Updated on: February 23, 2021

Setting the Record Straight on COVID-19 Vaccines

By
Original story posted on: February 15, 2021

This article will pose common questions or concerns from our listeners.

I am the co-host of Talk-Ten-Tuesdays because I am a national expert on clinical documentation improvement (CDI) and ICD-10, but I was first a physician who took a Hippocratic Oath to do no harm. I also have always had the goal of doing good, which is why I asked that Talk-Ten-Tuesdays and ICD10monitor focus on COVID-19 right now.

I am not proselytizing for any political purpose. I spend my days scouring the COVID-19 literature, and want to get the facts out to you. I want everyone to make informed decisions. If you are not sure if you should believe what I am telling you, I suggest you check the Centers for Disease Control and Prevention (CDC) website (https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.html), and read the literature for yourself. My only objective is to try to avoid the prospect of more people being sickened and possibly dying from a very serious disease, and to have all of our lives go back to some degree of normalcy.

This article will pose common questions or concerns from our listeners in bold font, and my responses, often with links to valid references, will follow.

  • I was asked about animal studies related to the COVID-19 vaccines. One of our listeners heard that all the animals died.
    • The trials did not skip animal studies. In the quest for expediency, studies performed on mice and macaque monkeys were run concurrently (that is, at the same time) to the Phase 1 human clinical trials. The animals developed high neutralizing antibody titers, and none of the animals died.
    • mRNA has been studied on animals for decades, and it does not cause dangerous inflammation to animals.
    • If you would like to review the data of the studies yourself:
    • Do you have any information for the autoimmune folks (e.g., those with lupus, rheumatoid arthritis, multiple sclerosis)? That is my hesitancy.
      • Autoimmune disease is listed on the CDC website as being commonly misperceived as a contraindication, but neither it, nor being on immunosuppressants or chemotherapy, is a listed contraindication for the COVID-19 vaccine or any other vaccination.
      • The only absolute contraindication against getting any of the vaccines under emergency use authorization (EUA) is allergic reaction to any of the components of the vaccine. Polyethylene glycol (PEG), the ingredient we use for bowel preps, and sold over the counter as MiraLax®, is the only significant component of the vaccine. A review of the scientific literature suggests that this is extremely unlikely to cause an allergic reaction; there were only 37 cases of an allergic reaction to PEG spanning from 1977 to 2016. (But this is 2021…)
      • The CDC says that “people living with autoimmune conditions can get an mRNA coronavirus vaccine, but there is no formal safety data available.”

    • Someone asked about a relative who had Guillain-Barre syndrome (GBS) several years ago, who believes they can’t get the vaccine.
    • A listener asked about the fact that the vaccines are not “FDA-approved.” Do we know when there will be formal FDA (Food and Drug Administration) approval?
      • All vaccines for COVID-19 have been released under EUA. This is based on the totality of scientific evidence available at the time of the EUA. EUA is a declaration by the Secretary of Health and Human Services that circumstances justify the emergency use of drugs and biological products, typically when there hasn’t been enough time to undergo formal FDA approval. The same FDA personnel who give formal FDA approval are the ones who reviewed the preliminary data and determined that an EUA was appropriate as they continue to evaluate the vaccines for formal approval.
      • It is a risk-benefit analysis. The risk of dying or perpetuating the pandemic outweighs the risk from the vaccine, according to the data obtained, and there is a benefit in preventing serious illness.
      • The trials for vaccines were done with volunteers numbering in the 30,000-40,000 range. There have been hundreds of millions of doses of vaccines administered worldwide, and in excess of 45 million in the United States. This is one huge science fair experiment, and so far, it seems to be safe. (https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/)
      • EUA fact sheets:
      • Another listener asked our opinion about the Russian vaccine.
        • The Russian vaccine against COVID-19 is a recombinant adenovirus-based vaccine with the gene for the SARS-CoV-2 glycoprotein S. It is a two-dose regimen taken 21 days apart, like Pfizer’s. There is a subtle difference in that each of the two doses uses a different adenovirus vector to try to induce higher immune responses. It is conceivable that the variants will be protected against better with Sputnik V. It is reportedly safe, and 91 percent effective against severe illness. Question of transmissibility is still an issue with Sputnik V, as with Moderna and Pfizer.
        • This vaccine has received authorization in over a dozen countries, although not in the U.S. My opinion is, “awesome!” We need all the vaccines we can get, because we have about 6 billion people to vaccinate. The COVID-19 pandemic is global, and our vaccination rollout must be worldwide.

      • One of our listeners said the risk of side effects is too high for her. We are also getting questions about pretreating to avert symptoms.
        • Many people have minor side effects from the vaccinations, usually a sore arm. There are typically more side effects from the second dose. (https://www.goodrx.com/covid-19/side-effects-covid-19-vaccine) About 10-15 percent of people have significant side effects, which are described as symptoms experienced with mild COVID-19, such as muscle aches, chills, and headache.
        • In fact, they say that the first dose of vaccine in people who already had COVID-19 resembles the side effect profile of the second dose in the uninitiated. Many of you know I had a bout of COVID-19 in March. I felt like I had been run over by a truck for five days. I felt bad for about six hours on the day after the first vaccine. I just took some Tylenol and climbed into bed early.
        • However, I am convinced this beats being intubated or dying. Additionally, the side effects are transient, whereas long-haul COVID or sequelae like strokes can go on forever. I also would feel terribly guilty if I passed the virus along to someone else who needed to be intubated or died.
        • The general consensus is that people should not pretreat prior to onset of symptoms. They have no data as to whether pretreatment might mitigate immune response. It’s better not to take a chance. I prefer to use acetaminophen for vaccine side effects, as opposed to nonsteroidals. I don’t know where inflammation and immune response intersect. Also, allow for needing to take the day after the second vaccine off, just in case. My kid sister had minimal symptoms; you may be lucky, too. If you or someone you know took medication prior to the vaccine, I would not be concerned that it negated the vaccine’s effects, however.

      • How do they know whether it is safe or not?
        • The vaccines were found to be pretty darned safe during the trials, and we now have a track record of millions of administrations. The rate of anaphylaxis is 2.1 cases per million doses of Moderna, and 6.2 cases per million doses of Pfizer. Johnson & Johnson (J&J, a single-dose, refrigeration vaccine, pending EUA) has not been associated with any anaphylaxis to date. No one has died from any of the vaccines, despite Facebook posts to the contrary. Those reports were thoroughly investigated and refuted. Obviously, we do not have long-term data yet, but there do not seem to be significant issues.
        • There are several systems aimed at monitoring safety and side effects. One is called V-safe, which is a smartphone-based app to check in with you via text, see if you have experienced any side effects, and remind you when your second shot is due. It checks in with you daily at the onset, and then weekly in follow-up. When you get vaccinated, I recommend you sign up for it (https://vsafe.cdc.gov/). The other system is the FDA/CDC’s Vaccine Adverse Event Reporting System (1-800-822-7967, or report online to https://vaers.hhs.gov/reportevent.html), which is not COVID-19-specific.

      • Filling out the form, the patient’s race is a requirement. Seems somewhat discriminatory.
        • The demographics are not to preclude anyone from receiving the vaccine. We can’t monitor what we don’t measure, so knowing the ethnicity and race of a vaccine recipient gives us the power to know who is getting the shots. All your data is recorded in your local and state immunization information system. In addition to logging basic information, records of which vaccine and lot you received for each shot is housed there to ensure that you get the same type of vaccine upon return.
        • There is definite disparity among the people being vaccinated. It is probably due to a combination of factors, including lack of access to sign-up, transportation, and locations and facilities where vaccines are being administered, as well as suspicion of the government and the healthcare system, and inability to take time off from work. The intent of the data field on the form is to try to foster equity.
        • Some of the inequity may be perpetuated by the process; clinics, institutions, and practices that effectively distribute their vaccine allotment get resupplied. If a clinic in a predominantly Black or LatinX neighborhood were to waste vaccine because no one was willing to get it, they might not have supply when reluctant folks are ready to bare their arms.

      • What is the time frame for taking the vaccine once you have had COVID-19? CDC was stating 90 days and my healthcare provider is stating something different.
        • You may be vaccinated after a case of COVID-19 once the infection is resolved and you are no longer in isolation. However, it is believed that you mount natural immunity for at least 90 days post-infection, so it is suggested that you might want to hold off for three months and let someone who has not had the virus (and therefore, doesn’t have any immunity) get their shot, since supplies are currently limited. If you had COVID-19 and received monoclonal antibodies, you must wait 90 days.
        • In the future, if obtaining a vaccination becomes easy, the general rule of thumb would be that you could get vaccinated 10 days after onset of symptoms, presuming you have recuperated.
        • It is difficult for laypeople and healthcare providers alike to keep up with the ever-changing guidelines from the CDC, as new data becomes available. It is recommended that you check with the CDC for updates and guidelines if your provider’s advice differs from what you have read or heard.

      • Is it safe in pregnancy?
        • I saw an article in which a hesitant interviewee stated that his wife’s friend lost her baby after getting the vaccine. Association does not imply causality. Miscarriage occurs in approximately 25 percent of recognized pregnancies. This may just have been a coincidence. A similar case was spread throughout social media. It was debunked by the affected female physician sharing that her miscarriage had preceded her vaccination by weeks.
        • The vaccine was not intentionally tested on pregnant or lactating women, but they do have some data on vaccines from patients who were unaware they were pregnant when they participated in the vaccine trials or got vaccinated. Neither Moderna nor Pfizer saw any evidence that the vaccine harmed human pregnancies, nor fetuses in animal studies. The CDC, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine agree that mRNA COVID-19 vaccines should be offered to pregnant and breastfeeding individuals who are otherwise in the queue for immunization.
        • Anecdotally, I vaccinated two pregnant women and one lactating woman last week. I had to ask them if they had discussed it with their obstetricians before administering their shot. They had, and with joint decision-making, opted to receive the vaccine.

      • Someone specifically asked about concerns of permanent placental problems in vaccinated women, because the questioner said that “the vaccine tells the body that it has COVID permanently, so this would be an ongoing problem for women of childbearing age.”
        • The vaccine is not telling the body that it has COVID-19 permanently. It is no different than other immunizations, like the measles, pneumonia, or influenza vaccine, in that it stimulates the body to develop immunity, but your body does not think you are perpetually infected. Your cells will recognize the organism if exposed post-vaccine and will rapidly produce antibodies to fend off infection.
        • Women who get infected with COVID-19 while pregnant can develop severe illness, although transmission to a fetus or newborn is reportedly a rare event. Risk-benefit analysis would support vaccination, in my opinion. As someone who had many pregnancy mishaps during my childbearing years, I would have jumped at the chance to get vaccinated.

      • Must the second vaccination be from the same pharmaceutical company as the first? Are there any mechanisms in place currently to ensure timely provision of the second dose, considering more emerging COVID-19 variant strains?
        • If you got Moderna for the first dose, approximately 28 days later, you should get a second Moderna dose. If you got Pfizer for the first dose, approximately 21 days later, you should receive the second Pfizer dose. We follow the science, and that is how the studies were done.
        • If we need a yearly booster shot, we will see what the recommendations will be regarding mixing and matching brands.
        • There are mechanisms in place to make sure that there is adequate supply for the second doses in the correct time frame. Many vaccination providers make the second appointment at the same time as the first. Some permit the vaccinee to schedule it independently to meet their needs. You actually can get the vaccine at a different site than the original shot, as long as it is the correct manufacturer.

      • Medicare pays 40 percent more for administration of vaccine A than vaccine B. Why?
        • The payments listed on cms.gov show $28.39 to administer single-dose vaccines, and $16.94/$28.39 for two-dose regimens. Their explanation is that the rates take into consideration the costs involved in administering the vaccine, including the resources necessary to schedule, perform required public health reporting, and provide patient education (https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment). It is a labor-intensive process, and there is effort involved in scheduling for that second dose.

      • Some expressed frustration at not being able to be vaccinated, either because their locale doesn’t seem to be offering it or they are not in an approved group.
        • I feel your pain. I can’t wait until my sons, brother, nieces, and nephews get their vaccines. Healthy and young, they have no clue when they are going to be eligible. One way to arrange for a vaccine is to volunteer to assist in the vaccination process. They need medical and non-medical personnel to run vaccination events.
        • There is definitely an uptick in availability occurring, although it will still be some time before there is enough vaccine for anyone who wants it. Similarly, the systems are revving up as well. This week, they are adding 24-hour-a-day stadium-located mega-events into the mix, and these may spread across the country. In addition, smaller vaccinators like local pharmacies and physician practices are getting allotments, too. Hang in there – it is coming!

      • One listener with multiple comorbidities said she works from home, rarely goes out in public, wears her mask, and washes her hands…so why would she get the vaccine? She added, “it will not prevent me from getting COVID-19, nor will it prevent me from spreading the disease, if I am asymptomatic.”
        • The real question, to me, is, “how will herd immunity ever be achieved if vaccinated people can still get infected and transmit the disease?” First, there will be a significant number of vaccinated people who will not contract the disease, even if exposed. Second, if a vaccinated person contracts COVID-19, they express a lower viral load, which seems to be related to transmissibility and severity of illness. If an unvaccinated person gets exposed to a small dose of virus, they may end up with a mild or asymptomatic case, whereas if they get a big dose of virus, they may develop severe or lethal COVID-19.
        • Once enough people are vaccinated and we cross the threshold of what is necessary to achieve herd immunity, we will be able to go back to the workplace, go to the grocery store without fear, and stop wearing masks (I’m saving the pretty ones I have sewn for any potential future epidemics!), but we should continue to wash our hands (I haven’t been sick with anything since I recovered from COVID-19 in March 2020!).
        • Herd immunity depends on enough of us getting vaccinated. We particularly want to quash this whole virus mutation business. If the vaccines no longer protect against variants, we may be back to square one. I hope we have learned some lessons from the first iteration if this occurs, though.
        • If you want to read a good article explaining this: https://www.scientificamerican.com/article/vaccines-need-not-completely-stop-covid-transmission-to-curb-the-pandemic1/

      • A reader shared their concern that perhaps some people are not receiving vaccine, but are getting injected with placebo.
        • Could there be disreputable scammers who are not providing people with true vaccine? I suppose anything is possible nowadays. However, if you are going somewhere like the local board of health, an approved pharmacy, or your healthcare practitioner, you are getting vaccine. You will get a card with the manufacturer and lot number. The vaccinator is going to reach into the refrigerator or cooler and randomly select a syringe that is holding vaccine. This is not another Tuskegee experiment. You are getting the vaccine.

In conclusion, be one of the at least 85 percent and get your vaccine. I care about you and everyone around you. I want our lives to go back to normal. Remember, vaccines don’t save lives – vaccinations do!

Programming Note: Listen to Dr. Erica Remer ever Tuesday when she co-hosts Talk Ten Tuesdays with Chuck Buck, 10 a.m. Eastern.

Erica E. Remer, MD, CCDS

Erica Remer, MD, CCDS has a unique perspective as a practicing emergency physician for 25 years, with extensive coding, CDI, and ICD-10 expertise. She was a physician advisor of a large multi-hospital system for four years before transitioning to independent consulting in July 2016. Her passion is educating CDI specialists, coders, and healthcare providers with engaging, case-based presentations on documentation, CDI, and denials management topics. She has written numerous articles and serves as the co-host of Talk Ten Tuesdays, a weekly national podcast. Dr. Remer is a member of the ICD10monitor editorial board, a former member of the ACDIS Advisory Board, and the board of directors of the American College of Physician Advisors.

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