Vaccine development takes time. It is a fact. As soon as the COVID-19 pandemic hit, the race for a new vaccine began. Unfortunately, that sense of urgency has also led to potentially misleading predictions and predictions about how a vaccine might be ready by the end of summer, by early fall, and now before winter. If it just could be that easy. The World Health Organization, which is trying to get a grip on expectations, has announced that it will not expect widespread vaccination before mid-2021.
The New York Times maintains an updated coronavirus vaccine tracker that lists the number of vaccines at various stages of development around the world. As of today, there is a "0" and only 3 in the approved box that are approved for early or limited use. These are located in Russia and China, which approved the vaccines before the final safety trials were completed.
According to the tracker, there are currently 37 human trials ongoing and 91 more in the preclinical phase.
The long road in vaccine development
Vaccines typically take years of research and testing before they are shipped for use. First, there is basic research to learn more about the virus, find its weaknesses, and find vaccine candidates. This can take years. Next up is the pre-clinical phase, where laboratory and animal testing is carried out to determine if the original ideas apply. At this stage, researchers can choose to abandon their original idea, move it forward, or optimize it based on what they have found.
But there is more.
Once the preclinical stage is complete, researchers must apply for permission to test their vaccine candidate in humans. A small group of healthy adults are involved in phase 1 studies. Here, the researchers find out whether the vaccine does what they want and trigger an immune response. If Phase I is successful, move on to Phase 2 as more candidates are vaccinated. Some participants belong to the high risk groups who could contract the virus. At this point the researchers are investigating how high a dose to give, how safe it is, and how best to give the vaccine.
And there is more.
If all of the previous bars have been cleared successfully, there will be a phase 3 study that will involve thousands of people and that may take years. In this case, the researchers may find side effects or side effects of the vaccine that were not seen in the smaller groups. This stage also gives a better picture of how effective the vaccine is compared to a placebo or other available vaccine, if that is not the first for a specific virus. Only after this study has been successfully completed can it be brought to market with the approval of the FDA. But then another kind of work begins. Production and sales can only begin after approval, which also takes some time.
There are times when swift tracking can be sacrificed when the FDA believes it is in the public's best interest.
The WHO is encouraged by the pace of research, but they are also realistic – vaccines released too early without proper testing could fail or, worse, be harmful. Because of this, there are concerns about the three vaccines in Russia and China, where there are no results from the Phase 3 study.
"We know at least six to nine [vaccine candidates] who have come a long way in research," WHO spokeswoman Margaret Harris told reporters in Geneva. However, she emphasized that "with regard to realistic schedules, we do not expect comprehensive vaccination until the middle of next year".
The US is preparing
Although a reliable vaccine may not be available until next year, the federal government has urged the federal states to prepare for the introduction of a vaccine as early as November. Although the WHO doesn't think it will, the White House speculates that there will be a vaccine by then. However, early preparation is not a bad idea, even if the hoped-for early vaccine does not materialize. With the infrastructure in place to distribute vaccines, anyone can be ready when the vaccines are cleared for use. It's also possible for the FDA to offer emergency clearance if a vaccine candidate looks strong and safe, so preparing early can lay the groundwork.
The emergency approval for a vaccine is controversial. The admission limit is lower than the standard procedure. In this case, it can only be determined later that the vaccine is not effective or is causing serious side effects. Infectious disease specialists and other experts are calling for vaccines not to be compromised. This can delay introduction, but it is likely to result in a vaccine that is more effective and creates more public and health confidence.