An experimental Moderna combination vaccine for influenza and Covid-19 showed in a pivotal study that it can elicit a higher immune response compared to vaccines that are already available to protect against infection from both viruses.

The post Moderna’s Flu & Covid-19 Combination Vaccine Succeeds in Phase 3 Clinical Trial appeared first on MedCity News.

Moderna’s mResvia is now the third FDA-approved RSV vaccine and the first one based on mRNA technology. It will compete for market share against RSV shots from GSK and Pfizer that won their FDA nods last year.

The post FDA Approves Moderna RSV Vaccine, an mRNA Alternative to GSK and Pfizer Products appeared first on MedCity News.

Metagenomi finds novel gene-editing tools by mining microbial samples from around the world. Already partnered with Moderna and Ionis Pharmaceuticals, the company said its IPO cash will support ongoing preclinical research.

The post Moderna & Ionis-Partnered Biotech Lands $94M in IPO Cash for Gene-Editing R&D appeared first on MedCity News.

The FDA said the updated messenger RNA vaccines from Pfizer/BioNTech and Moderna will protect against the omicron subvariants now prevalent in circulation. Left out of the FDA decision is Novavax, whose protein-based vaccine is still under regulatory review.

The post FDA Approves Updated Covid-19 Vaccines to Address Now Circulating Variants appeared first on MedCity News.

Moderna and Immatics aim to see if the combination of their respective technologies can lead to better cancer treatments spanning multiple therapeutic modalities. Milestone payments to immunotherapy developer Immatics could top $1.7 billion.

The post Moderna Puts Up $120M to Start Cancer Drug R&D Alliance With Immatics appeared first on MedCity News.

The FDA will decide this summer which strains the next Covid-19 vaccines should address. But companies are also taking a longer view, developing shots for the future that offer different features than the current ones and potentially broader protection against a wider range of pathogens.

The post The Public Health Emergency Is Expiring, So What Is the Future of Covid-19 Vaccines? appeared first on MedCity News.

Older adults and immunocompromised people may now get a second Covid-19 booster shot, according to amendments to the FDA authorizations of the mRNA vaccines. Further changes will be discussed at an advisory committee meeting planned for June.

The post FDA’s Covid-19 Changes Set Stage for the Vaccines to Emulate Seasonal Flu Shots appeared first on MedCity News.

Moderna is partnering with Life Edit, a subsidiary of ElevateBio that offers a suite of gene-editing technologies. The deal brings together the capabilities of both companies, which aim to develop in vivo gene-editing therapies.Mod

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Moderna’s mRNA vaccine for influenza has early data from a pivotal study showing it met trial goals assessing immune response against the more common strains of the virus, but missed against two less common types. A separate and ongoing Phase 3 study is assessing efficacy.

The post Moderna Flu Vax Prompts Response to More Common Strains, But Misses in Influenza B appeared first on MedCity News.

Moderna and Merck have been partners in the development of messenger RNA cancer vaccines since 2016. Merck is deepening the alliance by exercising an option that enables it to share equally in further work on a partnered cancer vaccine for melanoma.

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The FDA has authorized mRNA Covid-19 booster shots designed to protect against the original strain of the novel coronavirus, as well as the two omicron subvariants that are currently driving U.S. caseloads. An advisory committee to the CDC is scheduled to discuss these vaccines and vote on their recommended use on Thursday.

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Moderna is suing Pfizer and BioNTech, claiming they copied its messenger RNA work in developing their Covid-19 vaccine. The company notes that its patented work in respiratory infectious disease began years before the start of the Covid-19 pandemic, when the biotech was pursuing an mRNA vaccine for a different coronavirus.

The post Moderna’s Covid-19 vaccine patent suit points to different virus to make infringement case against Pfizer appeared first on MedCity News.

The U.S. government has signed a supply agreement securing 66 million doses of Moderna’s Covid-19 vaccine booster shots, which are designed to address the omicron subvariants driving new cases of infection. The agreement follows a similar supply agreement reached with Pfizer and BioNTech.

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New Covid-19 vaccine booster shots are coming and they’ll include protection against the omicron variant. The U.S. government agreed to a purchasing contract covering 105 million doses of the Pfizer/BioNTech vaccine for a planned vaccination campaign in the fall.

The post Feds commit $3.2B to lock in Covid-19 vax supply ahead of fall vaccination campaign appeared first on MedCity News.

Covid-19 vaccines from Pfizer and Moderna now have FDA emergency use authorization for children as young as 6 months old. If the Centers for Disease Control and Prevention signs off on these shots this weekend, these pediatric vaccines could become available for distribution early next week.

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Alnylam Pharmaceuticals has proprietary lipid nanoparticle technology used in its FDA-approved RNA therapies. The biotech company claims that the messenger RNA Covid-19 vaccines from Moderna and Pfizer infringe on a patent covering this LNP technology.

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The new Covid-19 variant, named Omicron, has mutations that could help it evade antibodies produced by the immune system. Scientists are conducting lab tests to better understand this new variant and pharmaceutical companies are testing how existing vaccines, as well as those in development, measure up the new mutations.

The post Concern about Covid-19 variant Omicron centers on spike protein mutations appeared first on MedCity News.

The FDA amended emergency use authorization of the Moderna and Johnson & Johnson Covid-19 vaccines, permitting booster shots. But the agency went further and said that a booster shot may be different than the one given for the primary vaccination.

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The short answer is that cancer vaccines represent no silver bullet but can prove potent in combination with other immunotherapy and drug cocktails.

The post Can mRNA vaccines do for cancer what they did with Covid-19? appeared first on MedCity News.

Moderna released preliminary clinical data showing its Covid-19 vaccine produced efficacy in adolescents that was comparable to what was seen in adults. The company plans to submit applications to regulators in early June seeking expansion of emergency authorization of the vaccine to include this younger age group.

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The FDA increased the maximum number of doses permitted for each vial of Moderna’s Covid-19 vaccine, a change intended to make more doses available. The regulator also authorized storage changes for the vaccines at vaccination sites.

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The CEOs of Pfizer, Moderna, McKesson and CVS Health explained that the distribution effort has gone well but the administration of the vaccine has now to catch up. They expect it to happen soon.

The post Vaccine rollout is an administrative problem, not a distribution issue and is expected to go away appeared first on MedCity News.

Moderna’s leadership team dodged questions about their assessment of the largely slow and dysfunctional vaccine rollout focusing instead of telling the story of the science behind a decade-old biopharma company whose first commercial product is making history.

The post Moderna CMO at JPM: Our job is complete when we deliver the vaccine appeared first on MedCity News.

The rollout of two newly authorized Covid-19 vaccines is a bright ray of hope at the pandemic’s darkest hour. Both are expected to be available to the public in the first few months of next year. Here are answers to some questions you might be asking yourself about the new vaccines.

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Moderna is using a Roche antibody test in clinical trials of its Covid-19 vaccine. The test can measure the antibodies created through vaccination, offering a window into how long protection lasts.

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As Covid-19 vaccine doses make their way around the country, there has been a lack of guidance and miscommunication at the federal level, leaving state officials to make key decisions on distribution amid a chaotic mass vaccination effort.

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The company’s vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which was developed by Pfizer and BioNTech.

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By creating new networks for 24/7 temperature monitoring, alerts and reporting, the challenges of deploying transportation at ultra-low temperatures can be overcome. This also illustrates the crucial role that precision measurement will have to play.

The post Precision measurement in 2021: Why accuracy is key to the vaccine ‘cold chain’ and disrupting the spread of Covid-19 appeared first on MedCity News.

Covid-19’s impact on children represents a tiny fraction of the suffering and death experienced by vulnerable adults. Yet it’s pretty serious having caused 154 deaths and more than 7,500 hospitalizations as of Dec. 3 among people 19 and younger in the United States.

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The nonbinding recommendation is a final hurdle before an official emergency use authorization for the vaccine, which could be the first shot approved for use in the U.S. Distribution, however, will remain a challenge.

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