Moderna has gone on to announce in May 2023 that the US FDA has gone on to approve its respiratory syncytial virus- RSV vaccine, which is for adults aged 60 years and older.
It is well to be noted that this is going to be the only RSV vaccine that is going to be available in the form of single-dose preferred syringes and is going to be sold under the brand name mRESVIA.
The vaccine is going to be the second product from Moderna to make an entry into the US market post the FDA nod for the biotech company’s COVID-19 vaccine called Spikevax in 2022. Though the review by the FDA had got delayed by a couple of weeks, the approval has gone on to come as massive for Moderna, as the dip in Spikevax sales has led to a very steep decrease in revenue, right from $19 billion in 2022 to only $7 billion in 2023.
Exceptional results from the Phase 2 trial
The mRESVIA vaccine happens to be built on a similar mRNA platform and makes use of the same lipid nanoparticles- LNPs as what Spikevax uses. The approval from the FDA happens to be based on Phase 3 trial, which happened to be conducted on almost 37,000 people aged 60 and above across 22 nations and went on to demonstrate that the jab was almost 84% effective in the case of the RSV lower respiratory tract disease- LRTD at almost 3 months. Another follow-up study suggested the efficacy to have dipped to 64% post eight and a half months.
As per the CDC- Centers for Disease Control and Prevention, RSV infections lead to 6,000 to 10,000 deaths and almost 60,000 to 160,000 hospitalizations in the US every year. Though Pfizer and GSK, have both gone on to launch the RSV shots in 2023, MRESVIA is going to be the only one that is going to be available in a prefilled syringe, which, as per Moderna, is going to save time and also decrease the risk in terms of administrative efforts. It is well to be noted that Moderna anticipates that mRESVIA is going to be available across the US by the 2024–25 season of respiratory viruses.
