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Bharat Biotech Applies For Phase-1 Trial Of Nasal Vaccine For COVID, DCGI Yet To Respond

Bharat Biotech has sent an application to DCGI for conducting the phase-1 trials of a nasal vaccine against COVID-19, the matter is yet to be taken up by DCGI.

Bharat Biotech, the developer of indigenous Coronavirus vaccine 'Covaxin' has sent an application to Drugs Controller General of India (DCGI) for conducting the phase-1 trials of a nasal vaccine against COVID-19, a government official has said while adding that the matter is yet to be taken up by the DCGI. The phase-1 of the nasal vaccine is said to begin during February-March this year. This development comes just a day after Joint Managing Director of Bharat Biotech Suchitra Ella announced that the firm has completed enrollment for phase-3 clinical trials of Covaxin.

As reported by PTI, Bharat Biotech's CMD Krishna Ella had earlier said an intranasal vaccine for Coronavirus will be more suitable than the ones injected through syringes, as for vaccinating a population as that of India, 2.6 billion syringes and needles would be required which may add up to the pollution, while a nasal vaccine will not only be simple to administer but also reduce the requirement of medical consumables such as syringes and needles, etc.

Clarifications over the safety of Coronavirus vaccines  

Amid the politicisation of vaccines by the opposition, Krishna Ella on January 4 responded to the adverse reactions by several politicians, experts and social media users towards Covaxin. Assuring the safety of Covaxin, he explained in detail the process of the clinical trials and the data available in the public domain regarding Covaxin.

Moreover, to come out clean amid the politicisation of vaccines and also to clear the apprehensions over the safety of the vaccine, ICMR chief Dr Balram Bhargava on Tuesday explained the clinical trials data available for the two vaccines - Covishield and Covaxin and the reason why they were given approvals. 

He assured that both vaccines were safe, immunogenic and hence approved for emergency usage. He also shared data of the ongoing phase-3 trials and the data published online regarding the two vaccines. The DCGI has allowed AstraZeneca - SII's 'COVISHIELD' and Bharat Biotech - ICMR's 'COVAXIN' vaccines for restricted use in an emergency situation.

 READ | Coronavirus LIVE Updates: India's Tally At 1,04,13,417; 2nd Nationwide Dry Run On Friday

READ | 2nd COVID-19 Vaccine Dry Run Begins; Health Minister Assures Sufficient Doses For Everyone

Second nationwide dry run begins

India has begun the second nationwide dry run of vaccine inoculation on January 8, with the massive mock drill being held in 736 districts across 33 States and Union territories, according to the information shared by the Ministry of Health and Family Welfare (MoHFW). The objective of the dry run is to simulate the actual vaccine administration event and to eliminate glitches or bottlenecks if any in the vaccine inoculation process.

The first nationwide dry run of the vaccination process was conducted on January 2 to test the mechanism laid out for the COVID-19 immunisation drive, which is expected to begin soon. The first major run-through was held on December 28 and 29 where the Centre conducted vaccination drive in four states, namely - Assam, Andhra Pradesh, Punjab, and Gujarat.  The government also said that it is ready to introduce the COVID-19 vaccine within 10 days from the date of emergency use authorisation. The DCGI has given the green signal for restricted emergency use approval to the two vaccines on January 3.

READ | COVAXIN Completes Enrollment Of 25,800 Volunteers For Phase-3 Trials Ahead Of 'dry Run'

READ | Amid Vaccine-politicisation, ICMR Chief Explains Covishield & Covaxin's Approvals & Data

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