(Newswire.net — May 19, 2020) —
As people across the world grow impatient with social distancing, worry about the future of the economy, and long for life to return to normal, we are all anxiously hoping that a coronavirus disease 2019 (COVID-19) vaccine will soon be approved by the Food and Drug Administration (F.D.A.).
While efforts to create a vaccine are moving ahead at a record pace, we may still have a long wait ahead of us. Most timelines predict that we’ll have to wait at least 12 to 18 months before a vaccine will be available. This leaves us with a lot of questions, and many of us are wondering why creating a vaccine takes so long.
To get a meaningful answer to this question, we have turned to talk show host and author Dr. Mehmet Oz of The Dr. Oz Show to tell us more. We talked with Dr. Oz about why the wait may be long and whether there is hope of a vaccine coming through sooner than expected. Dr. Oz also told us about several new treatments on the horizon and steps that could be taken to get the vaccine to people faster.
Developing a Safe Vaccine Takes Time
While many of us feel like there should be a COVID-19 vaccine already, Dr. Oz says that in truth most vaccines take more than 10 years to be developed, tested, and distributed to the general public. In fact, no vaccine has ever been developed and approved in less than four years. (The fastest was the mumps vaccine.) Since the need for a COVID-19 vaccine is incredibly urgent, however, some experts are saying that it will likely take far less time.
Dr. Anthony Fauci, current Director of the National Institute of Allergy and Infectious Diseases, initially said we would likely have to wait at least a year to 18 months for a vaccine to arrive, but he recently mentioned that a vaccine could be ready to distribute by January of 2021.
When we asked Dr. Oz what the holdup is, he clarified that the process of creating the vaccine isn’t the time-intensive part of the process. In fact, there are eight vaccine candidates that have already entered human clinical trials, according to The World Health Organization. What takes time, Oz says, is a rigorous testing and approval process that will ensure that the vaccine is both safe and effective.
While the uncertain timelines we’re hearing about can be frustrating, Dr. Oz says it is important to remember that the slow pace is actually for our own good. After all, the best way to create a vaccine that will be safe is to make sure both the development and testing processes are done correctly. And this means moving slowly, testing diligently, and ensuring that clinical trials are done right. Dr. Oz also mentions that in addition to being safe, determining a vaccine’s effectiveness requires significant testing.
To give us a clearer picture of the timeline, Dr. Oz laid out the basic stages in the process of vaccine approval. In the first phase of clinical trials, which several vaccines have already entered, the vaccine is tested on small groups of humans. During all phases of clinical trials, both safety and efficacy are evaluated. If a vaccine appears to be safe and effective, it is then tested on larger groups of human subjects. If at any point the vaccine is determined to be unsafe or ineffective, the trial stops and the vaccine is abandoned.
There are also some specifics that can prolong the testing process. For one, test subjects must be monitored for side effects during a clinical trial. According to Dr. Oz, this can extend the time the process takes because side effects don’t always show up right away: they can take time to arise, so subjects must be followed for a significant amount of time.
In addition, one of the most important things researchers must determine, according to Dr. Oz, is whether the vaccine results in immunity from COVID-19, and if so for how long. We need this information to know how the vaccine can be most effectively delivered to a large number of people, what dosage is appropriate, and how often people will need to be vaccinated.
In addition, because some coronaviruses have demonstrated what is known as disease enhancement when exposed to a vaccine, we have to be extra careful moving forward. Disease enhancement occurs when rather than making a host immune to the virus, the vaccine instead makes the disease worse. Moving slowly and testing carefully will ensure that a vaccine isn’t released too soon.
The worst-case scenario, says Dr. Oz, is that none of the vaccines we test end up working. In general, vaccine success rates are notoriously low, and there is still a lot we don’t know about COVID-19. HIV, herpes, and hepatitis C are just a few viruses that do not have a vaccine because attempts at creating one have not been successful. If this happens, Oz says we will just have to keep trying.
Once the research phase is over, the pace tends to pick up. At this point, clinical trial results are reviewed by the F.D.A. with a fine-toothed comb to ensure that the vaccine is truly safe and effective before manufacturing and distribution begin. The review committee is made of both scientists and attorneys, to ensure that liability is prevented for anyone who produces the vaccine. This usually takes around a year, although the urgency of COVID-19 may speed this up. Dr. Oz also notes that in the case of the COVID-19 vaccine, companies will likely get a head start on manufacturing. We discuss this further with him below.
Current COVID-19 Vaccine Test Updates
Across the world, extensive resources are being dedicated to COVID-19 vaccine research. At present, eight vaccines are being tested in humans throughout the world and 100 more are being evaluated in laboratories to see if they are ready for human testing. Dr. Oz says it is very promising that there are several different vaccines being tested because the more potential options we test at once, the more likely we are to find one that works.
While this is good news, and while multiple vaccine possibilities will certainly save researchers time, Dr. Oz reminds us that moving too fast through the process can have serious repercussions. For example, if a vaccine is pushed too quickly through the research phase, mistakes and flawed testing are more likely to occur, both of which could prevent F.D.A. approval.
If, however, a vaccine proves effective and safe early on in the clinical trial process, it could be approved by regulators for emergency use. If this were to happen, Dr. Oz says, essential workers, doctors, and nurses would be vaccinated immediately. Others working on the frontlines could also be first in line to get the vaccine. Everyone else would still have to wait, but it could certainly improve treatment outcomes.
No matter when an effective vaccine comes into existence, however, Oz says, if it is produced outside the U.S., it will take longer for people here to get it. Approvals of new drugs and vaccines are often seen outside the U.S. first, because regulatory approval processes are less stringent. According to Dr. Oz, other countries could see faster approval, and the F.D.A. will have to determine whether it is safe to commercialize and distribute these vaccines.
Are There Ways to Pick up the Pace?
Because COVID-19 has affected the world so dramatically, Dr. Oz says that many people are pushing for a process that is more efficient than the typical months to years.
Although safety is a concern, there are several parts of the process that could be expedited, including clinical trials. Currently, clinical trials require one phase to end before the next begins, but we could potentially allow phases to overlap. We could also start building production facilities before clinical trials are complete, and in some cases, producing the vaccines.
One unprecedented development currently happening is that two U.S. pharmaceutical companies, Johnson & Johnson and Moderna, have begun production of some possible vaccines despite not being certain that they will be approved. If either of these vaccine works and is approved, it will be ready for distribution much sooner than if companies had waited to produce billions of doses. If the vaccine is ineffective or not approved, it will be destroyed. In addition, the Bill and Melinda Gates Foundation says it will start building factories for seven vaccines, even though the U.S. will likely only have the capacity to use two, to keep the pace moving ahead.
Hope Beyond a Vaccine
While the vaccine approval process may take more time than we would like it to, Dr. Oz also mentions another promising treatment possibility: therapeutic antiviral drugs. These are the types of drugs we have successfully used to reduce deaths for viruses like H.I.V.
The World Health Organization is currently searching for antiviral drugs to treat COVID-19 patients and has been doing so since March. In fact, some antiviral drugs are being used on a volunteer basis as they have the potential to reduce deaths, hospitalizations, and help people recover more quickly at home. In exchange for the experimental drug treatments, patients must agree to be studied so data can be gathered about their effectiveness.
While we may have a wait in store for us before an effective COVID-19 vaccine arrives, Dr. Oz is hopeful that the many and various efforts we are currently making will pay off. In the meantime, if we can pair antiviral drugs with increased testing and contact tracing, where people who have had contact with an infected person are notified and quarantined, he says, the future could look significantly brighter.