Andrea Schaeffer,a Savannah Williams,a Christopher Sampson, M.D.b Marc Johnson, Ph.D.,c Lynelle Phillips, R.N., M.P.H.,d Taylor B. Nelson, D.O.,e Albert L. Hsu, M.D.f
a School of Medicine, University of Missouri-Columbia School of Medicine; Columbia, Missouri; USA.
b Department of Emergency Medicine; University of Missouri-Columbia School of Medicine; Columbia, Missouri; USA
c Department of Molecular Microbiology and Immunology; University of Missouri-Columbia School of Medicine; Columbia, Missouri; USA
d School of Public Health; University of Missouri Assistant Teaching Professor, University of Missouri School of Health Professions; Columbia, Missouri; USA.
e Division of Infectious Diseases, Department of Medicine, University of Missouri-Columbia School of Medicine; Columbia, Missouri; USA.
f Reproductive Medicine and Fertility Center, Department of Obstetrics, Gynecology and Women’s Health, University of Missouri-Columbia School of Medicine; Columbia, Missouri; USA.
Just a few months ago, Missouri had recorded some of the lowest COVID-19 case rates in the nation; in July 2021, Missouri skyrocketed to one of the top five states with the highest rates of new COVID-19 cases in the country. This has been largely due to the Delta (B.1.617.2) variant of COVID-19. Despite the recent rise in new cases, many counties in Missouri still have COVID-19 vaccination rates under 30%. These lower vaccination rates can be partly attributed to widespread skepticism and misinformation. Having a script of responses can be a useful tool to address common misconceptions and questions about the vaccine. Here are some of the top concerns about COVID-19 vaccines, as voiced by our patients, friends, and family members here in Missouri, with some suggested responses.
Just a few months ago, Missouri had recorded some of the lowest COVID-19 case rates in the nation. In July 2021, Missouri skyrocketed to one of the top five states with the highest rates1 of new COVID-19 cases in the country.2 This has been largely due to the Delta (B.1.617.2) variant of COVID-19, which has now been detected in over 85 countries; in the US, Delta has grown3 from 1% of all new COVID-19 sequences in early May, to nearly 100% of new sequences by early July.
Delta variant of COVID-19
The Delta (B.1.617.2) variant of SARS-CoV-2 carries several new mutations,4 appearing first5 in India last December, and now still evolving and moving throughout the United States. Delta has been estimated to be 40-60% more transmissible6 than the initial Alpha variant (“UK,” or B.1.1.7 variant). Data from Scotland7 suggest that people with the Delta variant may be twice as likely to be hospitalized as compared to those with the Alpha variant.
In Missouri, the majority of currently-hospitalized COVID-19 patients are under 65 years of age, with a median age of 52 years old at one hospital8 in southwest Missouri. The vast majority of hospitalizations, severe cases, and deaths from COVID-19 occur in individuals unvaccinated against COVID-19: the consensus of most surveillance studies is that approximately 80-90% of cases, over 95% of hospitalizations, and over 98% of deaths from COVID-19 occur among those who have not been vaccinated against COVID-19. Those reluctant or unwilling to get vaccinated are the most vulnerable to this latest wave of COVID-19, leading some to call this Delta storm a “Pandemic of the (Willfully) Unvaccinated.” Vaccine hesitancy and skepticism, coupled with lack of vaccines in many nations around the world, increases the chance of further mutations, potentially leading to more harmful variants of concern like Delta.
Despite the recent rise in new cases, many counties in Missouri9,10 have COVID-19 vaccination rates under 30%. As a state, Missouri only recently reached the benchmark of having 40% of its population fully vaccinated.9,10 These lower vaccination rates can be partly attributed to widespread skepticism and misinformation. Many remain “on-the-fence” about getting the vaccine and have lots of questions. Best practices for discussing vaccine hesitancy are to actively listen with patience and empathy, and to seek out specific patient concerns through open-ended questions.11,12 Indeed, it is also critical to approach these discussions with grace and a sense of humility; it has been challenging for all of us to keep up with rapidly evolving information throughout the course of this pandemic. Whatever your personal opinion on vaccines, civility is critical for an open and constructive dialogue, free from “vaccine shaming,” scolding, condescension, and bullying.
Given our state’s rise in COVID-19 cases, the Missouri State Medical Association recently13 recommended “for the great majority of patients, the vaccine is safe and effective, and the easiest way to slow the spread of the Delta variant. Your physician can answer questions about the vaccine,” and further encouraged “simple acts that can help stop the virus: practice social distancing when possible, voluntarily wear a mask in public places, and get tested if you feel sick.” This recommendation is partly due to emerging data14,15 on breakthrough infections in fully-vaccinated individuals. While the COVID-19 vaccines have been shown to be 95% effective against the original wild-type COVID-19 (and the alpha variant), the mRNA vaccines are less effective16 in preventing COVID-19 infection from the Delta variant.
The COVID-19 pandemic has created unparalleled medical, social, political, and economic challenges, and constantly-evolving guidelines have resulted in a public that is understandably uncertain and suffering from extreme “COVID fatigue.” Having a script of responses is a useful tool to address common misconceptions and questions about the vaccine. The following are some of the top concerns that our patients, friends, and family have expressed, regarding the COVID-19 vaccines, along with some suggested responses:
(1) “I’m young and I’m not going to die from COVID-19… so why should I get the vaccine?”
Suggested answer: this is a common concern and misconception. On the one hand, recent data17 in Missouri confirms that the average age of deaths from COVID-19 still remains at 79 years of age, and in general, younger patients are less likely to be hospitalized or die from COVID-19. However, that being said:
- Even if you don’t die, you might still get very sick from COVID-19 and need hospitalization. The average age of individuals hospitalized with COVID-19 is decreasing, and unfortunately, many 20-40 year-olds are now requiring hospitalization for COVID-19.
- Long-haul symptoms18 or “Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)” can be quite serious. We are seeing cases of cardiomyopathy and myocarditis after COVID-19 in young people. Even in athletes, the deconditioning, chest pain, shortness of breath, brain fog, and other symptoms associated with COVID-19 can persist long after the infection has cleared. Athletes getting the vaccines can protect their teammates from potentially season-ending COVID symptoms.
- Despite the lower risk of severe illness, younger patients are still capable of spreading infection to the sick and immunosuppressed, as well as to elderly friends and family. Protect your grandma, get the vaccine!
- If COVID-19 runs rampant through our communities over the coming weeks and months, our fall school semester and fall sports seasons might be affected yet again. Protect in-person school (and protect your local sports team), get the vaccine!
- The “young and healthy” remain at lowest risk of hospitalization for COVID-19, but any co-morbidity can put a young person with the Delta variant into the same risk category for severe illness or hospitalization as our nursing home residents. Delta is also different; unfortunately, our infectious disease experts can no longer fully predict who becomes severely ill from COVID-19.
(2) “I’ve already been sick with COVID-19, so I don’t need the vaccine.”
Suggested answer: in January 2021, when we had limited vaccine supplies, our CDC had indeed counselled that for those who had a recent illness with COVID-19, “it would be reasonable to defer the vaccine for up to 90 days after recovery.” In countries with limited vaccine access or supplies, it has also been recommended to reserve vaccines for those who have not yet tested positive for the virus, since prior exposure to COVID-19 likely confers some protection; however, such protection may be limited. Some considerations:
- Reinfection was once thought to be rare, but with the rise of COVID-19 variants (and particularly Delta), we know that prior infection is less effective19 than vaccination, in preventing future infections from SARS-CoV-2 and its variants.
- Many individuals who contracted the initial wild-type COVID-19 variant had mild symptoms or remained asymptomatic. Severity of illness correlates with antibody levels and systemic immune responses, so a prior mild episode of COVID-19 infection in 2020 may not be protective against re-infection by current or future variants.
- While prior infection with COVID-19 may result in a robust antibody response in most immunocompetent individuals, vaccination gives much higher titers of antibodies19 against COVID-19. Vaccination also seems to give a broader immunity,20 with the potential to protect against more viral strains.
(3) “Most of the COVID-19 vaccines are only under ‘Emergency Use Authorization,’ and only one is currently approved by the US Food and Drug Administration (FDA). They were produced so quickly that they must have skipped some steps in the testing, trials, and manufacturing! How do we know that the COVID-19 vaccine is safe?”
Suggested answer: it is true that “Operation Warp Speed” went quickly, and that some COVID-19 vaccines are still not FDA-approved. With people dying by the thousands, this pandemic required an emergent response, but that does not mean that steps were skipped.
- According to the FDA21, an Emergency Use Authorization “is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.”
- The FDA approval process requires a lot of time, but with so many millions of people vaccinated now, there is plenty of data on their performance, and we anticipate FDA approval for other COVID-19 vaccines in the coming months. Experts have collected massive amounts of data (from hundreds of millions of patients who received the COVID vaccines), and to date, all signs have pointed to the COVID-19 vaccines being safe and highly effective.
- Operation Warp Speed (OWS) was a partnership22 between the US Departments of Health and Human Services (DHHS) and Department of Defense (DOD) to help accelerate the development of a COVID-19 vaccine. No steps were skipped in the clinical trials, and there is no evidence that any corners were “cut” in the manufacture of the vaccines, only red tape. Operation Warp Speed23 went relatively quickly because our federal government underwrote the cost of the trials and the manufacture of the vaccine, so they could happen in parallel. Some of the clinical trial phases22 overlapped with each other in order to accelerate the process. Manufacturers usually commit to vaccine production only after there is evidence of efficacy, but with Warp Speed,22 companies worked to speed up vaccine production by prioritizing needed supplies, by using different platform technologies, and by initating large-scale vaccine manufacture concurrently with the clinical trials. Given the global public health emergency, our government helped pay for manufacture of all vaccines to start, after which there was a focus on those vaccines with proven effectiveness. Warp Speed was transparent in its operational details, and its scientific comprehensiveness is well-described.22,23
- Vaccine safety monitoring mechanisms work. There was a national pause24 in issuing the Janssen vaccine when rare reports of blood clots were noted in young women. The rate of blood clots from “Thrombosis with Thrombocytopenia Syndrome” was roughly 1 in a million. If they are picking up 1-in-a-million rates of significant side effects, there is clearly a lot of scrutiny happening, which is very reassuring. Ultimately, vaccinations with the Janssen vaccine resumed, because these side effects were exceedingly rare.
- The same level of scrutiny for full FDA approval is being applied to the COVID-19 vaccines, as to any other application for FDA approval; both Pfizer and Moderna applied for FDA approval of their respective vaccines. On 16 July 2021, the US FDA accepted25 Pfizer’s application under “priority review,” which means that a typical ten-month process may be shortened to as little as two months; indeed, the FDA recently approved26 the Pfizer-BioNTech COVID-19 Vaccine (now marketed as Comirnaty) for prevention of COVID-19 disease in individuals 16 years of age and older.
(4) “I don’t want something foreign in my body when I don’t know what it will do!”
Suggested answer: this is a common concern with a wide range of applications, from contact lenses, to prosthetics, to dental implants. Nothing comes without inherent risks, and vaccination is indeed not a risk-free decision. As with all vaccinations, there will be rare complications with this vaccine.
- Decision-making on the vaccine is also not risk-free. Those who get the vaccine assume the risks of vaccination. Those who do not get the vaccine assume the risks of infection without the vaccine. There are risks with either decision.
- Most vaccine side effects occur within 4-6 weeks; we are significantly past that window for the initial participants in the vaccination trials. Certain side effects are expected as a normal part of the body’s reaction to a vaccine, as the human body develops antibodies to protect against COVID-19. These side effects may include injection site pain, fever, fatigue, headache, muscle aches, and chills.
Regarding concerns over messenger RNA (mRNA) vaccines, mRNA technology27,28 has been used in cancer therapy for years, and it has now been applied to some COVID vaccines. These mRNA vaccines help your immune system to better identify and mount a defense against the virus, they do not affect or change your DNA. If you’re still worried about the mRNA technology, you can still protect yourself against the Delta storm; please consider getting the Janssen vaccine (or Novavax, once it is authorized for use), which use a disabled form of adenovirus to boost the immune response to the spike proteins found on the coronavirus.
- The current Delta storm is a Pandemic of the Unvaccinated, and the risks of not getting vaccinated including serious long-term consequences like myocarditis and Guillain-Barre syndrome, which are seen at much higher rates in those with natural infection by SARS-CoV-2, than with the vaccines:
- For those who are concerned about side effects, Guillain Barre syndrome (GBS) is also a rare side effect29 of the flu vaccine; however, the influenza vaccine has a very low rate of 1-2 cases per million. As of the time of this publication, GBS has been very rarely30 reported as a side effect of the mRNA vaccines for COVID-19.
(5) “I’m worried about the COVID-19 vaccine and infertility”
Suggested answer: infertility is an extremely stressful diagnosis for couples. For those who have been trying to conceive without success, the rampant misinformation on social media has been troubling.
- There is no current data31-36 that the COVID-19 vaccines may cause infertility and no credible scientific theories for how the COVID-19 vaccine could cause female infertility. Statements linking COVID-19 vaccines to female infertility are currently speculative at best.
- The most common cause for this confusion and misinformation was the false social media claim32-33 that the spike protein on the coronavirus has significant similarities to a different virus-derived “spike” protein called Syncytin-1, which is involved in development of the placenta during pregnancy, such that getting the vaccine would prompt a woman’s immune system to attack this protein. In fact, these two spike proteins are completely different and this is an implausible mechanism to affect a woman’s future ability to conceive: “A good analogy I’ve heard is that for your immune system to get mixed up and attack the placental protein, would be like you mistaking an elephant for an alley cat because they’re both gray.” 31 This argument also suggests that those previously infected with SARS-CoV-2 would also make the same antibodies, and therefore also have an increased risk of miscarriage or infertility, which has not been shown.33
- Studies looking to determine the effect of antibodies from COVID-19 vaccination and infection found no difference in implantation rates or success rates between SARS-CoV-2 vaccine seropositive, infection seropositive, or seronegative patients.36 In addition, antibodies from vaccination or natural immunization to SARS-CoV-2 showed no reactivity to syncytin-1.36 A recent JAMA study37 also showed no significant decrease in sperm parameters after receiving COVID-19 vaccines.
- There is also some early data32 suggesting that infection with the SARS-CoV-2 virus may actually damage male fertility. While not sexually transmissible, SARS-CoV-2 may have a negative impact on male fertility through decreasing testosterone levels and semen parameters.38,39 Specifically, there are reports of men with testicular pain/discomfort, disruption of the hypothalamic-pituitary-testicular axis (male reproductive hormones), orchitis, epididymitis and/or testicular damage in men after COVID-19; SARS-CoV-2 virus has also been found in testicular biopsies (for infertility treatment) and in testicular tissue from autopsies.32 COVID-19 disease has multi-organ manifestations (respiratory, cardiac, dermatologic, male reproductive systems), while the vaccine has been associated with mostly transient side effects. Given this data, it is possible that the COVID-19 vaccines may actually “protect” male fertility, by minimizing the potential negative impacts of COVID-19 disease on male reproductive function.32
Importantly, the American Society for Reproductive Medicine (ASRM) issued updated guidance35 on 23 July 2021 to state that:
- “COVID19 vaccination does not impact male or female fertility or fertility treatment outcomes.
- Existing data suggest COVID19 vaccination during pregnancy does not increase risk of miscarriage.
- COVID19 vaccination does not induce antibodies against the placenta.
- None of the currently available COVID-19 vaccines reach or cross the placenta. The intramuscularly administered vaccine mRNA remains in the deltoid muscle cell cytoplasm for just a few days before it is destroyed. However, protective antibodies to COVID19 have been shown to cross the placenta and confer protection to the baby after delivery.
- Reproductive endocrinologists should discuss COVID-19 vaccination with all patients and encourage vaccination for all patients during evaluation and treatment for infertility. Vaccination either pre-conception or early during pregnancy is the best way to reduce maternal/fetal complications. Physician counseling has been shown to have significant positive impact on patient willingness to consider vaccination.”
(6) “I’m pregnant, and I don’t want to get the COVID-19 vaccine while pregnant.”
Suggested answer: women naturally want to make the best decisions during pregnancy, and misinformation abounds. Physicians should be prepared to clearly discuss the risk and benefits of COVID disease versus vaccine while pregnant.
- Importantly, ACOG and the Society for Maternal Fetal Medicine (SMFM) issued updated guidance46-47 on 30 July 2021, to “recommend that all pregnant individuals be vaccinated against COVID-19. The organizations’ recommendations in support of vaccination during pregnancy reflect evidence demonstrating the safe use of the COVID-19 vaccines during pregnancy from tens of thousands of reporting individuals over the last several months, as well as the current low vaccination rates and concerning increase in cases.” This recommendation includes all pregnant, postpartum, and lactating individuals, as well as individuals considering pregnancy.
- A recent manuscript40 in New England Journal of Medicine also reviewed reassuring preliminary safety data for the COVID-19 vaccines in over 35,000 pregnant women.
- In the past, the American College of Obstetricians and Gynecologists (ACOG) had initially recommended41-42 that pregnant individuals have access to COVID-19 vaccines, as ongoing safety data (while limited) had not indicated any safety concern for pregnant individuals:
- “In the interest of patient autonomy, ACOG recommends that pregnant individuals be free to make their own decision regarding COVID-19 vaccination.”
- ACOG had further recommended41-42 shared clinical decision-making with patients, including considerations such as the level of activity of the virus in the community, the safety and efficacy of the vaccine, and the risk and potential severity of maternal disease: “These conversations provide an opportunity to remind patients about the importance of other prevention measures such as hand-washing, physical-distancing, and wearing a mask.” In this context, postponing vaccination until after delivery, while emphasizing other preventive measures during pregnancy, may have been considered reasonable in the past:
- However, becoming infected with COVID-19 while pregnant41-47 may have serious and even potentially life-threatening consequences. Data suggest that pregnant individuals with COVID-19 (compared to non-pregnant individuals) have a three-fold increased risk43-45 of severe disease, sometimes requiring critical care and/or intubation.
- If a pregnant individual is very concerned about contracting COVID-19 (either initial or secondary infection) or is at high risk of exposure due to employment, community spread, comorbidities, immunosuppression, etc., it has been very reasonable to recommend vaccination. Many national Ob/Gyn organizations report that they trust the COVID-19 vaccines more than they trust the COVID-19 disease process in pregnant individuals.41-42
- If a pregnant individual had been nervous about getting the COVID-19 vaccine due to minimal long-term data on pregnancy and fetuses, and that individual had felt confident in mitigation measures as reviewed above, it might have previously been reasonable to defer vaccination until more data was available, or until the individual was no longer pregnant. However, updated COVID-19 guidance46-47 from ACOG, SMFM, CDC, ASRM, and others indicates that this is no longer considered reasonable in the face of the rising number of Delta cases.
- In the meantime, mitigation measures for all pregnant women (regardless of vaccination status) during this surge of Delta cases is important, and so we urge hand-washing, crowd-avoidance, social-distancing, and masking-up in public for all pregnant women at the current time.
(7) “Every time I get the flu shot, I get the flu; I don’t want to get COVID or other side effects from the vaccine.”
- It is a common medical myth that you can get the flu from the vaccination. Flu vaccines are made from inactivated virus or viral proteins, not a live virus,48 so they cannot cause infection. There are some individuals who become infected by exposure after having been vaccinated, because vaccine efficacy is not perfect. Those who contract influenza after getting the flu shot also generally note a mild case of flu.
- While it is understandable to want to avoid feeling sick, it is impossible to get COVID from the vaccine. No vaccine contains COVID-19; the vaccines rather help your immune system to identify and fight the virus.
- The most common side effects of the COVID-19 vaccine include redness, pain, and swelling in the affected arm, as well as fatigue, headache, fever/chills, nausea, and muscle pain. Most side-effects resolve within a few days, and are indicative that the vaccine is likely working (as your immune system reacts to it).
- There is no evidence of anyone getting COVID-19 from the vaccine. Those who were exposed to SARS-CoV-2 shortly before getting the vaccine may perceive that the vaccine caused the disease, when the timing between vaccine and disease was mostly coincidental. Patients infected with COVID-19 after vaccination (“breakthrough infections”) generally have a very low risk of severe disease, hospitalization, or death.
(8) “The vaccine isn’t 100% effective, so why should I get it?”
Suggested answer: almost nothing in life is 100% and very little in science and medicine is 100% effective.
- The COVID-19 vaccines are, on average, 95% effective against wild-type and alpha strain of COVID-19. Generally, the vaccines are approximately 80% effective16 in preventing infection from the more recent Delta variant.
- It’s important to remember that you are not fully vaccinated until two weeks after your final COVID-19 shot (second shot for Moderna and Pfizer).
- There is very good data showing that in fully-vaccinated individuals, the risk of severe illness, hospitalization, or death from COVID-19 is significantly decreased compared to the risk for those who are unvaccinated.49 At the current time, consensus state and national reports suggest the mRNA vaccines are close to 100% effective in preventing hospitalizations and deaths.15
Early data50 still suggests that despite some loss of vaccine efficacy, mRNA vaccines still provide at least 60% protection from SARS-CoV-2 and help to prevent severe complications from the disease. Importantly, “60% protection” does not mean “almost a coin toss,” because vaccine efficacy50 combines metrics for prevention of infection, prevention of asymptomatic disease, prevention of symptomatic disease, and prevention of severe disease and death. Vaccine efficacy refers to the percent reduction in frequency of illness among vaccinated people compared to people who are not vaccinated, so a 60% efficacy could suggest that 70% of an unvaccination population can get an illness, compared to 30% of the vaccinated population. That’s not a coin toss!
(9) “There is no long-term data on the COVID-19 vaccines”
Suggested answer: this is true. We do not have 5-to-10 year data on these vaccines. However:
- Data on the COVID-19 vaccine is now approximately 1 year out, and all studies have failed to demonstrate any significant long-term side effects from the vaccines so far. Experience with prior vaccines indicates that most vaccine side effects occur within 4-6 weeks after immunization.
- The massive amounts of short-term and medium-term COVID-19 vaccine data are extremely reassuring.
(10) “I’m so sick and tired of COVID-19. Can’t we be done with it already?”
Suggested answer: yes, so are we!
- The best way to put COVID-19 in the rearview mirror is for everyone to take advantage of our modern science and technology.
- For those willing to get vaccinated against COVID-19 (but haven’t yet), “you’re running out of time.” The Delta variant is spreading quickly.
- For those who remain unvaccinated for any reason (including children under 12), please continue mitigation measures such as social distancing and masking-up in public.
As this wave of the COVID-19 pandemic continues to surge, our only hope for containment (without excessive morbidity and mortality) is in mitigation and harm reduction measures like social distancing, coupled with increased vaccination rates. It should be remembered that 100% vaccination rates are not likely to be an attainable goal, but that even small, incremental increases may provide a lasting positive effect on surges of SARS-CoV-2 and its variants. In the meantime, for those living in areas with surges and storms of the Delta variant, it’s certainly okay to “live your life,” but also time to get back to the simple things: hand-washing, crowd-avoidance, social distancing, and masking-up in public. We don’t want the storm to become a hurricane.
Conflicts of Interest: the authors of this article declare no conflicts of interest.
Acknowledgments: Robin Trotman, DO; George Turabelidze, MD/PhD, Jeff Howell, JD; Danny Schust, MD; Randall Williams, MD
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