Good news about Corona vaccine in India, second and third phase trials of Serum Institute approved
The Drugs Controller General of India (DCGI) has allowed the Serum Institute of India (SII) to resume the second and third phase trials (trials) of the corona vaccine.
16th September, 2020
Amidst the corona virus epidemic crisis, the most talked about corona vaccine is being discussed in the world. Meanwhile, there is good news about the Corona vaccine in India. The second and third phase trials of the corona vaccine have been approved by the Serum Institute in the country. The Drugs Controller General of India (DCGI) has allowed the Serum Institute of India (SII) to resume the second and third phase trials (trials) of the corona vaccine.
Oxford University's Corona vaccine has been allowed to resume trial in the country. The Controller General of Indian Medicine (DCGI), Dr.VG Somani, has allowed the Serum Institute of India (SIII) to resume the trial of Oxford's vaccine in the country. Its going on. The trial of this vaccine was stopped when a volunteer deteriorated. DCGI also stopped its trial in India. However, trials were allowed to begin on Saturday only after private investigators in Britain declared the vaccine to be safe.
The DCGI has imposed several conditions on Tuesday with permission to resume the trial. SII has been asked to take full care of the health of the volunteer during the trial and to keep a watchful eye on any disturbances. In case of disturbances, DCGI will have to give complete information about the dosage of medicines given to SII.
The Serum Institute of India (SII) requested permission to resume trials in India of the vaccine being developed by AstraZeneca AstraZeneca and the University of Oxford. He submitted the recommendations of the Data Security Monitoring Board (DSMB), UK. DCGI VG Somani, in a letter to the Serum Institute of India (SII), stated that the response of the institute has been carefully examined as per the recommendations of DSMB in India and UK.
The letter states that you (SII) can recommend a clinical trial as per the protocol already approved by DSMB, India on August 2, 2020 and prescribed under the New Drugs and Clinical Trials Rules, 2019, subject to the conditions mentioned above. There are provisions. According to the letter, additional care during screening, additional information in informed consent and close monitoring for similar incidents should be followed. DCGI has also asked the Serum Institute of India (SII) to submit a description of the drug used according to the protocol for the management of adverse events.
AstraZeneca had previously stopped the ongoing trial of the corona virus vaccine (recombinant) because a volunteer involved in the trial had developed an unexplained disease. It was reported that testing had been halted in the US, Britain, Brazil and South Africa.