by Nick Wanner, PA-C
On December 11, the FDA authorized emergency use of the Pfizer/BioNTech mRNA vaccine against SARS-CoV2. December 13, almost 200,000 vials departed the Pfizer plant in Portage, Michigan, with another 390,000 vials to ship soon thereafter. Each vial will contain five doses of the vaccine. In total, just shy of three million doses of the vaccine will be available to administer by the end of the first week of shipments. Operation Warp Speed has entered a new gear, and the nation prepares for months of vaccine education and administration to combat a virus that has infected more than 16 million Americans to date.
The new COVID-19 vaccine is unique as it utilizes mRNA. This type of vaccine research has been conducted since the early 2000s, which has allowed us a foundation to build this vaccine in a quick fashion. DNA is our genetic code, sitting in the center of the cell, enclosed in the nucleus. This DNA is transcribed and translated by a compound called RNA. Messenger RNA (mRNA) takes information from DNA, and encodes it into a single strand. The RNA then passes into the cytoplasm, where special proteins called ribosomes read an mRNA strand and translate it into proteins.
SARS-CoV2 has spike proteins on the surface of the molecule thought to be responsible for the virus entering human cells. This information had been studied previously with SARS and MERS, two known types of coronavirus that differ from COVID-19. The basis of vaccine research for COVID-19 is to create antibodies against spike proteins, theoretically blocking and disabling the virus from entering cells. mRNA can be synthesized based on the unique genetic code of the virus and its spike proteins. This process does not need to happen biologically, therefore explaining some of the rapid processing of the current vaccine. When the created mRNA enters the cells, our bodies will start creating viral proteins. By themselves, they cannot replicate like the full virus, and cannot cause infection. These created proteins will trigger an immune response our bodies need when coming in contact with wild-type COVID-19.
Two hurdles researchers had to overcome with not only mRNA vaccine work over the last decade, but with the current COVID-19 vaccine, was mRNA’s rapid degradation characteristic and the fact mRNA cannot cross the cell membrane on its own. Remarkably, researchers were able to solve both problems. Modified nucleosides (subunits of DNA and RNA) were incorporated to mRNA preventing rapid breakdown. Additionally, lipid nanoparticles (LNPs) create a fatty bubble around the mRNA allowing appropriate merging with the cell membrane to facilitate transfer of the mRNA into the cell. The mRNA stays within the cytoplasm and never enters the nucleus of the cell. As there is no entrance for the mRNA into the nucleus, it will not alter DNA.
As this vaccine has been one of the most talked about issues this year, there have been questions and concerns.
Will there be side effects of the vaccine?
Yes, any vaccine carries the potential of side effects. Common short term side effects can include injection site reaction, muscle aches, fatigue, and fever. The phenomenon of side effects to a vaccine is not something to criticize. Your body’s immune system is being triggered, and this is the result. These side effects are temporary and will go away.
How long will this vaccine be effective?
We know the effectiveness over a few months, but cannot completely guarantee the effectiveness at 6, 12, 18 months, etc as we do not have that data. However, results are looking promising for long-term benefit.
Was a phase 3 trial conducted?
Pfizer/BioNTech data demonstrated the vaccine was tolerated across all populations with over 43,000 participants enrolled. No serious safety concerns were observed, most of which would come within 6 weeks after administration of the vaccine. The only Grade 3 adverse event greater than 2% observed was fatigue at 3.8%. 170 confirmed cases of COVID 19 were evaluated, with 162 cases observed in the placebo group versus 8 cases observed in the vaccine group.
What is the efficacy of the Pfizer/BioNTech vaccine?
Efficacy was consistent across age, gender, race and ethnicity demographics. Observed efficacy in adults over 65 was greater than 94%.
Can I still get infected with COVID-19 if I get the vaccine?
We know this can protect against disease, but we do not know whether or not it prevents against all infection. This means that you could still be infected with COVID-19, shed viral material and pass it on to other people. This means that we will still be using masks, social distancing for the time being.
Why should I get a vaccine that might have side effects if I am healthy and the infection fatality rate (IFR) of COVID-19 is so low?
This is a complicated virus that has been shown to wreak havoc in certain patients, causing long-term health impairments. Unlike many viruses, SARS-CoV2 can cause vasculitis in numerous organs, including the heart, lungs and brain. This pattern has been described by many “COVID-19 long haulers”. The risk is low, but it is present. A stable vaccine can prevent this from occurring.
Will the COVID-19 vaccine change my DNA?
No, it will not. The mRNA enters the cell through the phospholipid bilayer and stops its journey in the cytoplasm, which is outside the nucleus, where the DNA is housed. mRNA cannot cross into the nucleus.
How will the COVID-19 vaccine impact healthcare delivery?
The vaccine will likely have both short and long-term impact on the healthcare industry. In the short term, healthcare providers can expect a significant increase in calls and emails as patients inquire about the availability of the vaccine and their options for getting it. This will likely put a strain on the contact centers of many healthcare providers, so it’s important to take action to prepare for the spike in interaction volume.
In the long-term, we should expect to see some return to normalcy as patients begin to seek the care they have been avoiding due to the ongoing pandemic. As demonstrated by the recent Patient Sentiment survey conducted by Avtex, patients have put off elective and preventive care appointments out of fear of contracting the virus. As that fear is lessened and eventually eliminated by the vaccine, it is likely that patients will begin to make those appointments. This may take some time, and many patients are likely to continue to make use of virtual appointments for the foreseeable future.
What actions should I take?
If you are a patient interested in being vaccinated, consult your healthcare provider to learn more.
If you are a healthcare provider looking for assistance managing the spike in interaction volume or optimizing your operations for the eventual return of patients, Avtex can help. Contact us to discuss your specific concerns today.