Latest news with #mRNA1083
Yahoo
23-05-2025
- Business
- Yahoo
MRNA Stock Down on Withdrawal of FDA Filing for COVID-Flu Combo Shot
Shares of Moderna MRNA declined nearly 8% yesterday after it announced that it had voluntarily withdrawn a regulatory filing seeking the FDA's approval for mRNA-1083, its investigational mRNA-based combination vaccine against influenza and COVID. Per the company, the decision was taken in consultation with the agency. This announcement did not come as a surprise since MRNA had already announced earlier this month, alongside its Q1 results, that the FDA had requested 'Phase 3 flu efficacy data.' This setback derailed the company's initial plans to secure a potential FDA approval for the vaccine before this year's end. Moderna plans to resubmit this filing later this year after vaccine efficacy data from the ongoing phase III study on its investigational seasonal influenza vaccine, mRNA-1010, is available. Interim data from this study is expected this summer. This decision also comes a day after the FDA issued new guidance for COVID vaccine boosters. As part of this guidance, COVID vaccine makers will be required to conduct randomized, placebo-controlled clinical studies demonstrating the real-world benefit of yearly COVID vaccine boosters in individuals aged under 65 years. The initial FDA filing, which sought approval for use in older adults aged 50 years and above, was supported by data from a phase III study announced last year. Data from this study showed that mRNA-1083 elicited higher immune responses against influenza and COVID compared with licensed standalone influenza and COVID vaccines. Year to date, Moderna's shares have plummeted 38% compared to the industry's 4% fall. Image Source: Zacks Investment Research Apart from Moderna, Novavax NVAX, Pfizer PFE and Sanofi SNY are also developing their respective COVID/flu combination vaccines. NVAX started a late-stage study last year evaluating its experimental COVID-influenza combination (CIC) vaccine candidate. This study is comparing the immunogenicity and safety of the CIC vaccine against separate administrations of Novavax's currently authorized COVID vaccine and a licensed seasonal influenza vaccine. Initial data from this study is expected later this year. Pfizer suffered a major setback in this space last year when it reported data from a phase III study on its investigational mRNA-based COVID/flu combination vaccine. The study missed one of its two primary immunogenicity objectives. PFE is currently evaluating adjustments to its combination vaccine program to improve immune responses against influenza B and plans to discuss the next steps with health authorities. Pfizer is developing this vaccine in collaboration with BioNTech. A recent entrant into this space is Sanofi, which is also developing its own COVID/flu combination vaccines. Last year, SNY announced that the FDA granted fast-track designation to two of its experimental combination vaccines for COVID and influenza, each being evaluated in separate phase I/II studies. While the first combination pairs the Fluzone HD vaccine with Novavax's COVID vaccine, the second combines Sanofi's Flubok influenza vaccine with the NVAX COVID vaccine. Moderna, Inc. price | Moderna, Inc. Quote Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sanofi (SNY) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report Moderna, Inc. (MRNA) : Free Stock Analysis Report Novavax, Inc. (NVAX) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Gizmodo
11-05-2025
- Health
- Gizmodo
Moderna's Super-Vaccine for Flu and Covid Works—Now Politics Could Sink It
A new trial suggests a combination vaccine may offer equal or better protection against both flu and covid-19 compared to current vaccines. Moderna's mRNA-based flu and covid-19 vaccine could provide the best of both worlds—if it's actually ever approved by the Food and Drug Administration. This week, scientists at Moderna published data from a Phase III trial testing the company's combination vaccine, codenamed mRNA-1083. Individuals given mRNA-1083 appeared to generate the same or even greater immune response compared to those given separate vaccines, the researchers found. But the FDA's recent policy change on vaccine approvals, orchestrated by Health Secretary Robert F. Kennedy Jr, could imperil the development of this and other future vaccines. The trial involved 8,000 people split into two age groups: those between the ages of 50 and 64, and those over 65. People were randomly given mRNA-1083 (plus a placebo) or two already approved flu and covid-19 vaccines. The vaccine seemed effective across both age groups, with mRNA-1083 participants showing at least the same level of humoral immune response (antibody-based) to circulating flu and covid-19 strains as participants who were given the separate vaccines. On average, this response was actually higher to the flu strains in particular among those given mRNA-1083. The experimental vaccine also appeared to be safe and well-tolerated, as the authors explained in their paper, published Wednesday in JAMA. The study results are certainly encouraging, and typically they would pave the way toward a surefire FDA approval. But the political situation has changed for the worse. The Department of Health and Human Services recently mandated an overhaul of the vaccine approval process, one that will require all new vaccines to undergo placebo-controlled trials to receive approval. While many experimental vaccines today are placebo-tested (including the original covid-19 vaccines), it's unclear whether this order will also apply to vaccines that can be compared to existing vaccines, like the combination mRNA-1083 vaccine, or to vaccines that have to be regularly updated to match fast-evolving viruses like the flu and covid-19. Some vaccine experts have said that these changes are unnecessary and potentially unethical, since it could leave some people vulnerable to an infection that already has a vaccine. The new rule also might delay the availability of upcoming seasonal vaccines, particularly the current covid-19 shots. A potentially important wrinkle for the mRNA-1083 vaccine is that no mRNA-based vaccine for the flu is currently approved. That reality could very well be all that the FDA needs to demand further placebo-controlled trials. RFK Jr. and other recent Trump appointees have also been highly skeptical of mRNA-based vaccines in general, despite no strong evidence that these vaccines are significantly less safe than other types. Kennedy, who has a long history of supporting the anti-vaccination movement, has even wrongly declared that the mRNA covid-19 vaccine was the 'deadliest vaccine ever made.' Moderna stated last week it doesn't expect its mRNA-1083 vaccine to be approved before 2026, following the FDA's request for late-stage data showing the vaccine's effectiveness against flu specifically. But it's worth wondering if even that timeline is now in jeopardy under the current public health regime.
