A novel vaccine combining protection against both COVID-19 and the flu, known as the Modern Multicomponent Vaccine (mRNA-1083), has demonstrated superior performance compared to administering separate vaccines. This finding stems from data derived from a phase 3 clinical trial,offering a possibly streamlined approach to respiratory disease prevention.

Key Findings from the JAMA Study

The study, recently published in JAMA, highlights that mRNA-1083 exhibited immunogenicity comparable to existing seasonal flu vaccines (targeting subtypes A/H1N1, A/H3N2, B/Victoria, and B/Yamagata) and the Omicron XBB.1.5 variant of SARS-CoV-2.

Implications for Public Health

Developed with the same messenger technology as the COVID-19 vaccines, this new immunizer represents a promising advancement, especially for individuals aged 50 and older, who are more vulnerable to complications from these respiratory illnesses. The potential approval of this combined vaccine could simplify vaccination campaigns by consolidating protection into a single dose, potentially increasing adherence among older adults and improving logistical efficiency.

Study Details: Immunogenicity and Safety Testing

The randomized clinical trial, funded by moderna, involved over 8,000 adults aged 50 or older. Participants were divided into two groups: one received the combined vaccine, and the other received separate vaccines, along with a placebo to simulate two doses.

The primary goal was to confirm that the combined vaccine induced a stronger immune response than current immunizers against flu and the XBB.1.5 variant of COVID-19. Researchers conducted serological tests, measuring antibody production to assess the immune response.

The results indicated that antibody levels were between 20% and 40% higher among those who took the combined vaccine compared to those who received separate vaccines. The combined vaccine demonstrated a stronger immune response against both COVID-19 and various influenza strains.

Expert Opinions

Jesse Goodman, former chief scientist at the Food and Drug Management (FDA), told NBC News that the data is promising and suggest that the combined vaccine can offer a protection equal to or greater than conventional vaccines. He added that antibody levels correlate with the degree of protection of the immunizer.

While side effects like fever and chills were more frequent in those receiving the combined vaccine, this is attributed to the simultaneous activation of the immune system against two different viruses, resulting in a more intense, yet expected, inflammatory response.

Regulatory Hurdles and Future Outlook

Despite the positive results, Moderna anticipates a potentially delayed approval from the FDA, projecting regulatory authorization in 2026 due to the need for additional data on influenza effectiveness. this timeline is also influenced by evolving regulatory policies.

It remains uncertain whether the FDA’s new rule, requiring placebo-controlled clinical trials for new vaccine approvals, will apply to this combined vaccine. the agency has previously imposed similar requirements on Novavax and may extend these to updated immunizers from Pfizer and Moderna.

According to Dr. Peter Hotez of the Texas Children’s Hospital Vaccine Development Center, MRNA vaccines have become the favorite targets of anti-vacin movements in the USA with state laws seeking to restrict its use.

Goodman also noted that an mRNA-based combined vaccine would be a strategic advancement, enabling faster responses to future flu pandemics, surpassing the current egg-based virus cultivation production process.

Significant Considerations

It is crucial to note that the study did not directly evaluate the clinical efficacy of the vaccine; that is, the number of vaccinated individuals who contracted the illnesses. While the vaccine generated a stronger immune response compared to traditional vaccines, actual protection levels still require confirmation.