[ad_1]
A vaccine has never been developed so quickly
We can say that we are facing a medical history, since the vaccine against the coronavirus (SARS-CoV-2, hereinafter coronavirus) will be the fastest developed of all time, and will not revert to the previous maximum holder. It takes an average of 10 to 15 years to develop, test, and market a vaccine, and the previous record dates back to 1960, when vaccination against mumps (epidemic mumps) was introduced to the general public in just four years.
For a new coronavirus, this time may be less than a year.
All vaccines must go through a multi-stage research and testing phase before they can be deemed safe by authorities and widespread use can begin. According to an article from Semmelweis University on this topic, the human phase of a so-called clinical trial can be divided into four phases.
Phase I trials are testing the new drug for the first time, in this case the coronavirus vaccine in humans. Volunteers are always involved in these experiments. The purpose of the studies is to test how the active substance is distributed in the body and to determine if the vaccine causes a serious side effect that puts you at greater risk than eliminates it.
A II. At this stage, a small specific group of patients is already being studied, and the main question is whether the drug is really suitable for treatment. Safety, tolerability and therapeutic effects, among others, are already being investigated and the dose optimized.
A III. During this phase, the results of the previous phase are confirmed and the product is already being studied in a greater number of patients. Furthermore, comparative studies with other drugs are being carried out. In all countries, the requirement is that the drug be controlled for two years after its introduction for safety reasons, emphasizes the University of Semmelweis. This is what IV. phase to examine long-term efficacy and safety, cost-effectiveness, and any rare side effects that may occur.
In some cases, there is a way to speed up these processes, especially if the research results are overwhelmingly positive. however, both Europe and the United States must meet strict standards for maximum security. In practice, this means skipping the fourth phase, which is possible in justified cases. Russia is an exception in this case, since they are not subject to the regulations of either the European Medicines Agency (EMA) or the United States Food and Drug Administration (FDA), so they have been able to comply with the Annex III. Parallel to Phase I, the inoculation of the population began, which raised a large amount of dust in the scientific world.
These are currently the most promising vaccines
The global press reports a breakthrough in the development of the coronavirus vaccine practically every day, but the truth is that despite the emergence of new names every hour among potential participants, everyone has been waiting for a solution of approximately the same market players from the beginning.
One of these is the Johnson and Johnson vaccine developed by the Commission, which began on September 23, III. phase studies and involve 60,000 people from different countries in the research. The company says there will be a particular emphasis on elderly and chronic patients, as they fall into the most vulnerable category. The first results show that your vaccine provides extremely effective protection against the virus. However, Johnson & Johnson almost certainly will not release the vaccine this year, as the III. The results of the phase will be executed at the end of the year, but rather in early 2021.
A Moderna Therapeutics The US-developed vaccine seems to have been Americans’ best hope for some time, and chances are high that it will be made first, like III. phase trials in which 30,000 Americans were vaccinated. Moderna recently reported that they are on track to produce at least 500 million doses a year starting early next year. Otherwise, this amount could reach 1 billion, as Moderna has a global strategic partnership with Lonza, Switzerland, which will also help with production. However, despite the good results, Stéphane Bancel, CEO of Moderna, told the New York Times that the vaccine could be used widely in the first half of 2021.
The largest pharmaceutical company in the world, United States. Pfizer the German BioNTechis working closely to develop its own vaccine, and a $ 2 billion contract has already been signed with the US government, under which Pfizer will deliver 100 million doses by December this year (if the vaccine can be approved by then). The two companies also launched the third phase on July 27, along with the second phase, and are focusing on areas that are focal points. Pfizer and BioNTech hope to get the green light from authorities later this year and produce 1.3 billion doses of the vaccine by the end of 2021.
The most important thing for Hungary is the British AstraZeneca and the University of Oxford joint development, as we also ask. The results of the first two clinical phases are extremely encouraging, and there was broad consensus in the industry that This may be the case in Europe. More than 18,000 participants around the world have already received the vaccine.
The tests had to be stopped recently because a patient had symptoms of spinal cord inflammation, but it turned out that it was not caused by the vaccine, so the tests could be restarted.
Not only is there stiff competition in the United States and Europe, there are also several promising projects underway in China. Of these, it is definitely worth highlighting the Sinovac, a Sinopharm and the CanSino Vaccines developed by Biologics. The latter was the first in the world to receive, albeit limited, permission from the state for its widespread use. The Chinese government has only allowed the vaccination of soldiers at the moment, and the CanSino vaccine will be retested in a year.
However, most are not vaccines from the companies mentioned above, but developed in Russia by the Gamaleya Research Center. Sputnik V was named on the front pages, which they claim is the first registered coronavirus vaccine on the market, although neither the FDA nor the EMA have approved its use, so it certainly won’t be used in Europe and the United States.
According to The Moscow Times, 5,000 volunteers have been vaccinated so far, and another 40,000 applicants will be tested for the drug in the near future.
Alexander Gintsburg, the director of Gamaleya, told the Russian daily Rossiiskaya Gazeta that the side effects of Sputnik V included fever and mild pain at the injection site, but that serious complications have not yet been reported. According to the Russians, like Johnson & Johnson, Sputnik V provides immunity after the first dose.
When will the first vaccine be available and when will the pandemic end?
By now, most countries have abandoned the assumption that flock immunity can be achieved without a vaccine. According to McKinsey research, there are between 90 and 300 million people in the world who enjoy natural immunity, but some studies also suggest that the BCG vaccine provides partial immunity. Additionally, there is a possibility that anyone who has previously been exposed to another type of coronavirus may also have some immunity to SARS-CoV-2.
According to McKinsey, about 70 percent of the population would need to be vaccinated in order to talk about any type of herd immunity.
that is, in this case, the epidemic will disappear.
According to a McKinsey study, considering all options and variants, the US could reach 70 percent vaccination in the third or fourth quarter of 2021, and it is not certain that a single vaccine is implemented, as there are indications of that the authorities will approve more. . Mass production and distribution of vaccines to the general public can take place within six months of authorization.
In the best case scenario, flock immunity could be realized as early as Q2 2021, but for that to happen, everything must happen at a perfect pace, which means there can be no interruptions.
In addition to the United States, the outlook is similar in other developed countries, which means that the epidemic can be overcome next year and only minor outbreaks are expected. However, experts say that even before herd immunity, life can return to normal, and this could happen next year. To do this, it is necessary to keep mortality low and, in this sense, there are significant advances in developed countries, which is also due to the fact that most countries were more prepared for the second wave.
[ad_2]
