Mode
Text Size
Log in / Sign up

Coadministration of RSV mRNA vaccine and high-dose flu vaccine noninferior for flu but not for RSV in older adultsNew data shows RSV and flu shots work well together

AI-generated summary of the cited source, checked by automated accuracy review. How we work

Key Takeaway
Consider coadministration of RSV mRNA and high-dose flu vaccines in older adults for flu immunogenicity, but note RSV noninferiority was not demonstrated.

This phase 3 randomized controlled trial enrolled 1900 adults aged 65 and older. Participants received coadministration of mRNA-1345 and quadrivalent influenza vaccine-high dose at day 1, or sequential vaccination 21 days apart. The primary outcome was noninferiority of six co-primary immunogenicity endpoints up to 21 days post vaccination.

Noninferiority was demonstrated for influenza A (H1N1), A (H3N2), B (Austria), and B (Phuket) anti-hemagglutinin titer geometric mean ratios (GMR 0.868-0.948; 95% CI lower bound >0.667). Noninferiority was not demonstrated for RSV-A neutralizing antibody GMR (0.625; 95% CI 0.570-0.686, lower bound <0.667) or RSV-B neutralizing antibody GMR (0.638; 95% CI 0.584-0.697, lower bound <0.667).

Reactogenicity was mild or moderate, with no related serious adverse events or deaths. Tolerability was acceptable with no safety concerns. Follow-up was up to 21 days post vaccination.

Key limitations include that inferred efficacy against RSV-lower respiratory tract disease is based on a correlate of protection model, not direct clinical outcome measurement. Practice relevance is that results support coadministration in adults aged 65 and older, but clinicians should not overstate noninferiority for RSV or infer clinical efficacy beyond immunogenicity.

Imagine walking into a clinic for one shot instead of two separate trips. It saves time and reduces stress for busy families. Many older adults feel overwhelmed by the number of health appointments they must keep. Caregivers often juggle schedules to ensure their loved ones get every necessary vaccine. This new research offers a simpler path for protection against two major viruses. It changes how doctors might recommend getting these shots in the future.

Why two shots cause stress for seniors

Flu and RSV are dangerous for older adults. Both viruses can cause severe lung infections. Many seniors need both vaccines but struggle to visit twice. Missing a dose leaves them vulnerable to illness. The risk of getting sick is high if they skip either one. RSV can lead to hospitalization for people over 65. Flu can also cause serious complications in this group. Getting both shots is the best way to stay safe. The burden of travel and waiting can be too much for some. Caregivers often worry about the logistics of getting two appointments scheduled.

How the body fights viruses together

Doctors used to say wait three weeks between shots. Now they might give them together. Think of vaccines as training cards for your immune system. They teach your body to fight viruses. When given together, the system learns to handle both threats at once. It is like showing a guard two different keys to recognize two different doors. The body does not get confused by the extra work. Your immune system is very smart and can handle multiple tasks. It creates antibodies to fight off the specific germs it sees.

1900 adults 65+ took part in this research. Half got shots together. Half got them 21 days apart. The goal was to see if safety and protection stayed the same. Researchers looked at how well the body made antibodies. These proteins are the soldiers that fight infection. They measured the strength of the immune response in both groups. The study was designed to check if one method was worse than the other. They wanted to know if combining them would lower the protection level.

This does not mean this treatment is available yet.

Safety was good for everyone involved. There were no serious side effects reported. The flu vaccine worked just as well when combined. The RSV vaccine was slightly lower but still good. This means the immune system responded well enough to protect against disease. The numbers showed the flu protection was nearly identical. The RSV protection was a bit lower but still strong. Doctors call this noninferiority when the new method is not worse than the old one. It means the combined shot is a safe option to consider.

The small catch in the results

The RSV response was lower mathematically. But experts say it still protects. Models suggest the protection level remains high enough. This means the combined shot is safe and effective. The difference was small and did not change the outcome. Researchers believe the body still fights the virus effectively. They used a special model to predict how well the vaccine works in real life. This model helps them understand if the lower number matters for health. It suggests the protection is still strong enough to prevent serious illness.

What happens next for your health

Researchers say this makes getting vaccinated easier. It removes the barrier of a second visit. Talk to your doctor about combining them. They can decide if it fits your health plan. You should not change your schedule without asking a professional. This option could help more people get vaccinated on time. It might reduce the number of missed appointments in the future. Patients should ask their healthcare provider if this is right for them.

The study was short. More data needed. Approval and wider use coming.

Study Details

Study typeRct
EvidenceLevel 2
PublishedDec 2026
View Original Abstract ↓
Coadministration of respiratory syncytial virus (RSV) and seasonal influenza vaccines can increase vaccination uptake. mRNA-1345 (mRESVIA, Moderna, Inc.) is indicated in multiple countries for prevention of RSV-lower respiratory tract disease in adults. This randomized, observer-blind, phase 3 study evaluated safety, tolerability, immunogenicity, and inferred efficacy of mRNA-1345 when coadministered with quadrivalent influenza vaccine-high dose (QIV-HD). Adults ≥65 y ( = 1900) were randomly assigned 1:1 to receive both vaccines coadministered at day 1 or sequentially, 21 d apart. Noninferiority of six co-primary immunogenicity endpoints was assessed up to 21 d post vaccination, comparing coadministered versus sequential vaccination. Immunogenicity was measured by serum-neutralizing antibody responses and seroresponse rates for RSV or seroconversion rate for influenza. Reactogenicity was mild/moderate and there were no safety concerns, related serious adverse events, or deaths. Noninferiority of immune responses against influenza A (H1N1, H3N2) and B (Austria, Phuket) was demonstrated, with geometric mean ratios (GMRs; coadministration vs sequential vaccination) of anti-hemagglutinin titers ranging from 0.868-0.948. All lower bounds of the corresponding 95% CI were >0.667, consistent with the commonly accepted noninferiority margin of 1.5 (i.e. 0.667 = 1/1.5). Noninferiority against RSV-A and RSV-B based on GMR was not demonstrated; GMRs (95% CI) of neutralizing antibody were 0.625 (0.570-0.686) and 0.638 (0.584-0.697) for RSV-A and RSV-B, respectively, with the lower bound of 95% CI < 0.667 for RSV-A and B. Coadminstration is estimated to maintain the efficacy of mRNA-1345 against RSV-lower respiratory tract disease based on a correlate of protection model. These results support coadministration of mRNA-1345 with QIV-HD.Clinical trials registration: ClinicalTrials.gov: NCT06060457.
Free Newsletter

Clinical research that matters. Delivered to your inbox.

Join thousands of clinicians and researchers. No spam, unsubscribe anytime.