On Friday Eastern Time, US vaccine manufacturer Moderna announced that its respiratory syncytial virus (RSV) vaccine has been approved by the US Food and Drug Administration (FDA), which will expand its commercial reach.
Modner stated that the latest approved RSV vaccine is a huge victory for the company in preventing lower respiratory diseases caused by syncytial virus infection in the elderly population (aged 60 and above).
In the early morning trading of the US stock market, Modena's stock price rose nearly 4% at one point, but then plummeted significantly and is currently down more than 6%. According to data, the effectiveness of the company's RSV vaccine in preventing at least two RSV symptoms (such as cough and fever) is 79%, lower than expected.
After COVID-19 Vaccine, major vaccine manufacturers around the world have focused on RSV vaccine. Pfizer, Johnson&Johnson, Sanofi, AstraZeneca, MSD, etc. have all entered the market. According to the World Health Organization (WHO), 64 million children worldwide are infected with RSV each year. According to data from the Centers for Disease Control and Prevention (CDC) in the United States, this virus causes 6000 to 10000 elderly deaths annually, with 60000 to 160000 hospitalizations.
RSV is a very common infectious pathogen that can infect almost everyone to some extent and can cause seasonal outbreaks of lower respiratory tract infections, including bronchiolitis and pneumonia.
The initial symptoms of RSV infection are similar to those of the common cold and influenza, but its transmission range and impact on children are greater. Public data shows that the incidence rate of RSV infection in children is about four times that of influenza.
But for decades, an effective vaccine against this virus has not been developed, including a major setback in the 1960s when an experimental vaccine harmed some children during testing.
MRESVIA
Until May last year, the world's first RSV vaccine - GlaxoSmithKline's Arexvy - was approved for sale in the United States, followed by Pfizer's RSV vaccine Abrysvo, which is expected to enter the best-selling vaccine category.
According to Modena, the vaccine approved on Friday is the world's first mRNA RSV vaccine, which will be sold under the mRESVIA brand.
The company stated that mRNA vaccines can teach the body to produce proteins recognized and attacked by the immune system, have the potential to treat various diseases, and are more effective than traditional vaccines.
Modena CEO St é phane Bancel stated, "The FDA has approved our second product mRESVIA, which is based on the advantages and versatility of our mRNA platform."
According to LSEG data, analysts predict on average that the sales of the Modena RSV vaccine will be $340 million in 2024 and will grow to $830.5 million next year.
Another good news is that a advisory panel from the CDC in the United States will vote in June on recommendations for vaccine use and target populations. Modner predicts that the target audience for his RSV vaccine will further expand before the autumn vaccination season.
Next, Modena's RSV vaccine will have the opportunity to compete with GlaxoSmithKline and Pfizer, both of which achieved sales of billions of dollars in RSV vaccines last year.