Moderna reports positive outcomes in a late-stage trial of their vaccine for a combination of Covid and flu.
On a Monday development, Moderna, a prominent vaccine manufacturer, publicized promising results from the final stage of testing for its coronavirus-influenza blend vaccine, dubbed mRNA-1083.
Expressing optimism, Moderna's Chief Medical Affairs Officer, Francesca Ceddia, informed CNN the findings were groundbreaking, implying that subjects in the trial who received mRNA-1083 displayed improved immune reactions when compared to those who were given stand-alone Covid-19 and influenza vaccines currently in circulation. The efficacy was maintained for those over the age of 65, a group that typically exhibits less robust immune responses relative to their younger counterparts.
Ceddia emphasized, "When we consider the combined vaccine, we frequently only focus on the aspect of convenience, one shot rather than two. However, the truly revolutionary aspect is not just that you offer the advantage of convenience but also that you provide evidence of clinical benefits. In my opinion, this is the most significant message."
Several companies have explored the potential for blending the coronavirus and influenza vaccines; nonetheless, Moderna is the first to demonstrate encouraging late-stage trial results.
Esteemed authorities in public health maintain that vaccines capable of shielding individuals from both viruses are necessary. Annually, both viruses contribute to millions of individuals contracting illness. Based on data from the U.S. Centers for Disease Control and Prevention, during the most recent flu season, between 35 to 64 million Americans caught the flu, while 390,000 to 810,000 people ended up being hospitalized and around 71,000 perished. Over the recent fall and winter months, Covid affected more than 500,000 Americans and claimed over 40,000 lives.
The Phase 3 trial organized by Moderna was a randomized, observer-blind, active control study, indicating that even the clinicians delivering the injections were unaware of the vaccines assigned to the subjects. The study recruited approximately 8,000 adults, evenly distributed into two age categories.
For one of the trial's subsets, Moderna compared the immunogenicity of participants over the age of 65 who received the mRNA-1083 vaccine with another group from the same age range vaccinated with Spikevax, Moderna's Covid-19 vaccine, and an enhanced influenza vaccine, Fluzone HD. Doctors advise seniors to receive more potent flu vaccines due to their weaker immune systems.
The remaining component of the experiment compared the performance of adults aged 50 to 64 who received the mRNA-1083 vaccine to another set of participants within that same age group immunized with Spikevax and a regular dose influenza vaccine known as Fluarix.
The presented trial results confirmed that in both age groups, the mRNA-1083 vaccine elicited a statistically significant higher immune response against three distinct flu strains and against Covid-19, as compared to the co-administered vaccines.
Ceddia claimed, "The titers are significantly higher. This is better." Titers denote a laboratory analysis that quantifies antibody counts in the blood, enabling a determination of a person's level of immunity.
Regarding the safety of the combination vaccine, Moderna reported that it was well-received, and the side effects paralleled those reported for the coadministered vaccines. The most frequent complaints included sore injection sites, fatigue, muscle pain, and headaches.
Although the findings have yet to be evaluated by peers, Moderna pledges to display the data at an imminent medical conference and intends to submit the trial for publication. Furthermore, they plan to consult the FDA about potential subsequent steps.
Sue Peschin, the chief executive and oof the Alliance for Aging Research, a nonprofit advocating for the promotion of aging and healthcare and championing greater accessibility to vaccines, expressed her support for the combination shot. She believes it could play a pivotal role in improving public health.
As vaccine hesitancy increases in the U.S. and vaccine fatigue has emerged during the pandemic, Peschin pointed to falling rates in the use of standard vaccines like the MMR vaccine and lower uptake of seasonal vaccines. Far fewer adults have received the latest Covid-19 vaccine, estimated to be around 25% of the eligible population; in contrast, almost half of all adults were inoculated against influenza last season.
Peschin contends, "We want to see an upswing in these numbers and if the combination shots facilitate this, then that's advantageous for everyone. It helps safeguard the entire community. We're eager to see the combination vaccines on the market if the FDA determines they're safe and effective."
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Moderna's Chief Medical Affairs Officer, Francesca Ceddia, mentioned that in addition to the convenience of a single shot, the combination vaccine offers "clinical benefits," which she believes is the most significant message.
The Phase 3 trial organized by Moderna included a subset of participants over the age of 65, who received the mRNA-1083 vaccine, and another group from the same age range vaccinated with a more potent flu vaccine and Moderna's Covid-19 vaccine, Spikevax.
