NEW DELHI, 23 Dec: 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 on Friday evening, official sources said.
The needle-free vaccine will be available at private hospitals as of now.
It is likely to be rolled out in the national Covid vaccination programme soon, they said.
The ministry’s approval for the intranasal vaccine 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.
iNCOVACC is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein. This vaccine candidate was evaluated in Phase 1, 2 and 3 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.
iNCOVACC 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 biotechnology department’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.
States to undertake mock drill
Meanwhile, states and union territories will undertake a mock drill across all health facilities on Tuesday to ensure the operational readiness of the Covid-dedicated facilities, with a specific focus on oxygen plants, ventilators, logistics and human resources, according to official sources.
The states have been asked to strengthen surveillance in accordance with the surveillance strategy already issued (health facility-based sentinel surveillance; pan-respiratory virus surveillance; community-based surveillance; and sewage/wastewater surveillance).
They have also been asked to ensure ramping up of the testing infrastructure, encourage precautionary dose uptake and ensure adherence to Covid-appropriate behaviour in view of the upcoming festive season and the New Year.
They have also been advised to ramp up whole genome sequencing and ensure that a large number of samples are sent for the same. (PTI)
