If the vaccine is taken off clinical trial mode, then the beneficiaries will no longer have to sign a consent form for taking the shot.
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An expert panel of India's central drugs authority on Wednesday recommended granting emergency use authorisation to Bharat Biotech's indigenously developed Covaxin while removing the condition for the vaccine to be administered in 'clinical trial mode', official sources said. The recommendations have been sent to the Drugs Controller General of India (DCGI) for consideration. If the vaccine is taken off clinical trial mode then the beneficiaries will no longer have to sign a consent form for taking the jab. The subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) went through the interim data of Covaxin's phase-3 clinical trial which showed that the vaccine has an efficacy of 80.6 per cent. Following this, the recommendations were made. The Hyderabad-based Bharat Biotech recently had approached the drug regulator for it to consider removing the 'clinical trial mode' condition. "The SEC reviewed the interim phase-three trial data of Covaxin on Wednesday after which it recommended emergency use authorisation to the vaccine while removing the condition of it being required to be administered under clinical trial mode," the source said. India's drug regulator had on January 3 granted permission for the restricted use of Covaxin in emergency situation in the public interest as an abundant precaution, in clinical trial mode, especially in case of infection by mutant strains. "The vaccine (Covaxin) which has been given emergency use authorisation under clinical trial mode is accompanied by three documents. One is the factsheet which is read out and explained to beneficiaries, second is a consent form... and the third an adverse event reporting form where the recipient has to report adverse events for the first seven days," an official had said earlier. Meanwhile, India has provided over 481 lakh doses of coronavirus vaccines to various countries, the government informed Lok Sabha on Wednesday. In written reply to a question in Lok Sabha, Minister of State for External Affairs V Muraleedharan said external supplies are done factoring in domestic production, requirements of the national vaccination programme and requests for the Made-in-India vaccines. The supplies will continue in the coming weeks and months in a phased manner, depending on production and needs of the national vaccination programme, he said. India started external supplies of Made-in-India vaccines on January 20, the minister said. Supplies are being undertaken in three ways -- grant, commercial sales by the manufacturers and through vaccine alliance GAVI's COVAX facility. According to details given by Muraleedharan of vaccines shipped from India till March 4, out of 481.06 lakh vaccine doses sent to various countries, 73.5 lakh doses have been supplied as grant assistance, 288.4 lakh on commercial basis and 119.16 lakh doses for COVAX.
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