 vaccines is a moment of great pride for our country. This move will further strengthen our collective fight against the pandemic and broaden vaccine coverage.”
What is the nasal vaccine Incovacc?
According to Bharat Biotech Incovacc is a “recombinant replication deficient adenovirus”. stimulates a broad immune response—neutralising IgG, mucosal IgA, and T cell responses. Immune responses at the site of infection, in the nasal mucosa, are important to block infection and transmission of Covid. The nasal route shows good potential for vaccination because of the organised immune systems of the nasal mucosa.
The vaccine is stable at 2-8°C. It is to be delivered through the nose, as a 2 dose series, four weeks apart. A total of 8 drops (0.5 ml per dose), four drops are administered into each nostril. The company claims that “there is no chance of getting Covid-19 post immunisation with Incovacc”.
Following are the results obtained by the company during the various trials of Incovacc:
- During the phase 3 clinical trials done in 3000 participants, Incovacc has generated good immunity following 2 doses given 4 weeks apart.
- Severe allergic reactions were rare while headache, fever, running nose, sneezing were side effects.
- Company has advised against receiving a dose for individuals who have severe allergic reaction to any of the ingredients of the vaccine, had severe allergic reaction after a previous dose of the vaccination, currently suffering from acute fever or infection.
Following are the key attributes of Incovacc:
- Immune responses at the site of infection (nasal mucosa), which are essential for blocking both infection and the transmission of Covid-19, are stimulated.
- It is non-invasive and does not require a needle.
How does Incovacc work?
According to Bharat Biotech, an intranasal vaccine stimulates a broad immune response—neutralising IgG, mucosal IgA, and T cell responses. To prevent Covid infection and transmission, immune responses at the infection site, the nasal mucosa, are crucial. Due to the well-organised immune systems of the nasal mucosa, the nasal route has a good potential for vaccination.
What is the efficacy of Incovacc?
According to experts, intranasal vaccines are more effective than intramuscular vaccines. Phase I, II, and III clinical trials evaluated one of the vaccine candidates with positive outcomes and showed good immunity. The saliva-measured mucosal IgA antibody levels of Incovacc recipients were significant. The upper respiratory tract’s mucosal IgA antibodies may help cut down on infections and transmission.
What are the possible side effects of Incovacc?
Headaches, fever, a running nose, and sneezing are among the side effects that have been reported. Bharat Biotech claims that a severe allergic reaction may very rarely occur after taking a dose, but the clinical trial did not report any such incidents.
Who can take the Incovacc?
The nasal vaccine is available to adults over the age of 18 who have received the two doses of Covaxin or Covishield vaccination but have not received a booster shot. The nasal vaccine, which is referred to as heterologous booster, will be given to individuals twice, separated by a period of 28 days.
What is the criteria of Incovacc for targeted user groups?
The government has approved Incovacc, which is indicated for primary to two doses scheduled as homologous boosting and heterologous boosting. In homologous boosting, a person receives the same vaccines from two previous injections. In heterologous boosting, a person receives a vaccine injection that is distinct from the primary dose.
The booster dose is a precautionary or third dose, while the primary dose is for first-time users. However, Cowin only lists it as a booster dose at this time. As a result, this can be used as a booster dose for anyone who has already received two doses of the vaccine.
What is the cost of Incovacc?
Incovacc, a Covid-19 intranasal vaccine costs Rs.800 (excluding 5% GST) for private markets and Rs.325 (excluding 5% GST) for government supplies.
What are the benefits of Incovacc?
- Intranasal vaccination can protect against infections at other mucosal sites, including the intestines, genital tract, and lungs, with improved compliance and a positive immune response.
- The nasal cavity is easier to reach, and administering vaccines is easier.
- Through mucosal antibody secretion, the vaccine provides cross-protection against variant strains.
- It is a better option for people who don’t like needles because it doesn’t hurt as much.
How does Incovacc’s cost compare to the prices of other Covid vaccines available in India?
The vaccine has been priced at Rs.325 per dose for governments and Rs.800 for private healthcare providers, excluding 5% GST. In contrast, private vaccination centres charge Rs.250 per dose for corbevax of Biological E, while private health facilities charge Rs.225 per dose for Covishield of Serum Institute and Covaxin of Bharat Biotech.
Currently, government hospitals offer free vaccinations as part of the public immunisation program.
How nasal vaccines have been used in other nations where they have already been introduced?
China and India have so far approved the use of two Covid vaccines that are administered through the nose or mouth and do not require a needle. China’s data are unavailable, but their use in India has not yet begun.
Are there any other modes of administering Covid vaccines besides these two?
A needle-free applicator is used to inject Covid vaccines into the dermis (inner layer of the skin) between the epidermis and hypodermis, in addition to nasal and intramuscular injections.
Can a nasal vaccine “Incovacc” be a ‘game changer’?
Hope has been voiced in a Science nature journal that intranasal vaccinations may be able to prevent even mild cases of covid. It says:
“These mucosal vaccines target thin mucous membranes that line the nose, mouth, and lungs. By prompting immune responses where SAR-CoV-2 first enters the body, mucosal vaccines could, in theory, prevent even mild cases of illness and block transmission to other people– something Covid-19 shots have been unable to do. Vaccines that produce sterilising immunity would be game changing for the pandemic.”
In terms of intranasal vaccine technology and delivery systems, Bharat Biotech chairman and managing director Krishna Ella referred to iNCOVACC as “a global game changer.” We continued product development in intranasal vaccines to ensure that we are well prepared with platform technologies for future infectious diseases, despite the lack of demand for Covid-19 vaccines. “INCOVACC has been designed for efficient distribution and easy administration,” he stated.
The most recent vaccine, according to doctors, will change the game and lessen the strain on the healthcare system. According to Rahul Sharma, additional director (pulmonology), Fortis Hospital, Noida, “the major potential game changer of this vaccine is its capacity to cut down the transmission rate of this infection in the society, which not only impacts the health issues but also reduces the burden on health infrastructure.”
The purpose of the INCOVACC vaccine is to protect against COVID-19, a virus brought on by SARS-CoV-2. Since its global spread in 2020, the COVID-19 infection has wreaked havoc on people’s health, the economy, and their social and political standing.
As the number of cases of Covid in China, the United States, Brazil, and other parts of the world rises, we need to be on our guard more and take every precaution to lower our chances of getting Covid infection. In India, the vaccination campaign for precautionary doses may be accelerated with the approval of the nasal covid vaccine.
We can defeat the novel coronavirus disease by adhering to standard COVID-19 protocols and appropriate safety measures.
(Written By – Ms. JIYA JAIN )
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