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      COVID coalition over, Moderna sues Pfizer and BioNTech over vaccines

      news.movim.eu / ArsTechnica · Friday, 26 August, 2022 - 16:47

    Moderna states that it doesn't want to halt production or distribution of Pfizer/BioNTech's vaccine, but it does want to be paid a license for its claimed patents.

    Enlarge / Moderna states that it doesn't want to halt production or distribution of Pfizer/BioNTech's vaccine, but it does want to be paid a license for its claimed patents. (credit: Getty Images)

    Now that the vaccine race is over and shots are broadly available, Moderna has filed suit against Pfizer and BioNTech, claiming they infringed on Moderna's mRNA patents from 2010-2016.

    Moderna, a Massachusetts-based firm, filed suit against New York-based Pfizer and BioNTech in Düsseldorf, Germany, related to the firms' joint Comirnaty vaccine and its similarities to Moderna's Spikevax. Moderna claims in the suit that it doesn't want to halt vaccine production. The suit also doesn't seek damages for sales before March 8, 2022, sales in lower or middle-income AMC 92 nations, or sales where "the US Government would be responsible for any damages."

    In a statement announcing the suit , Moderna stated that it expected Pfizer and BioNTech to "respect its intellectual property rights" and "consider a commercially reasonable license" to sell vaccines outside those accepted conditions, but the firms failed to do so.

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      Moderna to make two different omicron boosters: one for US, another for UK, EU

      news.movim.eu / ArsTechnica · Monday, 11 July, 2022 - 22:22

    A vial containing Moderna COVID-19 booster vaccine at a vaccination center.

    Enlarge / A vial containing Moderna COVID-19 booster vaccine at a vaccination center. (credit: Getty | SOPA Images )

    The type of COVID-19 booster dose you get later this year could depend on where you live.

    Vaccine maker Moderna is working up two omicron-targeting boosters for different countries. If the company's plans pan out, it will mark the first time that COVID-19 vaccines would target different versions of the pandemic coronavirus in different places. Until now, all vaccines, including boosters, have targeted the ancestral strain of SARS-CoV-2, first identified in Wuhan, China.

    Both of Moderna's next-gen booster candidates are bivalent vaccines, which target both the ancestral virus and some version of omicron. One booster option targets BA.1—the version of omicron that first burst out of South Africa last November, causing a towering wave of infection in the US in January 2022. That BA.1-based next-gen booster could be available in the EU, UK,  Australia, and elsewhere later this month or early August. Moderna's other booster option targets BA.4/5 and is intended for use in the US. However, it likely won't be ready until early to mid-fall.

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      FDA calls for fall boosters against BA.4/5 as subvariants take over US

      news.movim.eu / ArsTechnica · Friday, 1 July, 2022 - 00:00 · 1 minute

    Dr. Peter Marks, director of the Center for Biologics Evaluation and Research within the Food and Drug Administration, testifies during a Senate Health, Education, Labor, and Pensions Committee hearing on the federal coronavirus response on Capitol Hill on March 18, 2021, in Washington, DC.

    Enlarge / Dr. Peter Marks, director of the Center for Biologics Evaluation and Research within the Food and Drug Administration, testifies during a Senate Health, Education, Labor, and Pensions Committee hearing on the federal coronavirus response on Capitol Hill on March 18, 2021, in Washington, DC. (credit: Getty | Pool )

    On Thursday, the US Food and Drug Administration advised vaccine makers to reformulate COVID-19 booster shots for this fall. The boosters would target both the original strain of the pandemic coronavirus plus two new omicron subvariants—BA.4 and BA.5—which became the dominant versions of the virus circulating in the United States this week.

    The FDA's announcement comes two days after its independent expert advisors voted overwhelmingly in favor of updating boosters to include an omicron component. The vote—19 in favor, two against—was simply in favor of including an omicron component generally. But, in their afternoon-long discussion, experts offered opinions that led to the FDA's more specific guidance.

    Specifically, much of the committee expressed support for combination shots—aka bivalent boosters—that would target both the original virus and a version of omicron. There was also broad support for targeting the omicron subvariants BA.4 and BA.5 specifically, rather than earlier subvariants, such as the first, BA.1, which is no longer in circulation.

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      Moderna, Pfizer vaccines for under 5s overwhelmingly endorsed by FDA advisors

      news.movim.eu / ArsTechnica · Thursday, 16 June, 2022 - 00:07 · 1 minute

    A woman in protective gear leans over a toddler in a bed.

    Enlarge / Boston Medical Center Child Life Specialist Karlie Bittrich sees to a baby while in a pediatrics tent set up outside of Boston Medical Center in Boston on April 29, 2020. (credit: Getty | Boston Globe )

    A committee of experts advising the Food and Drug Administration voiced unanimous support Wednesday for the authorization of two COVID-19 vaccines for children under the age of 5. If the FDA authorizes the vaccines, it will mark the first time during the more than two-year pandemic that vaccines against COVID-19 will be available for this age group—the last group yet to be eligible for vaccination.

    Although children in this young age group have a relatively lower risk of severe disease and death from COVID-19 compared with older groups, they can and do become severely ill and die from the infection. As of last month, 45,000 children under 5 have been hospitalized for COVID-19 during the pandemic; roughly 50 percent of those hospitalizations occurred during the omicron wave. Of the children who land in the hospital, about 63 percent have no underlying medical conditions that put them at greater risk of severe COVID-19. And about a quarter of those hospitalized require intensive care.

    So far, 475 children under the age of 5 have died from COVID-19 during the pandemic, making COVID-19 far deadlier than other diseases we routinely vaccinate young children against, including influenza, measles, chickenpox, hepatitis A, and rotavirus.

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      Moderna’s omicron-combo booster outcompetes current booster

      news.movim.eu / ArsTechnica · Wednesday, 8 June, 2022 - 23:42

    Extreme close-up photo of a gloved hand holding a tiny jar.

    Enlarge / A vial of the current Moderna COVID-19 vaccine. (credit: Getty | Ivan Romano )

    A combination COVID-19 booster dose that targets the ancestral strain of SARS-CoV-2 and the initial omicron variant, BA.1, appears to outperform the current booster against both of those versions of the virus, Moderna reported Wednesday .

    Specifically, Moderna says the combination booster increased neutralizing antibodies against omicron 8-fold, while the original booster only increased antibody levels around 4.4-fold.

    The vaccine maker is angling to have this bivalent shot—dubbed mRNA-1273.214—be the go-to booster for seasonal shots this fall. The company will be submitting its data to the Food and Drug Administration in the coming weeks and says it hopes to have the bivalent booster available by late summer, if not early fall.

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      Switch to Moderna booster after Pfizer shots better against omicron in 60+

      news.movim.eu / ArsTechnica · Friday, 13 May, 2022 - 21:55

    The Comirnaty (Pfizer/BioNTech) and Moderna COVID-19 vaccines.

    Enlarge / The Comirnaty (Pfizer/BioNTech) and Moderna COVID-19 vaccines. (credit: Getty | Marcos del Mazo )

    People ages 60 and older who were initially vaccinated with two Pfizer-BioNTech COVID-19 vaccine doses were better protected from the omicron coronavirus variant after being boosted with a Moderna vaccine rather than another dose of the Pfizer-BioNTech vaccine.

    Those results are according to interim data from a small but randomized controlled clinical trial in Singapore and published this week in the journal Clinical Infectious Diseases.

    The study—involving 98 healthy adults—can't determine if the Moderna booster is simply superior to a Pfizer-BioNTech booster for older adults or if a mix-and-match booster strategy is inherently better. It also focused solely on antibody levels, which may or may not translate to significant differences in infection rates and other clinical differences. It also only followed people for 28 days after a booster, so it's unclear if the Moderna booster's edge will hold up over time.

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