Safety Monitoring of COVID-19 mRNA Vaccine Second Booster Doses Among Adults Aged ≥50 Years — United States, March 29, 2022–July 10, 2022

Hause, Anne M.; Baggs, James; Marquez, Paige; Abara, Winston E.; Baumblatt, Jane; Blanc, Phillip G.; Su, John R.; Hugueley, Brandon; Parker, Casey; Myers, Tanya R.; Gee, Julianne; Shimabukuro, Tom T.; Shay, David K.

doi:10.15585/mmwr.mm7130a4

Cited by 25 publications

(35 citation statements)

References 6 publications

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“…Reporting frequencies of reactions and health impacts among the 211,959 v-safe registrants aged ≥12 years who received an age-appropriate bivalent booster vaccination are similar to those described after receipt of first and second booster vaccine doses among adults aged ≥50 years ( 3 – 5 ). Among adults aged ≥18 years, reporting frequencies of local and systemic reactions after bivalent booster vaccination decreased with increasing age.…”

Section: Discussionmentioning

confidence: 69%

“…As of October 12, 2022, ACIP recommends that all persons aged ≥5 years receive an age-appropriate bivalent mRNA booster dose ≥2 months after completion of a COVID-19 primary series or receipt of a monovalent booster dose (3). Preliminary safety findings after bivalent booster vaccination among persons aged ≥12 years are similar to those after monovalent booster vaccination (3)(4)(5). Health care providers and patients can be reassured that adverse events reported after a bivalent booster dose are consistent with those reported after monovalent doses.…”

Section: Review Of Vaers Datamentioning

confidence: 59%

“…Most reports to VAERS for persons aged ≥12 years after a bivalent booster dose were nonserious (95.5%) and were usually similar to those after first booster vaccination and second booster vaccination among adults aged ≥50 years (3)(4)(5). Vaccination errors were among the most common events reported to VAERS (34.5%); most (88.2%) of which did not list an adverse health event.…”

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

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

Hause¹,

Marquez²,

Zhang³

et al. 2022

MMWR Morb. Mortal. Wkly. Rep.

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Section: Discussionmentioning

confidence: 69%

Section: Review Of Vaers Datamentioning

confidence: 59%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

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

Hause¹,

Marquez²,

Zhang³

et al. 2022

MMWR Morb. Mortal. Wkly. Rep.

Self Cite

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“…mRNA vaccines are reactogenic, commonly leading to considerable injection site effects and systemic effects, such as fever, myalgia or headache. Higher reactogenicity of mRNA-1273 versus BNT162b2 is observed but the cause of these differences is unclear 7 . Possible factors include a higher dose of mRNA in the mRNA-1273 formulation and/or differences in the LNP composition.…”

Section: Potential Impact Of Anti-peg Antibodiesmentioning

confidence: 97%

Impact of anti-PEG antibodies induced by SARS-CoV-2 mRNA vaccines

Carreño

Simon

et al. 2022

Nat Rev Immunol

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“…The COVID-19 Citizen Science study [ 1 ] and social media analytics [ 2 , 3 ] address some knowledge gaps, but not social- and age-related barriers to participation. Passive surveillance data [ 4 ] are subject to the same limitations and insufficient follow-up. Alternative research strategies are needed to complement the existing evidence base.…”

Section: Introductionmentioning

confidence: 99%

The Incidence and Effect of Adverse Events Due to COVID-19 Vaccines on Breakthrough Infections: Decentralized Observational Study With Underrepresented Groups

Gabashvili¹

2022

JMIR Form Res

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Background Despite continuing efforts to improve the inclusion of underserved groups in clinical research, gaps in diversity remain. Participation of special populations is especially important when facing problems of unprecedented complexity such as the COVID-19 pandemic. A better understanding of factors associated with the immune response in diverse populations would advance future preventive and curative approaches. Objective The objective of this study was to investigate the factors potentially responsible for adverse events following COVID-19 immunization. The study population included adults from rural areas, transitional countries, and those with medically understudied conditions, across a broad age range. Methods The study evolved from peer support networks developed during the COVID-19 pandemic. Participants were recruited digitally through online neighborhood and health communities. Some of the participants volunteered as study investigators assisting with offline recruitment and safety monitoring. Individuals who consented to participate were asked to share their vaccination experiences either using constantly evolving web-based surveys or via one-on-one communication. Inferential statistical analysis to estimate differences between study groups was performed using parametric and nonparametric tests. Results Of 1430 participants who shared their vaccination experiences, 648 had outcome measures at their 1.5-year follow-up. Significant differences were found between age groups, types of vaccine adverse events (VAEs), incidences of breakthrough infections, and health conditions linked to the microbiome. Pairwise comparisons showed that VAEs interfering with daily activities were significantly higher in both younger (18-59 years) and older age groups (80-100 years, P<.001) than in the 60-79–year age group. Short-term VAEs were associated with lower incidence of breakthrough COVID-19 infections relative to those who reported either minimal or long-term adverse events (P<.001). A genetic origin was suggested for some adverse reactions. Conclusions The findings of this study demonstrate that vaccine adverse reactions in older individuals are being overlooked, and the incidence of VAEs impairing immunity may be higher than previously perceived. Better preventive measures are needed for all those at risk for life-threatening and long-term adverse events due to vaccination. Supportive community-based studies focusing on these populations could add important data to the current body of knowledge. Further and more comprehensive studies should follow. Trial Registration ClinicalTrials.gov NCT04832932; https://clinicaltrials.gov/ct2/show/NCT04832932 International Registered Report Identifier (IRRID) RR2-10.1101/2021.06.28.21256779

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Safety Monitoring of COVID-19 mRNA Vaccine Second Booster Doses Among Adults Aged ≥50 Years — United States, March 29, 2022–July 10, 2022

Cited by 25 publications

References 6 publications

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

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

Impact of anti-PEG antibodies induced by SARS-CoV-2 mRNA vaccines

The Incidence and Effect of Adverse Events Due to COVID-19 Vaccines on Breakthrough Infections: Decentralized Observational Study With Underrepresented Groups

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