India’s 1st nasal dose given emergency nod | Latest News India - Hindustan Times
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India’s 1st nasal dose given emergency nod

By, New Delhi
Sep 06, 2022 11:36 PM IST

The drugs regulator approved India’s first nasal coronavirus vaccine on Tuesday, paving the way for access to a new method of inoculation that scientists believe could significantly boost protection from Covid-19 for the population, helping stop not just disease but also new infections to a great extent.

The drugs regulator approved India’s first nasal coronavirus vaccine on Tuesday, paving the way for access to a new method of inoculation that scientists believe could significantly boost protection from Covid-19 for the population, helping stop not just disease but also new infections to a great extent.

 (AP)
(AP)

The dose, Bharat Biotech-produced iNCOVACC, was approved by the Central Drugs Standards Control Organization (CDSCO), and the government will now have to formally decide to include it in the national Covid-19 immunisation program.

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“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.

“This step will further strengthen our collective fight against the pandemic,” he said in another tweet, in which he said the credit went to India’s capacities in science and research and “Prime Minister Narendra Modi’s leadership”.

Scientists have along seen nasal vaccines as a crucial breakthrough the world needs to end the pandemic. These vaccines target the mucous membrane in the nasal pathway, the site where the Sars-CoV-2 first infects the body. These vaccines elicit a protective coat of what is known as IgA antibodies over the membrane, which then prevent an infection from taking hold in the first place.

Conventional vaccines, mostly delivered as a shot in muscles, work differently: they trigger antibodies that circulate in the bloodstream; these antibodies are best suited to preventing the disease from taking hold, but are usually unable to avert an infection or transmission.

“Nasal vaccines might be able to prevent even asymptomatic Covid because they generate local IgA antibodies (first line of defence), cutting chain of transmission and possibly bringing an end to this pandemic,” said senior immunologist Dr Narinder Kumar Mehra.

On Monday, the first such vaccine to be approved anywhere in the world was China’s CanSino Biologics’s Convidecia Air.

The Bharat Biotech inoculation is delivered as nasal drops, given in two doses four weeks apart. It can be stored in regular refrigerator temperature of 2-8°C, making it easy to store and distribute across the country.

The vaccine has been evaluated in phase I, II and III clinical trials involving at least 3,000 participants with successful results, the company said, but was yet to release any of this data or study details.

The lack or late release of human trials data also marked Bharat Biotech’s Covaxin, the vaccine developed and produced by the company, that was the first along with Serum Institute of India’s Covishield to be used in India starting March last year.

“iNCOVACC was evaluated to determine its impact on safety. The reactogenic events and adverse events that were documented during the trial were highly comparable to published data from other Covid-19 vaccines. Product development data will be submitted to peer reviewed journals and will be made available in the public domain,” Bharat Biotech said in a statement.

The vaccine, people aware of the matter said, is currently approved for primary immunisation but may also be allowed for use as a booster with a significant proportion of target population having already been vaccinated. The company has conducted trials to see how it worked as a heterologous booster shot. Data on those results have not been made public.

In the past, Bharat Biotech officials said they have a capacity to churn out a billion doses a year of this vaccine, although there were no new estimates shared on Tuesday and no details were available about potential pricing.

The vaccine has been developed by the Washington University School of Medicine in St. Louis, US, and licensed for manufacturing and distribution by Bharat Biotech and another American company , Precision Biologics.

Bharat Biotech has the rights to distribute the vaccine in all markets except the United States, Japan and European nations, for which Precision has the rights.

“We are proud to announce the approval of iNCOVACC, a global game changer in intra nasal vaccines technology and delivery systems. Despite the lack of demand for Covid-19 vaccines, we continued product development to ensure that we are well prepared with platform technologies for future infectious diseases,” said Krishna Ella, founder and managing director, Bharat Biotech.

“We thank the ministry of health, the CDSCO, dept of Biotechnology, Govt of India, and Washington University St. Louis for their support and guidance. iNCOVACC has been designed for efficient distribution and easy administration,” Ella added.

In January, 2021, the company applied to CDSCO for permission to start clinical trials. The phase 3 trial was conducted at 14 sites across the country with 3,100 healthy adult volunteers. The company also assessed it as a booster dose studies for safety and immunogenicity in 875 people who were given two doses after having received a primary course of Covaxin and Covishield, the two most widely used shots in India.

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  • ABOUT THE AUTHOR
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    Rhythma Kaul works as an assistant editor at Hindustan Times. She covers health and related topics, including ministry of health and family welfare, government of India.

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