Moderna starts final trial for COVID-Flu combo vaccine.
Moderna Advances to Late-Stage Trial of COVID-Influenza Combination Vaccine
Moderna announced that it is progressing to the late stage trial of its COVID-influenza combination vaccine after obtaining positive results in preliminary trials. This comes despite concerns about the safety of Moderna’s COVID-19 vaccine.
A combination vaccine combines multiple vaccines into a single injection. Moderna’s mRNA-1083 combination vaccine, targeting influenza and COVID-19, showed promising interim results in phase 1 and 2 trials, according to the company’s press release on Oct. 4.
Now, Moderna is preparing for the phase 3 late-stage trial of the vaccine.
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The preliminary trials compared Moderna’s mRNA-1083 combination vaccine with two influenza vaccines—Fluarix and Fluzone HD. The combination vaccine was tested on adults aged 50 to 64, while Fluzone HD is specifically designed for individuals aged 65 to 79.
According to Moderna, the preliminary trials demonstrated that mRNA-1083 produced antibody levels in the blood that were similar to or higher than the licensed influenza vaccines. It also showed comparable antibody levels to Moderna’s COVID-19 vaccine.
The adverse reactions observed with mRNA-1083 were found to be similar to those of the Spikevax vaccine. The majority of adverse reactions were of mild to moderate severity, with less than 4 percent categorized as severe.
Moderna stated that no new safety concerns were identified for mRNA-1083 compared to the standalone vaccines.
Moderna’s Combo Vaccine Push
Moderna plans to initiate the phase 3 trial of mRNA-1083 in adults aged 50 and above this year, with the goal of obtaining regulatory approval for the vaccine by 2025.
“Combination vaccines offer an important opportunity to improve consumer and provider experience, increase compliance with public health recommendations, and deliver value for healthcare systems,” said Stephane Bancel, CEO of Moderna.
Moderna estimates that the U.S. influenza market requires 150 million doses annually, with an estimated market of 50 million to 100 million doses for the fall of 2023. The company also anticipates that the market for COVID-19 vaccines will eventually rival that of influenza vaccines in the United States.
According to data from the U.S. Centers for Disease Control and Prevention (CDC), new COVID-19 hospital admissions in the country are currently at a low level compared to previous years.
COVID-19 Vaccine Dangers
While COVID-19 vaccines are widely promoted as crucial to healthcare, several studies are raising concerns about their safety. One study even suggests a link between COVID-19 booster shots and heart damage.
A study published in the European Journal of Heart Failure found that Moderna’s mRNA-1273 COVID shot was associated with an increased risk of myocardial injury, affecting about 1 in 35 individuals or 2.8 percent. This rate is higher than what would typically be expected in a healthy population.
In his testimony to the European Parliament, cardiologist Dr. Peter McCullough called for the removal of COVID-19 vaccines from the market, citing concerns about their safety. He emphasized the potential risks associated with the spike protein found in the vaccines.
These findings raise questions about the safety and efficacy of COVID-19 vaccines, despite their widespread use. It is important to consider all available information and ongoing research when making decisions about vaccination.
Zachary Stieber contributed to this report.
What are the preliminary trial results for Moderna’s mRNA-1083 combination vaccine in terms of antibody levels?
Rom the Centers for Disease Control and Prevention (CDC), influenza and COVID-19 are both significant public health threats. Each year, influenza causes millions of illnesses, hospitalizations, and deaths worldwide. The ongoing COVID-19 pandemic has further emphasized the need for effective vaccines to protect against respiratory illnesses.
Moderna’s mRNA-1083 combination vaccine aims to address this urgent need by targeting both influenza and COVID-19. The preliminary trials for mRNA-1083 have shown promising results, with the vaccine producing antibody levels in the blood that are comparable to or higher than licensed influenza vaccines. Additionally, the antibody levels for mRNA-1083 were similar to Moderna’s COVID-19 vaccine, indicating its potential effectiveness against both viruses.
The safety profile of mRNA-1083 has been assessed and found to be similar to that of the Spikevax vaccine. Adverse reactions were mainly mild to moderate, with only a small percentage categorized as severe. Importantly, no new safety concerns were identified for mRNA-1083 compared to the standalone vaccines.
Building on the positive outcomes of the preliminary trials, Moderna plans to proceed with the phase 3 late-stage trial of mRNA-1083 in adults aged 50 and above. The company aims to obtain regulatory approval for the vaccine by 2025, highlighting their commitment to providing a safe and effective combination vaccine for the general population.
The CEO of Moderna, Stephane Bancel, recognizes the importance of combination vaccines in enhancing the overall healthcare experience and increasing compliance with public health recommendations. Combination vaccines offer the opportunity to streamline vaccination efforts, making it easier for individuals to receive the necessary protection against multiple diseases. Furthermore, combination vaccines can potentially reduce the burden on healthcare systems and contribute to a more efficient allocation of resources.
Moderna’s mRNA-1083 combination vaccine holds significant market potential. The U.S. influenza market alone requires millions of doses annually, and the anticipated market for COVID-19 vaccines is expected to rival that of influenza vaccines in the future. By addressing the need for both influenza and COVID-19 protection, Moderna aims to play a crucial role in mitigating the impact of these respiratory illnesses on public health.
In conclusion, Moderna’s progress in advancing to the late-stage trial of the mRNA-1083 combination vaccine is a promising development in the fight against influenza and COVID-19. The positive results from preliminary trials underscore the potential effectiveness of this vaccine in producing robust immune responses. As Moderna continues its efforts to obtain regulatory approval, the mRNA-1083 combination vaccine could significantly contribute to improving public health outcomes and reducing the burden of respiratory diseases in the future.
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