COVID Vaccine Q&A

 

COVID Vaccine Q&A

By Kim Marquardt, MSN-RN, Director of Health Services

*The following information was accumulated to the best of my knowledge and understanding with the research I have done. Please consult your medical provider for more information and before making any healthcare decisions.

How did the vaccine development happen so fast? The lengthy process in the development of vaccines mostly has to do with the length of time it takes to conduct the clinical trials - specifically to recruit participants, and then wait for those participants (who were either vaccinated or given a placebo) to naturally be exposed to the disease and collect data on level of immunity in the vaccinated group. Before COVID, every vaccine developed was done so for diseases that were relatively rare plus it was difficult to get participants for the clinical trials in general. With COVID, the disease was very widespread (meaning lots of people were being exposed all the time), and individuals were very eager to participate in the trials. This drastically sped up the process.

Were animal trials skipped altogether? No, animal trials were done a little differently this time though, they were done simultaneously with the smaller Phase I and II portions of the trials, so the individuals in those groups did absolutely take an unknown risk without animal trials having been completed beforehand. HERE are the results of the Moderna animal trials, and HERE are the results of the Pfizer.

What were the results of the Phase III clinical trials for the mRNA vaccines? The mRNA vaccines showed a very strong immune response in protecting against COVID infection as well as protecting against severe symptoms when vaccinated individuals did contract COVID. The real goal with COVID is to avoid hospitalization and death, so we can accept some level of vaccine failure from preventing the disease, as long as it prevents hospitalization and death, which it has been proven to do. Other than mild, somewhat "typical" side effects, the trials amazingly showed zero serious safety signals.

What about the concern of antibody dependent enhancement (ADE)? ADE is indeed a concern and was something that came up in previous mRNA vaccine trials. ADE is when our bodies make non neutralizing antibodies against a disease, antibodies that could potentially make the illness worse if we contract it again (or in the case of a vaccine, when exposed to the wild virus). The clinical trials with the COVID mRNA vaccines showed no signs of ADE and a large number of neutralizing antibodies (the good ones) generated. Now with 1.7 billion doses of mRNA vaccine having been given globally, no additional concerns of ADE have arisen.

Didn't a lot of older people die after getting the vaccine? When you look at data with regards to death in relationship to a vaccine (or any other potentially correlated factor) you have to consider what the normal rate of death would have been in that demographic. In other words, if we hadn't vaccinated these individuals, how many of them would have died from natural causes or preexisting conditions anyway? People over the age of 70/80 die at a higher rate than younger people. You have to consider this info before blaming a vaccine or any other confounding factor. The vaccines have not been shown in follow up to be associated with any unusual death rates in the elderly.

Will I get myocarditis or Guillain-Barre from the vaccine? What we need to understand about syndromes like myocarditis and Guillain-Barre is that they are indeed (rarely) associated with vaccines but are also (more commonly) associated with viral infections. You are just as at risk, if not more so, of developing these associated conditions if infected with COVID as with getting the vaccine. A risk/benefit analysis resulting in an individualized personal decision is the goal. Vaccines indeed have risk, but so do viral infections.

Can't I just take hydroxychloroquine or ivermectin if I get COVID and be fine? In efforts to combat this viral pandemic, scientists have studied numerous pharmaceutical interventions including all the medications you have heard about on the news and social media. The fact of the matter is, randomized controlled trials (the gold standard of scientific research) have not born out a net benefit with many of these drugs, including hydroxychloroquine. Ivermectin is currently under review in a large clinical trial of its own and we will have those results soon. When considering these medications, the reason why it is so important to prove a net benefit is because so few medications that the pharmaceutical industry develops and releases are actually beneficial to any large degree. The human body is so much better at combatting disease than any pill or treatment we have ever innovated. That is why vaccines are such a miracle of modern medicine. They effectively harness the human body's natural ability to fight disease. This is why any vaccine shown to be safe and effective is a much better solution than any pharmaceutical option that comes along with varying degrees of side effects and other potentially harmful variables.

Shouldn’t we wait to have long-term safety data before distributing a vaccine? There is actually no historical precedent to have long-term safety data before the distribution of a vaccine. This is a new and novel expectation regarding the COVID vaccines rooted in the concern that they were developed too quickly and that clinical trials were rushed (refer to #1 and #2 above), or perhaps that the mRNA vaccines are the first of their kind. The perception that we have had long term data before distributing vaccines in the past was related to how long the trials took to complete, not that the researchers were specifically waiting for a particular amount of time to pass to assess side effects. Many vaccines have been around for many decades giving us a false sense that a vaccine has to be a decade or more old to have been proven safe. There is no historical evidence, in more than 200 years since the smallpox vaccine was created in 1798, of a vaccine reaction happening beyond about the 2 month mark after the shot/series. If you think about it further, if you had a health concern 5, 8, or 15 years (for example) after receiving a vaccine, how would it ever be determined or verified with any certainty that it was related to the vaccine many years before?

Isn't it wrong for a government or institution to mandate the vaccine? Shouldn't it be a personal choice? The government and both public and private institutions have been mandating, or rather "heavily incentivizing" vaccines for decades. This is nothing new. Children must be fully vaccinated against childhood illnesses to attend public school. Allied health professionals must be fully vaccinated and prove blood titers (antibodies in the blood against illnesses) as an enrollment criteria to enter college and participate in clinical rotations. Military members are all vaccinated during boot camp and additionally against geographically associated illnesses before traveling to foreign countries. When you think of it in this context, the government or any institution requiring vaccination for enrollment, travel, or certain activities in the face of a worldwide pandemic resulting in the deaths of millions of people, it starts to make more sense. It in fact, falls in line with how our country (and the world) has utilized vaccines since their inception to control and mitigate infectious diseases around the globe.