Even if the Government's Resolution 86 allows the use of immune birth data obtained from the evaluation results between the period 3 clinical trial for extrapolation of the protection effect of the vaccine, the design Pilbracy research for Nano Covax is still a very large challenge of 9:00 / 7: 06 Southern clinical trials three-stage is required for drug production and vaccines. Before the urgent prevention of Covid-19, this condition is slightly reduced. But the next question: How to demonstrate the safety, effective protection of the test vaccine? From the laboratory "field" in the goals of clinical trials, indicators for free The translation of the vaccine can basically determine by a series of experiments in standard laboratories. The safety and efficient protection indicator, according to the general standards, still with statistical data on response After injection, resistance of volunteers before the disease. The bigger the test scale, the number of participants, the more ethnic groups, ethnic areas, gender, age, the condition of the background
... as diverse, the more and more confidential data
With the Covid room vaccine -19, in this clinical data system, a most important data is the number of people while participating in phase 3 clinical trials, infected with SARS-COV-2 virus. Attached is the time of infection, infection status, transformed into illness or not, how the severity of the disease ... The number of cases, the case must be large enough to allocate to volunteer groups with calculations Diverse domain, ethnic, gender, age, background disease. Yes, when decoding infected cases, that disease belongs to the test or placebo vaccine vaccine group, the correct calculation is effective for the protection of the vaccine. 3 is to bring the test vaccine to "field". The test requires a lot of time collecting enough data to assess the safety, the effectiveness of the protective product of the test and sufficient to consider switching to the procedures for circulation. Look at the Ministry of Health at the end of 2020, When Covid-19 comes from Wuhan (China) beginning to become a global pandemic, the Ministry of Health soon called on manufacturers in water to collect the vaccine research. Medical Ministry also reviewed and seen Legal submission for vaccine development at that time despite very modern but it would be difficult to meet urgent requirements for prevention of pandemic
Best, in August-2020, the Ministry of Health issued Decision 3695 Guide to withdraw Compact many processes and legal procedures. This is an important premise for domestic producers such as Nanogen - so far quickly entered the midst of the 3 clinical trial of Nano Covax Vaccine, or IVAC - preparing to enter the phase 2 clinical trial COVIVAC products. In this guide, the ability to completely completely complete phase 3 clinical trial has been taken into account. At the time of building a guide, the prevention of Covid-19 epidemics across the country is very accumulated pole. The number of F0 cases is very discovered so the ability to "catch cases" in phase 3 is predicted very difficult. Medical Ministry, Ministry of Foreign Affairs has even calculated the plan to request countries with cooperative translation Internal vaccine clinical trial. However, the feasibility is not high and the legal procedure for international cooperation requires a lot of time. This difficulty is difficult, Decision 3695 opens an alternative approach: in the case of Vietnam? There are enough cases of diseases to design the validity of the vaccine according to the disease case criteria, it is possible to design the bridging research, comparing the immunity of the vaccine's immunity to another vaccine, which has the research results Save the protection effect, recognized by the country with a national management system in Vaccine (NRA) according to WHO standards. However, the test results can be used for immunity to extracurricular effects The protection of the vaccine. Prime Minister Pham Minh Chinh in a visit and worked with Nanogen Company - Research unit, production of Covid-19 Nanocovax room vaccine in Ho Chi Minh City High-Tech Park. Photo: The Government's Resolution 86 issued on August 10, has formed a specific mechanism and policy for the development of Covid-19 internal vaccine. Accordingly, only the evaluation results between phase 3 clinical trials (other pharmaceutical laws must complete all three stages), the research vaccine has been able to apply for a conditional circulation registration ... What opportunities for Nano Covax? Nano Covax are leading in the Covid-19 internal vaccine race, with technology described as recombinant protein. The third phase 3 clinical trial is in the moral council in National Biomedical Studies and the Ministry of Health approved in the direction of separation into 3A - with 1,000 volunteers first and phase 3b - with 12,000 volunteers next. Separating Phase 3A is the fact that the situation is required to use the mechanism of the bridging comparison mechanism, there are data to conduct, instead of waiting for the final results of the whole period 3. The problem is at the present time, When nanogen is urgently developing research reports . Dịch vụ:
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