NEW DELHI, Dec 23: Bharat Biotech’s intranasal Covid vaccine has been approved by the Union Health Ministry as a booster dose for those aged 18 years and above and is likely to be introduced on the Co-WIN platform this evening, official sources said.
The needle-free vaccine will be available at private hospitals as of now and can be administered as a precaution dose to adults who have been vaccinated with two doses of either Covishield or Covaxin.
It is likely to be rolled out in the national Covid vaccination programme soon, they said.
The ministry’s approval for the intranasal vaccine as a booster comes amid a spurt in Covid cases in China and some other countries.
The nasal vaccine — BBV154 — had received approval of the Drugs Controller General of India (DCGI) in November for restricted use in an emergency situation for those above 18 years as a heterologous booster dose.
“The vaccine branded as iNCOVACC is likely to be introduced on the Co-WIN platform Friday evening onwards. For now, it will be available in private hospitals,” an official source said.
“Intranasal vaccine is another example of India’s research and development prowess in the vaccine development arena. Secondly, it is easy to administer and builds up immune barriers in the respiratory tract through which respiratory viruses enter the body.
“The intranasal vaccine is now approved and recommended as one of the options for precaution dose,” chairman of the National Technical Advisory Group on Immunisation (NTAGI) Dr NK Arora said.
The intranasal vaccine 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 Hyderabad-based vaccine-maker had said in a statement.
Clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule as well as a heterologous booster dose for subjects who have previously received two doses of either Covishield or Covaxin.
The vaccine was developed in partnership with the Washington University, St. Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated in preclinical studies for efficacy.
Product development related to preclinical safety evaluation, large-scale manufacturing scale up, formulation and delivery device development, including human clinical trials, were conducted by Bharat Biotech.
Product development and clinical trials were funded in part by the Government of India through the Department of Biotechnology’s Covid Suraksha programme.
The Government has advised those eligible to take the precaution dose and follow Covid-appropriate Behaviour, including wearing masks and social distancing.
Union Health Minister Mansukh Mandaviya will hold a meeting with the Health Ministers of the States and Union Territories at 3 pm over the Covid-related situation in the country.
Prime Minister Narendra Modi had on Thursday cautioned people against complacency and urged them to wear masks in crowded places, while also directing officials to strengthen surveillance measures, especially at international airports. (PTI)
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