Saturday, September 18, 2021

Covaxin trials for kids likely soon in Nagpur – ET HealthWorld

Nagpur: For parents concerned about sending their children, especially primary students, to school due to the Covid-19 pandemic and waiting for vaccine approval for those below 18 years, there is light at the end of the tunnel, reports Chaitanya Deshpande.

Bharat Biotech, makers of indigenous Covid-19 vaccine, Covaxin, are expected to start vaccine trials for the paediatric population by February-end or early March this year. Sources confirmed that a leading children’s hospital in the city has been selected as one of the sites for trials on children. The trials will start as soon as Bharat Biotech, a company from Hyderabad, gets formal go-ahead from the government of India.

‘Will be first such trial in the world’

In January, Bharat Biotech MD Krishna Ella had said that the vaccine for children will be ready in the next four months — by May 2021.

“It will be the first such trial in the world in which paediatric population right from toddlers to teens will be tested for the Covid-19 vaccine,” Dr Ashish Tajne, coordinator for these trials, said. Dr Tajne further said that Nagpur was one of the sites for Covaxin’s phase I, II, and III human trials.

“Trials for Covaxin through intradermal route are under way in the city. Soon, Covaxin trials through nasal route will also commence. However, the paediatric trial has a special importance,” he said.

According to him, these trials will be conducted in age slabs like 2-5 years, 6-12 years, and 12-18 years. “Special protocol will be maintained. It will be a crucial trial in the fight against Covid-19,” Tajne said.

As per international regulations, only vaccines based on inactivated virus can be administered to children under the age of 16 years. Hence, Covaxin is the only suitable option for children in India. Other made-in-India vaccines are based on mRNA and chimpanzee adenovirus vector platforms.

Earlier, in January, the Drug Controller General of India had given conditional approval for administering Covaxin to children above 12 years of age. But later in the month, the government disapproved this authorisation.

After this, Bharat Biotech declared that it will be submitting a proposal for Covaxin trials for children between 2-12 years. A senior paediatrician from the city, who is most likely to be the principle coordinator of these trials at Nagpur, said that formal announcement about the trials will be done only after receiving government’s final nod.

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