The pharmaceutical company Moderna started the last and longest step in the testing process of its COVID-19 vaccine candidate at the end of July – a phase 3 clinical trial. It’s an enormous undertaking: your goal is to recruit 30,000 people, inject some of them with an experimental vaccine, and then follow each one of them to see how many get infected with the coronavirus and how many don’t. This will take months, even if the federal government’s Warp Speed operation compresses the timeline if possible. These months may seem endless when over a thousand people die from COVID-19 every day in the United States.
However, the process is long and intense for a reason. Just because there is a vaccine does not mean that it is reasonable or ethical to only give it to people before there is evidence that it works. If you stick to the process, the vaccines on the market today are so safe.
“It is fundamentally wrong to believe that because there is an emergency, we should somehow throw away aspects of scientific research,”
The researchers already know a lot about some of the vaccine candidates. For example, the Moderna vaccine has gone through both phase 1 and phase 2 clinical trials and has been tested on monkeys. The studies have not set any major red flags and they have shown that people who were injected with the vaccine produced antibodies to the coronavirus. But none of them tried to answer the question people want to know the answer to: can this vaccine stop people from getting COVID-19 in the real world?
To answer this question, the researchers are turning to a phase 3 study. You will dose thousands of people with the vaccine candidate and thousands more with a placebo vaccine. Then you will see if fewer people receive COVID-19 in the vaccine group than in the placebo group. They also pay attention to side effects.
The amount of data we currently have about COVID-19 vaccines is only a fraction of what scientists need before they would recommend spreading it out a little. “The evidence that would convince me to get a COVID-19 vaccine or to recommend that my loved ones be vaccinated does not yet exist,” wrote Natalie Dean, assistant professor of biostatistics at the University of Florida, in one New York Times op-ed.
If a vaccine is a car, phase 1 and 2 studies are done while it is still in the factory. In these studies, scientists are still trying to put together a vaccine that may work – finding out what parts they may need and how they should be used. If this assembly process goes well, the vaccine candidate can proceed to phase 3, where it is needed for a closely monitored journey on test tracks and in the real world. “In phases 1 and 2, you can say,” We have a lot of things to do and decide, “says London.” Phase 3 says, ‘Great, now we’re testing it.’ ”
These real tests are often unsuccessful. Only a small percentage of pharmaceutical products – even those that look promising in early studies – go through phase 3 and are eventually approved for use. The success rate is higher for vaccines than for treatments, but many of the vaccination successes are due to viruses that scientists already know a lot about. New viruses such as the new corona virus are much more difficult to develop and less likely to succeed.
9. Consider this brand new analysis by Lo and colleagues: https://t.co/CV6FKoqKYb. Look at their breakdown of the data. Green highlights stand for the industry that uses the existing knowledge. But yellow paths are more difficult to crack. pic.twitter.com/nh8OcdloOO
– Alex John London (@AlexJohnLondon), August 3, 2020
If you stick to the metaphor of the car, there is a chance that once a vaccine reaches the test track, it will stop working (not really protecting people from COVID-19) or, in the worst case, crash (have serious side effects). The first test drives must be carefully monitored so that developers can monitor exactly what is happening.
When the scientists see clear signs of this during the phase 3 studies is At work, they would end the study early and begin approving it from the Food and Drug Administration. “If what we’re testing really shows that it works, scientists shouldn’t test it on humans anymore,” says Karen Maschke, who studies ethics in human research at the Hastings Center in New York. But that’s a rare exception to the rule. In almost all cases, you should do an exam to the end, she says.
It is particularly important to take vaccines throughout the process, as they are intended for people who are already healthy. If someone is already sick, the benefits of trying a treatment (even if it’s unclear how well it actually works) can be worth the potential risks. It is ethically much more difficult to justify something that is still experimental for a healthy person. “A vaccine is the kind of thing we’ll give hundreds of millions of healthy people, or maybe that vaccine could be given to a billion people,” says London. “We need to know it’s safe.”
Even if it has no side effects, it is risky to give an experimental vaccine to people outside of a clinical trial and before researchers know if it actually works. People who receive an undetected vaccine may feel safer and no longer take as many precautions (such as wearing masks or avoiding indoor gatherings) against COVID-19, London says. This could increase the spread of the disease if the vaccine doesn’t work. “We need to know if it works because people will change their behavior after they get it,” says London.
Release of a vaccine to the public before it has been shown to be safe and effective could also undermine public confidence in vaccines. “With concerns about science and the anti-scientific mood, you really have to be very, very careful to get enough data,” says Maschke. Researchers must be able to provide the number of people they have tested the vaccine with and their statistical analysis as justification for a recommendation. “Confidence in the process of developing new drugs and new drugs is fragile,” says London. “We cannot put it in danger.”
According to London, the clinical trial process is usually not treated as focused, says London. “The public has a window into a discussion that they are normally not involved in,” he says. This process can be confusing even in the best of times. Press releases, sound bites, and jargon can create the illusion that scientists know more about vaccine candidates than they do, or that they look more promising than they actually are. For example, if experts say that a vaccine performed well in a phase 1 trial, it means they haven’t seen anything that would stop it from moving on to the next phase of the process.
“It doesn’t mean that the public is interested in things – is it safe? If I take that, it means that I have no more adverse events a year later. and it will protect me if I am exposed to the corona virus, ”he says.
It is possible to answer these questions, but it will take some time. Driving at warp speed can save something Time, but solid, conclusive answers are worth the wait.