New Delhi: Bharat Biotech’s intranasal Covid vaccine has been approved by the Union Health Ministry as a booster dose for those above 18 years of age and is likely to be introduced on the Co-WIN platform on Friday evening, official sources said.
The needle-free vaccine will be available in private hospitals until now and adults who have been vaccinated with two doses of Covishield or Covaxin can be given as a preventive dose.
The national Covid vaccination program is likely to be rolled out soon, they said.
The ministry’s approval of the intranasal vaccine as a booster comes amid a surge in Covid cases in China and other countries.
The intranasal vaccine — BBV154 — 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.
“The vaccine branded as iNCOVACC is likely to enter the Co-WIN platform on Friday evening. For now, it will be available in private hospitals,” an official source said.
“The intranasal vaccine is another example of India’s research and development prowess in vaccine development. Second, it is easy to administer and creates immune barriers in the respiratory tract when respiratory viruses enter the body.
“Nasal vaccination is now accepted and recommended as one of the options for preventive dosing,” National Advisory Group on Immunization Chairman NK Arora told PTI.
The iNCOVACC intranasal vaccine is a replication-deficient adenovirus-vectored vaccine with a spike protein stabilized before fusion. This vaccine candidate was evaluated in Phase I, II and III clinical trials with successful results, the Hyderabad-based vaccine maker said in a statement.
Clinical trials were conducted to evaluate iNCOVACC as a primary dosing schedule, as well as as a heterologous booster dose, in subjects who had previously received two doses of Covishield or Covaxin.
Vaccine with Washington University, St. It was developed in collaboration with Louis, who designed and developed the recombinant vectored adenoviral construct and tested its efficacy in preclinical studies.
Bharat Biotech conducted product development, including human clinical trials, related to preclinical safety evaluation, large-scale manufacturing, formulation and delivery device development.
Product development and clinical trials were partially funded by the Government of India through the Department of Biotechnology’s Covid Suraksha programme.
The government has advised those eligible to take a preventive dose and follow appropriate anti-Covid behavior, including masks and social distancing.
Union Health Minister Mansukh Mandaviya will hold a meeting with health ministers of states and Union territories at 3 pm on the Covid-related situation in the country.
Prime Minister Narendra Modi on Thursday warned people against complacency and asked them to wear masks in crowded places, while ordering officials to strengthen surveillance measures, especially at international airports.