Vaccines take time to develop. That’s a fact. So as soon as the COVID-19 pandemic hit, the race for a new vaccine took off. Unfortunately, this sense of urgency has also lead to potentially misleading statements and forecasts about the how a vaccine might be ready by the end of the summer, by early fall, and now, before winter. If only it was that easy. The World Health Organization, trying to manage expectations, has said that they don’t expect to see any widespread vaccination before mid-2021.

The New York Times maintains an updated Coronavirus Vaccine Tracker that lists the numbers of vaccines in the various stages of development around the world. As of today, there’s a “0” in the approved box, and only 3 that are approved for early or limited use. These are in Russia and China, which approved the vaccines before final safety trials were completed.

According to the tracker, there are currently 37 ongoing trials in humans and another 91 in the preclinical phase.

The Long Road Ahead in Vaccine Development

Vaccines usually take years of research and testing before they’re shipped out for use. First, there’s basic research to learn about the virus, find its weaknesses, and come up with vaccine candidates. This can take years. Next is the pre-clinical stage, when there are lab and animal tests to see if the original ideas bear out. At this stage, the researchers may decide to abandon their original idea, move forward with it or tweak it based on what they found.

But there’s more.

Once the pre-clinical stage is done, the researchers have to apply for permission to start testing their vaccine candidate in people. Phase 1 trials involve a small group of healthy adults. This is where the researchers learn if the vaccine does what they want, invoke an immune response. If phase I is successful, they move to phase 2, when more candidates are vaccinated. Some participants are in the high risk groups that could contract the virus. At this point, the researchers are looking at how high a dose to give, safety, and how best to give the vaccine.

And there’s more.

Finally, if all the previous bars have been successfully cleared, there is a phase 3 trial, which involves thousands of people and can last years. This is when the researchers may find side effects or adverse reactions to the vaccine that weren’t seen in the smaller groups. This phase also gives a better picture of how effective the vaccine is when compared with a placebo or other available vaccines if this isn’t the first one for a particular virus. It is only after this trial is successfully completed that it can be brought to market with the FDA’s approval. But then a different type of work begins. Only after the approval can production and distribution begin, which also takes time.

There are times when corners can be cut, through fast tracking, if the FDA believes it is in the public's best interest.

The WHO is encouraged by the pace of research, but they also are realistic – vaccines that are released too early, without proper testing, could fail or, worse, be harmful. This is why there is concern about the 3 vaccines in Russia and China, where there are no phase 3 trial results.

"We know of at least six to nine [vaccine candidates] that have got quite a long way with the research already," WHO spokeswoman Margaret Harris told reporters in Geneva. But she stressed that, "in terms of realistic timelines, we are really not expecting to see widespread vaccination until the middle of next year."

The U.S. Is Preparing

Although it may not be until next year that a reliable vaccine is available, the federal government has urged the states to prepare for a vaccine rollout as early as November. While the WHO doesn’t believe this will be the case, the White House speculates that there will be a vaccine by that point. However, early preparation is not a bad idea even if the hoped for early vaccine doesn't materialize. If the infrastructure for vaccine distribution is in place, then everyone can be ready to go when vaccines are cleared for use. It is also possible that the FDA may offer emergency authorization if a vaccine candidate looks strong and safe, so early prep can help lay the groundwork.

Emergency authorization for a vaccine is controversial. The bar for approval is lower than it is for the standard procedure. When this occurs, it may only found later that the vaccine is not effective or causes serious side effects. Infectious disease specialists and other experts are urging that corners not be cut when it comes to approving vaccines. This may delay a roll-out, but it will likely result in a vaccine that works more effectively and inspires more confidence among the public and the healthcare community.