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Co-administration of RSV and COVID-19 mRNA vaccines maintains humoral immune responses in older adultsTrial shows coadministering RSV and COVID-19 vaccines is safe

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Key Takeaway
Consider co-administration of RSV and COVID-19 mRNA vaccines as a viable strategy for older adults.

The study investigated the immunological impact of co-administering an AS01E-adjuvanted RSV prefusion F protein-based vaccine with a COVID-19 mRNA vaccine in adults aged 50 and older. The primary objective was to determine if co-administration maintained noninferiority in humoral immune responses compared to a sequential regimen administered one month apart.

Results indicated that co-administration achieved noninferiority for both RSV-A and RSV-B humoral responses. However, the trial reported a marginal miss of the noninferiority criterion specifically for the SARS-CoV-2 Omicron XBB.1.5 humoral immune response. Safety data indicated that the most common solicited events, such as site pain and fatigue, were generally mild to moderate in intensity and of short duration. Serious adverse events were balanced between the study groups.

The authors noted the marginal miss in the SARS-CoV-2 metric as a limitation, though they suggested this does not imply clinically relevant interference. Clinically, the results support the feasibility of co-administering these vaccines to simplify immunization schedules for older adults. While the SARS-CoV-2 data was slightly outside the predefined noninferiority margin, the overall safety profile and RSV immune responses support the co-administration approach.

For many adults, especially those over the age of 50, staying healthy means protecting against multiple respiratory viruses at once. Both the respiratory syncytial virus (RSV) and COVID-19 can cause serious illness in older adults. Because these infections often happen at the same time of year, patients often want to know if they can get their vaccinations together rather than waiting weeks apart. This study looked at whether giving these two vaccines at the same time affects how well the body builds protection.

Researchers conducted a large trial involving 833 adults aged 50 and older. They divided the participants into two groups. One group received both the RSV vaccine and the COVID-19 mRNA vaccine at the same time. The other group received the same two vaccines, but they were given about one month apart. The goal was to see if giving them together would weaken the immune response compared to giving them separately.

The results showed that giving the vaccines together was effective for the RSV component. The immune response for both RSV-A and RSV-B was comparable to the group that received the vaccines separately. For the COVID-19 vaccine, the results were very close to the goal, though they technically missed the specific statistical mark by a small margin. However, the researchers noted that this small difference does not mean the vaccines interfered with each other in a way that would matter for a patient's actual protection.

In terms of safety, the study found that the vaccines were well tolerated. The most common side effects were pain at the injection site, muscle aches, and fatigue. Most of these symptoms were mild to moderate and lasted about three days. There were no significant differences in serious health events between the group that got the shots together and the group that got them apart.

It is important to remember that while this study is a strong piece of evidence, it is just one trial. While the results are very encouraging for doctors and patients, individual health needs can vary. Because the study was specifically designed to show that the vaccines work well together, it provides a strong foundation for current medical practices. For patients today, this means that giving the RSV and COVID-19 vaccines at the same time is a practical and safe option. You can talk to your healthcare provider about the best timing for your specific health needs. The evidence suggests that you do not need to wait a month between these two specific vaccinations to get protected.

What this means for you:
Giving RSV and COVID-19 vaccines at the same time is shown to be safe and effective for adults over 50.

Study Details

Study typeRct
Sample sizen = 833
EvidenceLevel 2
Follow-up600.0 mo
PublishedOct 2026
View Original Abstract ↓
BACKGROUND: This trial evaluated coadministration of the AS01E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine (adjuvanted RSVPreF3) and an Omicron XBB.1.5-based coronavirus disease 2019 (COVID-19) mRNA vaccine in ≥50-year-olds. METHODS: This phase 3, open-label, multicenter trial randomized ≥50-year-olds 1:1 to coadministration (Co-Ad group) or sequential administration approximately 1 month apart (Control group) of adjuvanted RSVPreF3 and the COVID-19 mRNA vaccine. Primary objectives were to demonstrate noninferiority of humoral immune responses at 1 month postvaccination in terms of RSV-A, RSV-B, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers, with the upper limit of the 95% CI of adjusted geometric mean titer (GMT) group ratios (Control/Co-Ad) ≤1.50. Secondary objectives included assessment of reactogenicity up to 4 days and safety up to 6 months after vaccination. RESULTS: Overall, 833 participants were vaccinated (Co-Ad: 417; Control: 416). Noninferiority was achieved for RSV-A (GMT ratio: 1.12 [95% CI: .97-1.28]) and RSV-B (GMT ratio: 1.08 [95% CI: .94-1.23]) and marginally missed for SARS-CoV-2 Omicron XBB.1.5 (GMT ratio: 1.31 [95% CI: 1.13-1.51]). Within 4 days postvaccination, the most frequently reported solicited events were administration-site pain, myalgia, and fatigue. Most solicited events were of mild-to-moderate intensity, and the overall median duration was ≤3 days and comparable between groups. Unsolicited and serious adverse events were generally balanced between groups. CONCLUSIONS: Adjuvanted RSVPreF3 coadministered with a COVID-19 mRNA vaccine maintained an acceptable safety profile in ≥50-year-olds. The marginal miss of the noninferiority criterion for SARS-CoV-2 does not suggest clinically relevant interference. Therefore, the results support the coadministration of these vaccines. CLINICAL TRIALS REGISTRATION: Clinical Trials.gov. NCT06374394.
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