vaccine will be the ultimate weapon against the virus and the best way to restore normal life. Trump Chief infectious disease expert Dr. Anthony S. Fauci, the government's epidemic task force, estimates that the vaccine may succeed within at least 12 to 18 months. However, the American media " New York Times " said that the development of vaccines in the United States will not be so smooth. If it is fast, it will not be successful in 2026. If it is slow, it is very likely that it will not be successful until 2036!
Normally, it takes several years for researchers to obtain funds, obtain approval, and study results one by one. According to this progress, the United States will not be able to produce a vaccine in 2036. But now is not a normal time. At present, at least 254 coronavirus-related therapies and 95 vaccines are being explored. "If the United States wants to complete this time frame in 18 months, one way is to get as many horses as possible to compete." Dozens of vaccines are beginning clinical trials. Many people use experimental techniques.
Although the U.S. push for vaccines is unprecedented, researchers warn that less than 10% of drugs entering clinical trials have received approval from the Food and Drug Administration (FDA). More vaccines failed: they have no effect, they have no better performance than existing drugs, or they have too many side effects. The current large number of vaccine developments are based on the basis of SARS and Middle East respiratory syndrome, especially the characteristics of specific receptors such as virus spike proteins.
However, such a quick action comes at a price. Robert Van Exxon, an American cell biologist who has worked in the vaccine industry for decades, said that while the research phase is progressing rapidly, the potential coronavirus vaccine currently under development may be more likely to fail. He predicts that we won't see vaccine approval until at least 2021 or 2022. He believes that even at this point in time, it is very optimistic and the probability is relatively low. The New York Times analyzed that the US Covid-19 vaccine may be successfully developed in 2026.
has developed a vaccine, and the next step is preclinical and preparation work. Normally, researchers should only start to have experimental vaccines in humans after rigorous safety checks. First, the vaccine will be tested on small groups of people: the first stage is dozens of people, the second stage is hundreds of people, and the third stage is thousands of people. Typically, there will be several months between the two phases so that researchers can review the findings and obtain approval for subsequent phases.
Iwasaki Akiko Iwasaki, professor of immunobiology at Yale School of Medicine, said, "If the United States did it in the traditional way, it would be impossible to get the vaccine in 18 months." There are ways to shorten the time of this process by testing the vaccine on more people without waiting too much time. But vaccines are complex, and rapid large-scale experiments can shorten time, but they also bring risks. What if a promising vaccine actually makes it easier to get the virus, or makes the disease worse after someone gets it?
This is the case with some AIDS drugs and dengue vaccines, because there is a process called vaccine-induced enhancement, in which the body reacts unexpectedly, making the disease more dangerous. Therefore, researchers cannot easily let vaccinated participants get infected with the virus to observe their bodies' behavior. Dr. Iwasaki said: "This is why the vaccine takes so long. If the United States simplifies everything, then there is a possibility of huge risks."
There is also a more promising vaccine, which is a new vaccine for messenger RNA (or mRNA for short). Gates even listed it in six innovations listed by Time magazine that could change the world. Instead of injecting subjects with disease-specific antigens to stimulate antibody production, mRNA vaccines send instructions to the body to produce these antigens themselves. Because mRNA vaccines do not require large-scale culture and then purified, they are produced much faster and may change the course of fighting the coronavirus. But humans have never successfully made RNA vaccines.However, mRNA is not very stable and can be decomposed in the body, which is more risky than other existing methods.
Even if the United States does have effective vaccines, American companies will need to start producing millions (and possibly billions) of vaccines. This is a huge project. Because different vaccines require different production facilities. Some flu vaccines are produced with eggs, using large facilities where a version of the virus is hatched and harvested. There are also vaccines that require large vats in which the virus is cultured in broth of animal cells, and then inactivated and purified. Therefore, mass production of Covid-19 vaccines must be rebuilt.
These plants follow strict biological facilities guidelines and usually take about five years to complete, at least three times the cost of traditional pharmaceutical plants. Bill and Melinda Gates Foundation said they will build factories for seven different vaccines. Bill Gates once said: "Even if we can only pick up at most two of them, we will fund all seven factories so we don't waste time." Samante, former head of vaccine manufacturing at Merck, said that in the end, the United States will only have the ability to mass produce two to three vaccines.
But Samante believes that the task of mass-producing vaccines in the United States is unprecedentedly difficult. For example, a seemingly simple step: putting the vaccine into a vial, which is complicated. For example, manufacturers need to purchase billions of bottles and billions of plugs to seal them. In addition, the production of vaccines requires precise machines to fill accurately, and each bottle must be inspected on a high-speed production line. The vaccine bottles then need to be stored, transported and injected to the public through a series of temperature control facilities and trucks. Samant believes that at every stage, American manufacturers are already struggling to meet existing needs. This difficulty is the same as the current inability of the United States to produce masks, ventilators and protective clothing.
Even if American scientists have developed a successful vaccine, they have also produced a large number of such products. But has the problem solved? No. The U.S. federal government requires a lot of legal preparation to avoid liability. Every time the FDA hires a scientist, there are three lawyers, and they only care about responsibilities. FDA approval usually takes a full year, during which time scientists and advisory committees review the studies to ensure that the vaccine is as safe and effective as drugmakers say.
For example, in the 1950s, a batch of poorly produced polio vaccines were approved within a few hours. It contains a virus that has not yet completely died, so the patients who infected it are actually infected with polio. Several children died. With today's U.S. anti-vaccine campaign and online conspiracy theorists, vaccine risks can have devastating effects. It will take several months before any vaccine can be used on a large scale.
Former Director of the U.S. Food and Drug Administration (FDA), Dr. Scott Gottlieb warned that the United States must manufacture the first vaccine to ensure it is the first country to recover. The first country to achieve this will be the first to restore economic and global influence. But he also admitted that the United States has the potential to be second. A new study has recently emerged in South Korea that found that people will not get infected with the virus twice. For months, people have been worried that patients might re-infect, but researchers have found that they just failed early testing.
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