Tuesday, June 18, 2024

FDA Delays Moderna’s Respiratory Syncytial Virus Vaccine Approval; Company Aims for Quick Resolution

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Moderna, renowned for its groundbreaking contributions to combatting the COVID-19 pandemic with its innovative vaccines, embarked on a new frontier by venturing into the realm of respiratory syncytial virus (RSV) prevention. However, its ambitious endeavor faced an unexpected hurdle upon reaching the United States market. Citing unforeseen “administrative constraints,” the Food and Drug Administration (FDA) conveyed to Moderna that the evaluation process for its mRNA-1345 vaccine would extend beyond the anticipated deadline of May 12. This unexpected notification stirred concern among investors, resulting in a notable decline of nearly 3% in Moderna’s share price.

Investors are particularly concerned about the delay’s potential impact on the availability of mRNA-1345 for the impending respiratory syncytial virus season, set to commence in the fall. The apprehension stems from the crucial timing of vaccine availability, as healthcare providers typically plan and procure vaccines well in advance to ensure readiness for the upcoming season’s demands. Any delay in regulatory approval could disrupt this timeline, potentially resulting in limited access to mRNA-1345 when needed most.

To alleviate these concerns, Moderna sought to reassure investors by affirming that the FDA is working diligently to expedite the review process. The company emphasized that the regulatory agency aims to finalize its evaluation of mRNA-1345 by the end of May, thus signaling a commitment to minimizing any potential delays in vaccine availability. This assurance is crucial for maintaining investor confidence in Moderna’s ability to navigate regulatory hurdles effectively and deliver its innovative vaccine to the market in a timely manner.

Moderna Prioritizes Transparency Amid FDA Review Delays for Respiratory Syncytial Virus Vaccine

The looming RSV season adds urgency to the situation, as healthcare systems brace themselves for an anticipated increase in respiratory infections during the colder months. Timely access to effective vaccines like mRNA-1345 is essential for mitigating the burden of RSV-related illnesses and reducing strain on healthcare resources. Therefore, investors are closely monitoring developments surrounding the FDA review process, recognizing the significance of timely regulatory approval for Moderna’s respiratory syncytial virus vaccine.

In addition to addressing immediate investor concerns, Moderna’s proactive communication regarding the FDA review timeline underscores its commitment to transparency and accountability. By keeping stakeholders informed about the progress of regulatory proceedings, the company demonstrates its dedication to open communication and stakeholder engagement. This approach not only fosters trust among investors but also enhances Moderna’s reputation as a responsible corporate entity capable of effectively managing regulatory challenges.

Overall, while the delay in FDA approval for mRNA-1345 raises valid concerns among investors, Moderna’s proactive efforts to provide updates and assurances regarding the review process help mitigate uncertainty. By maintaining transparency and emphasizing its commitment to meeting regulatory requirements, Moderna seeks to instill confidence in its ability to navigate regulatory hurdles and bring its promising respiratory syncytial virus vaccine to market expeditiously.

Respiratory Syncytial Virus

Moderna’s Respiratory Syncytial Virus Vaccine Faces Stiff Market Competition

mRNA-1345 faces stiff competition in the burgeoning RSV vaccine market from GSK’s Arexvy and Pfizer’s Abrysvo, both of which are conventional protein-based vaccines and were introduced in time for the 2023-24 respiratory syncytial virus season. GSK emerged as the frontrunner in initial sales, reporting £1.2 billion ($1.5 billion) in revenue by the end of 2023, compared to Pfizer’s $515 million. Sales for the first quarter of 2024 stood at £182 million and $145 million, respectively.

Despite the delay, Moderna emphasized that the FDA has not raised any safety, efficacy, or quality concerns regarding mRNA-1345. The vaccine remains slated for review at the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) meeting scheduled for June 26-27. ACIP approval is a prerequisite for the commercial launch of the vaccine.

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Moderna’s Respiratory Syncytial Virus Vaccine Shows Promising Efficacy in Phase 3

Moderna’s application is primarily based on phase 3 data demonstrating 83.7% efficacy in preventing respiratory syncytial virus lower respiratory tract disease (RSV-LRTD) in individuals aged 60 and above. The vaccine’s development has been swift, commencing clinical testing in 2021, and is integral to Moderna’s efforts to offset the decline in COVID-19 vaccine sales.

While the delay presents a setback, the RSV market is substantial, given the sizeable older adult population. Annually, millions of RSV cases are recorded worldwide, resulting in approximately 360,000 hospitalizations and over 24,000 deaths.

Stephen Hoge, President of Moderna, expressed gratitude to the FDA for its diligence and reiterated the company’s commitment to assisting the agency in completing the application review process and participating in the June ACIP meeting. Additionally, Moderna is diversifying its portfolio by developing vaccines for influenza, combined flu/COVID, flu/COVID/RSV, and cancer.

 

Resource: Moderna, May 10, 2024

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