Respiratory Syncytial Virus Vaccine (GSK)

Dive Brief:Shares in Moderna dropped by more than 20% Monday morning after the biotechnology company slashed its revenue guidance for 2025 by $1 billion.Moderna now expects revenue next year to land between $1.5 billion and $2.5 billion, down from a September estimate of $2.5 billion and $3.5 billion. The company is accelerating previously announced cost-cutting plans, signaling it aims to reduce expenses by $1 billion this year.Moderna, which makes vaccines for COVID-19 and respiratory syncytial virus, has been struggling to appease investors as sales of its shots have come in lower than expected. CEO Stphane Bancel recently acknowledged the company was too optimistic with its RSV forecasting.Dive Insight:Vaccine makers faced a difficult year in 2024, as demand for both COVID and RSV shots ebbed compared to 2023.According to Jefferies analyst Michael Yee, COVID vaccinations involving Moderna, Pfizer and Novavax products dropped by 8% at the end of 2024 versus the year prior. And RSV, which was targeted by Moderna as its next big market, proved more challenging than the company anticipated.Approved in May 2024, Modernas shot mResvia competes with Pfizers Abrysvo and GSKs Arexvy, which were both cleared in the U.S. a year earlier. But all three companies were caught off guard by updated guidance from the Centers for Disease Control and Prevention that narrowed its prior recommendation for RSV immunization.We were also too optimistic about our ability to break into the market given the headwinds from a midyear approval and launch, Bancel wrote in a Jan. 6 letter to shareholders.In Mondays announcement, Moderna disclosed unaudited sales of between $3 billion to $3.1 billion for 2024, lower at the high end by $400 million than its Nov. 7 guidance. MResvia contributed minimal sales to that total, per the company.The company has an expansive pipeline that it expects will deliver an increasing cadence of approvals. Still, investors appear to be remaining cautious of Modernas future success.Closely watched is a vaccine for cytomegalovirus, or CMV, a virus that can cause birth defects, in late-stage testing. However, the shot didnt clear an early bar for declaring success in a Phase 3 study, reinforcing doubts on the studys odds of success, Mani Foroohar wrote in a Leerink note to clients Monday. Final efficacy data is expected this year.The company is also anticipating a decision from the Food and Drug Administration in May for its next-generation COVID vaccine. Data readouts for Modernas norovirus and seasonal flu vaccines could also come this year. '

Pfizer and GSK’s RSV vaccines have a new warning at the request of the FDA, relaying an increased risk of Guillain-Barré syndrome within the first 42 days post-vaccination. The agency said in a bulletin Tuesday that “the overall body of evidence suggests increased risks of GBS with Abrysvo and Arexvy, but that available evidence is insufficient to establish a causal relationship.” The FDA approved updated labels for both companies on Monday. The neurological autoimmune condition is marked by tingling or weakness in people’s arms and legs, and sometimes arise within weeks after an infection. GSK said in a statement that it has its own ongoing safety studies, including on the risk of GBS, but that it remains “confident in the benefit-risk profile of Arexvy for the prevention of RSV-LRTD.” Pfizer reiterated the FDA’s conclusion in a statement. Key data underpinning the decision came from an FDA post-marketing study assessing the risk of GBS across the two vaccines, finding there were nine excess cases of the condition per million doses administered of Pfizer’s Abrysvo, and seven excess cases per million doses administered of GSK’s Arexvy to adults 65 and older. The FDA previously presented the study findings at the CDC’s Advisory Committee on Immunization Practices in October, which showed a statistically significant risk increase for GSK’s vaccine but not Pfizer’s, given that it had fewer doses administered in the study. Still, the agency concluded then that Pfizer’s shot came with an elevated risk. FDA presenters concluded then that the risk of GBS post-vaccination of either shot remained “rare” and that the risks didn’t deviate based on whether people received other vaccines at the same time. An FDA reviewer told the CDC panel that it could not break down the risk by age based on the sample size of the post-marketing study. Moderna, which had its RSV vaccine approved after the post-marketing study began, was not included in the FDA’s label change. At the time of ACIP’s October meeting, no cases of GBS had been found within 42 days of vaccination in Moderna’s clinical trials and post-licensure surveillance data wasn’t yet available. Other vaccines have had varying risks associated with GBS, including the flu vaccines which have a small, one-to-two-case risk increase per million doses of flu vaccine administered. For Johnson & Johnson’s one-shot Covid-19 vaccine, the GBS risk was 11 times higher within the first 42 days than the Pfizer or Moderna options. The label warning follows a bleak second vaccination season for RSV makers, marked by tightened guidance, significantly less uptake and now a safety warning. Prescription data through the middle of December found that uptake was roughly 50% less than through the same period in 2023, according to Jefferies research.