Moderna COVID-19 Vaccine

by David O. Freedman, M.D. last updated 2022-09-13 10:30:03.834303-04:00 © Antimicrobial Therapy, Inc.
Spikevax, mRNA-1273

Introduction

  • CDC vaccination recommendations updated as of Sept 1, 2022 for new bivalent booster vaccines.
  • Omicron-containing booster vaccines (all booster doses now bivalent) should retain neutralization for original SARS-CoV-2, induce a strong response against BA.5 and induce broad cross-neutralization against future variants.
  • Moderna COVID-19 Vaccine, Bivalent is restricted to 18 years of age and older as a one-time only booster at least 2 months after either completion of primary vaccination with any monovalent vaccine, or receipt of the most recent booster dose with any monovalent vaccine.
  • Only monovalent and not bivalent vaccines are authorized at this time for primary series doses in heretofore unvaccinated persons.
  • The 2-month interval for a bivalent booster in the multiply boosted is arbitrary and considerable evidence on boosters in general indicates a longer interval is optimal; further study is required.
  • See COVID-19, Vaccines for general vaccine indications, efficacy, duration of protection, choice and interchangeability

Vaccine

  • Type:  Lipid nanoparticle (LNP) encapsulated mRNA
  • Moderna COVID-19 Vaccine, Monovalent (original strain). (Spikevax; mRNA-1273)
  • Moderna COVID-19 Vaccine, Bivalent (original and Omicron BA.4/BA.5). Not branded at present.

Dose

  • Available Moderna vaccine vials in the US. Choice of product (differential color-coded vials) should be under the supervision of a pharmacist.

Age

indication

Vaccine

composition

Primary series

Booster dose

Dose

Injection volume

Dose

Injection volume

6 months–5 years

Monovalent

25 µg

0.25 mL

NA

NA

6–11 years

Monovalent

50 µg

0.5 mL

NA

NA

12–17 years

Monovalent

100 µg

0.5 mL

NA

NA

18 years and older

Monovalent

100 µg

0.5 mL

NA

NA

18 years and older

Bivalent

NA

NA

50 µg

0.5 mL

Schedule (normal host)

 

Age
group

Number of primary doses

Number of bivalent booster doses

Recommended bivalent booster dose

Interval between 1st and 2nd primary dose*

Interval between primary series and booster dose

6 mos–5 yrs

2

None

NA

4–8 wks

NA

6–11 yrs

2

None

NA

4–8 wks

NA

12–17 yrs

2

1

Pfizer-BioNTech

4–8 wks

>2 months

>18 years and older

2

1

Moderna or Pfizer-BioNTech

4–8 wks

>2 months

Storage

  • Store as follows:
    • -50°C to -15°C (-58°F to 5°F): Until expiration date
    • 2-8°C (36-46°F): 30 days
    • 8-25°C (46-77°F): 24 hrs
    • After first puncture 2-25°C (36-77°F): Discard after 12 hrs

Toxicities

Contraindications

  • Anaphylaxis or immediate allergic reaction (within 4h) to a previous dose of an mRNA vaccine or separately to a vaccine constituent including polyethylene glycol (PEG) or polysorbate. 
    • Do not vaccinate with any mRNA vaccine
  • History of a known diagnosed allergy to a vaccine component

Precautions

  • Immediate allergic reaction (within 4h) to any other vaccine or injectable therapy not related to a component of mRNA-COVID-19 vaccines or polysorbate.
  • Persons with a reaction to a vaccine or injectable therapy that contains PEG
  • History of myocarditis or pericarditis after a dose of an mRNA or Novavax COVID-19 vaccine, avoid future doses of any COVID-19 vaccine
  • Allergy-related contraindication to one type of COVID-19 vaccine is a precaution to the other types of COVID-19 vaccines
  • Defer vaccination until resolution of a moderate or severe acute illness, with or without fever

Not contraindications

  • Food (including egg and gelatin), pet, insect, venom, environmental, latex, oral medications; any other history of anaphylaxis not related to vaccine or injectables.
  • History of GBS in proximity to another vaccine.

Adverse effects

  • Similar safety profile when  monovalent or bivalent vaccine is used as a 4th dose (2nd booster)
  • Pain at the injection site, sometimes severe, occurs frequently
  • Fatigue, headache, and myalgia common but are mild to moderate, occurring within 1–2 days of vaccination, and resolving within 1–2 days of onset.
    • more frequent following dose 2 and among adolescents and younger adults compared with older adults.
  • Myocarditis: 131 myocarditis cases reported to VAERS after 123 million mRNA booster vaccinations
    • Risk primarily in adolescent and young adult males
    • No increase in children ages 5–11 years following 1st booster
    • Rates are lower following 1st booster dose vs. dose 2 of primary series (and lower following dose 1 vs. dose 2 of primary series)
    • 8-week interval between the first and second primary series doses of Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccines may be optimal for some people to reduce myocarditis.

Special Populations

Pregnancy

  • Vaccinate according to standard recommendations if pregnant, breastfeeding, attempting or contemplating conception
    • Pregnant and recently pregnant persons at increased risk for severe illness and the fetus is at increased risk
  • Benefits outweighs risks of vaccination
  • Antibodies are transferred to the newborn
  • No contraindications to breastfeeding

Immunocompromised / HIV

Age
group

Number of primary doses (all monovalent)

Number of bivalent booster doses

Recommended bivalent booster dose

Interval between 1st and 2nd primary dose

Interval between 2nd and 3rd primary dose

Interval between primary series and booster dose

6 mos–5 yrs

3

None

NA

4 weeks

>4 weeks

NA

6–11 yrs

3

None

NA

4 weeks

>4 weeks

NA

12–17  yrs

3

1

Pfizer-BioNTech

4 weeks

>4 weeks

>2 months

>18 yrs

3

1

Moderna or Pfizer-BioNTech

4 weeks

>4 weeks

>2 months

  • Self-attestation to moderately or severely immunocompromised status is acceptable
  • New immunocompromise after a 2-dose mRNA primary series do not need additional primary doses;  immunocompromised schedule for the booster dose.
  • Revaccinate HCT or CAR-T-cell therapy recipients with an mRNA vaccine or Novavax >3 months after HCT or CAR-T-cell therapy 
  • Consider revaccination if 1 or more doses of vaccine (primary series and bivalent booster doses) received during short-course treatment with B-cell-depleting therapies (e.g., rituximab, ocrelizumab)  beginning at about 6 months after completion of therapy
  • Administration of vaccines should not be delayed in patients on ongoing immunosuppressives
    • Administer vaccine doses approximately 4 weeks before the next scheduled therapy for patients on ongoing B-cell-depleting therapies

Serologic Testing

  • Antibody testing is not recommended to assess for immunity following COVID-19 vaccination or to assess the need for vaccination in an unvaccinated person
    • No correlates of protection are available and assays vary widely
    • +ve IgG only minimally reassuring, -ve IgG unhelpful in patients whose ability to mount a B-cell response is uncertain

Comments

  • Age-appropriate vaccine product and dosage is based on age on the day of vaccination.
    • a move from a younger age group to an older age group during the primary series, requires the vaccine product and dosage for the older age group
  • Vaccines are not recommended for outbreak management or for post-exposure prophylaxis
  • mRNA vaccines do not have a risk of modifying the vaccine recipient’s genetic makeup as mRNA does not enter cell nucleus where host DNA is located.