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Bharat Biotech’s Intranasal COVID-19 Vaccine Gets DCGI Approval For Restricted Use

The world’s first intranasal COVID-19 vaccine, iNCOVACC, received approval from DCGI under restricted use in emergency situations for ages 18 and above

Bharat Biotech's Intranasal COVID-19 Vaccine Gets DCGI Approval For Restricted Use
iNCOVACC was evaluated in phase I, II and III clinical trials with successful results

New Delhi: The Drugs Controller General of India (DCGI) on Tuesday (September 6) approved Bharat Biotech’s intranasal COVID vaccine for restricted emergency use in those aged above 18 years. “Big Boost to India’s Fight Against COVID-19! Bharat Biotech’s ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by @CDSCO_INDIA_INF for primary immunization against COVID-19 in 18+ age group for restricted use in emergency situation,” Union Health Minister Mansukh Mandaviya tweeted.

In a statement, the Hyderabad-based firm said its iNCOVACC (BBV154), the world’s first intranasal COVID-19 vaccine, received approval from DCGI under restricted use in emergency situation for ages 18 and above.

Also Read: Immense Efforts Are On For Next-Generation COVID-19 Vaccines: COVID Panel Chief

Mr Mandaviya said this step will further strengthen “our collective fight” against the pandemic. India has harnessed its science, research and development (R&D), and human resources in the fight against COVID-19 under Prime Minister Narendra Modi’s leadership, he said.

With the science-driven approach & Sabka Prayas, we will defeat COVID-19

https://twitter.com/mansukhmandviya/status/1567080427575459840?s=20&t=Lg7CDF3T4KFIRAy8MvCT2w

iNCOVACC is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein. This vaccine candidate was evaluated in phase I, II and III clinical trials with successful results, the press release from the vaccine-maker said.

Clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule, as heterologous booster dose for subjects who have previously received two doses of the two commonly administered Covid vaccines in India.

Also Read: Vaccinated People Infected By Omicron Have Four Times Greater Protection: Study

Krishna Ella, chairman and managing director of Bharat Biotech, said,

We are proud to announce the approval of iNCOVACC, a global game changer in intranasal vaccines technology and delivery systems. Despite the lack of demand for COVID-19 vaccines, we continued product development in intra-nasal vaccines to ensure that we are well prepared with platform technologies for future infectious diseases

Phase III trials of the vaccine were conducted for safety, immunogenicity in about 3,100 subjects, in 14 trial sites across India, Bharat Biotech said.

BBV154 has been specifically formulated to allow intranasal delivery. In addition, the nasal delivery system has been designed and developed to be cost-effective in low and middle-income countries.

This trial has been permitted to be conducted at nine sites.

Also Read: “New COVID Sub-Variant In Delhi Evading Antibodies”: WHO Chief Scientist To NDTV

(This story has not been edited by NDTV staff and is published from a syndicated feed.)

NDTV – Dettol have been working towards a clean and healthy India since 2014 via the Banega Swachh India initiative, which is helmed by Campaign Ambassador Amitabh Bachchan. The campaign aims to highlight the inter-dependency of humans and the environment, and of humans on one another with the focus on One Health, One Planet, One Future – Leaving No One Behind. It stresses on the need to take care of, and consider, everyone’s health in India – especially vulnerable communities – the LGBTQ population, indigenous people, India’s different tribes, ethnic and linguistic minorities, people with disabilities, migrants, geographically remote populations, gender and sexual minorities. In wake of the current COVID-19 pandemic, the need for WASH (Water, Sanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign will continue to raise awareness on the same along with focussing on the importance of nutrition and healthcare for women and children, fight malnutrition, mental wellbeing, self care, science and health, adolescent health & gender awareness. Along with the health of people, the campaign has realised the need to also take care of the health of the eco-system. Our environment is fragile due to human activity, which is not only over-exploiting available resources, but also generating immense pollution as a result of using and extracting those resources. The imbalance has also led to immense biodiversity loss that has caused one of the biggest threats to human survival – climate change. It has now been described as a “code red for humanity.” The campaign will continue to cover issues like air pollution, waste management, plastic ban, manual scavenging and sanitation workers and menstrual hygiene. Banega Swasth India will also be taking forward the dream of Swasth Bharat, the campaign feels that only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and the country can become a Swasth or healthy India.

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