Boosters
Bella Blankenship, PharmD
Ever since FDA amended the EUAs in late August 2022 for the Moderna COVID-19 vaccine and the Pfizer–BioNTech COVID-19 vaccine to authorize bivalent formulations of the vaccines for use as a booster dose, patients have had questions. Here’s what pharmacists need to know to navigate these important updates.
1. Which patients can receive a Pfizer–BioNTech or Moderna bivalent COVID-19 booster?
To be eligible for an updated bivalent booster, patients must
- Have completed the primary series of Pfizer–BioNTech, Moderna, Novavax, or Janssen/Johnson & Johnson vaccinations
- Had a 2-month period since their last primary series or booster COVID-19 vaccine
Manufacturer-specific age limits
- Patients 0–4 years old are not eligible to receive any bivalent booster (as this story went to press).
- Patients 5 years and older can receive Pfizer–BioNTech’s bivalent booster.
- Patients 6 years and older can receive either Pfizer–BioNTech or Moderna.
Contraindications
Contraindications to the newly approved bivalent booster vaccines remain the same as monovalent doses.
- History of a severe allergic reaction after a previous dose or to a component of another mRNA COVID-19 vaccine
- History of a known diagnosed allergy to a component of the COVID-19 vaccine
2. Can a patient who completed their primary series of Pfizer–BioNTech receive a Moderna bivalent booster, and vice versa?
People age 6 years and older may get a different product for a booster than they got for their primary series, as long as it is Pfizer–BioNTech or Moderna. Eligible children 5 years of age who completed their primary series (with either Moderna or Pfizer–BioNTech) may only receive Pfizer–BioNTech for their bivalent booster.
3. My pharmacy stocks so many COVID-19 formulations. How do I prevent vaccine mix-ups?
Strategies to avoid vaccine mix-ups include
Human safeguards
- Double-check correct formulation as part of a drug utilization review process.
- Verify formulation with another individual before administration (e.g., pharmacist, technician, student pharmacist).
Administrative safeguards
- Use color-coded bins with specific labels for each formulation.
- Keep monovalent and bivalent vials in separate locations within the refrigerator, or in separate refrigerators if possible.
Technology safeguards
- Utilize barcode scanning whenever possible.
Vaccine administration errors contribute to decreased vaccine confidence among patients. If an error occurs, follow your organization’s error reporting protocols.
4. How should I respond to patients who are concerned that the bivalent boosters have not been studied in humans?
Pharmacists should be sure to use opportunities to answer patient’s questions on the new vaccines and to instill vaccine confidence. There are several key points to make when easing a patient’s concerns on this issue:
- Emphasize that every year the influenza vaccine composition changes and is not re-studied in humans.
- mRNA vaccine technology is easily manipulated to develop boosters as the most prevalent strains evolve.
5. How does preparation, administration, and storage differ from other COVID-19 vaccine formulations?
Pfizer–BioNTech
- Labeling: Vials for 5–11 year olds have an orange cap and a label with an orange border. Vials for people age 12 years and over have a gray cap and a label with a gray border.
- Dose: Bivalent boosters are administered in the same manner as primary vaccines, but the doses differ between 5–11 year olds (0.2 mL or 10 mcg) and those 12 and older (0.3 mL or 30 mcg).
- Storage: Bivalent booster vials are stored in the same manner as previous formulations, in the refrigerator for up to 10 weeks and at room temperature for up to 12 hours.
Moderna
- Labeling: These vials have a dark blue cap and a label with a gray border that reads “Bivalent.”
- Dose: Bivalent boosters are all administered intramuscularly, but the dose varies by age. Patients 6–11 years old receive a 0.25 mL (25 mcg) dose while patients 12 and older receive a 0.5 mL (50 mcg) dose.
- Storage: Bivalent booster vials are stored in the same manner as previous formulations, in the refrigerator for up to 30 days and at room temperature for 24 hours. ■