Moderna Delays FDA Approval for RSV Vaccine to End of May

Moderna announced that the Food and Drug Administration (FDA) has delayed the approval of its vaccine for respiratory syncytial virus (RSV) to the end of May due to “administrative constraints” at the agency. Investors are closely watching this approval as it could significantly boost the company following the rapid decline of its Covid business last year.

Reasons for the Delay

The FDA was expected to decide on the RSV shot on Sunday. However, due to administrative issues, the agency informed Moderna of the need for more time. “Moderna has not been informed of any issues related to the vaccine’s safety, efficacy, or quality that would prevent its approval,” the company stated in a release.

Context of the RSV Vaccine

If approved, the RSV vaccine would be Moderna’s second product to launch in the U.S. after its once-blockbuster COVID-19 vaccine. It would also be the third RSV vaccine to enter the market after shots from Pfizer and GSK rolled out last year. Moderna has been testing the shot 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 seniors every year and results in 60,000 to 120,000 hospitalizations.

Moderna said its RSV vaccine is still on track to be reviewed by an advisory panel to the Centers for Disease Control and Prevention (CDC) during a meeting on June 26 and 27. This panel will vote on recommendations for the shot’s use and intended population, which is necessary before it enters the market. “Moderna is very grateful to the FDA for their continued efforts and diligence,” said Dr. Stephen Hoge, president of Moderna. “We look forward to helping the agency complete the review of our application and the June [advisory] meeting.”

Moderna’s mRNA Platform

The approval of the RSV vaccine would demonstrate the versatility of Moderna’s messenger RNA (mRNA) platform beyond treating COVID-19. The biotech company uses this technology to tackle various diseases, including RSV, cancer, and a highly contagious stomach bug known as norovirus.

Market Impact

Investors have high hopes for the long-term potential of Moderna’s mRNA product pipeline. The company’s shares are up more than 20% this year after falling nearly 45% in 2023. The approval of the RSV vaccine could provide an additional boost to Moderna’s recovery in the market.

Although challenging, the FDA’s delay in approving Moderna’s RSV vaccine indicates no safety or efficacy issues. The company remains confident in the process and looks forward to the upcoming advisory panel meeting. With this new vaccine, Moderna continues to demonstrate the potential of its mRNA technology to address multiple diseases and remain a significant player in biotechnology.