Covaxin trials now set to be conducted on children across six hospitals as also Glenmark plans to roll out its phase 3 trials of its nasal COVID-19 treatment

INDIA – The Indian government is aggressively trying to curb the COVID -19 pandemic with the roll out of various programs across the state.

Currently the state has embarked on two programs in a bid to curb the spread of the virus with the first one being conducting vaccine trials on children (Covaxin trials) and the second one involving phase 3 trials of a nasal therapy meant to cure COVID-19 symptoms.

The Covaxin trials will be conducted on 175 children aged 2-6, 6-12 and 12-18 who will be given the first dose of the vaccine after which they will be monitored.

India has approved three vaccines: Covaxin, Covishield and Sputnik for immunization of adults aged 18 years and above.

However, there are no vaccines approved for children at present. The US and the UK have approved Pfizer for use in children above 12 years.

Bharat Biotech, the company manufacturing Covaxin, was permitted by the drug regulatory body to conduct clinical trials of its vaccine on May 12, following which phase II/III trials were started at various centres, including AIIMS Delhi.

It started with the screening of teens between 12 and 18 years, the oldest of the targeted population, to rule out Covid-19 and presence of antibodies against the virus.

The trials also required parents to these kids sign a consent of approval.

Those who cleared the screening process were administered the vaccine. Same process was followed in kids aged between 2 – 6 and 6 – 12 years.

The clinical trials are significant given the apprehension of an impending third wave of the pandemic in the country which, many experts said, might affect the children more. However, there is no evidence to support the claim.

For the second program, Glenmark Pharmaceuticals will be conducting a phase 3 trial on a nitric oxide nasal spray, which it claims is effective in treatment of Covid-19.

The company had sought emergency approval for import and marketing of the nasal spray from the drug regulator last week.

However, the subject expert Committee (SEC) under the drug regulator recommended Glenmark to conduct the Phase III trial.

Glenmark will now join hands with Sanotize a Canadian company to help develop the drug meant to treat COVID-19 symptoms.

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