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By Mallory Olson
University of Kentucky

Over the past year, a novel, highly contagious virus has spread across the world. Scientists and researchers have worked quickly to respond with vaccine development, two of which have been approved by the U.S. Food and Drug Administration (FDA) for emergency use so far.

As the vaccine rollout continues for frontline health care workers and others in the most vulnerable populations, it is important to separate fact from fiction with regard to the safety and efficacy of the vaccines.
Vince Venditto, PhD, assistant professor in the University of Kentucky College of Pharmacy’s Department of Pharmaceutical Science, has extensive expertise in vaccine design. He was trained in organic synthesis and vaccine development. He is currently working on a clinical trial with community pharmacies to understand the prevalence of SARS-CoV-2 in Kentucky.
He is busting myths about the vaccines to help inform your decision to get vaccinated.

• The vaccine has been rushed, so it cannot be safe. – Fiction. While the timeline from the start of the pandemic to the approval of the vaccine has been faster than any other vaccine, the technology has been in development for many years. When mRNA vaccines were developed (the technology behind Pfizer and Moderna’s vaccines) the technology was touted as a quick and efficient method to produce vaccines at unprecedented speed, and this proved true for SARS-CoV-2. Pfizer and Moderna have been working in this space for many years and it was because of their strong foundation in this technology that they were able to generate a vaccine in less than a year.

• There has not been enough testing. – Fiction. The COVID-19 vaccines, like all drugs that are approved for human use, undergo significant scrutiny from various independent evaluators to ensure efficacy and safety during the clinical trials, and then by the FDA for approval. After FDA approval, safety and efficacy continue to be monitored for adverse events. Some of the COVID-19 vaccines being tested in clinical trials were halted because of a serious illness in a few subjects, however, the illnesses were not associated with the vaccine.
Pausing a clinical trial is a very common event and indicates that the independent safety monitoring boards are ensuring that only safe vaccines are approved for use. Since approval, there have been a few reports of a rare, but serious, allergic response in a small number of patients and the safety monitoring boards continue to evaluate these events to ensure the safety of those who receive the vaccine.

• There is an advantage to having multiple vaccines, not just one that works. – Fact. While one vaccine is a significant achievement, it is critical that multiple vaccines, based on different technologies, are approved for use. There are several reasons for this. First, the number of doses necessary to immunize the whole U.S. and the entire world is not practical using one vaccine, given the different reagents necessary to produce the vaccines. Approval of multiple effective vaccines will reduce the burden on a single manufacturer to ensure that everyone across the world can have access to a vaccine in a timely manner.
Second, not all vaccines work well in all populations. Historically, there are examples of vaccines that are more effective in specific ethnic populations for reasons that are not well understood. Because of this, multiple vaccines will ensure that everyone has access to an effective vaccine.

• We do not know what is in the vaccine. – Fiction. We know exactly what is in the vaccine. This varies from vaccine to vaccine based on the company’s specific design, but the first two approved vaccines from Pfizer and Moderna contain oil droplets with genetic materials to express non-infectious pieces of the virus.

• We do not know anything about the side effects. – Fiction. Each of the clinical trials are being conducted in >30,000 people from around the world and all subjects are monitored for side effects. Half of the subjects in the clinical trial are receiving placebo and half are receiving the vaccine. In general, subjects report soreness and swelling at the injection site, as well as fever, chills, tiredness and headache, which should go away after a few days. This is exactly what you want to happen because it means your immune system is active and doing its job.
The subjects in the clinical trials continue to be followed for any additional side effects and none have been observed. Everyone who receives the vaccine in the trial or after approval will continue to be monitored for side effects to ensure continued safety in different populations and conditions.

• COVID-19 will eventually go away on its own. – Fiction. It is unlikely that SARS-CoV-2 will go away on its own. Just like the common cold – which is also a coronavirus – it continues to make kids sick every year, but as we age and continue to be exposed, we generate an immune response that prevents us from getting sick. The vaccine helps to accelerate this process to protect us. However, we are only a year into this pandemic and scientists will continue to monitor how many people are infected each year.

• Receiving an mRNA vaccine will not affect your DNA/genetics. – Fact. The mRNA vaccine is fantastic technology because it has no way to get into your DNA but can still induce a strong immune response. It does so by generating pieces of the virus for our immune systems to respond to. Once the mRNA is used by our cells, it is destroyed and has no long-term effects on our cells.

• The vaccines are just placebos. – Fiction. Clinical trials require vaccine groups and placebo groups to show that the vaccine is effective. Once a proper comparison between these groups can be made, all vaccines administered will contain the active ingredients to induce an effective immune response to the virus.

• There is a chip or marker in the vaccine used to track you. – Fiction. This is simply not true.

Venditto adds, “I would personally get any of the approved vaccines, absolutely. I will also wait for my turn to ensure that those at highest risk can get vaccinated first since I am able to work remotely.”