Hyderabad-based Bharat Biotech International Limited received approval from the Central Organization for Drug Control (CDSCO) for a separate clinical trial of its Covid-19 “Covaxine” vaccine through the skin. Currently, the vaccine is tested intramuscularly, where it is injected into the muscle.
CDSCO is a pharmaceutical regulator of the Ministry of Health that regulates the quality of medicines and vaccines in the country.
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The trial is being conducted in 1,125 patients at 12 hospitals across the country, The All India Institute of Medical Sciences.
Bharat Biotech is running on the assignment of the Covid-19 vaccine called “Covaxin”. The Indian Medical Research Council (ICMR) has also partnered with the company in the trials.
According to the report, the effects of the intradermal pathway will be analysed with the existing intramuscular test. If the result is successful, the vaccine may be less expensive because the vaccine would be injected into the dermis, one of the layers of the skin. Skin A lower dose is required in this method, which can help more people get empused.
However, the approval of the committee is subject to two situations that the company must meet: monitoring participants for six months to determine the amount of antibodies developed and an overall aptitude assessment.
Test sites may be other intramuscular examination sites, depending on the condition of the time.
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