Katie Taylor, BCBST News Center, April 14, 2021
As of April 5, more than 165 million Americans have received a COVID-19 vaccine. With eligibility expanding in Tennessee to include anyone over the age of 16, we understand some people may still have questions.
We asked these four BlueCross medical experts to share what they’ve learned so far about the safety and effectiveness of COVID-19 vaccines, and what to expect when getting one:
- Dr. Andrea Willis, senior vice president and chief medical officer
- Dr. J.B. Sobel, vice president and chief medical officer of senior products
- Dr. Jeanne James, vice president & chief medical officer of BlueCare Tennessee
- Dr. Stephen Peake, medical director of senior products
Vaccine development and testing
Can you tell us more about the different vaccines that are available? How were they developed and tested?
Dr. Sobel: There are three vaccines currently approved by the Food and Drug Administration (FDA) under Emergency Use Authorization (EUA). Pfizer and Moderna are messenger RNA (mRNA) vaccines. This type of vaccine teaches our body how to make a protein which then triggers an immune response. That immune response produces antibodies, which is what protects you from the virus if it were to enter your body. The third is the Johnson&Johnson viral vector vaccine, and it works by using a modified virus (that poses no threat of contracting COVID-19) to instruct our cells to make antibodies. This process produces the same antibodies and a similar immune response as the mRNA vaccine.
It’s important to note that all three of these vaccines have gone through the normal testing and approval process with the FDA that all other vaccines have gone through.
In the clinical trials that have included tens of thousands of participants, they have been found to be safe and effective.
The level of immune response is greater than even the flu vaccine in recent years.
Dr. Willis: U.S. health officials recently called for a pause in distribution of the Johnson&Johnson vaccine due to extremely rare cases of blood clots. These clots occurred in just 6 reported cases out of the nearly 7 million Americans who received this vaccine, and illustrates how closely medical experts are following adverse reactions to all of the COVID-19 vaccines. This side effect is sometimes seen with other medications, as well. We’ll continue to monitor these developments and share information with our members.
What is an FDA Emergency Use Authorization (EUA) and how is it different than FDA approval?
Dr. Sobel: All three vaccines are currently approved under an EUA and have been through phase 1, 2 and 3 clinical trials. The data must show that they are both safe and effective before they can be granted approval for emergency use. The difference between an EUA and FDA approval is the ongoing and routine monitoring for safety and efficacy that is required as part of a full approval. Now that the vaccines are being widely used, there’s more data and the manufacturers can complete the Biologics License Applications (BLA) process. The BLA is the application manufacturers submit to obtain full FDA approval. It looks like at least one of the currently used COVID-19 vaccines in the United States is on track to request full approval this spring or summer.
Dr: Willis: We’re in the midst of a pandemic, which is an emergency situation. We wouldn’t want to withhold something from the public that can be beneficial, so in these circumstances, an EUA can be granted. Manufacturers will continue to gather data and seek full approval. As with all aspects of medicine and therapeutics, medical experts will keep studying and learning about these vaccines. And full approval will incorporate lessons learned and best practices.
It’s important to remember that even with emergency use authorizations, all recommended safety protocols have been followed.
I’ve heard the mRNA vaccines are new. Can you tell us more about that technology?
Dr. Sobel: Researchers chose to use mRNA technology for the COVID-19 vaccine for two reasons: one, it has the ability to be developed more quickly than other vaccine types. And two, it builds very strong immunity. These are the two things that were needed for the best chance of ending this pandemic as quickly as possible. The technology has existed for decades, and this health crisis proved to be the best fit for it.
Dr. Willis: The pandemic brought this technology to the forefront. Manufacturers put a specific and focused effort on it due to the national health crisis. As Dr. Sobel mentioned, there were tens of thousands of participants in the clinical trials, and that’s actually not common. There’s usually far less participation. The pandemic brought up the level of responsiveness, which I’m grateful for. A common misconception is that this technology affects your DNA. This is simply not true.
How long will the antibodies last from the COVID-19 vaccine, and how frequently will we need to get it?
Dr. Peake: Research on this topic is still ongoing, but conservatively, health experts are saying six months. This means that we will have to get a booster shot; it’s just a question of when.
Dr. Willis: Yes. The FDA has already cleared a process to approve boosters at a faster pace. That’s good news, so we can hopefully stay ahead of the emerging COVID-19 variants.
Speaking of variants, what is a variant?
Dr. Sobel: Variants are different types of the same virus. Over time, the protein coat around a virus can change and this can create differences among the characteristics of the virus. These changes can include how likely it is to cause active infection, what symptoms are visible and even how deadly it can be.
Dr. Willis: This is why you often hear that we’re in a race between variants and vaccines. The more that a virus is able to circulate, the greater the chances are that it’s going to mutate. This is another reason it’s so important to go ahead and get vaccinated.
Can you still be an asymptomatic carrier of the virus after getting the vaccine?
Dr. James: Research is showing that all three of the vaccines are very effective in preventing serious infection, hospitalization and death. What we’re still learning is if you can still experience an asymptomatic infection that you can spread to someone else after getting the vaccine. Early data shows that vaccines may help keep people from spreading the virus, but we’re still learning as more people get vaccinated. That’s part of the reason why experts recommend still wearing your mask, washing your hands and social distancing until more people are vaccinated.
When will a vaccine for children younger than 16 be available?
Dr. James: The exciting news is that I think it’ll be fairly soon. There’s at least one vaccine that’s applying now for EUA in the 12- to 15-year-old range. Tests are ongoing for children under 12, and they’ll likely continue all the way down to six months old. They are hopeful for authorization by this fall.
Would you recommend one vaccine over another?
Dr. Willis: The best vaccine is the one that you can get as soon as possible. Any vaccine you choose is going to give you protection that you don’t have today.
What to know and expect when getting a vaccine
Have you received your vaccine? Can you tell us about your experience?
Dr. Peake: I had both doses of the Pfizer vaccine in February. I had a sore arm with each for about 24 hours. I’ve heard reports of a fever and some swelling from others, but these are all minor and subside on their own. I got the vaccine so it’ll be safe to be around my family again.
Dr. Sobel: I’ve also received the Pfizer vaccine. I had some arm soreness the day after both injections, but no other symptoms. I got vaccinated because I wanted to protect my family and those around me. I want to get back to work and get out and see people again.
But more than anything else, I want to reach herd immunity, which is when enough people have protection that this virus stops spreading, even if a relatively small portion of the population is not yet immunized.
Dr. James: I have similar reasons as Dr. Peake and Dr. Sobel, but I also want to be a good example. I know there are people that trust me and want to know if I’ve gotten vaccinated. I want to share my experience to hopefully encourage others who may be undecided.
Dr. Willis: I want to be a good example as well. I know there is hesitancy, especially in minority communities, but minority communities have been disproportionately impacted by COVID-19. We have something that can help us out of this pandemic, and I want to be a part of that.
Can you get the vaccine if you take a daily prescription medication?
Dr. James: Yes. We haven’t seen any evidence that the vaccines interfere with medication or vice versa. If anything, it’s even more important that you get the vaccine since that medication may be for a condition that puts you at a high risk for severe complications from COVID-19.
Can you take medicine to treat side effects that you may experience from the vaccine?
Dr. Sobel: Since the vaccine is stimulating an immune response, there can be side effects like local soreness and pain, body aches and fever. It’s common to want to take Tylenol, Motrin, Advil or Aleve before your vaccine to reduce this possibility, but according to the Centers for Disease Control and Prevention (CDC), you should not premedicate unless you’re specifically directed to by a physician, as this can reduce your body’s ability to develop a strong immune response. However, you can treat any actual symptoms after you get vaccinated.
Should I get the vaccine if I’ve already had COVID-19?
Dr. Peake: Yes. Once you’ve gone through the quarantine period and you’re no longer experiencing symptoms, the CDC recommends getting the vaccine.
If you’re feeling ill with a relatively minor condition like a sinus infection, should you wait to get the vaccine?
Dr. Sobel: Yes. The questionnaire you complete when making your appointment for the vaccine will actually ask you how you are feeling. The CDC guidance is to wait. It’s best to not have any fever or active infection within the last 14 days before you receive your COVID-19 immunizations.
Does the vaccine have any impact on fertility?
Dr. Peake: No. Pregnancy is actually considered a high-risk condition for COVID-19 and that makes it even more important for pregnant women to get the vaccine. There is no data to show that there is any impact on either male or female fertility.
Dr. Willis: The American College of Obstetricians and Gynecologists have endorsed getting the vaccine, as well as the Society for Maternal-Fetal Medicine and the American Society for Reproductive Medicine.
Dr. James: It’s also important to note that studies have shown that newborns whose moms have had COVID-19 or who have received the vaccine, have been born with antibodies. The vaccine can help protect both mom and the baby and that’s just another reason why it’s important to get vaccinated.
Should you wait to receive any other immunizations after receiving your COVID-19 vaccine?
Dr. Sobel: The current recommendation is to not receive any other vaccine within 14 days of the COVID-19 vaccine. Most immunizations have a window to receive both the first and second dose, so it shouldn’t be an issue to delay. I would prioritize the COVID-19 vaccine, so you can have the most protection at this critical time, before you receive any other recommended vaccinations. It’s best to have discussions around immunizations with your health care provider if you have questions on timing or priority of immunizations.
What else should Tennesseans know about COVID-19 vaccines?
Dr. Willis: It’s a unanimous decision between the four of us that you should get your vaccine. We’re not just talking about it, we’ve done it, and it’s important to us. It’s important to your community and it’s important to your family. Everyone has the opportunity to be a role model.
Our message is clear: get your vaccine.
Need more advice?
First, get to know exactly how vaccines work and what to expect when you get one. If you have questions or concerns about vaccines based on your health status, speak to a provider who knows your medical history. Your friends and family may have good intentions, but they may not know your body like you and your doctor, so it’s important to speak to a provider who knows you well.
If you do decide to go online to learn more about vaccines, do seek reputable sources like the CDC, FDA or World Health Organization (WHO). You can also visit BCBSTupdates.com to get the latest facts on and support for COVID-19 and vaccines, along with information on how BlueCross BlueShield of Tennessee is supporting its members and communities through the COVID-19 pandemic.