Covaxin Next Phase Clinical Trials For 2 To 18 Age Group To Begin

 - Sakshi Post

India battling the second wave of the coronavirus pandemic with a record surge in daily cases and deaths due to COVID-19. In the second wave, children below the age of 18 years and newborns have tested positive for COVID-19 in some parts of India. Now, experts are predicting that the third wave is just a few months aways and children are likely to get infected with the virus. There are chances that they can be diagnosed with mucormycosis fungal infection after contracting the virus. 
Till now, the government announced that those who have crossed 18 years of age can get vaccine. Bharat Biotech on Tuesday was recommended by an expert panel to send its COVID-19 vaccine Covaxin for phase II and phase III clinical trial on children in between the age of 2 to 18 years. 

The officials said that the trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.

Following extensive deliberation, the committee recommended the firm to conduct phase II/III clinical trial of whole virion inactivated coronavirus vaccine in the 2 to 18-year-old age group, with the condition that the company shoud submit interim safety data from the phase II clinical trial, along with DSMB guidelines, to the CDSCO before moving on to the phase III clinical trials.

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