Moderna's Combined Covid and Flu Vaccine: A Promising but Uncertain Future
Moderna's mRNA-1083, a combination flu and Covid-19 vaccine, has shown extremely promising results in Phase III trials. The data suggests it elicits an immune response equal to, or even stronger than, separate vaccines for each disease. Participants across two age groups (50-64 and over 65) demonstrated comparable or superior antibody responses, particularly against flu strains. The vaccine also appeared safe and well-tolerated.
Regulatory Hurdles
While these results are typically a precursor to FDA approval, recent policy shifts cast a shadow of uncertainty. A mandated overhaul of the vaccine approval process now requires all new vaccines to undergo placebo-controlled trials. This raises concerns, particularly for vaccines like mRNA-1083, which could be compared to existing vaccines and might necessitate redundant testing. This new rule might not only impede the development of innovative vaccines such as this combined one, but also delay the seasonal flu and Covid-19 shots.
The absence of an FDA-approved mRNA-based flu vaccine adds another layer of complexity. This fact alone could necessitate further placebo-controlled trials for mRNA-1083, despite the compelling data already obtained. Adding to the challenges is the current political climate, marked by skepticism towards mRNA vaccines, regardless of scientific evidence supporting their safety and efficacy.
Moderna currently anticipates approval no earlier than 2026, pending the submission of additional data. However, given the recent regulatory changes and political headwinds, even this timeline remains tenuous. The situation highlights the interplay between scientific progress and political influence in the realm of public health.
Source: Gizmodo