Bharat Biotech's intranasal Covid vaccine iNCoVACC gets CDSCO Panel nod for PMS study
New Delhi: In a significant development, the vaccine manufacturer Bharat Biotech International Limited has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) for conducting an active post-marketing surveillance study (PMS study) of ChAd36-SARS-CoV-S COVID-19 Vaccine (recombinant) which is intranasal Covid-19 vaccine, iNCOVACC.
This came in line with the proposal presented by the vaccine major Bharat Biotech for conducting an active post-marketing surveillance study of ChAd36-SARS-CoV-S COVID-19 Vaccine (recombinant) as per the condition of manufacturing and marketing permission.
Intranasal Covid-19 vaccine, iNCOVACC is an Adenoviral vector-based (expressing a stabilized spike protein) SARSCoV-2 vaccine for nasal administration only. iNCOVACC vaccination course consists of TWO separate doses of 0.5mL ( 8 drops, 4 drops in each nostril). The second dose should be administered after 28 days ( 4 weeks from the first dose).
iNCOVACC® is indicated for active immunization against SARS-CoV-2 virus infection for age ≥ 18 years for restricted use in emergency situation in the public interest.
Earlier, the Medical Dialogues Team had reported that the vaccine manufacturer had already received approval from the Central Drugs Standard Control Organisation (CDSCO) for the nasal vaccine, the first of its kind in India, for immunization against SARS-CoV-2 virus infection for age group ≥18 years, as per Restricted Use in Emergency Situation.
Also Read:Intranasal COVID vaccine: Bharat Biotech to launch iNCOVACC on January 26
Furthermore, Bharat Biotech's COVID-19 intranasal vaccine iNCOVACC is now available on the CoWIN portal and is priced at Rs 800 (excluding GST) for private markets and Rs 325 (excluding GST) for government supplies.
At the recent SEC meeting for COVID-19 held on 06.04.2022, the expert panel reviewed the proposal presented by vaccine major Bharat Biotech for conducting an active post-marketing surveillance study of ChAd36-SARS-CoV-S COVID-19 Vaccine (recombinant), which is intranasal Covid-19 vaccine, iNCOVACC.
After detailed deliberation, the committee recommended conducting the post-marketing surveillance study (PMS study) as per the protocol presented.
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