Category: Flu Vaccine

A combination flu and COVID-19 vaccine developed by Moderna generated a higher immune response in a late-stage trial than standalone vaccines, the company said Monday.

A two-in-one shot could improve vaccination rates and reduce the burden on the health care system.

Modernas phase 3 clinical trial studied two groups of about 4,000 people in each.

In one group, consisting of participants ages 65 and older, researchers compared the combo vaccine, called mRNA-1083, to the influenza vaccine Fluzone HD and Spikevax, Modernas COVID shot.

In the second group, of people 50 to 64, scientists compared mRNA-1083 to the flu vaccine Fluarix and Spikevax.

The study found that not only were immune responses from the combo vaccine not inferior to the other shots, they were statistically significantly higher against three flu strains H1N1, H3N2, and B/Victoria as well as COVID-19.

"Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses," Modern CEO Stphane Bancel said in a statement.

Pfizer and Novavax are also developing combo flu and COVID shots, but Moderna is the first to report positive phase 3 results.

Building on the momentum of positive Phase 3 data across our respiratory portfolio, we continue to address significant unmet medical needs and advance public health, Bancel said.

Moderna said it will present its data at an upcoming medical conference and submit the study results for publication, when they will be peer reviewed. It will then engage with regulators.

The vaccine will not be available for this years flu season.

Moderna said the combination shot also appears to be safe. The majority of side effects reported were minor, the most common being injection-site pain, fatigue, muscle aches and headache. The side effects were consistent with the other vaccines monitored in the study, the company said.

Francesca Ceddia, chief medical affairs officer for Moderna, noted in a blog post that, as of last month, flu vaccine uptake in the United States was more than double COVID-19 immunization rates (48.4% vs. 22.4%). Meanwhile, COVID-related hospitalizations are higher than with the flu and more than double among older adults.

The convenience that a combination vaccine could offer patients may help fill this gap while simplifying and routinizing vaccination against both diseases, which could help improve compliance with public health recommendations, Ceddia wrote.

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Moderna reveals promising study results on combo flu-COVID vaccine - Spectrum News

FILE - A patient is given a flu vaccine Friday, Oct. 28, 2022, in Lynwood, Calif. Seasonal flu continues to pick up steam in the U.S. But among respiratory viruses, COVID-19 remains the main cause of hospitalizations and deaths, health officials said Friday, Dec. 1, 2023. (AP Photo/Mark J. Terrill, File)

Dr. Jeffrey Kopin, Chief Medical Officer forNorthwestern Medicine Lake Forest Hospital, joinsJohn Williams to talk about a new study that showed a healthy diet and lifestyle can slow down Alzheimers, the percentage of men who are using weight-loss drugs, the status of Modernas combined COVID-flu vaccine, and when we should be thinking of getting the next COVID shot.

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Dr. Jeffrey Kopin: When will we see combined COVID-flu vaccine? - WGN Radio - Chicago

The journey towards a combined flu and Covid-19 vaccine just got one step closer following Modernas announcement of positive data from a Phase III trial of its mRNA vaccine candidate.

Compared to two individual vaccine administrations, a single shot of the combined vaccine elicited a stronger immune response against both diseases.

Named mRNA-1083, Modernas jab comprises a seasonal influenza vaccine candidate, mRNA-1010; and a next-generation Covid-19 vaccine prospect called mRNA-1283, both of which have fared well in their own respective Phase III trials.

Now, in a Phase III trial (NCT06097273) for mRNA-1083, Moderna said the candidate brought about statistically significantly higher immune responses compared to existing vaccines on the market. The trial met its primary endpoints, Moderna said in a 10 June press release.

The study evaluated the safety, reactogenicity and immunogenicity of the vaccine in around 8,000 participants, equally split into two independent age cohorts one with adults aged 65 years and older and the other with adults aged between 50 to 64 years. In the older age group, Modernas candidate was pitted against the companys Covid-19 vaccine Spikevax and Sanofis flu vaccine Fluzone HD. In the younger age group, Fluzone HD was substituted for GSKs Fluarix, whilst Spikevax remained.

Moderna stated that a single dose of mRNA-1083 was non-inferior versus the co-administered comparators. According to Moderna, those who received the combined vaccine showed an improved immune response compared with those who had the flu and Covid vaccines separately. The drugmaker added that the immune response was seen across three influenza virus strains (H1N1, H3N2, and B/Victoria) and against SARS-CoV-2.

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As for safety, mRNA-1083 was in line with licensed vaccines used in the trial. The most common adverse reactions included injection site pain, fatigue, and headache.

The most recent flu season in the UK had a great deal more cases than previous years. Englands National Health Service (NHS) revealed that flu cases in late January were up 75% from the same period last year. At some of the highest levels in winter, data showed an average of 2,226 patients were in hospital each day with flu, three-quarters up from the same week in January 2023.

Modernas CEO Stphane Bancel said: Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses.

While other companies are developing their own combined Covid-flu vaccine, Moderna is ahead of the competition being the only one testing in Phase III trials. Pfizer and BioNTech, for example, announced positive data from a Phase I/II trial in October 2023.

Bancel stated that Moderna is the only company with a positive Phase III flu and Covid combination vaccine.

Although Moderna has not published the full dataset from the Phase III trial, it plans to present the results in more detail at an upcoming medical conference, in addition to a submission for publication. The company said it will engage with regulators on next steps.

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Moderna races ahead in flu and Covid-19 combo vaccine race with Phase III win - Clinical Trials Arena

COLORADO SPRINGS, Colo. (KRDO) - A new study shows promising results for a possible combined COVID-19-Flu shot.

The study isn't yet peer-reviewed, but Moderna, the company behind it, reports recipients saw an improved immune response. Other companies have also been testing a combined COVID-Flu vaccine, but Moderna is the first to announce positive trial results.

In the video above, KRDO 13 medical expert, Dr. Neha Sharma provides more information on potential combination vaccines.

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HEALTHY COLORADO: Combination COVID-Flu shots - KRDO

Finland may be about to become the first country in the world to start dishing out preventative bird flu vaccines to some citizens. Its being reported that the first shipments of vaccine secured by the European Union (EU) will be heading there, so that those most at risk of exposure to the virus can be offered some protection.

Reuters reports that the EU is due to sign a contract with vaccine manufacturer CSL Seqirus to secure 665,000 doses of a preventative avian influenza vaccine on behalf of 15 nations within the EU and European Economic Area (EEA). Similar efforts are underway in the US, Canada, and UK, but with the EUs deal slated for completion on June 11, 2024, its looking likely the first nation to begin its vaccination efforts will be Finland.

The Zoonotic Influenza Vaccine Seqirus, which was authorized for use by the European Medicines Agency (EMA) in October 2023, was developed against a strain of bird flu in the H5N8 classification.

This is slightly different from the bird flu thats recently been hitting the headlines with outbreaks on dairy farms in several US states thats an H5N1 virus. However, since the vaccines main target is the hemagglutinin surface protein on the virus the H part, which is common to both H5N8 and H5N1 its hoped that it will still offer some protection against H5N1.

So far, three farm workers in the US are known to have contracted the virus after exposure to infected cows, and theres no evidence of transmission between people. While the risk is generally considered low, those whose occupations bring them into close contact with animals will be the proverbial canaries in the coal mine if this virus starts to make more frequent jumps to humans.

The US Centers for Disease Control and Prevention (CDC) is recommending that anyone spending time around dairy cows or raw milk practice good hand hygiene and wear personal protective equipment, including gloves, respirators, and safety goggles. Its hoped a vaccine, even against a slightly different avian flu virus, will offer another layer of protection.

No EU/EEA countries have yet reported a human case of H5N1. The risk of zoonotic influenza transmission to the general public in EU/EEA countries is considered to be low, said the European Centre for Disease Prevention and Control in its weekly report for June 1-7.

That said, Finland saw a number of outbreaks of highly pathogenic H5N1 in 2023, in wild birds and among mammals on a number of the countrys over 500 fur farms, which resulted in large-scale culling.

Animals that are farmed for fur, like mink, are known to be susceptible to avian flu, but outbreaks on fur farms, as well as the ongoing situation with dairy cows in the US, are particularly concerning to epidemiologists as they raise the specter of sustained transmission between mammals, which itself increases the chance of a virus making the jump to humans.

Last year the situation looked very alarming, said Hanna Nohynek, chief physician with the Infectious Diseases Control and Vaccines Unit at the Finnish Institute for Health and Welfare, according to Euractiv. This year has been more calm, but we know from the US that the virus is still around, so we want to protect those who are working with animals that might be affected.

To that end, STAT News reports that Finnish authorities are planning to start delivering doses to poultry farmers, fur farm workers, vets, and scientists studying the virus as soon as the vaccines are in the country.

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Finland To Offer Bird Flu Vaccines To At-Risk Groups In Possible World-First Move - IFLScience

PIERRE, S.D.(MITCHELLNOW)The United States and Europe are taking steps to acquire or manufacture H5N1 bird flu vaccines that could be used to protect at-risk poultry and dairy workers, veterinarians, and lab technicians, which influenza experts say could curb the threat of a pandemic.

U.S officials announced they were moving bulk vaccine from CSL Seqirus that closely matches the current virus into finished shots that could provide 4.8 million doses of vaccine. Dawn OConnell of the U.S. Administration for Strategic Preparedness and Response said the government is looking closely at the possibility of vaccinating farm workers and others in close contact with the virus. The U.S. has contracts with CSL and GSK to test pre-pandemic vaccines that more closely match the circulating virus than older H5N1 vaccines in the stockpile. The U.S. is moving forward with the CSL vaccine, a Department of Health and Human Services official confirmed. Only 40 people nationwide have been tested for the virus

In addition to the three human cases reported in the United States, since 2022, bird flu in the United States has infected over 90 million chickens, more than 9,000 wild birds and 81 dairy herds.

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Bird Flu Vaccine Possibly in the Works - KMIT

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Moderna announced that its combination COVID and flu vaccine showed positive results in a late-stage trial.

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Moderna says combined COVID-19, flu shot shows positive results - CBS Boston

According to a report in the Financial Times, Moderna's combined COVID-19 and flu vaccine has demonstrated efficacy equivalent to that of separate shots in late-stage trials, according to results published on Monday. The phase 3 trial, involving over 8,000 adults aged 50 and older, showed that the combination vaccine was as effective as Moderna's standalone COVID-19 vaccine and two widely used flu vaccines, Fluzone and Fluarix. The combined shot also exhibited higher efficacy against three specific flu strains, including H1N1 swine flu.

Moderna plans to publish the interim data in a peer-reviewed journal and submit it for US regulatory approval later this year, with an FDA decision potentially coming by next summer. If approved, Moderna aims to launch the first combined COVID-19 and flu shot by the 2025 winter season. The combined vaccine also demonstrated an acceptable safety and tolerability profile.

CEO Stphane Bancel highlighted the market potential, noting that the convenience of a single shot could increase vaccine uptake, especially among those hesitant about multiple injections. This new product could allow Moderna to access the $8 billion seasonal flu vaccine market, which is larger than the market for COVID-19 vaccines.

The announcement comes as Moderna's share price has increased by 37% this year, driven by investor interest in its H5 pandemic flu vaccine candidate and broader efforts to diversify its mRNA-based vaccine portfolio. Moderna's stock, though still down about 67% from its peak during the pandemic, has been buoyed by recent positive developments, including the approval of a vaccine targeting respiratory syncytial virus.

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Moderna's combined COVID-Flu vaccine proves effective - KNEWS - The English Edition of Kathimerini Cyprus

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The signs and symptoms of a brain tumor to look out for; the simple change that's turned using an inhaler into a breath of fresh air; what researchers say is a bigger threat than war, terrorism, addiction and disease, and for the first time, the CDC says bird flu has caused respiratory symptoms in an infected dairy worker.

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There's a renewed focus on developing a bird flu vaccine. New research shows promise - CBS News

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US government to fund Moderna's mRNA bird flu vaccine trial - USA TODAY