According to the Food and Drug Administration (FDA) website: “On August 23, 2021, the FDA approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”
Scott Stienecker, MD, PPG - Infectious Disease explains what this new approval means for those still considering vaccination for members of their household.
Emergency use authorization
While the Pfizer COVID-19 vaccine was previously approved for emergency use authorization (EUA), which is less than full authorization, there was by no means an unsubstantial amount of data to support it.
When you look at a rare disease, such as rabies, you must wait for an exposure to collect data. You would have “x” number of people exposed, then administer the vaccine and gather data to gauge vaccine successes, failures, etc. It can take some time to gain enough cases to obtain official approval in instances like this. But with COVID, we had millions of people infected, so it didn’t take long to come up with the 44 thousand subjects included on the final application. We were able to move fairly quickly, and there was already a great deal of research behind it.
The fear of long-term effects
A common misconception is that people think they will get the vaccine and then 5, 10, 20 years down the line a new complication will arise. That’s simply not going to happen. An mRNA vaccine is like a set of instructions for your body. You get injected, it gets broken down within a couple of days – even hours – and there is nothing left. There is no residual material to cause issues down the road.
Whether you are dealing with a natural infection or the mRNA vaccine, you will know the side effects you will experience, if any, within 4-8 weeks.
Creating the mRNA vaccine
While the mRNA vaccine developed to fight COVID-19 was a different formulation, mRNA vaccines have been around for some time. In fact, we’ve been using mRNA vaccines to fight Ebola for the last 3-4 years.
When you look at the virus, the cells are covered in red “spikes.” The vaccine is created based on these spikes, also known as the spike protein, which, it’s important to note, is not a live virus.
Scientists isolated antibodies from those who had been infected, deconstructed those antibodies (proteins) and figured out the antibody sequence needed to create an effective vaccine. The antibody in the vaccine is the same spike protein that’s on the outside of the virus cells. The vaccine gives your body the code necessary to recognize and prevent these spikes from attaching.
Official FDA approval
The FDA has officially approved the Pfizer vaccine for individuals 16 and older, but nothing about the vaccine has changed.
The new approval does, however, give us a great opportunity to talk about the importance of the vaccine. My thoughts on it now are no different than they were 9 months ago. To be quite frank, this is a brain-rotting, heart-stopping, destructive virus. COVID not only kills people, but it alters their lives forever.
We know that 10-20% of those infected who are currently part of the workforce, will not be coming back. This has huge implications for, not only that person’s livelihood and their employer, but also industries as a whole, many of which were already hurting for employees.
You have a 100% chance of either becoming infected or vaccinated. Herd immunity is impossible at this point. With infection, you have a 2% chance of dying and a 10-20% percent chance you’ll never work again.
The recent variant of the virus is one thousand times more transmissible than previous strains. The vast majority of patients experiencing severe symptoms and requiring admission into the ICU are unvaccinated individuals. Because the viral load is so high, breakthrough infections are possible, but those who have received the vaccine, will see their trained T cells and B cells – the cells that make antibodies to help kill the virus – respond within four days.
The case for vaccinating young adults
Although studies are still in process for children ages 6-12, we have data demonstrating that the vaccine is safe and effective for those 12 and up. There is nothing in the vaccine that will alter DNA or contribute to long-term changes. We’re seeing kids who get COVID and end up with brain fog, chronic fatigue and other symptoms that impair their ability to learn or participate in athletics. When you compare the risks of getting the virus to the mild sore arm and potential side effects of the vaccine, it’s a smart option for protecting this population.
You can learn more about scheduling your COVID vaccine by visiting the Allen County Department of Health website, call 211 or visit ourshotin.gov.
