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Expert Panel Recommends Permission For Phase 1 Clinical Trial Of Bharat Biotech’s Nasal Vaccine

According to Krishna Ella, the chairman of Bharat Biotech, an intranasal vaccine will not only be simple to administer but also reduce the use of medical consumables such as needles, and syringes significantly impacting the overall cost of a vaccination drive

Expert Panel Recommends Permission For Phase 1 Clinical Trial Of Bharat Biotech's Nasal Vaccine
Highlights
  • One drop of vaccine in each of the nostrils is sufficient: Bharat Biotech
  • Phase-I trials of nasal vaccine will start in Feb-March: Bharat Biotech
  • If nasal vaccine works, it can be a game-changer: V K Paul, NITI Aayog

New Delhi: An expert panel of India’s drug regulator CDSCO on Tuesday (January 19) recommended granting permission for conducting phase 1 clinical trial of an intranasal vaccine against COVID-19 developed by Bharat Biotech, official sources said. A top government official said that if this vaccine works it can be a game changer in the fight against COVID-19. Bharat Biotech applied to the Drugs Controller General of India (DCGI) seeking permission for conducting phase 1 and phase 2 clinical trials of the intranasal vaccine following which the subject expert committee of the CDSCO on Tuesday deliberated on the application and recommended granting permission for phase 1 trial.

Also Read: Once COVID-19 Vaccine Vial Is Opened, It Needs To Be Used Fully Within Four Hours: Senior Doctors

Based on the safety and immunogenicity data of the phase 1 clinical trial, the company would be given permission for conducting phase 2 clinical trial,” an official said on the condition of anonymity. Earlier in the day, in response to a query on whether a nasal vaccine would be effective against the disease, NITI Aayog member (health) V K Paul at a press conference said,

A nasal vaccine candidate has been identified. It has come for consideration to the drug regulator for phase 1 and phase 2 clinical trials. It looks like an exciting development because potentially, yes, this route can be used to deliver the safe antigen against which an immunological response would happen. If it does work it can be a game-changer because it is so easy to use and we look forward to this development. Such a possibility is very plausible scientifically.

Also Read: Number Of People Vaccinated Against COVID-19 More Than Double Of Number Of Active Cases: Government

The nasal vaccine is different from the intramuscular vaccine which recently was approved by the Indian drug regulator for restricted emergency use approval under clinical trial mode. Krishna Ella, the chairman of Bharat Biotech, had earlier said the company is focusing on the intranasal vaccine as existing vaccines require two-dose intramuscular injections and a country like India needs 2.6 billion syringes and needles which may add to pollution.

An intranasal vaccine will not only be simple to administer but reduce the use of medical consumables such as needles, syringes, etc significantly impacting the overall cost of a vaccination drive, he had said.

One drop of vaccine in each of the nostrils is sufficient,” he had said. BBV154 (intranasal COVID-19 vaccine) preclinical testing has been completed for toxicology, immunogenicity and challenge studies. These studies have been conducted in the USA and India. Phase I human clinical trials will commence during Feb-March 2021, an e-mail reply from the vaccine maker told PTI.

Also Read: Going For Vaccination Is Voluntary, People’s Confidence Will Get Boosted Slowly: Delhi Health Minister

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

NDTV – Dettol Banega Swasth India campaign is an extension of the five-year-old Banega Swachh India initiative helmed by Campaign Ambassador Amitabh Bachchan. It aims to spread awareness about critical health issues facing the country. In wake of the current COVID-19 pandemic, the need for WASH (WaterSanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign highlights the importance of nutrition and healthcare for women and children to prevent maternal and child mortality, fight malnutrition, stunting, wasting, anaemia and disease prevention through vaccines. Importance of programmes like Public Distribution System (PDS), Mid-day Meal Scheme, POSHAN Abhiyan and the role of Aganwadis and ASHA workers are also covered. Only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and become a Swasth or healthy India. The campaign will continue to cover issues like air pollutionwaste managementplastic banmanual scavenging and sanitation workers and menstrual hygiene

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