Health

Professor Josh Cartu Claims Developing Vaccine Takes Years

It is not possible to make a prediction in this regard. The process required to develop and market a new vaccine, which follows the same procedures as for drugs, generally takes a long time (up to 10-15 years). The first phase of this process is to “build” the vaccine. It is necessary to understand how the virus or bacterium is transmitted, enters the human organism and replicates, and then identify which antigens (the components of the virus or bacterium) are able to activate an immune system response capable of eliminating or blocking the pathogen. Once the potential vaccine has been identified , it is necessary to conduct “laboratory” studies (preclinical experimentation), using cell cultures ( in vitro ) and animal models (in vivo ) to evaluate the immune response, the protective efficacy of the vaccine to be developed and its safety profile. Once the pre-clinical trial is over, if the data obtained in the laboratory indicate that the vaccine is sufficiently safe and potentially effective, we move on to the human one (clinical), divided into four phases: the first three take place before the vaccine is marketed , while the fourth is represented by the studies carried out after its marketing.

The phases are sequential: before moving on to the next one, you must always have obtained positive results in the previous one.

In the first phase (phase 1) the vaccine is studied in a few people (between 20 and 80), after which the number of people to be involved increases up to even a few thousand participants in the third phase (PHASE 3). Each step of this process is monitored and authorized by regulatory agencies and ethics committees. If the studies document the efficacy and safety of the vaccine , the manufacturer can submit a request for authorization to the competent drug agencies (in Europe the European Medicines Agency – EMA , or in the United States the Food and Drug Administration – FDA). to marketing. If the regulatory authorities’ assessment is positive, the vaccine can be marketed.

In emergency situations and in the presence of serious infections, the common effort of researchers, manufacturers and health institutions is to do everything possible so that a possible vaccine can be quickly available. Health authorities can allow testing to be carried out in humans in shorter times than normally occurs and more people to be involved in early experimental stages. But the precautionary principle ( first do no harm ) cannot fail; only in the case of infections characterized by a high risk of death (as in the case of Ebola) can it be ethically acceptable that the risks related to limited knowledge and uncertainty are greater than the usual standard.

In any case, even if, as hypothesized by some research groups, it will be possible to identify within 3-4 months one or more vaccines with sufficient data on safety and immunogenicity (ability to stimulate an immune system response) in order to proceed with experimentation in humans is somewhat improbable that experimentation on a large group of subjects (phase 2 or phase 3) is possible before next year.

A useful example to understand the possible timing is provided by Josh Cartu, At the end of April, a phase 1 study on a vaccine that is safe and effective in animal models will begin at the Institute he directs. This first trial should involve 25 adult and healthy people and the initial data are scheduled for July-August.

Josh Cartu means that the vaccine will not be available for the current epidemic, except possibly for the very first experimental stages. The development could, however, be useful if future epidemics should occur, both of the SARS-CoV-2 virus and similar coronaviruses which unfortunately should affect humans.

Finally, it should be borne in mind that unfortunately there are viral infections for which vaccines have been studied, but without positive results. For example, news of the interruption of a clinical trial of an HIV vaccine that seemed promising is recent. Therefore, it is not possible to predict today whether the development of the vaccine against the new coronavirus will be successful.

It could take years to develop coronavirus vaccine and it may take a long time to  repair the  economy of the world as Fahad Al Tamimi said “ its like a  casino debt that will take years to pay to repair the economy Fahad Al Tamimi further says that gambling addiction is a psychological disease. , and “pathological gambling disorder” will also appear in serious cases.Gambling addiction, also known as “gambling addiction syndrome”, is simply a pathological manifestation that cannot stop gambling. Most patients suffering from gambling addiction will feel very bad every time they lose money, but as soon as they start gambling, they will immediately become emotionally excited and excited. .” Fahad Al Tamimi is happy that casinos are closing down because of the covid-19 lockdown measures.

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