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Vaccine: Specific Groups and Populations

1. Who has been vaccinated? Who hasn’t?

So far, in the US… All living US presidents have been vaccinated.  All 50 state governors have been vaccinated. Nearly all of Congress has been vaccinated.  More than 96% of American physicians are vaccinated. About three-fourths of our military opted to be vaccinated in advance of the mandate to do so. But nearly all people dying of COVID-19 are unvaccinated; in Indiana, 98.5% of people under the age of 65 who died from COVID-19 are unvaccinated.

2. Which groups of patients have been included in studies? And who is approved to receive which vaccines?
  • Pfizer
    • FDA-approved in patients ≥16 years of age
    • Studied in patients 12-15 years of age with EUA (Emergency Use Authorization) for use from the FDA
    • Studied in patients 5-11 years of age with data submitted to the FDA in September 2021.
    • Data from clinical trials in patients 2-4 years of age are underway, with data expected late 2021 to early 2022.
  • Moderna
    • Studied in patients ≥18 years of age, with EUA for use from the FDA
      • Submitted to the FDA for approval
    • Studied in patients 12-17 years of age, has submitted request for EUA to the FDA
  • Johnson & Johnson
    • Studied in patients ≥18 years of age, with EUA for use from the FDA
3. Is there any risk to someone who is immunocompromised or taking an immuno-suppressant and then getting the vaccine?

Patients receiving immunosuppressive therapy (high dose systemic corticosteroids, some cancer drugs), were not included in the initial vaccine studies.

  • Patients with short-term corticosteroids could be included if it had been >28 days since receipt of these drugs in the Pfizer trial
  • Patients who received ≤14 days of high dose corticosteroids (≥20 mg/day) in the past 6 months were excluded from the Moderna trial.

There are no specific safety concerns at this time in immunocompromised patients.  There could be concerns related to lower level of efficacy/immune response, but this should be weighed against the fact that patients who are immunocompromised are at higher risk to have a poor outcome from COVID infections themselves.

  • Patients who are receiving intravenous medications that may cause immunosuppression should speak with their specialist/physician to determine if modified schedules or vaccine timing is appropriate.
  • Patients who receive steroid injections should wait about 48 hours to receive a vaccine injection.  This is mostly related to possible side effects, as if the patient has a reaction to either injection, it could be difficult to determine which medication caused the reaction.

The FDA has stated that the vaccine may potentially be less effective in immunocompromised patients, but they did not state any safety concerns among this group. That is why third doses are being recommended.  These are considered different from the term “boosters.”  It is highly recommended that patients with immunocompromising conditions get a 3rd dose of the vaccine.  Although breakthrough infections leading to hospitalization is fairly rare in the general population, immunocompromised patients make up a large percentage of those more serious cases.  The third dose of the vaccine significantly increases antibody response in immunocompromised patients.

Unfortunately, there is limited information about the Johnson & Johnson vaccine and second doses in immunocompromised patients at this time.

https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html

4. Who should receive a third dose?

A third dose of mRNA vaccines (Pfizer or Moderna) is now available for immunocompromised patients who received their second dose at least 28 days earlier.

Below are the conditions listed that qualify patients for a third mRNA dose.  Patients who are unclear if they qualify, or have questions about one of the specific drugs mentioned, should check with their provider or pharmacist.

Conditions listed that qualify moderately-to-severely immunocompromised people for a third mRNA dose:

  • Active treatment for cancer (tumors or cancers of the blood)
  • Receipt of organ transplant and taking immunosuppressive therapy
  • Receipt of stem cell transplant in past 2 years, or still taking immunosuppression therapy.
  • Moderate or severe primary immunodeficiency (e.g. DiGeorge, Wiskott-Aldrich syndromes)
  • Advanced or untreated HIV infection
  • Active treatment with high-dose corticosteroids (i.e. 20 mg or more prednisone or equivalent per day), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, TNF blockers, and other biologic agents that are immunosuppressive or immunomodulatory.

Patients who qualify can schedule an appointment at any location that offers the same vaccine they had previously received.  Those seeking third doses should bring along their vaccine card so that the first/second doses may be verified, and to record the third dose.

5. Can pregnant women receive the COVID vaccine?

Yes.  The risk of significant illness and complications from COVID is higher in the pregnant population.  The American College of Obstetrics and Gynecology (ACOG), as well as Tri-State Perinatology and the Society for Maternal Fetal Medicine strongly encourage pregnant women to be vaccinated.

Women who contract COVID-19 while pregnant are at higher risk for negative outcomes for themselves and their babies, including ICU admission/intubation, preterm delivery, long-term symptoms in the mother (making motherhood more difficult) and even an increased risk of death over other women of the same health profile who are not pregnant.

Although there is no formal recommendation from ACOG regarding one vaccine over the other, pregnant patients should be informed about the very small (but increased risk) of thrombosis and Guillain-Barre Syndrome with the Johnson & Johnson vaccine compared to the mRNA vaccines.

6. Can women who are breastfeeding receive the vaccine?

Yes.  Similar to pregnancy, patients who are breastfeeding may receive the COVID vaccine.  COVID-19 antibodies are also passed through the breastmilk, which may provide the baby some level of protection against COVID-19.

7. Is it safe to get the vaccine when you are trying to conceive?

The American College of Obstetricians and Gynecologists has issued a statement on this issue. It says: For Individuals Contemplating Pregnancy

  • Vaccination is strongly encouraged for non-pregnant individuals within the ACIP prioritization group(s).
  • Further, ACOG recommends vaccination of individuals who are actively trying to become pregnant or are contemplating pregnancy and meet the criteria for vaccination based on ACIP prioritization recommendations. Additionally, it is not necessary to delay pregnancy after completing both doses of the COVID-19 vaccine.
  • If an individual becomes pregnant after the first dose of an mRNA COVID-19 vaccine series, the second dose should be administered as indicated.
  • Importantly, routine pregnancy testing is not recommended prior to receiving any EUA-approved for FDA-approved COVID-19 vaccine.

Fertility concerns are one of a number of false rumors circulating around social media. Further information on this particular rumor, including its origins, can be found here:  https://apnews.com/article/fact-checking-afs:Content:9856420671 Below is further explanation from a blog on WebMD Health News*.  It uses examples that are very relatable. 

  • Some of the rumors around the vaccine mechanism causing infertility are related to a protein called syncytin-1, which shares similar genetic instructions with part of the spike of the new coronavirus. That same protein is an important component of the placenta in mammals. If the vaccine causes the body to make antibodies against syncytin-1, the rumors say, it might also cause the body to attack and reject the protein in the human placenta, making women infertile.
  • The coronavirus’s spike protein and syncytin-1 share small stretches of the same genetic code, but not enough to make them a match. An example would be like two people having phone numbers that both contain the number 7. You couldn’t dial one number to reach the other person, even though their phone numbers shared a digit.
  • During the trial, 23 women conceived, likely by accident. Twelve of these pregnancies happened in the vaccine group, and 11 in the placebo group. They continued to be followed as part of the study.

*From blog on WebMD Health News https://www.webmd.com/vaccines/covid-19-vaccine/news/20210112/why-covid-vaccines-are-falsely-linked-to-infertility

Finally, the impact of COVID vaccination has been studied, and the spike protein from vaccination (or from history of infection) does not cause sterility.

https://www.sciencedirect.com/science/article/pii/S2666334121000684

8. Are there any contraindications to getting the vaccine if I have a pacemaker, ICD or atrial fibrillation?

There are no contraindications to getting the vaccine based on presence of a heart condition or cardiac device.

9. What is the effectiveness of the vaccine for someone who is overweight?

The trials for the vaccines included more than 70,000 people, including a variety of people with various health conditions.  Weight was not a factor in the effectiveness of the vaccine.

10. I can’t take a flu shot because of my history of Guillain-Barré Syndrome. What does this mean for me for the COVID vaccine?

Here is information from the CDC site:  At this time, no cases of Guillain-Barré syndrome (GBS) have associated with vaccination among participants in the Pfizer-BioNTech or Moderna COVID-19 vaccines. 

With few exceptions, ACIP’s general best practice guidelines for immunization does not include history of GBS as a contraindication or precaution to vaccination. Persons with a history of GBS may receive an mRNA COVID-19 vaccine unless they have a different contraindication to vaccination. Any occurrence of GBS following mRNA COVID-19 vaccination should be reported to VAERS.

Note:  There have been cases of GBS in patients who have been vaccinated with the mRNA vaccines, but these cases have been at the same rate as what typically occurs in the general population, which is why these cases haven’t been linked to vaccination.  Although still very rare, there does appear to be a higher rate of GBS in patients receiving the JnJ vaccine than would be expected to occur in the general population.

More information is available at https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html

11. What if I’m receiving a long-term antibiotic for a wound infection. Can I receive the vaccine?

Yes.  There are no contraindications for taking the vaccine while on any antibiotics.  Patients should be mostly recovered (improving, no fever, etc.) before receiving the vaccine.

12. If someone has had monoclonal antibody treatments (such as BAM), how long should they wait for their vaccine?

The CDC is recommending 90 days.  It is unknown how the receipt of monoclonal antibodies will impact the effectiveness of the COVID vaccine. (Also see #7 in the “Vaccine Scheduling” section)

13. If I’ve already had COVID, why should I get vaccinated?

A more comprehensive blog article on this topic has been published at www.deaconess.com/your-health, but here are some of the key points from it:

  • Natural immunity wanes.  Natural immunity results from the antibodies made by a person’s immune system when they’re infected with a particular pathogen.  When someone is infected with COVID-19, they do develop antibodies to the SAR-CoV-2 virus (the virus that causes the COVID-19 infection).  But over time, those antibodies begin to reduce in number. This process is different from person-to-person, and impossible to predict.  Additionally, the only way to maintain antibodies against the virus long-term is to get vaccinated, or to become infected again.
  • Natural immunity may not adequately protect against variants. The genetic make-up of viruses changes and evolves over time.  (For example, the flu changes each year, requiring a somewhat different shot every fall.) SAR-CoV-2 is doing the same thing, and prior infection from earlier variants of the virus may not offer the same protection for new variants. Immunity from vaccination, however, offers broader coverage because it creates antibodies to the protein on the outside of the virus, which is remaining more consistent. According to a recent study among Kentucky residents, those who were previously infected with an earlier form of the SARS-CoV-2 virus who are unvaccinated are more than twice as likely to be infected as someone who was previously infected but is also vaccinated.
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