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

ABSTRACT

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).

Plain Language Summary

What is the context?

• Updated booster shots against COVID-19 disease are likely to offer more protection as the virus is changing over time.

• It is important for doctors, other healthcare providers and patients to know whether COVID-19 booster vaccines can be given at the same time as other vaccines recommended for adults.

What is new?

• The results of our study showed that an mRNA-based COVID-19 booster vaccine could be given at the same time as the seasonal influenza vaccine.

• When given together, both vaccines led to immune responses and had side effects that were similar to those observed when they were given at separate times.

What is the impact?

• The potential benefits of administering more than 1 vaccine during a healthcare visit include improved coverage and a reduced number of doctor visits needed to receive all vaccines.

• Co-administration of COVID-19 booster vaccines and influenza vaccines could be an attractive option for patients and healthcare professionals.

KEYWORDS:

• Co-administration
• COVID-19 vaccine
• immunogenicity
• influenza vaccine
• mRNA-1273

Acknowledgments

The authors thank the participants, site personnel and investigators who took part in the study. The authors also thank PPD (part of Thermo Fisher Scientific), Moderna, and GSK project team members for their contribution to the study and/or development of the manuscript, especially Amy Page (GSK), Marta Palla (GSK), Tomas Mrkvan (GSK). The authors also thank Business & Decision Life Sciences Medical Communication Service Center for editorial assistance and manuscript coordination, on behalf of GSK. Dr Joanne Wolter (independent, on behalf of GSK) provided writing support.

Disclosure statement

Abdi Naficy is employed by GSK and holds shares in GSK. Adrienne Kuxhausen is employed by GSK. Harry Seifert is employed by GSK and holds shares in GSK. Andrew Hastie is employed by GSK and holds shares in GSK. Brett Leav is employed by Moderna and holds shares in Moderna. Jacqueline Miller was employed by the GSK until May 2020 and is now employed by Moderna. Jacqueline Miller also reports she holds shares in GSK and Moderna. Kate Anteyi is employed by Moderna and holds shares in Moderna. Agnes Mwakingwe-Omari is employed by GSK and holds shares in GSK. All authors declare no other financial and non-financial relationships and activities or conflict of interest.

Author contributions statement

All authors participated in the design or implementation or analysis, and interpretation of the study, and the development of this manuscript. All authors had full access to the data and gave final approval before submission.

Data availability statement

Please refer to GSK weblink to access GSK’s data sharing policies and as applicable seek anonymized subject level data via the link https://www.gsk-studyregister.com/en/.

Trademark statement

Fluarix is a trademark owned by or licensed to GSK.

Spikevax is a trademark of Moderna.

Patient consent statement

The study was conducted according to Good Clinical Practice guidelines and the protocol was approved by all applicable institutional review boards. Written informed consent was obtained from each participant prior to enrollment.

Supplementary material

Supplemental data for this article can be accessed on the publisher’s website at https://doi.org/10.1080/21645515.2024.2327736

Additional information

Funding

GlaxoSmithKline Biologicals SA funded this study and was involved in all stages of study conduct, including analysis of the data. GlaxoSmithKline Biologicals SA also took in charge all costs associated with the development and publishing of this manuscript.