Editor’s note: Ultimately, statements below are not intended to be a substitute for professional medical advice, diagnosis, or treatment, and do not constitute medical or other professional advice. Organizations will need to follow state and federal authorities’ guidance.
With the long-awaited COVID-19 vaccine finally being administered in the U.S., there has been a lot of public confusion about its efficacy, safety, and development.
While the web can be a wonderful tool to search facts, it can also be full of dangerous misinformation. I have heard more people than I can count say things like, “Well, I am not getting the vaccine because I don’t get sick,” or “I don’t trust a vaccine that was produced that quickly,” or my very favorite, “I am not letting Bill Gates inject me with a tracker.”
People certainly have the right to choose whether they want to take the COVID-19 vaccine (CoV-2) or not. However, it is important that they are armed with the knowledge to make an educated decision on the matter.
What Does mRNA Mean?
Let’s start with discussing the “genetically encoded” mRNA vaccine that has been developed for COVID-19. What does this actually mean?
While the concept of messenger RNA vaccines has been in the works for decades, in recent years scientists have overcome some major hurdles to allow the advancements needed. A messenger RNA vaccine works by providing a genetic code for our cells to produce a viral protein which, in turn, prompts the body to initiate an immune attack.
The genetic code does not cause the disease, nor does it alter the cell itself (which is one of the false claims). But rather it enables the person to develop an immunity against the virus through the creation of the viral protein.
One of the previous challenges with mRNA vaccine development was that only low levels of proteins could be produced. Those proteins degraded quickly making it ineffective. RNA could also create a hyper-immune response to the protein that it created.
In the early 2000s, scientists at the University of Pennsylvania, Katalin Karikó and Drew Weismann, discovered that by altering the nucleosides – the building blocks of RNA – they could drastically increase the protein production by the RNA, thus making it affective and avoiding an undesirable immune response.
This was a huge breakthrough for mRNA vaccine production. There was still the issue of the rapid degradation after injection, but Karikó and Weissman discovered that by encasing mRNA in small bubbles of fat known as lipid nanoparticles it would allow delivery to the cells without damaging the molecule.
While these mRNA vaccines have been being tested for a range of infectious diseases from rabies to influenza, the CoV-2 vaccine has been the most advanced in reported efficacy. This is the start of a new era in mRNA-type vaccines and is exciting in itself just because of what this means for the future of vaccine development.
Does Quick Turnaround Affect Vaccine Development?
The fact that the vaccine was developed so quickly seems to raise some questions for the public about its overall safety. It is important to understand that although the COVID-19 vaccine has been developed at record speed, no steps have been skipped in the development.
Typically, these steps are drawn out for years due in part to funding, availability of researchers, and volunteers for trials. This vaccine received everyone’s attention because of the urgency reflected in the death toll.
You may recall that during the trials of the AstraZeneca vaccine, one participant out of thousands died. Even though it was not initially clear whether the vaccine itself contributed to the death of the participant, the trials were put on hold until it was determined that the death was in fact not related to the vaccine.
This is an example of responsible experimentation because Astra-Zeneca properly paused their trials, thus losing an astronomical amount of money by not being one of the first to the finish line.
A typical timeline for vaccine development can be up to 10 years with the pre-clinical analysis, with Phase I (small number of people receiving the vaccine) taking around two years.
Phase II begins with the vaccine being given to larger groups of people, typically hundreds. This phase usually takes around a year.
Phase III typically takes around two years and involves administration of the vaccine to thousands of participants. The regulatory review, approval, and production can take another five years combined. Again, none of these steps have been skipped in the development of COVID-19 vaccines, but many of the common delays have been avoided because of the diligence of scientists, physicians, and participants.
How Did the FDA Approve the Vaccine So Quickly?
Normally, as mentioned above, the timeline for vaccine approval is much longer. However, the FDA has very specific standards in which it evaluates the safety, efficacy, and steps of development. They have not deviated from these standards in approving the CoV-2 vaccine, but rather sped up the review and approval process so the vaccine could be available quicker.
“The Development and Licensure of Vaccines to Prevent Covid-19 – Guidance for Industry” defines the process in which they approve the CoV-2. In addition, the CDC has installed several real-time tracking measures to ensure the continued safety surveillance of the vaccine.
The CDC V-safe is a smartphone-based app for people who receive the vaccine to report any side effects or adverse events. It also sets a reminder for the recipient when they need their second dose. There are also interstate data bases for vaccine surveillance that provide ongoing information to the public as the vaccine becomes widely available.
It is easy to fall victim to all of the continued misinformation being launched on the internet and social media. The death toll from COVID-19 continues to climb, healthcare workers are tired, loved ones are dying, and disbelief in science is rampant.
We can eradicate this virus if we have faith in the scientists and medical experts who have worked tirelessly to provide us with this vaccine. In the meantime, we have to keep pushing forward with social distancing, masks in public places, and proper hand sanitization so we can reduce the spread.