DCGI approves Bharat Biotech’s nasal COVID dose for trials | Fusion - WeRIndia

In the wake of increasing COVID-19 cases in the country, many pharma companies are conducting clinical trials for their vaccines against or manufacturing medicines for its treatment.

Recently, Dr Reddy’s Molflu got approval for EUA in adult COVID-19 patients, who are at higher risk of the progression of the disease.

Now Bharat Biotech’s nasal COVID dose got approval for clinical trials from the Drugs Controller General of India (DCGI).

Bharat Biotech wants to conduct clinical trials on 5,000 individuals to test its intranasal COVID-19 vaccine.

The company chooses two groups of individuals for this clinical study. Half of them have been vaccinated with Covishield and the remaining half with Covaxin.

As per sources, the interval between both doses, i.e. the second dose and booster dose, will be six months. If everything is finished as per plan and clinical trials are conducted on time, the intranasal vaccine will be available by March.

Bharat Biotech proposed the booster dose for all those who received both doses of either Covishield or Covaxin. For this, it aims to conduct clinical trials. It submitted its proposal. Now the company got approval for conducting Phase III clinical trials for its intranasal vaccine to be given as a booster dose.

Bharat Biotech recently got EUA for Covaxin to be used for children aged 12-18 years from DCGI. The company claimed that no serious or adverse effects were reported during the clinical trials. For the study, 976 children were screened for SARS-CoV-2 by RT-PCR and ELISA testing, and 525 were enrolled. Among them, 374 children reported mild or moderate-severe symptoms. One of the most common symptoms reported by the majority of children was pain at the injection site. Around 80 per cent of these symptoms got resolved within a day.

The company also conducted phase II and III and multicenter studies in paediatric subjects to evaluate the safety and immunogenicity of Covaxin in children aged 2-18 years.

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