FDA postpones decision on Moderna RSV vaccine

Moderna announced on Friday that the U.S. Food and Drug Administration (FDA) has postponed its decision on approving Moderna's experimental vaccine for respiratory syncytial virus (RSV) due to administrative delays. The FDA had initially planned to complete its review by Sunday, May 12, but has now extended the deadline. Moderna confirmed that the FDA has not indicated any issues that could obstruct the vaccine's approval and is striving to finalize its evaluation by the end of the month.

The FDA's decision on this vaccine, labeled mRNA-1345, is crucial for Moderna as it aims to make this its second commercial product. Designed to prevent RSV-related illnesses, the vaccine is targeted at older adults. Moderna has been gearing up to release the vaccine before the fall immunization season. According to the company, they are still on schedule to meet this goal, with approval potentially arriving in time for a June advisory panel meeting held by the Centers for Disease Control and Prevention (CDC).

Jefferies analyst Michael Yee reassured clients that the FDA should be able to approve the vaccine by the end of May, minimizing any significant delays. Yee noted that the absence of a major amendment request or outright rejection from the FDA should alleviate investor concerns.

Moderna is banking on the RSV vaccine to counterbalance the plummeting sales of its COVID-19 vaccine. However, analysts are divided on the commercial success of the new RSV shot. It faces stiff competition from rival vaccines developed by GSK and Pfizer, which were launched a year earlier. GSK's vaccine, in particular, has captured the majority of the market, securing two-thirds of sales and generating over $1 billion last year.

The CDC advisory panel is scheduled to convene on June 26, which could mark a significant milestone for Moderna if the vaccine receives approval by then.