United States: On Monday, Moderna announced that its experimental mRNA-based flu vaccine elicited a robust immune system response compared to one of its rivals already on the market in the final-stage study that can pave the way for the product to be on sale and the company to have another combination shot against flu and Covid.
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In May, Moderna pulled on its own volition an application for endorsement of its combination shot against COVID-19 and flu and told reporters it would refile it with efficacy data of its solo flu vaccine phase three trial.
This move was made following negotiations with the Food and Drug Administration (FDA), which is in the midst of a huge restructuring under Health and Human Services Secretary Robert F. Kennedy Jr., a high-profile vaccine denier, as CNBC News reported.
The company intends to re-submit the application of the combination vaccine and apply the stand-alone flu shot later this year with the new data, Stephen Hoge, the company head of research and development, told in an interview.
Moderna says its experimental flu shot met its goal in a late-stage trial, clearing the path for its broader strategy of selling combination vaccines https://t.co/5f6lREDJ5J Promising results for $MRNA. Using mRNA offers potential for a better targeted flu shot.
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Once the flu vaccine has gotten past regulators, the company would be able to move the combination shot along, Hoge said.
He said Moderna is projecting approvals next year, pending reviews of the two shots.
Moderna stock rose almost 3 percent in preset Monday. Hoge stated that the combination jab would make vaccination easier, and this would aid the healthcare system since it would make the lives of doctors and nurses easier, eliminate the costs, and enhance its adoption by the patients.
As the race toward launching a combination shot with the competitive Pfizer and Novavax has so far seen, the firm seems to be the first in the industry.
Moderna, however, does not provide revenue estimates on its individual products because Hoge said every individual disease, Covid, flu, and respiratory syncytial virus, is a multibillion-dollar market.
“We’re obviously hoping that our products allow us to earn our fair share of them,” he stated, as CNBC News reported.
During a trial of phase three, more than 40,000 people aged 50 and up followed the production of a single dose of a shot developed by Moderna, known as mRNA-1010, or those of a typical competitor vaccine, as well.
The shot of Moderna became 26.6 percent more effective than the other one in the general sample of the population.