Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Persons Aged ≥12 Years — United States, August 31–October 23, 2022

Antibody response to third and fourth BNT162b2 mRNA booster vaccinations in healthcare workers in Tokyo, Japan

“…The situation surrounding vaccine administration has changed frequently. For example, administration of fourth and fifth vaccinations has started, and bivalent mRNA vaccines for the B.1.1.529 (Omicron) variants have been approved [ 27 ]. These bivalent vaccines were authorized for use as booster vaccines after two doses of the monovalent vaccination.…”

Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Children Aged 5–11 Years — United States, October 12–January 1, 2023

“…Among events reported to VAERS, vaccination errors were reported with a similar frequency among children aged 5–11 years after monovalent (71%) or bivalent (84%) booster vaccination ( 7 ). Vaccination errors represented a smaller proportion of events (35%) reported among persons aged ≥12 years who received bivalent booster vaccination ( 4 ). CDC provides updated clinical guidance, educational materials, and training opportunities after each update to COVID-19 vaccine recommendations.…”

“…The Advisory Committee on Immunization Practices (ACIP) recommends that all persons aged ≥6 months receive an age-appropriate bivalent mRNA booster dose ( 3 ). The safety of bivalent mRNA booster doses among persons aged ≥12 years has previously been described ( 4 ). To characterize the safety of bivalent mRNA booster doses among children aged 5–11 years after receipt of bivalent Pfizer-BioNTech and Moderna booster doses, CDC reviewed adverse events and health impacts reported to v-safe, * a voluntary, smartphone-based U.S. safety surveillance system established by CDC to monitor adverse events after COVID-19 vaccination, and to the Vaccine Adverse Event Reporting System (VAERS), a U.S. passive vaccine safety surveillance system co-managed by CDC and FDA † ( 5 ).…”

Vaccination and treatment options for SARS-CoV2 infection affecting lactation and breastfeeding

“…With the emergence of COVID-19 variants, the US Food and Drug Administration (FDA) has authorized the bivalent formulations of the Pfizer and Moderna mRNA COVID-19 vaccines, which target the original strain of SARS-CoV-2 and the Omicron variants BA.4 and BA.5. 33 While data specific to the bivalent vaccines in lactating people are not available, a review of the adverse events reported during August 31, 2022 to October 23, 2022, which was the time period after initial authorization of the bivalent vaccines, indicated that most events were nonserious. Among the 211,959 persons who voluntarily reported to the v-safe system, the most common event was injection site reaction (e.g., itching, pain, redness, swelling or hardness) (60.8%), followed by fatigue (40.4%), headache (30.6%), and myalgia (29.6%) within the week after vaccination.…”

“…Among the 211,959 persons who voluntarily reported to the v-safe system, the most common event was injection site reaction (e.g., itching, pain, redness, swelling or hardness) (60.8%), followed by fatigue (40.4%), headache (30.6%), and myalgia (29.6%) within the week after vaccination. 33 Of the 5,542 reports received through the Vaccine Adverse Event Reporting System (VAERS) during the same time period, most were also considered nonserious, such as headache (11.9%), fatigue (10.9%), and fever (10.6%). The minority (4.5%) of reports were considered serious based on need for hospitalization, prolonged hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death.…”