mRNA Vaccines

What severity of COVID-19 would you recommend use of this medication (i.e. mild, moderate, or severe illness; outpatient vs inpatient use)?

1. COVID-19 prevention in those 16 years and older (Pfizer-BioNTech)
2. 5 years and older (Moderna)
3. Pfizer-BioNTech and Moderna are currently conducting trials enrolling ages down to 12 years old. Results are tentatively expected mid-2021.

Would you recommend restricting this medication in some way (for example, “can be considered in consultation with ID”)

• M Health Fairview will follow Minnesota Department of Health guidance for prioritization of populations for vaccine administration.

Primary series: 2-dose series of an mRNA COVID-19 vaccine (Pfizer-BioNTech and Moderna) or a single dose of Janssen vaccine

Additional primary dose: a subsequent dose of vaccine administered to people who likely did not mount a protective immune response after initial vaccination. An additional primary mRNA COVID-19 vaccine dose is recommended for moderately or severely immunocompromised people who received a 2-dose mRNA vaccine primary series

Booster dose: a subsequent dose of vaccine administered to enhance or restore protection by the primary vaccination which might have waned over time

Homologous booster dose: the same vaccine product used for the booster dose as was administered for the primary series

Heterologous booster dose (mix-and-match booster): the vaccine product used for the booster dose differs from the product administered for the primary series

Emergency Use Authorization (EUA): mechanism to facilitate the availability and use of medical products, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, the U.S. Food and Drug Administration (FDA) can make a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval

Emergency Use Instruction (EUI): a provision of the 2013 Pandemic and All-Hazards Preparedness Reauthorization Act which gives CDC legal authority to create and issue EUI to permit emergency use of FDA-approved medical products. The EUI consist of Fact Sheets to inform healthcare providers and recipients about such products’ approved, licensed, or cleared conditions of use

• Pfizer-BioNTech:
  • For those aged 5-11 years old: Series of 2 doses (10 mcg/dose) 21 days apart
  • For those aged 12+ years old: Series of 2 doses (0.3 mL each, 30 mcg/dose) 21 days apart
• Moderna: Series of 2 doses (0.5 mL each, 100 mcg/dose) 28 days apart

1. Recipients should be monitored for adverse effects for 15-30 minutes based on risk for allergic reactions based on CDC recommendations in Appendix B
2. Information about characteristics of potential allergic reactions, vasovagal reactions, and vaccine side effects can be found in Appendix D.
3. Vaccine administration errors, serious adverse events (even if it is uncertain whether the vaccine caused the event), deviations from CDC recommendations, cases of Multisystem Inflammatory Syndrome, and cases of COVID-19 that result in hospitalization or death are reportable.
   1. The CDC provides recommendations for management of administration errors and deviations in Appendix A.
4. Events should be reported through the Vaccine Adverse Effect Reporting System (VAERS). Information on how to submit a report is available at VAERS or 1-800-822-7967.

• Both are currently available through federal and state distribution only

The following recommendations are based on the interim recommendations from the Centers for Disease Control (CDC) and Advisory Committee on Immunization Practices (ACIP) unless specified otherwise.

Are there recommendations for pregnant and/or lactating persons?

1. Vaccination is recommended for people who are pregnant, lactating, trying to get pregnant now, or who might become pregnant in the near future
2. The American College of Obstetricians and Gynecologists (ACOG) recommend vaccination including pregnant and lactating individuals
   1. If an individual becomes pregnant after the first dose of a COVID-19 vaccine requiring two doses (Pfizer-BioNTech or Moderna), the second dose should be administered as indicated
   2. There are anecdotal reports of temporary changes in menstruation patterns (e.g., heavier menses, early or late onset, and dysmenorrhea) in individuals who have recently been vaccinated for COVID-19
3. ACOG recommends that pregnant and recently pregnant people up to 6 weeks postpartum, including pregnant and recently pregnant health care workers, receive a booster dose of COVID-19 vaccine following the completion of their initial COVID-19 vaccine or vaccine series
4. Although the overall risks are low, pregnant and recently pregnant people (for at least 42 days following the end of pregnancy) with COVID-19 are at increased risk for severe illness (requiring hospitalization, intensive care unit admission, mechanical ventilation, or extracorporeal membrane oxygenation or illness that results in death) when compared with non-pregnant people
5. A growing body of evidence on the safety and effectiveness of COVID-19 vaccination—in both animal and human studies—indicates that the benefits of vaccination outweigh any known or potential risks of COVID-19 vaccination during pregnancy
6. There are limited data on the safety of COVID-19 vaccines in lactating people or the effects of COVID-19 vaccines on the breastfed infant, milk production, and secretion. However, the mRNA vaccines cannot cause infection in the lactating person or infant
7. There is currently no evidence that any COVID-19 vaccines cause fertility problems, however, results from ongoing late-term fertility studies are not yet available (as of 11/23/21)

Are there recommendations for immunocompromised persons? 

1. Eligible immunocompromised people should receive a COVID-19 vaccine series as soon as possible
2. Moderately or severely immunocompromised persons may not mount a protective immune response after initial vaccination, and their protection may wean over time
3. Moderate and severe immunocompromising conditions/treatments include but are not limited to:
   1. Active treatment for solid tumor and hematologic malignancies
   2. Receipt of solid organ transplant and taking immunosuppressive therapy
   3. Receipt of CAR-T cell therapy or hematopoietic cell transplant (HCT) (within 2 years of transplantation or taking immunosuppressive therapy
      1. CAR-T cell therapy or HCT recipients who received doses of COVID-19 vaccination prior to receiving these therapies should be revaccinated with a primary series at least 12 weeks after transplant or CAR-T cell therapy
   4. Moderate or severe primary immunodeficiency (e.g. DiGeorge syndrome, Wiskott-Aldrich syndrome)
   5. Advanced or untreated HIV infection (CD4 count <200/mm3, history of an AIDS defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
   6. Active treatment with high-dose corticosteroids (i.e. ≥20 mg prednisone or equivalent per day when administered for ≥ 2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis factor (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory
   7. For additional questions, ACIP’s general best practices for vaccination of people with altered immunocompetence, the CDC Yellow Book, and the Infectious Diseases Society of America policy statement, 2013 IDSA Clinical Practice Guideline for Vaccination of the Immunocompromised Host, can be consulted for additional information about the degree of immune suppression associated with different medical conditions and treatments
4. Moderately or severely immunocompromised persons aged ≥12 years (Pfizer-BioNTech recipients) or ≥18 years (Moderna recipients) should receive an additional primary dose of the same mRNA COVID-19 vaccine administered for the primary series ≥28 days after completion of the initial 2-dose series (for a 3-dose primary series, this is not the same as a booster dose)
5. All adults are eligible to receive a booster dose of COVID-19 vaccine (see the booster dose section for more information)
6. Considerations for timing:
   1. Whenever possible, doses should be completed at least two weeks before initiation or resumption of immunosuppressive therapies
7. Serologic testing or cellular immune testing outside of the context of research studies is not recommended at this time
8. The Transplantation Society (TTS) has published recommendations for those with solid organ (SOT) and hematopoietic stem cell transplants (HSCT)
   1. Transplant patients may receive any of the approved/authorized COVID-19 vaccines (Moderna, Pfizer-BioNTech, J&J)
   2. All transplant recipients should be vaccinated irrespective of past COVID-19 infection or SARS-CoV-2 antibodies
   3. SOT and HSCT candidates should receive the COVID-19 vaccine
   4. For SOT patients, vaccination should be delayed at least one month after transplant surgery or rejection treatment. Longer delays may be required for patients who received anti-B (i.e., rituximab) or anti-T cell (anti-thymocyte globulin, alemtuzumab)
   5. For HSCT patients in regions with accelerated transmission rates, COVID-19 vaccination may start at the 3rd month of HSCT. In regions where the risk of community acquisition of COVID-19 is lower, it is reasonable to wait until the sixth month after HSCT when better vaccine response is expected
   6. Routine adjustment of immunosuppressive medications before vaccination is not recommended
   7. The development of approaches to educate patients on the importance of vaccination and consider tracking vaccination rates by each center are recommended
   8. In February 2021, a study examining safety of SARS-CoV-2 mRNA vaccines in solid organ transplant patients at Johns Hopkins University was published
      1. 187 solid organ transplant recipients were enrolled
      2. 52% were kidney, 19% liver, 14% heart, 9% lung, 3% kidney/pancreas, and 3% other multiorgan recipients
      3. Maintenance immunosuppression included tacrolimus (87%), mycophenolate (69%) or azathioprine (11%), and steroids (55%)
      4. Participants received the Pfizer-BioNTech (50%) or Moderna (50%) vaccines
      5. Transplant rejection was not seen during early follow-up
      6. Adverse events were similar to the randomized trials of these vaccines
      7. There were no reported cases of Guillain-Barré, Bell’s Palsy, or other neurological diagnoses or allergic reactions requiring epinephrine

Are there recommendations for those with autoimmune diseases?

1. No imbalances were observed in the occurrence of symptoms consistent with autoimmune conditions or inflammatory disorders in clinical trial participants who received mRNA vaccine compared to placebo
2. Those without contraindications may receive an mRNA vaccine
3. If people with autoimmune diseases are immunocompromised because of medications such as high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis factor (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory, recommendations for immunocompromised individuals should be followed

Are there recommendations for those with a history of Guillain-Barré syndrome (GBS)?

1. With few exceptions, ACIP’s general best practice guidelines for immunization does not include history of GBS as a contraindication or precaution to vaccination
2. Those without contraindications may receive an mRNA vaccine
3. Any occurrences of GBS following vaccination should be reported to VAERS

Are there recommendations for those with Bell’s palsy?

1. Cases of Bell’s palsy were reported following vaccination in both the Pfizer-BioNTech and Moderna trials, however, available data were insufficient for the FDA to conclude that the cases were causally related to vaccination
2. Those without contraindications may receive an mRNA vaccine
3. Any occurrences of Bell’s palsy following vaccination should be reported to VAERS

1. This is product dependent.

1. Infrequently, persons who have received dermal fillers may develop swelling at or near the site of filler injection (usually face or lips).
2. This appears to be temporary and can resolve with medical treatment, including corticosteroid therapy.
3. Those who have received injectable dermal fillers who have no contraindications may be vaccinated.
4. These persons should be advised to contact their healthcare provider for evaluation if they develop swelling at or near the site of dermal filler following vaccination. After evaluation, it may be appropriate to file a vaccine adverse events report (VAERS). Information about how to do this can be found under ‘Drug Monitoring’.

Are there recommendations for those receiving antiviral therapy?

1. Administration of antiviral drug(s) at any interval before or after vaccination with any of the currently FDA approved COVID-19 vaccines (including the adenovirus vector J&J vaccine), is unlikely to impair development of a protective antibody response

Are there recommendations for those with a current or prior history of SARS-CoV-2 infection?

1. Vaccination is recommended for everyone aged 5 years and older, regardless of a history of symptomatic or asymptomatic SARS-CoV-2 infection
   1. Current evidence suggests that the risk of SARS-CoV-2 reinfection is low after a previous infection but may increase with time due to waning immunity. Among individuals infected with SARS-CoV-2, substantial heterogeneity exists in their immune response. Conversely, the immune response following COVID-19 vaccination is more reliable, consistent, and predictable
   2. A primary vaccination series decreases the risk of future infections in people with prior SARS-CoV-2 infection. Numerous immunologic studies have consistently shown that vaccination of individuals who were previously infected enhances their immune response, and growing epidemiologic evidence indicates that vaccination following infection further reduces the risk of subsequent infection, including in the setting of increased circulation of more infectious variants
2. Vaccination should be offered after recovery from the acute illness (if the person had symptoms) and criteria have been met for them to discontinue isolation
3. Viral or serologic testing to assess for acute or prior infection solely for the purposes of vaccine decision-making is not recommended as present data are insufficient to determine an antibody titer threshold that indicates when an individual is protected from SARS-CoV-2 infection

Are there recommendations for those with a known SARS-CoV-2 exposure?

1. COVID-19 vaccines are not currently recommended for outbreak management or for post-exposure prophylaxis
2. Protection is not immediate; the vaccine is a 2-dose series and it takes 1 to 2 weeks following the second dose before a person is considered fully vaccinated
3. Because the median incubation of SARS-CoV2 is 4-5 days, current evidence suggests that vaccination of persons following a known SARS-CoV-2 exposure is unlikely to be an effective strategy for preventing disease from that particular exposure
4. Residents with a known COVID-19 exposure living in congregate healthcare settings (e.g., long-term care facilities), where exposure and transmission of SARS-CoV-2 can occur repeatedly for long periods of time, may be vaccinated
5. Residents of other congregate settings (e.g., correctional and detention facilities, homeless shelters) with a known COVID-19 exposure may also be vaccinated, in order to avoid delays and missed opportunities for vaccination given the increased risk for outbreaks in these settings
6. Persons residing in congregate settings (healthcare and non-healthcare) who have had an exposure and are awaiting results of SARS-CoV-2 testing may be vaccinated if the person does not have symptoms consistent with COVID-19
7. For asymptomatic persons or those with mild disease (not requiring supplemental oxygen) who test positive after the 1st dose, the 2nd dose should not be delayed.
8. For persons who develop symptomatic COVID-19 disease after their first dose, defer the administration of the second dose until they have recovered from their acute illness and are eligible to discontinue isolation.

Are there recommendations for persons who test positive for SARS-CoV-2 after receipt of the first dose of vaccine, but before receiving the 2nd dose?

1. Vaccination of people with known infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and they have met criteria to discontinue isolation to avoid potentially exposing healthcare personnel and others

Are there recommendations for people with a history of multisystem inflammatory syndrome in children (MIS-C) or adults (MIS-A)?

1. The mechanisms of MIS-C and MIS-A are not well understood but include a dysregulated immune response to SARS-CoV-2 infection
2. The risk of recurrence of the same dysregulated immune response following reinfection with SARS-CoV-2 or MIS-like illness following vaccination with COVID-19 vaccine is unknown
3. Given the lack of data on the safety of COVID-19 vaccines in people with a history of MIS-C or MIS-A, a conversation between the patient, their guardian(s), and their clinical team or a specialist (e.g., specialist in infectious diseases, rheumatology, or cardiology) is strongly encouraged to assist with decisions about the use of COVID-19 vaccines
4. Given the widespread transmission of SARS-CoV-2 across the United States and increases in hospitalizations of children and adolescents, several experts consider the benefits of COVID-19 vaccination for children and adolescents (i.e., a reduced risk of severe disease including potential recurrence of MIS-C after reinfection) to outweigh a theoretical risk of an MIS-like illness or the risks of myocarditis following COVID-19 vaccination for people who meet all of the following criteria:
   1. Clinical recovery has been achieved, including return to normal cardiac function
   2. It has been ≥90 days since their diagnosis of MIS-C
   3. They are in an area of high or substantial community transmission of SARS-CoV-2 or otherwise have an increased risk for SARS-CoV-2 exposure and transmission; and
   4. Onset of MIS-C occurred before any COVID-19 vaccination
5. Those with a history of MIS-C or MIS-A that do not meet the above criteria may choose to be vaccinated. Considerations may include:
   1. Clinical recovery from MIS-C or MIS-A, including return to normal cardiac function
   2. Personal risk of severe acute COVID-19 (e.g. age, underlying conditions)
   3. Level of COVID-19 community transmission and personal risk of reinfection
   4. Timing of any immunomodulatory therapies

Is vaccination appropriate for patients with Post-COVID conditions Long COVID?

1. Patients with Post-COVID conditions may express vaccine hesitancy due to concerns that vaccination may worsen associated symptoms
2. An observational cohort study of 44 previously hospitalized patients with persistent symptoms found that vaccination was not associated with worsening of symptoms, quality of life, or mental well-being
3. The best way to prevent post-COVID conditions is to prevent COVID-19 illness by getting vaccinated against COVID-19
4. Additional questions about Post-COVID conditions may be answered by the Interim Guidance on Evaluating and Caring for Patients with Post-COVID Conditions

Are there recommendations for persons who received passive antibody therapy (monoclonal antibodies, convalescent plasma, hyperimmune SARS-CoV-2 IVIG)?

1. Data regarding safety or efficacy of COVID-19 vaccines in those who have received passive antibody products or post-exposure prophylaxis is limited
2. Based on the estimated half-life of such products and anticipated period of protection against infection (when receiving anti-SARS-CoV-2 monoclonal antibodies for post-exposure prophylaxis) or reinfection (when receiving passive antibody therapy for treatment), COVID-19 vaccination should be temporarily deferred for:
   1. Passive antibody product used for post-exposure prophylaxis: 30 days
   2. Passive antibody product used for COVID-19 treatment: 90 day
   3. However, if passive antibody products and a COVID-19 vaccine dose are administered within these recommended deferral periods (30 or 90 days), the vaccine dose does not need to be repeated

Are there recommendations for persons receiving antibody therapies that are not specific to COVID-19 (Intravenous immunoglobulin, RhoGAM)?

1. These products are unlikely to substantially impair development of a protective antibody response, and thus may be given simultaneously with or at any interval before or after COVID-19 vaccination

Are there recommendations regarding vaccination of those being tested for tuberculosis?

1. COVID-19 vaccination should not be delayed because of testing for TB infection
2. Testing for TB infection with one of the immune-based methods, either the tuberculin skin test (TST) or an interferon release assay (IGRA), can be done before, after, or during the same encounter as COVID-19 vaccination

Are there recommendations regarding persons who were vaccinated outside the United States?

1. Yes, this depends on the product that they received, and whether it has a World Health Organization Emergency Use Listing (WHO-EUL)
   1. Those who completed all of the recommended doses of a WHO-EUL COVID-19 vaccine not approved or authorized by FDA or people who completed a heterologous (mix and match) series composed of any combination of FDA-approved, FDA-authorized, or WHO-EUL COVID-19 vaccines
      1. Are considered fully vaccinated
      2. Under the EUI, moderately or severely immunocompromised people aged ≥12 years should receive an additional primary dose of Pfizer-BioNTech COVID-19 Vaccine (30 µg formulation [purple cap]) at least 28 days after receiving the second vaccine dose of their primary series
      3. Under the EUI, those aged ≥18 years (including moderately or severely immunocompromised people who received an additional primary dose) should receive a single booster dose of Pfizer-BioNTech COVID-19 Vaccine (30 µg formulation [purple cap]) at least 6 months after completing their primary series
   2. Those who received only the first dose of a multidose WHO-EUL COVID-19 primary series that is not FDA-approved or FDA-authorized, or who received all or some of the recommended doses of a COVID-19 vaccine primary series that is not listed for emergency use by WHO
      1. Should be offered primary vaccination with an FDA-approved or FDA-authorized COVID-19 vaccine (i.e., 2-dose mRNA series or single Janssen dose), with a minimum interval of at least 28 days since receipt of the last dose of a non-FDA-approved/authorized vaccine
      2. After completion of primary vaccination with an FDA-approved or FDA-authorized COVID-19 vaccine, these individuals are considered fully vaccinated, and are not recommended to receive an additional primary or booster dose at this time