Along with the recent rollout of two new coronavirus vaccines have come a bevy of questions and concerns regarding the efficacy, safety and science behind these vaccines. In order to answer some of your questions, we turned to Dr. Jim Heise, Chief Medical Officer at Door County Medical Center, as well as Dr. Ashok Rai, President and CEO of Prevea Health and Dr. Michael Landrum, Infectious Disease Specialist at Bellin Health.
Dr. Heise’s comments are provided courtesy of Door County Medical Center. Dr. Rai’s and Dr. Landrum’s remarks are provided courtesy of Brown County Public Health. Note: Comments have been edited for length and clarity.
What is an mRNA vaccine?
There are currently two SARS-CoV-2 vaccines that have been approved for emergency use by the FDA: the Pfizer-BioNTech vaccine and the Moderna vaccine. Both of these vaccines are mRNA—or messenger RNA—vaccines. Dr. Heise explains: “The messenger RNA vaccine is a new technology. Most of us have heard of DNA, which is the master molecule in all of the nuclei of our cells that actually codes for everything that creates life. DNA is a coiled ladder that has two chains, which are connected together. When you take it apart, you end up with a single chain of RNA. Messenger RNA is a strand of RNA in our cells that can encode—or create—a brand new protein.
“What the vaccine does is put some messenger RNA into the cytoplasm—the liquid that surrounds the nucleus of the cell—via a specifically designed fat globule, and encodes for a protein that looks like that little spike on the outside of the coronavirus molecule.”
Once the “protein factory” in our cells begins to produce that protein, our body will recognize it as foreign. “Essentially,” Dr. Heise points out, “the body is fooled into thinking that there is SARS-CoV-2 coronavirus in the body and it generates antibodies as part of its immune response.” And, Dr. Rai adds that our bodies will “remember that immune response. So, when you are exposed to the SARS-CoV-2 virus, it cannot infect you because your body now recognizes the spike protein as foreign and destroys the virus.”
Importantly, Dr. Heise notes, “These vaccines do not change our genetic code at all. Messenger RNA hardly lasts—it gets into the cell, codes for the new protein, and dissolves away. There is no way that messenger RNA can get into the nucleus of the cell and affect our DNA. So, don’t let anybody tell you that it can cause genetic problems because it can’t.”
How effective are these vaccines?
Both the Pfizer-BioNTech vaccine and the Moderna vaccine have been shown to be around 95% effective at preventing COVID-19. “That’s an astonishing number when you consider that the flu vaccination typically is about 60% effective,” Dr. Heise says. Dr. Landrum echoes that sentiment; “This is a home run in the 9th inning of a very long pandemic. This is really what can end the pandemic and bring us all back to the more normal type of lifestyle that we’re used to.”
What that efficacy rate means is, for every 100 people who are exposed to the SARS-CoV-2 coronavirus, only 5 will go on to develop symptoms of COVID-19. However, Dr. Landrum notes that even if you’re in the 5% who received either vaccine and still developed COVID-19, the symptoms “would be less severe, and you would be much less likely to need hospitalization than someone who had developed COVID-19 and not gotten the vaccine.”
How are these vaccines administered?
Both vaccines require two doses—an initial injection and a follow-up booster. The Pfizer-BioNTech vaccine booster is given 21 days after the first shot, the Moderna booster after 28 days.
Regarding concerns that people may miss the getting the second dose, Dr. Rai comments, “What Pfizer has presented so far is a 4-day window around the second dose, and we’ll see what Moderna presents this week—they may have a different window. But the CDC was pretty clear that we want to make sure the second dose happens, even if it’s outside of the 4-day window.”
In order to make sure people receive the second dose, hospitals have put in place fail-safe systems. First, everyone that is vaccinated will receive a card stating which vaccine (Pfizer-BioNTech or Moderna) he or she received and the date their second dose is due. Additionally, Dr. Rai notes, “All the hospitals that are participating as vaccinators have electronic medical records and systems” to help remind you when it’s time for the second dose. “On top of that,” he adds, “once you’re immunized, the Wisconsin Immunization Registry will be able to contact you in order to make sure you receive the second dose.”
These vaccines were developed so quickly—are they safe?
“It’s true that these vaccines were brought out in record time, especially when you consider the fact that other vaccines have taken years or decades to come to market,” Dr. Heise says. “The reason that it happened with this kind of speed,” he adds, “is because all resources were brought to bear in the context of this pandemic.”
Dr. Landrum points to several factors that contributed to the quick development of the Moderna and Pfizer-BioNTech vaccines: “We knew from previous research with other coronaviruses that the spike protein should be the target of this vaccine—we didn’t have to spend years trying to sort that out when SARS-CoV-2 first appeared. Then, there was a huge infusion of cash from the government. This meant that the timeline for many of the processes in vaccine development, which normally happen ‘step-by-step’ and stretch out over years, were collapsed because those steps were performed at the same time. For example, vaccine developers were able to assume the vaccines would work and started manufacturing vaccines almost a year ago when the very first studies were started. They were able to do this because the fear of great financial loss from starting manufacturing early—before the vaccines were even proven to be effective—was taken away by the huge sum of money that was provided by the government. Typically, these companies wait until several years of research have passed before they take that financial risk.”
Importantly, Dr. Landrum notes, “The safety monitoring for these vaccines has been the same as any other vaccine and has been studied quite well. With all of the vaccines under development right now, they’re not cutting corners in terms of the evaluation of whether they are safe or not. For example, the first approval from the FDA for the Pfizer-BioNTech vaccine came after a collection of, on average, approximately two months of follow up on all study participants (nearly 44,000 people). So, that’s enough time for the vast majority—over 98–99%—of vaccine side effects to be exhibited.
What are the possible side effects of these vaccines, and can they give me COVID-19?
Some vaccines do rely on live, but weakened, viruses. These are known as “live attenuated” vaccines and examples include the MMR vaccine and the influenza vaccine. “However,” Dr. Rai comments, “it’s really important to know that there is no live virus associated with this vaccine.” Dr. Heise notes, “You cannot get COVID from these vaccines. It just doesn’t work that way.” He adds, “The messenger RNA that gets into the cell and creates the spike protein to make the body think it has been infected by the coronavirus can’t create COVID-19—it’s just not possible.”
However, a small number of people will experience side effects with both the Pfizer-BioNTech and Moderna vaccines, which can include:
- Soreness and pain at the injection site
- Muscle aches
- Low-grade fever
When you get sick, much of the discomfort that you feel (see the list above) comes not from the infection, but from your body’s immune response. The same is true of most vaccines, and mRNA vaccines are no different. Indeed, Dr. Heise remarks that side effects are “caused by your body’s cytokines—the inflammatory mediators that are released by your body in response to infection,” and are evidence that your immune system is responding properly to the vaccine. “The good news,” he adds, “is that the side effects are short lived—usually about 12 hours—and then you’re doing okay.”
How soon after I receive the vaccine will I begin to develop immunity from the SARS-CoV-2 coronavirus—in other words, when will I be safe from getting or spreading the coronavirus?
According to Dr. Heise, “The first doses will provide some degree of immunity in 10 days. The second dose completes and backs up that immunity.” Dr. Rai adds, “About a couple of weeks after the second dose, you should have enough protection that if the SARS-CoV-2 coronavirus tried to enter into your body, your body would detect it and prevent COVID-19.”
Nevertheless, Dr. Rai says that it is important to understand that “the primary endpoint of the studies, which were conducted on these vaccines, looked only at effectiveness in preventing you from developing COVID-19.” Remember, COVID-19 is the disease caused by SARS-CoV-2. So, in other words, the studies did not look specifically at whether infection was completely prevented, but rather if illness was prevented. This means that it may still be possible to spread the virus even after getting the vaccine.
Will I need to continue wearing a mask after I get the vaccine?
“The simple answer to this question is, ‘Yes, masks are going to be needed for the foreseeable future,’” says Dr. Heise. There are a couple of reasons for this. The first, as mentioned above, is that we still don’t know if the people will be able to transmit the virus to others even after being vaccinated. Second, “It’s going to take awhile to get all of us vaccinated,” Dr. Heise says, adding, “and herd immunity, which happens with vaccination over the course of time, will take a while to take effect. So, until such time that this virus gets down to such a low level that we’re not really seeing it anymore, masks, social distancing—those hygienic measures—will have to continue.”
Who is getting the vaccine first, and when can my friends and family get it?
So far, Wisconsin has received a little over 49,000 doses of the Pfizer-BioNTech vaccine, which have already been distributed throughout the state. The vaccine is being rolled out in phases. Currently, we are in Phase 1a, which allocates vaccines to frontline healthcare workers and residents and staff at long term care facilities—those are the people that are felt to be at highest risk. “Once those individuals get the vaccine,” says Dr. Landrum, “then it will move on to other groups such as essential workers (Phase 1b), which can be defined any number of different ways by the state, and then on to people that have high risk health conditions for COVID-19 such as those older than 65 and those with other chronic health conditions (Phase 1c). From there, it will move on to the general population (Phase 2).” Dr. Heise adds, “I think it’s going to be into the spring before we’ll see general immunizations of the entire population, maybe into the summer. We’ll just have to wait and see—see what the supply is—and be ready when it becomes time to get vaccinated.”
What would you say to people that are hesitant to get the vaccine?
“If somebody has concerns,” Dr. Rai remarks, “It’s really important to talk to your healthcare provider about it. For us to be done with COVID-19,” he adds, “we need to get a lot of people vaccinated—we’re talking about 60, 70, 80% of our population—and there isn’t an individual I know that doesn’t want to move on. We know the vaccines are safe, we know they’re very effective, so if you’re concerned, let’s sit down and talk about it.”
“There are a number of ways that the pandemic has impacted our community,” Dr. Landrum points out. “People have lost their lives, people have lost jobs, and other people have burned through all of their savings and are now struggling to find ways to pay the rent. And, I’ve never seen the hospital with floor after floor consumed with deaths day after day—all from the same, singular disease. There is just a tremendous amount of loss and suffering from COVID-19. So, I would say to people, ‘All of this loss and suffering stops if enough of us get vaccinated.’ This is the way we end the pandemic, and so please consider getting vaccinated for yourself, for your community, for your friends and family.”
Dr. Heise adds, “As we go forward with the vaccination process, it’s going to be important to listen to reliable sources. Follow the science. Talk to people—ask questions of physicians and others that know something about vaccinations. You’re probably going to hear a lot of scary things in the press, on social media, things like that. Resist the temptation to believe those things right off the top. Don’t be afraid of this—all of us want to do the right thing.”