Bivalent COVID-19 Vaccine Boosters Granted Emergency Use Authorization
Column Author: Christine Symes, MSN, APRN, CPNP | Infectious Diseases
Column Editor: Angela Myers, MD, MPH | Director, Division of Infectious Diseases | Professor of Pediatrics, UMKC School of Medicine | Medical Editor, The Link Newsletter
On Aug. 31 the United States Food and Drug Administration amended the emergency use authorization of the Moderna COVID-19 and the Pfizer-BioNTech COVID-19 vaccines to authorize bivalent formulations for single booster doses. The Advisory Committee on Immunization Practices for the Centers for Disease Control and Prevention voted on Sept. 1 to endorse the recommendation for updated boosters for children 12 years of age and older. These boosters should be given at least two months following completion of a primary vaccine series or previous booster vaccination. These vaccines contain two messenger RNA (mRNA) components of the SARS-CoV-2 virus. One is the original strain of SARS CoV-2 (BA.1) to provide an immune response that is broadly protective against COVID-19, and the other is an mRNA component common to both the Omicron BA.4 and BA.5 lineages of the virus. The goal of these updated vaccines is to have a vaccine that is best matched to the predominantly circulating Omicron variants of the virus.1
The Moderna vaccine is authorized as a single booster dose in individuals 18 years and older. The Pfizer-BioNTech vaccine is authorized as a single booster dose in those 12 years of age and older. The previous monovalent mRNA COVID-19 vaccines are no longer authorized as booster doses for individuals 12 years of age and older. Side effects from the bivalent booster vaccine are anticipated to be the same as commonly reported side effects from the previous monovalent mRNA COVID-19 vaccines. Both are contraindicated in those with previous severe allergic reaction to any component of the Pfizer-BioNTech or Moderna COVID-19 vaccines.
Specifics on Pfizer-BioNTech bivalent vaccine
Vial: Gray top vial
Storage: Pfizer-BioNTech COVID-19 Vaccine, Bivalent may arrive frozen at ultra-cold conditions in thermal containers with dry ice. Once received, frozen vials may be immediately transferred to the refrigerator 2°C to 8°C (35°F to 46°F), thawed, and stored for up to 10 weeks. Vials may be stored at room temperature 8°C to 25°C (46°F to 77°F) for a total of 12 hours prior to the first puncture. After first puncture, the multiple dose vial should be held between 2°C and 25°C (35°F to 77°F) and discarded 12 hours after first puncture.
Doses per vial: 6 doses per vial
Dilution: No dilution needed2
FACT Sheet Link: Pfizer bivalent vaccine fact sheet
Specifics on Moderna bivalent vaccine
Vial: Dark blue top vial
Storage: The Moderna COVID-19 Vaccine multiple dose vials are stored frozen between -50°C and -15°C (-58°F to 5°F). During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Vials can be stored refrigerated between 2°C and 8°C (36°F to 46°F) for up to 30 days prior to first use. Vials may be stored at room temperature between 8°C and 25°C (46°F to 77°F) for a total of 24 hours. Vials should be discarded 12 hours after the first puncture.
Doses per vial: 5 doses per vial
Dilution: No dilution needed3
FACT Sheet Link: Moderna bivalent vaccine fact sheet
August 2022 COVID-19 statistics
In the month of August 2022, daily average rates for new COVID-19 cases in the U.S. were 69,828. Daily average new deaths from COVID-19 were 342. Daily average new hospital admissions were 4,396. In all individuals >5 years of age, 34.8% had received their complete primary vaccine series and at least one booster dose.4 Uptake of the vaccine for the 6 months-4 years age group has been slow, with only 7% receiving at least one dose of the vaccine.
White House health officials held a briefing Sept. 6 to stress the importance for all people over the age of 12 to be vaccinated with the primary series and boosted if it has been more than two months since their last booster or completion of the primary series. The officials also said that vaccinations “will likely shift to an annual injection, tailored to the latest strains, for the majority of the population, with more frequent doses offered for higher-risk people.”5 It is anticipated that the bivalent COVID-19 made by Pfizer will be authorized for children 5-11 years sometime in October. Moderna is also seeking emergency use authorization of its updated vaccine in the 6- to 11-year-old and 12- to 17-year-old age groups. It will be great if the bivalent booster is available and recommended for these ages as they come in for their annual influenza vaccine over the next few months.
COVID-19 vaccines remain the best tool to prevent people from getting seriously ill, being hospitalized, and dying from COVID-19 illness. People get the most protection from COVID-19 by staying up to date with the recommended vaccines, including recommended boosters.
- Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose | FDA