RSV

2023 - 1 - 19

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Image courtesy of "Infection Control Today"

Moderna: Vaccine Shown Effective Against RSV in Older Adults in ... (Infection Control Today)

Moderna announced encouraging news about its RSV mRNA-1345 vaccine and plans to submit for regulatory approval in the first half of 2023.

For this Moderna trial, the group of 2 or more symptoms met the endpoint first and showed that the vaccine was 83.7% effective. The placebo group had 55 cases, and the mRNA-1345 group had 9. In October 2022, [GSK also announced](https://www.infectioncontroltoday.com/view/gsk-rsv-vaccine-trial-demonstrates-promising-results) that its RSV vaccine trial demonstrated promising results for older adults. The placebo group contained 17 cases, and the mRNA-1345 group had 3 cases. The most common adverse reactions noted were injection site pain, myalgia, arthralgia, fatigue, and headache. The data evaluated the efficiency of Moderna’s RSV vaccine, mRNA-1345, in protecting older adults.

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Image courtesy of "TIME"

Moderna's mRNA-Based RSV Vaccine Just Passed a Major Test (TIME)

Newly reported results from a late-stage human trial suggest Moderna's mRNA vaccine platform will work against another viral infection.

[hospitalized](https://www.cdc.gov/rsv/research/index.html) for RSV in the U.S., including many premature infants, who are at highest risk for the respiratory illness. Among [adults over age 65](https://www.cdc.gov/rsv/research/index.html), there are 60,000 to 120,000 hospitalizations each year, and 6,000 to 10,000 deaths. Pfizer is also developing a [RSV vaccine for pregnant women](https://time.com/6226678/rsv-virus-kids-babies-symptoms/), who would be immunized to [protect their newborns](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-data-phase-3-global) after delivery. [submitted a request](https://www.pfizer.com/news/press-release/press-release-detail/us-fda-accepts-priority-review-biologics-license-0) for expedited review of its mRNA version of an RSV vaccine for older adults last December. Burton says the company has five additional trials ongoing involving the RSV vaccine, including in young children and pregnant women. By late December, monthly RSV cases in the U.S. [Ukraine Yellow Kitchen Photo](https://time.com/6247839/ukraine-yellow-kitchen-photo-dnipro/?utm_source=roundup&utm_campaign=20230105) “The pandemic did a couple of things: It helped us to understand the importance of respiratory viruses and how we can protect against them, and provided a platform that has been tried and tested in an unprecedented number of people, which gives us extraordinary confidence [in the safety and effectiveness of the vaccine].” Paul Burton, chief medical officer at Moderna, says that the company’s experience in developing the COVID-19 mRNA vaccine played a “huge” role in the development of the RSV shot. Among 37,000 people over age 60 in 22 countries, the vaccine was 83.7% effective in reducing moderate RSV illness, defined as two or more symptoms of the disease, and 82.4% effective in reducing more severe illness encompassing three or more symptoms compared to those receiving placebo. 17, the Massachusetts-based company said an early look at data from the late-stage trial of its RSV vaccine shows that the shot is effective. But even before the pandemic hit, the company was developing an mRNA-based vaccine against another scourge, respiratory syncytial virus (RSV), which primarily affects infants and the elderly.

Moderna reports positive RSV vaccine results, pressuring Pfizer, GSK (BioPharma Dive)

Moderna on Tuesday reported positive results for its experimental respiratory syncytial virus vaccine, saying the shot was about 84% effective in preventing ...

The results were announced in October 2022, several months after Pfizer had revealed preliminary [data](https://www.biopharmadive.com/news/pfizer-follows-gsk-with-positive-phase-3-results-for-rsv-vaccine/630536/) for its RSV vaccine. Safety will continue to be monitored as the study progresses. Along with GSK, Pfizer and Moderna, Johnson & Johnson, Sanofi and Bavarian Nordic are also testing RSV vaccines. According to the - Moderna’s Phase 3 trial measured how well the vaccine prevented at least two symptoms of RSV-associated respiratory infection in adults older than 60. The infection can be particularly dangerous in children younger than 5 and in adults over the age of 65.

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Image courtesy of "CNBC"

RSV vaccine: Moderna, Pfizer start a new FDA approval race (CNBC)

Moderna and Pfizer produced Covid vaccines in record time, and now novel RSV vaccines are on a similar trajectory for both drug companies' R&D platforms.

"What the CDC said was it saw a small signal in a database and discovered nothing," and he added that Pfizer also did its own investigation in Israel, the U.S. "If you look at data, the clinical data run by independent data safety monitoring boards [the FDA in the U.S. The RSV approval process is just one part of a widening vaccine industry for these two companies. We can use the same people, the same equipment and raw materials as the Covid vaccine." "This is a transition year," Bourla said, as Covid shots move from a government funded business to a commercial business. ... As we looked at the impact on the world and hospitalizations and deaths, we said we need to find a solution." The RSV successes come after a particularly bad RSV season in the U.S. Pfizer, he said, already has priority review in the FDA approval process because of the data set's strength and because the disease does not have vaccine. and the world, it was No. Bancel told CNBC that common side effects of this type of virus vaccine, such as fever, were only slightly higher in those receiving the RSV shot in the trial (4%) versus those in the control group getting a placebo (2.8%). That caught the attention of Moderna, which for years has been working on its mRNA technology. 2 cause of hospitalizations in the U.S.

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Image courtesy of "CBS News"

Moderna says its' RSV vaccine highly effective in older adults (CBS News)

The respiratory syncytial virus, which dominated respiratory infections just a few months ago, does not only cause breathing problems in babies and toddlers but ...

for more features. And in a large clinical trial, those 60 and older who received the RSV vaccine were almost 84-percent less likely to develop symptoms compared to those who didn't receive the shot.

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Image courtesy of "BioSpace"

Moderna Racks Up Phase III RSV Success | BioSpace (BioSpace)

Moderna announced positive topline results from a Phase III trial with older adults and a vaccine candidate aimed at preventing respiratory syncytial virus.

This candidate employs the same lipid nanoparticle envelope as the company’s COVID-19 vaccine, Spikevax. [priority review](https://www.biospace.com/article/gsk-rsv-vaccine-candidate-snags-priority-review-designation/) to GlaxoSmithKline’s RSV vaccine candidate for older adults. [announced](https://www.biospace.com/article/releases/moderna-announces-mrna-1345-an-investigational-respiratory-syncytial-virus-rsv-vaccine-has-met-primary-efficacy-endpoints-in-phase-3-trial-in-older-adults/) positive topline results from a Phase III trial with older adults and a vaccine candidate aimed at preventing respiratory syncytial virus (RSV) called mRNA-1345.

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Image courtesy of "WAMC"

Syracuse-area twins first to test promising RSV prevention tool (WAMC)

A new passive RSV immunization that developers say is under federal review got started with twin baby girls at Upstate Medical University.

But she said they did get a spot in medical history when AstraZeneca asked to use their photos for research papers. Back in the 1960s, a "It has to be given monthly," Domachowske said. And you can see the pharma people that were attending, taking notes, calling their colleagues saying, 'Stop, stop the work.” That’s where we’d been stuck for years until 2014, when Domachowsk attended a medical conference in Argentina. [recent RSV surge](https://www.waer.org/2022-11-17/golisano-runs-low-on-cribs-cancels-elective-procedures-amid-rsv-surge) overwhelmed hospitals across the country. But Meany was worried about it back then after seeing multiple friends with kids in the hospital for the illness — [up to 80,000 children](https://www.cdc.gov/rsv/research/index.html) under five are admitted for RSV each year. But for years, he’s worked with AstraZeneca on a monoclonal antibody that's a ready-made immune defense against RSV. The second pregnancy for Cheryl Meany quickly turned from joyful to terrifying. Domachowske expects a greenlight by spring and nirsevimab to be on available by the next RSV season in the fall. “Everyone is sitting there staring with their mouths gaping open like, 'This is why all of our work hasn't led to anything for decades," Domachowske said. So she needed a moment to process when her husband proposed enrolling the soon-to-be-born babies in an experimental study for an RSV immunization.

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Image courtesy of "New Zealand Doctor Online"

Moderna announces MRNA-1345, an investigational respiratory ... (New Zealand Doctor Online)

mRNA-1345 demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms in older adults ...

The interim analysis was based on 64 cases of RSV-LRTD with two or more symptoms, of which 55 occurred in the placebo group and 9 occurred in the mRNA-1345 group, and 20 cases of RSV-LRTD with three or more symptoms, of which 17 cases were observed in the placebo group compared with three cases observed in the mRNA-1345 group. The overall rate of Grade 3 or greater solicited local adverse reactions was 3.2% for mRNA-1345 and 1.7% for placebo. The overall rate of severe (Grade 3 or greater) solicited systemic adverse reactions was 4.0% for mRNA-1345 and 2.8% for placebo. "This trial will help to understand the role of severe acute respiratory infections in older adult populations and inform the future implementation of vaccines in adults in lower-resource areas." Following review by an independent Data and Safety Monitoring Board (DSMB), the primary efficacy endpoints have been met, including vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-associated lower respiratory tract disease (RSV-LRTD) as defined by two or more symptoms. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced positive topline data from its ConquerRSV Phase 3 pivotal efficacy trial of mRNA-1345, an investigational mRNA vaccine targeting respiratory syncytial virus (RSV) in older adults.

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Image courtesy of "NewsNation Now"

RSV vaccine 84% effective in older adults, Moderna reports (NewsNation Now)

An experimental RSV vaccine demonstrated an 83.7% efficiency against the virus in older adults, biotech company Moderna announced Wednesday.

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Image courtesy of "Philstar.com"

Moderna reports positive results for RSV vaccine (Philstar.com)

US biotech company Moderna announced positive interim trial results for its vaccine against respiratory syncytial virus in adults over the age of 60.

RELATED: Related: Moderna plans to apply for regulatory approval for the vaccine in the US, Europe and other regions in the coming months. Moderna's vaccine was found to be nearly 84 percent effective against RSV-linked diseases in Phase III trials — the final stage of human testing — the firm said in a statement. There are no jabs currently available for the virus, which is a top cause of lower respiratory diseases, commonly leading to bronchiolitis in children and pneumonia in the elderly. PARIS, France — US biotech company Moderna on Tuesday announced positive interim trial results for its vaccine against respiratory syncytial virus (RSV) in adults over the age of 60.

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Image courtesy of "The Spokesman-Review"

Moderna gains as RSV shot prevents most cases in older people (The Spokesman-Review)

Moderna's vaccine against RSV was highly effective in preventing the lung disease in older people, paving the way for the company to seek its first approval ...

Pfizer’s vaccine prevented 67% of RSV cases overall in older adults and 86% of severe cases in a final-stage trial presented at a conference last fall. A priority, six-month review could allow the RSV vaccine could to get on the market by year end, he said. If approved, this would be Moderna’s first non-COVID product – a major milestone for the company after it rose to prominence during the pandemic. GSK’s shot prevented about 83% of RSV cases and 94% of severe RSV cases in older adults. The success sets up a potential three-way competition for the RSV vaccine market in older adults, after decades with no vaccine at all. The shot blocked about 84% of mild respiratory syncytial virus infections and 82% of severe cases in a Phase 3 study, Cambridge, Massachusetts-based Moderna said Tuesday.

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