Moderna says FDA approval of RSV vaccine delayed until end of May | Parami News

The endorsement of the US Food and Drug Administration (FDA) for its respiratory syncytial virus (RSV) vaccine was delayed until end of May due to “administrative constraints” in the agency.

On Sunday, it is expected that FDA will decide on RSV shot. In a news release, the biotech company stated that the agency did not tell Moderna about any concerns regarding the vaccines’ safety, efficacy or quality that could prevent its approval.

Moderna is in focus for investors who hope the upcoming clearance can compensate for last year’s sharp drop in activity caused by COVID-19 pandemic. The RSV shot would be company’s second product launch in America if approved after once-viral COVID-19 vaccine; this would be third RSV vaccine into market after RSV injection which was released by Pfizer and GSK last year.

Moderna stated that its RSV vaccination is still scheduled for review by a Centers for Disease Control and Prevention (CDC) advisory committee. It will meet on June 26th – 27th.

Moderna has been testing this immunization candidate on older adults because their risk of severe respiratory syncytial viral infections is higher. Each year, according to CDC statistics, between 6,000 and 10,000 elderly people die from the virus with an additional 60,000 to 120,000 hospitalizations occurring as well.

“Moderna greatly appreciates continued efforts and diligence by FDA,” said Dr. Stephen Hoge President of Moderna in a press release. “We anticipate assisting the agency through its application process up to (advisory) meeting scheduled for June”.

This confirmation will highlight how versatile Moderna’s messenger RNA platform can be beyond simply treating COVID-19. The start-up uses it in addressing various conditions such as respiratory syncytial virus aside from cancer and norovirus which are highly contagious stomach diseases.

Investors have high expectations about the future potential of Moderna’s mRNA product line: Having dropped by nearly 45% in 2023, company shares have increased by over 20% this year.