Moderna said FDA approval of its RSV vaccine was delayed until the end of May
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modern on Friday said the Food and Drug Administration had delayed approval Respiratory syncytial virus vaccine until the end of May due to “administrative restrictions” at the agency.
The FDA is expected to make a decision on the RSV shot on Sunday. The biotechnology company said the agency did not notify Moderna of any issues related to the safety, effectiveness or quality of the vaccine that would prevent its approval.
Investors are closely watching the upcoming approval as Moderna tries to recover from a rapid decline in its Covid business last year. If approved, the RSV vaccine will become the company’s second product launched in the US after the once blockbuster Covid vaccine. This will also be the third RSV vaccine to enter the market after vaccination from Pfizer And GSK launched last year.
Moderna said its RSV vaccine is still in the process of being reviewed by the Centers for Disease Control and Prevention’s advisory panel for a while. meeting on June 26 and 27. That panel will vote on proposals on intended uses and intended recipients, which are needed before it goes on the market.
Moderna tested the drug in older adults, who are more vulnerable to severe cases of RSV. According to CDC data, the virus kills between 6,000 and 10,000 elderly people each year and leads to 60,000 to 120,000 hospitalizations.
“Moderna is grateful to the FDA for their tireless efforts and diligence,” Dr. Stephen Hoge, president of Moderna, said in a statement. “We look forward to helping the agency complete its review of our application by June [advisory] meeting.”
The approval would demonstrate the versatility of Moderna’s messenger RNA platform beyond treating Covid. Biotech companies are using that technology to tackle a range of diseases. These include RSV, cancer and a highly contagious stomach disease called norovirus.
Investors have high hopes for the long-term potential of Moderna’s mRNA product line: The company’s shares are up more than 20% this year after falling nearly 45% in 2023.
