Bharat Biotech gets nod to conduct Covaxin trial through skin
Hyderabad-based Bharat Biotech International Limited got approval from the Central Drugs Standard Control Organisation (CDSCO) to conduct a separate clinical trial of their Covid-19 vaccine ‘Covaxin’ through the skin. Currently, the vaccine was being tested through intramuscular route, where it is injected directly into the muscle.
The CDSCO is a pharmaceutical regulatory body under the health ministry. It regulates the quality of drugs and vaccines in the country.
The trial is being conducted on 1,125 patients at 12 hospitals across the country including All India Institute of Medical Sciences.
The Bharat Biotech is working on the Covid-19 vaccine project call “Covaxin”. Indian Council for Medical Research (ICMR) has also partnered with the company on the trials.
As per the report, the findings of the intradermal route will be analysed separately along with the current intramuscular trial. If the result proves to be successful, the vaccine could be made cheaper as the vaccine would be injected in the dermis, one of the layers of the skin. Lesser dosage is required in this method which can then help in more people getting vaccinated.
However, the committee’s approval is subjected to two conditions that the company is required to follow— following up on participants for six months to check how much antibodies have been developed along with general health assessment.
The sites for the study should be different from the sites of the intramuscular study, according to the second condition.