Latest news with #mRESVIA
Yahoo
17 hours ago
- Health
- Yahoo
FDA OKs new COVID-19 vaccine for 65 and older, others with conditions
May 31 (UPI) -- The Food and Drug Administration has approved Moderna's new COVID-19 vaccine, days after the federal government tightened vaccine standards for the virus. The FDA announced Friday that mNEXSPIKE can be given to adults 65 and older and those 12 to 64 with at least one underlying condition that could put them at risk of severe infection. Recipients also must have been previously vaccinated for COVID-19. The company, headquartered in Cambridge, Mass., said Saturday it expects to have the vaccine available for the 2025-2026 respiratory virus season. Moderna also produces Spikevax for COVID-19, and mRESVIA for the respiratory syncytial virus, or RSV. "The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19," Stéphane Bancel, chief executive officer of Moderna, said. "COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA's timely review and thank the entire Moderna team for their hard work and continued commitment to public health." STAT reported the next-generation COVID-19 vaccine uses a refined target to generate antibodies against the SARS-CoV-2 virus. The dose is one-fifth the doage used in Spikevax, the current vaccine. Moderna conducted a randomized, observer-blind Phase 3 clinical trial of approximately 11,400 participants aged 12 years and older to test the mRNA-1283. The primary efficacy was to demonstrate the vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared with Spikevax, Moderna's updated COVID-19 vaccine approved on Sept. 6, 2024. The new vaccine showed a 9.3% higher relative vaccine efficacy than the mRNA-1273 in individuals aged 12 years and older. It was 13.5% better in adults aged 65 and older. In the Phase 3 trial, the most common side effects were injection site pain, fatigue, headache and myalgia. The company said there is a very small chance that mNEXSPIKE could cause a severe allergic reaction, usually within a few minutes to 1 hour after getting a dose of mNEXSPIKE. Myocarditis, which is inflammation of the heart muscle, and pericarditis, which is inflammation of the lining outside the heart, have occurred in some people who have received mRNA COVID-19 vaccines, Moderna said. Of those with problems, they are among males12 through 24. The FDA has asked Moderna to conduct post-marketing studies to continue to evaluate the safety and effectiveness of the product. This includes a study on the outcomes of pregnant people and their babies when the vaccine was administered during pregnancy. The study is to be submitted by the end of 2032. Pfizer was the first COVID-19 vaccine to receive emergency approval in December 2020 and Moderna was followed one week later. The first COVID-19 cases were reported in the United States in January 2020. The FDA first granted Pfizer-BioNTech full COVID-19 approval for those 12 and older in August 2021 and Moderna in January 2022. They remain available under emergency use authorization for children as young as 6 months. On Friday, the Centers for Disease Control and Prevention said children without underlying health conditions "may receive" a COVID-19 vaccine, contradicting a directive by Health and Human Services Secretary Robert F. Kennedy Jr. earlier in the week. The CDC updated the childhood immunization schedule published late Thursday. Kennedy, who said the agency would stop recommending the shots for healthy children, noted the guidelines would be changed. The new schedule also requires health insurance companies, Medicare and Medicaid plans to continue to cover the vaccines for children. COVID-19 shots during pregnancy are listed as "No Guidance/Not Applicable," where they were previously recommended for all pregnant adults. Earlier this month, the FDA approved Novavax's COVID-19 vaccine with age restrictions after a six-week delay. The agency approved the vaccine only for people 65 and older and those 12 and older with at least one underlying condition at a higher risk of severe illness. This week, HHS notified Moderna that it was canceling contracts worth $766 million to develop, test and license vaccines for flu subtypes that could trigger future pandemics, including the dangerous H5N1 bird flu virus. The first COVID-19 case was reported in the United States on Jan. 20, 2020. About 23% of U.S. adults are estimated to be up to date with the vaccine, according to the CDC through April. For children 6 months and up to 18, it is an estimated 13.%, the CDC reported.
UPI
18 hours ago
- Health
- UPI
FDA OKs new COVID-19 vaccine for 65 and older, others with conditions
A vial of the Moderna COVID-19 vaccine in the Meuhedet Clinic in Jerusalem on January 3, 2022. The FDA approved a new version of the vaccine on Friday. File photo by Debbie Hill/UPI | License Photo May 31 (UPI) -- The Food and Drug Administration has approved Moderna's new COVID-19 vaccine, days after the federal government tightened vaccine standards for the virus. The FDA announced Friday that mNEXSPIKE can be given to adults 65 and older and those 12 to 64 with at least one underlying condition that could put them at risk of severe infection. Recipients also must have been previously vaccinated for COVID-19. The company, headquartered in Cambridge, Mass., said Saturday it expects to have the vaccine available for the 2025-2026 respiratory virus season. Moderna also produces Spikevax for COVID-19, and mRESVIA for the respiratory syncytial virus, or RSV. "The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19," Stéphane Bancel, chief executive officer of Moderna, said. "COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA's timely review and thank the entire Moderna team for their hard work and continued commitment to public health." STAT reported the next-generation COVID-19 vaccine uses a refined target to generate antibodies against the SARS-CoV-2 virus. The dose is one-fifth the doage used in Spikevax, the current vaccine. Moderna conducted a randomized, observer-blind Phase 3 clinical trial of approximately 11,400 participants aged 12 years and older to test the mRNA-1283. The primary efficacy was to demonstrate the vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared with Spikevax, Moderna's updated COVID-19 vaccine approved on Sept. 6, 2024. The new vaccine showed a 9.3% higher relative vaccine efficacy than the mRNA-1273 in individuals aged 12 years and older. It was 13.5% better in adults aged 65 and older. In the Phase 3 trial, the most common side effects were injection site pain, fatigue, headache and myalgia. The company said there is a very small chance that mNEXSPIKE could cause a severe allergic reaction, usually within a few minutes to 1 hour after getting a dose of mNEXSPIKE. Myocarditis, which is inflammation of the heart muscle, and pericarditis, which is inflammation of the lining outside the heart, have occurred in some people who have received mRNA COVID-19 vaccines, Moderna said. Of those with problems, they are among males12 through 24. The FDA has asked Moderna to conduct post-marketing studies to continue to evaluate the safety and effectiveness of the product. This includes a study on the outcomes of pregnant people and their babies when the vaccine was administered during pregnancy. The study is to be submitted by the end of 2032. Pfizer was the first COVID-19 vaccine to receive emergency approval in December 2020 and Moderna was followed one week later. The first COVID-19 cases were reported in the United States in January 2020. The FDA first granted Pfizer-BioNTech full COVID-19 approval for those 12 and older in August 2021 and Moderna in January 2022. They remain available under emergency use authorization for children as young as 6 months. On Friday, the Centers for Disease Control and Prevention said children without underlying health conditions "may receive" a COVID-19 vaccine, contradicting a directive by Health and Human Services Secretary Robert F. Kennedy Jr. earlier in the week. The CDC updated the childhood immunization schedule published late Thursday. Kennedy, who said the agency would stop recommending the shots for healthy children, noted the guidelines would be changed. The new schedule also requires health insurance companies, Medicare and Medicaid plans to continue to cover the vaccines for children. COVID-19 shots during pregnancy are listed as "No Guidance/Not Applicable," where they were previously recommended for all pregnant adults. Earlier this month, the FDA approved Novavax's COVID-19 vaccine with age restrictions after a six-week delay. The agency approved the vaccine only for people 65 and older and those 12 and older with at least one underlying condition at a higher risk of severe illness. This week, HHS notified Moderna that it was canceling contracts worth $766 million to develop, test and license vaccines for flu subtypes that could trigger future pandemics, including the dangerous H5N1 bird flu virus. The first COVID-19 case was reported in the United States on Jan. 20, 2020. About 23% of U.S. adults are estimated to be up to date with the vaccine, according to the CDC through April. For children 6 months and up to 18, it is an estimated 13.%, the CDC reported.
Yahoo
02-05-2025
- Business
- Yahoo
Moderna Inc (MRNA) Q1 2025 Earnings Call Highlights: Navigating Challenges with Strategic Cost ...
Revenue: $108 million for Q1 2025, a 35% decrease year-over-year. Net Product Sales: $86 million, primarily from COVID vaccine sales. Net Loss: $1 billion, an improvement from a $1.2 billion loss in Q1 2024. Loss Per Share: $2.52, improved from a loss of $3.07 in the prior year period. Cash and Investments: $8.4 billion at the end of Q1 2025. Cost of Sales: $90 million, representing 104% of net product sales. R&D Expenses: $856 million, a 19% decrease year-over-year. SG&A Expenses: $212 million, down 23% year-over-year. Income Tax Provision: $7 million, not material due to valuation allowance. Full-Year Revenue Guidance: $1.5 billion to $2.5 billion for 2025. Projected Cost of Sales for 2025: Approximately $1.2 billion. Projected R&D Expenses for 2025: Approximately $4.1 billion. Projected SG&A Expenses for 2025: Approximately $1.1 billion. Capital Expenditures for 2025: Projected to be approximately $400 million. Projected Cash and Investments by End of 2025: Approximately $6 billion. Warning! GuruFocus has detected 4 Warning Signs with MRNA. Release Date: May 01, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Moderna Inc (NASDAQ:MRNA) achieved a 19% reduction in combined cost of sales, R&D, and SG&A expenses compared to the first quarter of 2024, demonstrating strong financial discipline. The company ended the quarter with $8.4 billion in cash and investments, providing a solid financial foundation. Moderna Inc (NASDAQ:MRNA) expanded its market presence with mRESVIA receiving approvals in Australia, Taiwan, the UK, and Switzerland, enhancing its global reach. The oncology portfolio was expanded with the Checkpoint program, showing promising early data and aligning with the company's strategy to diversify its pipeline. Moderna Inc (NASDAQ:MRNA) has a robust late-stage pipeline with multiple regulatory filings and ongoing Phase 3 trials, indicating potential future growth opportunities. Moderna Inc (NASDAQ:MRNA) reported a net loss of $1 billion for the quarter, reflecting ongoing financial challenges. Total revenue for the quarter decreased by 35% year-over-year, highlighting a decline in sales performance. The company observed lower vaccination rates compared to the previous year, impacting its COVID vaccine sales. The flu COVID combination vaccine's approval timeline has been extended to 2026 due to additional efficacy data requirements, delaying potential revenue from this product. The company faces uncertainties in vaccination rates and competitive market environments, which could impact future revenue projections. Q: You noted that based on FDA feedback for Phase 3 Flu efficacy data, you now expect an extended review timeline and you're targeting approval in 2026. Could you comment any further on your interactions with the FDA and why they decided to require this? And more broadly, just to the potential risk of the vaccine business outlook under the new administration? A: Thank you, Salveen, for the question. We have moved forward quickly in enrolling cases for the flu efficacy study, which we originally thought might be a two-season study. We now expect a readout soon with a large number of cases. It makes scientific sense to include this in the review for our flu COVID combination. We have demonstrated efficacy for the COVID component, and now we are focusing on the flu component. We continue to have productive exchanges with the FDA across all submissions, and we see a real need for COVID vaccination, especially this fall. Q: What's the latest on your thinking, whether seeing INT Phase 3 data in 2026 is still a reasonable expectation? What are your plans for new trials, expansions, and other indications for both INT and the newly prioritized Checkpoint? A: The Phase 3 melanoma study reached its target enrollment in September 2024. Based on historical event rates, we expect to have enough events for an efficacy analysis in 2026. We are pleased with the enrollment in the non-small cell lung cancer study but haven't provided a specific timeline. For Checkpoint, we are encouraged by early data and plan to expand into additional cancer indications. Q: Given how close we are to the PDUFA, it's business as usual for the 1283 review. Can you talk about how interactions are going for that program and your confidence in approval given the new leadership and recent denial of the Novavax program? A: It has been business as usual with the FDA. We have had constructive exchanges of scientific information, and we are confident in making the existing PDUFA date. We continue to provide high-quality data to all regulators, including the FDA, to support their assessments. Q: Regarding a recent media article about vaccine trials requiring placebo controls, what do you think that will do to enrollment? Will it be harder to enroll, and is that going to be required for all respiratory vaccines? A: We can't comment on a policy change that hasn't been communicated to us. Our COVID, RSV, CMV, and norovirus vaccines have been conducted as placebo-controlled studies. It will depend on FDA and HHS guidance at a program level. Our responsibility is to provide the data that regulators need to stand behind our products. Q: Can you elaborate on the process for COVID strain selection moving forward given the regulatory uncertainties? A: It is up to regulators in each country to tell us what updates they may want for the coming year. We expect to hear from WHO, EMA, and the US FDA within the next month about what they would like to see for the fall. The process is up to them, and we will follow their guidance. Q: Regarding the flu COVID combination and the updated timing, is it your expectation that you would need to refile with updated flu efficacy data, or could it be a major amendment? A: It will depend on consultation with the FDA. It is appropriate to submit the data as an amendment to the BLA, but it could also make sense to update the BLA submission broadly. We will follow the FDA's guidance on the most pragmatic approach. Q: What particular milestones or expectation changes drove you to increase the cost-cutting program? A: Much of this is extending our guidance to 2027, reflecting the completion of large Phase 3 trials by then. We are focusing on what we can control, which is our cost base, to fulfill our commitment to breakeven by 2028. The majority of cost reductions will come from the completion of Phase 3 trials and continued improvements in procurement and operational efficiency. Q: For norovirus, have you identified the source of the GBS case, and have there been any additional cases noted? A: We have not seen additional GBS cases, which is encouraging. Causality may never be known, as GBS cases occur in the background population. We will continue to monitor for additional cases in our ongoing Phase 3 study. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
01-05-2025
- Business
- Yahoo
Moderna Cuts Costs as COVID Sales Slump
Moderna (NASDAQ:MRNA) accelerates cost cuts, trimming 2026 GAAP operating expenses by up to $500 million as COVID-19 vaccine sales dwindle. Moderna reported a Q1 net loss of $1 billion, narrower than last year's $1.2 billion deficit, on revenue of $108 million that plunged 35% year-over-year as Spikevax sales fell to $84 million and RSV vaccine mRESVIA added just $2 million. Warning! GuruFocus has detected 4 Warning Signs with MRNA. The company's total operating expenses fell to $1.16 billion from $1.43 billion in Q1 2024, reflecting management's push for efficiency across R&D, SG&A and manufacturing. CEO Stephane Bancel highlighted a 19% reduction in combined R&D and SG&A costs versus last year, driven by project reprioritization and streamlined supply chains, while CFO Jamey Mock noted that cash and investments still stand at a healthy $8.4 billion. Looking ahead, Moderna now targets 2026 operating costs of $5.4 billion to $5.7 billiondown from its prior $5.9 billion forecastand sees 2027 expenses falling further to $4.7 billion$5 billion, painting a two-year cost-saving of up to $1.7 billion. The company reiterated full-year 2025 revenue guidance of $1.5 billion to $2.5 billion, with roughly $200 million expected in H1 reflecting the seasonality of respiratory vaccines. Those figures sit below 2024's COVID-fueled peak but underscore Moderna's aim to recast itself as a diversified mRNA powerhouseeven as its flu/COVID combo shot won't hit the market until after Phase 3 flu-efficacy data in 2026. Moderna is banking on regulatory approvals for mRESVIA in markets including Australia and Switzerland and on its burgeoning oncology pipeline, where a Phase 2 checkpoint program is underway. Yet the delay in its next-generation combo vaccine exemplifies the regulatory and competitive hurdles in the vaccine space. As COVID shot demand stabilizes at a seasonal cadence, Moderna's aggressive expense cuts and pipeline milestones will determine its path to profitability and shape mRNA sector valuations. Investors will be eyeing Moderna's H2 RSV launch cadence, upcoming Phase 3 oncology readouts and any mid-year update on the flu/COVID combo vaccinekey catalysts for the stock's next leg. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
01-05-2025
- Business
- Yahoo
Moderna beats Wall Street estimates for first-quarter profit and sales
By Patrick Wingrove (Reuters) -Moderna (MRNA) on Thursday reported first-quarter profit and sales that beat Wall Street estimates, helped by the company's cost-cutting efforts following waning post-pandemic demand for its COVID-19 vaccine. The U.S. vaccine maker also said it did not expect to get regulator approval for its combination shot to protect against both COVID-19 and influenza until 2026, after the U.S. Food and Drug Administration said it required late-stage data demonstrating the shot's efficacy against the flu. Moderna previously said it hoped to launch the vaccine for the autumn respiratory disease season in 2025 or 2026. The Cambridge, Massachusetts-based drugmaker said it plans to cut its adjusted operating costs by as much as $1.7 billion by 2027 compared to its estimate for this year. It expects operating costs for 2027 to be between $4.7 billion and $5 billion, the company said. Finance chief James Mock said in an interview Moderna expects those costs to fall as it completes several late-stage vaccine trials. Moderna posted an adjusted loss of $2.52 per share for the quarter, beating analysts' estimates of a $3.14 per share loss, according to LSEG data. Mock said the smaller-than-expected loss was driven "all by cost cutting." The company brought in $108 million in quarterly revenue, down 35% on last year but coming in slightly ahead of analysts expectations of $106.2 million, according to LSEG data. The company's COVID shot Spikevax generated $84 million, while $2 million came from sales of mRESVIA, its RSV vaccine. Analysts had expected sales of $75.67 million and $3.3 million respectively for Spikevax and mRESVIA. The drugmaker has been banking on revenue from newer mRNA shots to make up for falling sales of its COVID vaccine and less-than-expected uptake of its respiratory syncytial virus vaccine, which sent shares down nearly 60% last year. The Trump administration has this year raised concerns about the prospects for new vaccines, following its decision to delay the regulatory approval of Novavax's rival COVID-19 vaccine. The FDA had set a goal date of April 1 for the decision and missed that deadline. Drugmakers have also been grappling with the prospect of sector-specific tariffs, following the Trump government's decision to launch a probe into pharmaceutical imports that sets the stage for levies on the industry. Mock said the tariff policies in place today will have a "very immaterial" impact on Moderna, as all of the company's drug substance for the United States is made in Massachusetts. Moderna reiterated its full-year 2025 product sales forecast of $1.5 billion to $2.5 billion, with most expected in the second half of the year. The company had previously said it expected $200 million of its predicted revenue for 2025 to come in during the first half of the year. By subscribing, you are agreeing to Yahoo's Terms and Privacy Policy
