Moderna Stock (NASDAQ:MRNA)
The management of Moderna (NASDAQ:MRNA) announced that the pivotal phase III ConquerRSV study evaluating mRNA-1345, the company’s mRNA-based respiratory syncytial virus (RSV) vaccine, had achieved the primary efficacy endpoints, which caused Moderna stock price to surge 6.5% in after-market trading on January 17.
Moderna is a Cambridge, Massachusetts-based pharmaceutical and biotechnology company that focuses on RNA therapeutics, primarily mRNA vaccines. To elicit an immune response, these vaccines employ a copy of a molecule known as messenger RNA.
An Efficient and Well-Tolerated Vaccine
RSV-associated lower respiratory tract disease (RSV-LRTD) is defined as two or more symptoms of the disease in older adults. The ConquerRSV study, which evaluated mRNA-1345 in older adults aged 60 years and above, achieved vaccine efficacy of 83.7% against RSV-associated lower respiratory tract disease (RSV-LRTD). Additionally, the vaccination demonstrated efficacy of 82.4% against RSV-LRTD, which is characterized by the presence of three or more symptoms. It was found that mRNA-1345 was well tolerated, and there were no safety issues found.
On the basis of these data, management anticipates submitting mRNA-1345 for regulatory approval during the first half of the year 2023.
These findings are based on a preliminary investigation of 64 patients diagnosed with RSV-LRTD who had two or more symptoms. While the study is currently in progress, management plans to offer an updated review of safety and tolerability when they submit their findings to the regulatory agency. This will be done as soon as possible.
In comparison to the 8.8% loss that was experienced by the industry over the past year, Moderna stock fell by 9.6%.
The ConquerRSV research is one of the five current studies that Moderna is conducting to evaluate the RSV vaccine. The other four trials are as follows: Additionally, the business is conducting research on mRNA-1345 in children as part of an early-stage clinical trial. In addition, the vaccination is also being tested in combination with other medical interventions in clinical research. In addition, Moderna is in the process of developing mRNA-1230, a crucial combination respiratory vaccine candidate, as an annual vaccination against COVID-19, influenza virus, and RSV. This development is taking place within the context of phase I research.
At this time, there are no vaccinations against RSV infections that have been licensed by the FDA. The likelihood of having RSV disease is highest in those in their later years.
Pfizer and GSK Have Also Produced RSV Vaccines
In addition to Moderna, pharmaceutical companies Pfizer (NYSE:PFE) and GSK (NYSE:GSK) have also produced potential RSV vaccines of their own, which are presently undergoing evaluation by the FDA.
Pfizer made the announcement one month ago that it had been awarded priority review by the Food and Drug Administration (FDA) for its regulatory application, with the FDA seeking clearance for its RSV vaccine candidate, RSVpreF. Pfizer’s submission asks for a review of the use of RSVpreF in older individuals older than 60 to prevent lower respiratory tract infections (LRTI). It is anticipated that the FDA will make a final decision on Pfizer’s RSV vaccine by the month of May 2023.
The RSVPreF3 RSV vaccine developed by GSK for older individuals is currently undergoing priority assessment by the FDA, and a decision is anticipated to be made in May 2023. Regulatory petitions seeking clearance of GSK’s RSV vaccine are currently being examined not only in the United States but also in Japan and Europe.
Either the vaccine developed by Pfizer or the one developed by GSK has a chance of becoming the first RSV vaccine to be licensed in the United States.
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