Experts say New Vaccines can Quickly be made without Cutting Corners; but how do we Tell if a Vaccine is Safe?
Vaccine development is underway and moving at unprecedented speed. Experts revealed that it is possible for a safe and effective vaccine for SARS-CoV-2, the coronavirus that causes COVID-19, to be available sometime in 2021, possibly even by the end of 2020.
However, the quick turnaround times to obtain a vaccine has a lot of people concerned about safety and efficiency, leading to high levels of “vaccine hesitancy,” which the World Health Organization considers a serious threat to global health.
A nationally representative survey by Consumer Reports revealed that almost a third of Americans were not likely to get a coronavirus vaccine when it becomes available for fear that it would be unsafe. Other surveys by different agencies have found similar results. This is understandable as the speed to create a vaccine seems to imply rush development.
This also led to speculation that the rush to distribute vaccines by November 1 by the Centers for Disease Control and Prevention was more political.
People are used to believing that vaccines usually are developed on a scale of years. But experts say that the recent pandemic requires a much faster timeline. Experts pressed on to say that a safe and effective vaccine fast—by the end of 2020 or the first half of 2021—is doable.
Natalie Dean, an assistant professor of biostatistics specializing in infectious disease and vaccine development at the University of Florida said that the fast turnaround “reflects a real achievement in the scientific community to be able to come together and move everything so quickly. The way that’s been achieved has not been by cutting corners.”
Fast Testing and Production without Compromising Safety
Government help in paying for expensive clinical trials for safe and effective vaccines and in covering the cost of jump-starting production has massively helped with the fast turnaround.
Experts revealed that the first few stages of developing a vaccine are relatively quick to accomplish. The process involves initial preclinical lab work and animal studies. This is followed by phase one and two clinical trials, wherein the vaccine is given to a relatively small population—from dozens to a few hundred— which will reveal any immediate red flags about safety and side effects and further show if the vaccine triggers an immune response that might help prevent people from getting ill.
The slowdown begins at stage three where a much larger, typically involving at least 30,000 people, the population is required and cost hundreds of millions of dollars. The expense has pharmaceutical companies apprehensive to move on until there are assurance and evidence that it will work out.
The elimination of financial and time barriers has turned out at least eight potential products closer to or have already begun phase three trials.
The safety issue is addressed in the third phase of the trial. In this phase, half of the trial population is given the real vaccine, and the other half a placebo shot and are allowed to continue their day-to-day lives. Researchers will then track how many of the trial populations develop side effects attributable to the vaccine in the months to follow.
Some minor side effects are considered acceptable, such as low-grade fever and headache. However, since the vaccine is tested on a healthy population base, it is important that they don’t cause serious side effects.
Phase three will have thousands of people being given the vaccine and this population is enough to reveal the most common side effects. If problems occur to even just one study participant, trials will either be paused or stopped.
Adequate Testing to Groups
Vaccines may work differently for different populations. That is why it is important that trials are representative of populations with different ages, ethnicities, and health conditions.
This is particularly relevant considering people of color have been disproportionately more likely to suffer severe complications from the virus.
Moderna reported that about 26 percent enrolled in its trial are from “diverse communities,” while Pfizer revealed that 40 percent of global participants and 24 percent of U.S. participants involved in its trial have “diverse backgrounds.” Moderna’s CEO told CNBC in August that enrollment has been slowed down to ensure that the trial sufficiently represented communities most affected by COVID-19.
Consumers will not be able to know what works best in a given group until there is more data publicly available.
The FDA says that a vaccine should be able to prevent infection or severe disease in at least 50 percent of the population for it to be approved. This is the minimum level of efficacy that could help achieve “herd immunity,” which is when enough people are immune that the virus stops spreading through the population. But the target is at least 70 to 75 percent effective against COVID-19.
To speed up testing, phase three trials prioritize and use populations who most likely will be exposed to the virus, such as essential workers.
The benchmark is about 150 people enrolled in a phase three trial getting the coronavirus. If the vast majority that will get sick is from the placebo group and only a handful of cases from the potential vaccine group, then that would make it clear about a vaccine’s efficiency.
FDA approval comes after a panel of outside experts review data trials’ safety and efficiency and provides their recommendation, but this is nonbinding.
Populations who are at a higher risk of infection or of complications from COVID-19 will be prioritized once a vaccine is approved.
Initial estimates are at more than 100 million people in the U.S. alone and include healthcare workers, the staff of long-term-care facilities, and those with health conditions that make them more susceptible to complications from a coronavirus infection.
This will take months as the roll-out process is complex, particularly involving many of the products furthest along to be stored at subzero temperatures and the possibility of needing two doses, spaced out, per person.
The FDA says the agency “may also decide to authorize the use of a vaccine for certain populations before it’s fully approved for the general public.”
Most potential vaccines furthest along rely on new technologies that have not been used before, therefore it is imperative that development and testing are on-going, even if one vaccine appears to be effective.
Even after approval and use, those who were given the vaccine will also continuously be tracked and monitored to ensure safety and efficacy. Roll-out of the vaccine to millions of people can still reveal rare side effects, thereby requiring monitoring of real-world results.
Dean says that when a vaccine has been found effective, “it’s not like you’re going to flip a switch and everything is going to be better. We need to continue to try to increase mask-wearing, improve contact tracing, prioritize ventilation, and develop rapid tests that quickly identify infectious people. A vaccine “has to be part of an integrated response.”
Editor’s note on the How to Know if A Vaccine is Safe and Effective:
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