કોરોના વેક્સિન અંગે સારા સમાચાર:10 દિવસમાં કોવીશીલ્ડનો ટ્રાયલ ડેટા રેગ્યુલેટર પાસે હશે; આગામી મહિનાથી ભારતમાં પણ વેક્સિનેશન શરૂ થશે
The good news about the corona vaccine: in 10 days the regulator will have the trial data of Covishield; Vaccination will also start in India from next month
The Serum Institute of India (SII) will submit to the regulatory body by the end of December the data of the final phase of its vaccine Covishield medical test. If the data is satisfactory, Kovishield could receive emergency clearance in the first week of January. This means that the vaccination process can start from January. The vaccine is being developed in collaboration with Oxford University and the British firm AstraZeneca.
According to media reports, SII will hand over the final data to the regulator in the next ten days. In fact, just last week, a meeting of the Subject Expert Committee (SEC) of the drug regulator Central Drugs Standards Control Organization (CDSCO) was held. Along with Kovishield, data on Bharat Biotech's covacin and Pfizer's vaccine was also discussed. Emergency clearance has been sought for all three vaccines. The committee raised some questions on the application for emergency approval to the three vaccine candidates and sought answers from the companies.
The committee asked the SII to update the safety data of the ongoing Phase-2/3 clinical trials in India. In addition, data on immunogenicity trials of clinical trials in the UK and India are presented. The decision on the emergency approval of the drug regulator in Britain was also questioned. Pfizer asked for some time before the committee. While India Biotech will have to wait for the data of Phase-3 trials of Covexin.
What is the rule regarding emergency clearance in India?
According to Dr. Gagandeep Kang, India's top vaccine scientist and professor at the Christian Medical College in Vellore, new clinical trials have become the norm in India last year. It gives the regulator the right to allow emergency use of a drug or vaccine even without a trial in an emergency.
Dr. According to Kang, monitoring is the same as clinical trials, even after emergency use is permitted. Details of each patient are required. It is monitored. A company that has been licensed elsewhere for its product has to submit full details of pre-clinical and clinical trials to the regulator.
The process takes place in two stages at the regulator level when the company seeks permission for emergency restricted use. The Subject Expert Committee considers such an application. After its approval, the case goes before the apex committee. The committee also has secretaries of departments concerned with the Ministry of Health. A new incarnation of the Corona has appeared in the UK
Scientists were worried that if the corona virus mutated and changed its form, would the vaccine being developed around the world be effective? The World Health Organization (WHO) has responded. Mike Ryan, director of the World Health Organization's Health Emergency Program, said he had not yet received any data on the effects of the virus on the vaccine.
Matt Hancock, the UK's health minister, said a new variant of the corona virus had been reported in the south of England. There have been 1,000 cases of infection. During a WHO virtual press briefing, Ryan asked if the virus was more dangerous. Does this help the virus to be easily transmitted? Does this affect the diagnostics? Will this affect the effectiveness of the vaccine? All these questions have not been answered yet. We do not have any information to suggest that the effect of the vaccine is diminishing. In fact, the Pfizer and Bioentech vaccines were introduced to the general public in the UK last week.
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