Post by Nadica (She/Her) on Nov 8, 2024 3:12:51 GMT
Safety of Simultaneous vs Sequential mRNA COVID-19 and Inactivated Influenza Vaccines - Published Nov 6, 2024
Key Points
Question
What are the comparative reactogenicity, safety, and short-term effects on health-related quality of life of simultaneous vs sequential receipt of messenger RNA (mRNA) COVID-19 and influenza vaccines?
Findings
In this randomized, placebo-controlled clinical trial of 335 persons receiving mRNA COVID-19 and inactivated influenza vaccines simultaneously vs sequentially 1 to 2 weeks apart, the proportion of participants with at least 1 moderate or severe reaction of fever, chills, myalgia, or arthralgia was not higher after simultaneous compared with sequential receipt.
Meaning
The findings support simultaneous administration of mRNA COVID-19 and inactivated influenza vaccines as an acceptable option to achieve timely vaccination.
Abstract
Importance
Limited randomized clinical trial data exist on the safety of simultaneous administration of COVID-19 and influenza vaccines.
Objective
To compare the reactogenicity, safety, and changes in health-related quality of life (HRQOL) after simultaneous vs sequential receipt of messenger RNA (mRNA) COVID-19 vaccine and quadrivalent inactivated influenza vaccine (IIV4).
Design, Setting, and Participants
This randomized, placebo-controlled clinical trial was conducted between October 8, 2021, and June 14, 2023, at 3 US sites. Participants were nonpregnant persons aged 5 years or older with the intention of receiving both influenza and mRNA COVID-19 vaccines.
Interventions
Intramuscular administration in opposite arms of either IIV4 or saline placebo simultaneously with mRNA COVID-19 vaccine at visit 1. Those who received placebo at visit 1 received IIV4 and those who received IIV4 at visit 1 received placebo 1 to 2 weeks later at visit 2.
Main Outcomes and Measures
The primary composite reactogenicity outcome was the proportion of participants with fever, chills, myalgia, and/or arthralgia of moderate or greater severity within 7 days after vaccination visits 1 and/or 2, using a 10% noninferiority margin. Secondary outcomes were solicited reactogenicity events and unsolicited adverse events (AEs) for 7 days after each visit separately and HRQOL after visit 1, assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index. Serious AEs (SAEs) and AEs of special interest (AESIs) were assessed for 121 days. Outcomes were compared between groups.
Results
A total of 335 persons (mean [SD] age, 33.4 [15.1] years) were randomized (169 to the simultaneous group and 166 to the sequential group); 211 (63.0%) were female, and 255 (76.1%) received bivalent BNT162b2 mRNA COVID-19 vaccine. The proportion with the primary composite reactogenicity outcome in the simultaneous group (25.6% [n = 43]) was noninferior to the proportion in the sequential group (31.3% [n = 52]) (site-adjusted difference, –5.6 percentage points [pp]; 95% CI, −15.2 to 4.0 pp). Respective proportions in each group were similar after each visit separately (visit 1, 40 [23.8%] vs 47 [28.3%]; visit 2, 5 [3.0%] vs 9 [5.4%]). No significant group differences in participants with AEs (21 [12.4%] vs 16 [9.6%]), SAEs (1 [0.6%] vs 1 [0.6%]), and AESIs (19 [11.2%] vs 9 [5.4%]) were observed in the simultaneous vs sequential groups, respectively. Among participants with severe reactogenicity, the mean (SD) EQ-5D-5L Index score decreased from 0.92 (0.08) to 0.92 (0.09) prevaccination to 0.81 (0.09) to 0.82 (0.12) postvaccination.
Conclusions and Relevance
In this randomized clinical trial assessing simultaneous vs sequential administration of mRNA COVID-19 and IIV4 vaccines, reactogenicity was comparable in both groups. These findings support the option of simultaneous administration of these vaccines.
Trial Registration
ClinicalTrials.gov Identifier: NCT05028361
Key Points
Question
What are the comparative reactogenicity, safety, and short-term effects on health-related quality of life of simultaneous vs sequential receipt of messenger RNA (mRNA) COVID-19 and influenza vaccines?
Findings
In this randomized, placebo-controlled clinical trial of 335 persons receiving mRNA COVID-19 and inactivated influenza vaccines simultaneously vs sequentially 1 to 2 weeks apart, the proportion of participants with at least 1 moderate or severe reaction of fever, chills, myalgia, or arthralgia was not higher after simultaneous compared with sequential receipt.
Meaning
The findings support simultaneous administration of mRNA COVID-19 and inactivated influenza vaccines as an acceptable option to achieve timely vaccination.
Abstract
Importance
Limited randomized clinical trial data exist on the safety of simultaneous administration of COVID-19 and influenza vaccines.
Objective
To compare the reactogenicity, safety, and changes in health-related quality of life (HRQOL) after simultaneous vs sequential receipt of messenger RNA (mRNA) COVID-19 vaccine and quadrivalent inactivated influenza vaccine (IIV4).
Design, Setting, and Participants
This randomized, placebo-controlled clinical trial was conducted between October 8, 2021, and June 14, 2023, at 3 US sites. Participants were nonpregnant persons aged 5 years or older with the intention of receiving both influenza and mRNA COVID-19 vaccines.
Interventions
Intramuscular administration in opposite arms of either IIV4 or saline placebo simultaneously with mRNA COVID-19 vaccine at visit 1. Those who received placebo at visit 1 received IIV4 and those who received IIV4 at visit 1 received placebo 1 to 2 weeks later at visit 2.
Main Outcomes and Measures
The primary composite reactogenicity outcome was the proportion of participants with fever, chills, myalgia, and/or arthralgia of moderate or greater severity within 7 days after vaccination visits 1 and/or 2, using a 10% noninferiority margin. Secondary outcomes were solicited reactogenicity events and unsolicited adverse events (AEs) for 7 days after each visit separately and HRQOL after visit 1, assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index. Serious AEs (SAEs) and AEs of special interest (AESIs) were assessed for 121 days. Outcomes were compared between groups.
Results
A total of 335 persons (mean [SD] age, 33.4 [15.1] years) were randomized (169 to the simultaneous group and 166 to the sequential group); 211 (63.0%) were female, and 255 (76.1%) received bivalent BNT162b2 mRNA COVID-19 vaccine. The proportion with the primary composite reactogenicity outcome in the simultaneous group (25.6% [n = 43]) was noninferior to the proportion in the sequential group (31.3% [n = 52]) (site-adjusted difference, –5.6 percentage points [pp]; 95% CI, −15.2 to 4.0 pp). Respective proportions in each group were similar after each visit separately (visit 1, 40 [23.8%] vs 47 [28.3%]; visit 2, 5 [3.0%] vs 9 [5.4%]). No significant group differences in participants with AEs (21 [12.4%] vs 16 [9.6%]), SAEs (1 [0.6%] vs 1 [0.6%]), and AESIs (19 [11.2%] vs 9 [5.4%]) were observed in the simultaneous vs sequential groups, respectively. Among participants with severe reactogenicity, the mean (SD) EQ-5D-5L Index score decreased from 0.92 (0.08) to 0.92 (0.09) prevaccination to 0.81 (0.09) to 0.82 (0.12) postvaccination.
Conclusions and Relevance
In this randomized clinical trial assessing simultaneous vs sequential administration of mRNA COVID-19 and IIV4 vaccines, reactogenicity was comparable in both groups. These findings support the option of simultaneous administration of these vaccines.
Trial Registration
ClinicalTrials.gov Identifier: NCT05028361