Safety of co-administration of mRNA COVID-19 and seasonal inactivated influenza vaccines in the vaccine adverse event reporting system (VAERS) during July 1, 2021–June 30, 2022

Moro, Pedro L.; Zhang, Bicheng; Ennulat, Carol; Harris, Margaret; McVey, Rachel; Woody, Gina; Marquez, Paige; McNeil, Michael M.; Su, John R.

doi:10.1016/j.vaccine.2022.12.069

Cited by 16 publications

(12 citation statements)

References 14 publications

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“…This observation is supported by a recent report on COVID-19 and seasonal influenza vaccine co-administration from the US Vaccine Adverse Event Reporting System, which concluded that co-administration of the first mRNA COVID-19 booster dose (Moderna or Pfizer-Biotech) and seasonal influenza vaccines did not reveal any unusual or unexpected pattern of AEs. 31 …”

Section: Discussionmentioning

confidence: 99%

No immunological interference or concerns about safety when seasonal quadrivalent influenza vaccine is co-administered with a COVID-19 mRNA-1273 booster vaccine in adults: A randomized trial

Naficy,

Kuxhausen,

Seifert

et al. 2024

Human Vaccines & Immunotherapeutics

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The objective of the study was to assess the safety and immunogenicity of mRNA-1273 COVID-19 booster vaccination when co-administered with an egg-based standard dose seasonal quadrivalent influenza vaccine (QIV). This was a phase 3, randomized, open-label study. Eligible adults aged ≥ 18 years were randomly assigned (1:1) to receive mRNA-1273 (50 µg) booster vaccination and QIV 2 weeks apart (Seq group) or concomitantly (Coad group). Primary objectives were non-inferiority of haemagglutinin inhibition (HI) and anti-Spike protein antibody responses in the Coad compared to Seq group. 497/498 participants were randomized and vaccinated in the Seq/Coad groups, respectively. The adjusted geometric mean titer/concentration ratios (95% confidence intervals) (Seq/Coad) for HI antibodies were 1.02 (0.89–1.18) for A/H1N1, 0.93 (0.82–1.05) for A/H3N2, 1.00 (0.89–1.14] for B/Victoria, and 1.04 (0.93–1.17) for B/Yamagata; and 0.98 (0.84–1.13) for anti-Spike antibodies, thus meeting the protocol-specified non-inferiority criteria. The most frequently reported adverse events in both groups were pain at the injection site and myalgia. The 2 groups were similar in terms of the overall frequency, intensity, and duration of adverse events. In conclusion, co-administration of mRNA-1273 booster vaccine with QIV in adults was immunologically non-inferior to sequential administration. Safety and reactogenicity profiles were similar in both groups (clinicaltrials.gov NCT05047770).

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Section: Discussionmentioning

confidence: 99%

No immunological interference or concerns about safety when seasonal quadrivalent influenza vaccine is co-administered with a COVID-19 mRNA-1273 booster vaccine in adults: A randomized trial

Naficy,

Kuxhausen,

Seifert

et al. 2024

Human Vaccines & Immunotherapeutics

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“…We believe the findings from our study are novel and have important public health implications for future autumn or winter vaccination campaigns. While the CDC recommended coadministration of COVID-19 vaccine and SIV in the 2022-2023 season, this was based primarily on safety data from clinical trial and community settings that suggested similar or only marginally higher rates of reactogenicity with coadministration . However, to our knowledge, no data describing the impact of coadministration of COVID-19 vaccines and SIV were available before our study.…”

Section: Discussionmentioning

confidence: 99%

“…While the CDC recommended coadministration of COVID-19 vaccine and SIV in the 2022-2023 season, 27 this was based primarily on safety data from clinical trial and community settings that suggested similar or only marginally higher rates of reactogenicity with coadministration. 15 , 16 , 17 , 19 , 20 However, to our knowledge, no data describing the impact of coadministration of COVID-19 vaccines and SIV were available before our study. Our findings, which describe coadministering these vaccines in a diverse population of more than 3 million US adults during the most recent 2022-2023 respiratory infection season, provide contemporary data from routine clinical practice, and may help reassure health care professionals that giving these vaccines together is not only safe, but likely to yield similar effectiveness against COVID-19– and influenza-related outcomes.…”

Section: Discussionmentioning

confidence: 99%

“…During the 2020-2021 and 2021-2022 influenza seasons, the US Centers for Disease Control and Prevention (CDC) recommended COVID-19 and influenza vaccines be administered 14 or more days apart, given that no data describing the safety, immunogenicity, or efficacy of coadministering these vaccines were available at the time. 14 Subsequently, data from clinical trials 15 , 16 , 17 , 18 and community settings 19 , 20 , 21 emerged showing the 2 vaccines could be safely coadministered. Based on these emerging safety data and evidence that coadministration improves uptake, 22 , 23 , 24 , 25 , 26 the CDC revised COVID-19 vaccine recommendations to allow coadministration with SIVs for the 2022-2023 season.…”

Section: Introductionmentioning

confidence: 99%

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Estimated Effectiveness of Coadministration of the BNT162b2 BA.4/5 COVID-19 Vaccine With Influenza Vaccine

McGrath,

Malhotra,

Miles

et al. 2023

JAMA Netw Open

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ImportanceNo data comparing the estimated effectiveness of coadministering COVID-19 vaccines with seasonal influenza vaccine (SIV) in the community setting exist.ObjectiveTo examine the comparative effectiveness associated with coadministering the BNT162b2 BA.4/5 bivalent mRNA COVID-19 vaccine (BNT162b2-biv [Pfizer BioNTech]) and SIV vs giving each vaccine alone.Design, Setting, and ParticipantsA retrospective comparative effectiveness study evaluated US adults aged 18 years or older enrolled in commercial health insurance or Medicare Advantage plans and vaccinated with BNT162b2-biv only, SIV only, or both on the same day between August 31, 2022, and January 30, 2023. Individuals with monovalent or another brand of mRNA bivalent COVID-19 vaccine were excluded.ExposureSame-day coadministration of BNT162b2-biv and SIV; receipt of BNT162b2-biv only (for COVID-19–related outcomes) or SIV only (for influenza-related outcomes) were the comparator groups. For adults aged 65 years or older, only enhanced SIVs were included.Main Outcomes and MeasuresCOVID-19–related and influenza-related hospitalization, emergency department (ED) or urgent care (UC) encounters, and outpatient visits.ResultsOverall, 3 442 996 individuals (57.0% female; mean [SD] age, 65 [16.7] years) were included. A total of 627 735 individuals had BNT162b2-biv and SIV vaccine coadministered, 369 423 had BNT162b2-biv alone, and 2 445 838 had SIV alone. Among those aged 65 years or older (n = 2 210 493; mean [SD] age, 75 [6.7] years; 57.9% female), the coadministration group had a similar incidence of COVID-19–related hospitalization (adjusted hazard ratio [AHR], 1.04; 95% CI, 0.87-1.24) and slightly higher incidence of emergency department or urgent care encounters (AHR, 1.12; 95% CI, 1.02-1.23) and outpatient visits (AHR, 1.06; 95% CI, 1.01-1.11) compared with the BNT162b2-biv–only group. Among individuals aged 18 to 64 years (n = 1 232 503; mean [SD] age, 47 [13.1] years; 55.4% female), the incidence of COVID-19–related outcomes was slightly higher among those who received both vaccines vs BNT162b2-biv alone (AHR point estimate range, 1.14-1.57); however, fewer events overall in this age group resulted in wider CIs. Overall, compared with those who received SIV alone, the coadministration group had a slightly lower incidence of most influenza-related end points (AHR point estimates 0.83-0.93 for those aged ≥65 years vs 0.76-1.08 for those aged 18-64 years). Negative control outcomes suggested residual bias and calibration of COVID-19–related and influenza-related outcomes with negative controls moved all estimates closer to the null, with most CIs crossing 1.00.Conclusions and RelevanceIn this study, coadministration of BNT162b2-biv and SIV was associated with generally similar effectiveness in the community setting against COVID-19–related and SIV-related outcomes compared with giving each vaccine alone and may help improve uptake of both vaccines.

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“… 4 Additionally, studies have not reported any new or unexpected safety concerns, and the safety profile of each vaccine when administered alone aligns with published studies on co-administration of these vaccines. 31 Possibly, the organizational model adopted this year, consisting of five pairs of days between October and December, compared to the previous year when the vaccination center operated daily, has contributed to the increase in co-administration. In the previous year, approximately 1,200 healthcare workers administered both vaccines but on separate days, as they had the flexibility to visit the center daily and space out the two administrations.…”

Section: Discussionmentioning

confidence: 99%

Co-administration of SARS-CoV-2 and influenza vaccines in healthcare workers: Results of two vaccination campaigns in a large teaching hospital in Rome

Pascucci,

Lontano,

Regazzi

et al. 2023

Human Vaccines & Immunotherapeutics

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The concurrent administration of COVID-19 and influenza vaccines has arisen as a promising approach to bolster protection against respiratory pathogens and improve vaccination rates. However, there remains a lack of data regarding the prevalence of co-administration across several vaccination campaigns, especially among healthcare workers (HCWs). Therefore, this study aims to shed light on the acceptance of co-administration strategies among HCWs during the two campaigns following the introduction of the anti-SARS-CoV-2 vaccine. A retrospective cohort study was conducted among the HCWs of the Fondazione Policlinico Universitario “A. Gemelli” IRCCS, a research hospital in Rome. Hospital administrative databases were accessed to gather information about vaccination for SARS-CoV-2 and influenza during the 2021/2022 and 2022/2023 vaccination campaigns. The study included 7399 HCWs. The co-administration of anti-SARS-CoV-2 and influenza vaccines presented a significant rise in 2022/2023 compared to the previous vaccination campaign (+38%): this was confirmed for every professional category, with the largest increases among resident doctors (+47%) and physicians (+44%), and also for every age category, but it was particularly evident for the youngest health professionals. The probability of co-administration uptake during the 2022/2023 campaign was significantly higher for males, and for those that received co-administration during the 2021/2022 campaign, while the probability was lower for nurses and administrative staff. This study highlights the co-administration procedure as a valuable and effective tool in annual vaccination campaigns for SARS-CoV-2 and influenza. The procedure’s safety and streamlined logistics make it increasingly attractive for implementation, particularly among HCWs.

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Safety of co-administration of mRNA COVID-19 and seasonal inactivated influenza vaccines in the vaccine adverse event reporting system (VAERS) during July 1, 2021–June 30, 2022

Cited by 16 publications

References 14 publications

No immunological interference or concerns about safety when seasonal quadrivalent influenza vaccine is co-administered with a COVID-19 mRNA-1273 booster vaccine in adults: A randomized trial

No immunological interference or concerns about safety when seasonal quadrivalent influenza vaccine is co-administered with a COVID-19 mRNA-1273 booster vaccine in adults: A randomized trial

Estimated Effectiveness of Coadministration of the BNT162b2 BA.4/5 COVID-19 Vaccine With Influenza Vaccine

Co-administration of SARS-CoV-2 and influenza vaccines in healthcare workers: Results of two vaccination campaigns in a large teaching hospital in Rome

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