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High-Dose Flu Shot Beats Standard Dose in At-Risk Patients

High-Dose Flu Shot Beats Standard Dose in At-Risk Patients

Medscape7 days ago
TOPLINE:
The high-dose influenza vaccine demonstrated superior immunogenicity over the standard-dose vaccine in immunocompromised patients, with increased seroconversion rates for H1N1, H3N2, and B strains, while showing similar safety profiles.
METHODOLOGY:
Researchers conducted a meta-analysis of 16 randomised clinical trials comparing inactivated high-dose (60 µg haemagglutinin antigen load per strain) and standard-dose (15 µg haemagglutinin antigen load per strain) influenza vaccines in immunocompromised patients.
Spanning nine influenza seasons, these studies enrolled 1862 patients, of whom 954 received the high-dose vaccine and 908 the standard-dose vaccine.
Primary outcomes were immunogenicity (measured using geometric mean haemagglutination inhibition titres at 21-42 days post-vaccination), seroprotection and seroconversion rates, and safety profiles.
TAKEAWAY:
At 21-42 days post-vaccination, the geometric mean haemagglutination inhibition titres were 32% higher for H1N1, 55% for H3N2, and 39% for B strains among recipients of the high-dose vaccine than among those of the standard-dose vaccine.
Seroconversion rates were consistently higher among recipients of the high-dose vaccine than among those of the standard dose vaccine for H1N1 (risk ratio [RR], 1.30; 95% CI, 1.04-1.57), H3N2 (RR, 1.22; 95% CI, 1.03-1.41), and B (RR, 1.39; 95% CI, 1.15-1.63) strains.
Seroprotection rates were similar across most strains, except for the H1N1 strain, for which the high-dose vaccine conferred slightly higher protection (RR, 1.04; 95% CI, 1.00-1.09).
Safety profiles were similar between both the groups for most adverse events; however, injection-site pain occurred more often with the high-dose vaccine (RR, 1.29; 95% CI, 1.04-1.54).
IN PRACTICE:
"Our data suggest that HD [high-dose] influenza vaccine could be recommended for immunocompromised patients. Future clinical trials including larger sample sizes and analysing clinical effectiveness will be of great interest to provide recommendations for specific immunocompromised populations," the authors wrote.
SOURCE:
This study was led by Mario Rivera-Izquierdo, School of Medicine, University of Granada, Granada, Spain. It was published online on June 22, 2025, in the Journal of Infection.
LIMITATIONS:
This study was limited by the absence of data from some original studies and by the annual change in high-dose vaccine formulations, which may have limited the applicability of the findings to other seasons. The immunocompromised populations included were very specific. Moreover, most studies did not assess the clinical effectiveness of the high-dose vaccine.
DISCLOSURES:
This study was supported by the Instituto de Investigación Biomédica de Lleida Fundación Dr Pifarré (IRBLleida). The authors reported having no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
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Experimental Moderna flu shot more effective than approved vaccine, company says
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  • The Hill

Experimental Moderna flu shot more effective than approved vaccine, company says

Moderna Inc. said Monday its experimental flu shot showed positive results in a late-stage trial. In a Phase 3 study, the company's mRNA-1010 flu vaccine's efficacy was nearly 27 percent higher for adults 50 and older than a currently available shot. The shot also showed strong efficacy against each of the major influenza strains in the shot including A/H1N1, A/H3N2 and the B/Victoria lineages. Efficacy appeared consistently strong across age groups, flu vaccination status and among people with various risk factors, Moderna said in a statement. The trial enrolled more than 40,800 adults 50 and older from 11 countries. 'The severity of this past flu season underscores the need for more effective vaccines,' said Stephane Bancel, chief executive officer of Moderna. 'An mRNA-based flu vaccine has the potential advantage to more precisely match circulating strains, support rapid response in a future influenza pandemic, and pave the way for COVID-19 combination vaccines.' Seasonal flu-related hospitalizations and outpatient visits reached a 15-year high during the 2024-25 season, according to the CDC. At least 600,000 Americans were hospitalized last year due to flu-related illness, agency data show. According to the CDC, seasonal flu-related hospitalizations and outpatient visits reached a 15-year high during the 2024-2025 season. [2] More than 600,000 Americans were hospitalized due to flu-related illness last year, leading to substantial direct and indirect costs, as well as widespread disruption to daily life and work After consulting the Food and Drug Administration, Moderna withdrew its application last month for a dual flu and COVID-19 vaccine for adults 50 years old and older. Moderna plans to resubmit the application for the combination vaccine with the new data, according to CNBC. The company also plans to submit the data on the mRNA-1010 shot to U.S. regulators this year.

High-Dose Flu Shot Beats Standard Dose in At-Risk Patients
High-Dose Flu Shot Beats Standard Dose in At-Risk Patients

Medscape

time7 days ago

  • Medscape

High-Dose Flu Shot Beats Standard Dose in At-Risk Patients

TOPLINE: The high-dose influenza vaccine demonstrated superior immunogenicity over the standard-dose vaccine in immunocompromised patients, with increased seroconversion rates for H1N1, H3N2, and B strains, while showing similar safety profiles. METHODOLOGY: Researchers conducted a meta-analysis of 16 randomised clinical trials comparing inactivated high-dose (60 µg haemagglutinin antigen load per strain) and standard-dose (15 µg haemagglutinin antigen load per strain) influenza vaccines in immunocompromised patients. Spanning nine influenza seasons, these studies enrolled 1862 patients, of whom 954 received the high-dose vaccine and 908 the standard-dose vaccine. Primary outcomes were immunogenicity (measured using geometric mean haemagglutination inhibition titres at 21-42 days post-vaccination), seroprotection and seroconversion rates, and safety profiles. TAKEAWAY: At 21-42 days post-vaccination, the geometric mean haemagglutination inhibition titres were 32% higher for H1N1, 55% for H3N2, and 39% for B strains among recipients of the high-dose vaccine than among those of the standard-dose vaccine. Seroconversion rates were consistently higher among recipients of the high-dose vaccine than among those of the standard dose vaccine for H1N1 (risk ratio [RR], 1.30; 95% CI, 1.04-1.57), H3N2 (RR, 1.22; 95% CI, 1.03-1.41), and B (RR, 1.39; 95% CI, 1.15-1.63) strains. Seroprotection rates were similar across most strains, except for the H1N1 strain, for which the high-dose vaccine conferred slightly higher protection (RR, 1.04; 95% CI, 1.00-1.09). Safety profiles were similar between both the groups for most adverse events; however, injection-site pain occurred more often with the high-dose vaccine (RR, 1.29; 95% CI, 1.04-1.54). IN PRACTICE: "Our data suggest that HD [high-dose] influenza vaccine could be recommended for immunocompromised patients. Future clinical trials including larger sample sizes and analysing clinical effectiveness will be of great interest to provide recommendations for specific immunocompromised populations," the authors wrote. SOURCE: This study was led by Mario Rivera-Izquierdo, School of Medicine, University of Granada, Granada, Spain. It was published online on June 22, 2025, in the Journal of Infection. LIMITATIONS: This study was limited by the absence of data from some original studies and by the annual change in high-dose vaccine formulations, which may have limited the applicability of the findings to other seasons. The immunocompromised populations included were very specific. Moreover, most studies did not assess the clinical effectiveness of the high-dose vaccine. DISCLOSURES: This study was supported by the Instituto de Investigación Biomédica de Lleida Fundación Dr Pifarré (IRBLleida). The authors reported having no conflicts of interest. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

Moderna Announces Positive Phase 3 Results for Seasonal Influenza Vaccine
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USA Today

time7 days ago

  • USA Today

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[1] According to the CDC, seasonal flu-related hospitalizations and outpatient visits reached a 15-year high during the 2024-2025 season. [2] More than 600,000 Americans were hospitalized due to flu-related illness last year, leading to substantial direct and indirect costs, as well as widespread disruption to daily life and work. [3] P304 ( NCT06602024 ) is a Phase 3, randomized, observer-blind, active-controlled, case-driven, pivotal efficacy, immunogenicity and safety study. The trial enrolled 40,805 adults aged 50 years and older across 11 countries. Participants were randomly assigned to receive either a single dose of mRNA-1010 or a standard-dose licensed comparator, with a median follow-up of six months. Safety and tolerability of mRNA-1010 were consistent with reported results from a previous Phase 3 study. [4] The majority of solicited adverse reactions (SARs) were mild. Injection site pain was the most common local SAR, and fatigue, headache and myalgia were the most common systemic SARs reported. There were no significant differences between the groups in the rates of unsolicited adverse events, serious adverse events, or adverse events of special interest. Moderna plans to present these data at an upcoming medical conference and submit for peer-reviewed publication. The Company will engage with regulators on filing submissions for mRNA-1010. About Moderna Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's engagement with regulators on filing submissions for its standalone flu vaccine candidate; and the efficacy, safety and tolerability of mRNA-1010. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading 'Risk Factors' in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at . Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release. Moderna Contacts Media: Chris Ridley Head of Global Media Relations +1 617-800-3651 Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 SOURCE: Moderna, Inc. View the original press release on ACCESS Newswire

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