As China grapples with a dramatic surge in COVID-19, patients running out of hospitals and drug stocks, India is also stepping up its fight against the virus. A day after Prime Minister Narendra Modi asked citizens to dress up and be vigilant, the Union Health Ministry approved Bharat Biotech’s intranasal COVID vaccine.
The center has announced that the two-dose vaccine, iNCOVACC, will be used as a booster dose for those over 18 and is likely to be introduced on the Co-WIN platform on Friday evening. A source told news agency PTI, “The iNCOVACC brand vaccine is likely to enter the Co-WIN platform on Friday evening. It will be available in private hospitals for now.”
Bharat Biotech’s intranasal COVID vaccine received approval from the Drug Controller General of India (DCGI) in November as a heterologous booster dose limited to emergency use in adults above 18 years of age.
Let’s take a look at this nasal COVID vaccine and why it could be a big deal in the new phase of the fight against the virus.
how is it
according to News18The vaccine works by using a chimpanzee cold virus to deliver a harmless copy of the coronavirus spike protein to the lining of the nose.
The concept behind using the intranasal route is that influenza and COVID-19 follow the same infection pattern (the nose and mouth route to the lungs), which is why mucosal immunity is important.
iNCOVACC was developed in collaboration with Washington University in St Louis, which designed and developed the recombinant adenoviral-vectored construct and evaluated it for efficacy in preclinical studies.
A press release from the vaccine maker said iNCOVACC, a replication-deficient adenovirus-vectored vaccine with a pre-fusion stabilized SARS-CoV-2 spike protein, is the first vaccine in the world to receive primary series and heterologous booster approval.
Vaccine candidate I., II and III. It was evaluated in early stage clinical trials with successful results and has been specially formulated to allow intranasal delivery via nasal drops, he said.
Heterologous booster dose studies were conducted for safety and immunogenicity in approximately 875 subjects, in which BBV154 intranasal vaccine was administered after two doses of COVID-19 vaccines. Peppermint These trials were conducted at nine sites in India.
“Immunogenicity was assessed by serum neutralizing antibodies by PRNT assays and serum IgG by ELISA. To evaluate the vaccine, taken by the intranasal route, IgA was evaluated by ELISA in serum and saliva. The ability of iNCOVACC®️ to elicit long-term memory T and B cell responses against progenitor and omic variants was also evaluated,” the company said. Telangana Today.
“We are pleased to sponsor EUA’s expansion of iNCOVACC®️, which allows more people to use this intranasal vaccine, and hopefully reduce transmission,” said Michael S Diamond, MD, PhD, of Washington University in St. Louis, developed the nasal vaccine technology with David Curiel, MD, PhD, a colleague at Washington University.
The vaccine was previously approved under Limited Use in Emergency Situations for those 18 years of age and older for two main doses.
III. phase I trials for safety, immunogenicity were conducted in approximately 3,100 subjects at 14 test sites across India, including Indian Institute of Medical Sciences, Delhi and Patna (Bihar), Aatman Hospital, Ahmedabad (Gujarat), PGIMS, Rohtak (Haryana). , and Prakhar Hospital, Kanpur, and Rana Hospital, Gorakhpur (Uttar Pradesh).
What advantages does it have?
Bharat Biotech says the nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries.
Bharat Biotech said iNCOVACC®️ is stable at 2-8°C for ease of storage and distribution, depending. Telangana Today.
The company has established large manufacturing capabilities at various locations in India, including Gujarat, Karnataka, Maharashtra and Telangana with operations across India.
Economic Times the company said iNCOVACC®️ has the dual benefit of enabling rapid development of variant-specific vaccines and easy nasal delivery for mass immunization to protect against emerging variants.
It promises to become an important tool in mass vaccinations in times of pandemics and endemics.
Bharat Biotech earlier said it is easy to administer because it is non-invasive and does not require trained healthcare personnel.
It also eliminates needle-related risks such as injury and infection, has higher compliance and is scalable in terms of manufacturing.
News18 He cited an article published by the Gavi Vaccine Alliance, which cited other advantages, including that the sprays do not need to be refrigerated and do not need to be administered by health professionals.
“People could self-administer them at home,” the article says, and “they are likely to become more popular with the millions of people who don’t like needles.”
Bharat Biotech Chairman and CEO Dr Krishna Ella told PTI, “Despite no demand for Covid vaccines, we have continued product development in intranasal vaccines to ensure we are well prepared with platform technologies for future infectious diseases… We have also started variant development. – COVID to prepare specific vaccines for the future”.
Ella was mentioned earlier by the news agency PTI Saying that any injectable vaccine only protects the lower level (of the body). Therefore, people vaccinated with injectable vaccines can still have a positive RT-PCR, the nasal jab protects the whole body.
Rajesh S Gokhale, Secretary, DBT & Chairman, BIRAC, said, “DCGI’s approval of Bharat Biotech’s iNCOVACC (BBV154) intranasal vaccine for use as a heterologous dose of currently available COVID-19 vaccines is a moment of great pride for our country. Movement this will further strengthen the collective fight against the pandemic and expand vaccine coverage.”
With contributions from agencies
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