FDA Postpones Decision on Moderna's RSV Vaccine to Late May

Moderna anticipates its respiratory syncytial virus (RSV) vaccine will be ready for the June Advisory Committee on Immunization Practices (ACIP) meeting, despite a delay from the FDA. Initially, the FDA was expected to reach a decision by May 12, but due to "administrative constraints," the decision has been postponed until the end of May.

Moderna emphasized that the FDA has not identified any issues with the vaccine that would prevent its approval. The company remains optimistic that the vaccine will be discussed at the June ACIP meeting. Stephen Hoge, M.D., President of Moderna, expressed confidence in supporting the FDA's review process and looked forward to the upcoming ACIP meeting.

Investment analysts at William Blair were not significantly concerned by the delay, noting that the administrative nature of the postponement suggests the vaccine is still on track for approval within the biologics license application review cycle. They highlighted that a decision by the end of May would still allow Moderna's vaccine to be considered in the ACIP’s June meeting, where immunization recommendations are made.

The broader investor community appeared to share a similar sentiment, with Moderna’s share price falling slightly by 2.7%, from $122.69 to $119.38 on Friday morning.

Moderna is aiming to be the third player in the $10 billion adult RSV vaccine market, following GSK and Pfizer. However, Moderna’s candidate does not boast the same level of blockbuster data that its COVID-19 vaccine achieved. One primary concern is the durability of the RSV vaccine. Earlier this year, Moderna reported a decrease in efficacy from three months to nine months post-vaccination. GSK’s Arexvy demonstrated an average efficacy of 67.2% over two seasons, while Pfizer’s Abrysvo showed 65.1% efficacy in the first year, dropping to 55.7% in the second season.

Moderna hopes to gain an advantage with the administration of its vaccine, promoting its prefilled syringe as a significant benefit compared to existing vaccines. The company believes that if its vaccine is easier for pharmacists to administer, it will be more widely adopted. CEO Stephane Bancel mentioned during a recent first-quarter earnings call that Moderna's team was in constant communication with pharmacists to ensure the vaccine’s ease of use.

In summary, despite the FDA's administrative delay, Moderna remains confident about the approval and discussion of its RSV vaccine at the upcoming June ACIP meeting. Investors and analysts alike seem to believe that the delay will not significantly impact the vaccine's overall approval timeline, keeping Moderna in the race within the competitive RSV vaccine market.