India’s 1st Intranasal Covid Vaccine Gets DCGI Nod For Emergency Use

The Drugs Controller General of India (DCGI) on Tuesday approved Bharat Biotech’s intranasal Covid vaccine for restricted emergency use in those aged above 18 years. 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.

“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.

He 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 under Prime Minister Narendra Modi’s leadership, he said.

“With the science-driven approach & Sabka Prayas, we will defeat COVID-19,” Mandaviya said in another tweet. 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.

Officials said those who have already received the first and second doses of other vaccines will not be eligible to get iNCOVACC as the “precaution” third dose.

The Hyderabad-based firm said its iNCOVACC (BBV154), the world’s first intranasal COVID-19 vaccine.

Designed and developed to be cost effective

• iNCOVACC is a recombinant replication deficient adenovirus vectored vaccine with a prefusion stabilized spike protein. This vaccine candidate was evaluated in phase I, II and III clinical trials with successful results.
• Phase III trials of the vaccine were conducted for safety, immunogenicity in about 3,100 subjects, in 14 trial sites across India.
• iNCOVACC has been specifically formulated to allow intranasal delivery through nasal drops. The nasal delivery system has been designed and developed to be cost effective in low and middle-income countries.
• Product development and clinical trials were funded in part by the government of India through the Department of Biotechnology’s COVID Suraksha programme.
• 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-19 vaccines in India.
• iNCOVACC has the double benefit of enabling faster development of variant specific vaccines and easy nasal delivery that enables mass immunisation to protect from emerging variants of concern. It promises to become an important tool in mass vaccinations during pandemics and endemics.

What is the role of DCGI?

• The Central Drugs Standard Control Organisation (CDSCO) headed by the Drugs Controller General (India) is the central authority for regulating the quality of drugs marketed in the country under the Drugs and Cosmetics Act, 1940.
• The mission of CDSCO is to safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices.
• Regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licenses as Central License Approving Authority are major functions of CDSCO.
• The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 have entrusted various responsibilities to central and state regulators for regulation of drugs and cosmetics. It envisages uniform implementation of the provisions of the Act and Rules made there under for ensuring the safety, rights and well being of the patients by regulating the drugs and cosmetics.
• CDSCO is constantly striving to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.
• The CDSCO, with its headquarters in New Delhi has six zonal offices, six  sub-zonal offices, seven Central Drugs Testing Laboratories and nine airport & 18 sea port offices (including inland container depots.