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  1. Learn how we’re changing the world of medicine. Discover career opportunities, our product pipeline, and browse media resources. Meet Moderna.

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      Moderna receives full approval for COVID-19 vaccine by U.S....

  2. www.modernatx.com › about-us › our-storyOur Story - Moderna

    Moderna receives full approval for COVID-19 vaccine by U.S. FDA. The U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for SPIKEVAX (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 18 years of age and older in the U.S. We’re making biotech history. Since 2010, we have worked to build the ...

  3. Mar 26, 2024 · Moderna Achieves Positive Interim Results from Phase 3 Trial of Next-Generation COVID-19 Vaccine. March 26, 2024. Download. mRNA-1283 induced a more robust immune response compared to Spikevax® COVID-19 vaccine, mRNA-1273.222. Next-generation mRNA vaccine design offers the potential of longer shelf life and storage advantages, and paves the ...

  4. The Moderna COVID‑19 vaccine, sold under the brand name Spikevax, is a COVID-19 vaccine developed by the American company Moderna, the United States National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA). Depending on the jurisdiction, it is authorized for use in ...

    • Spikevax
    • mRNA
    • Who Can Be Vaccinated?
    • Can Children and Adolescents Take The Vaccine?
    • Is It Safe?
    • How Efficacious Is The Vaccine?
    • What’s The Recommended Dosage?
    • Is A Booster Dose Recommended For This Vaccine?
    • Can This Vaccine Be ‘Mixed and Matched’ with Other Vaccines?
    • Does It Prevent Infection and Transmission?
    • Does It Work Against New Variants?
    • How Does This Vaccine Compare to Other Covid-19 Vaccines Already in use?

    Should pregnant and breastfeeding women be vaccinated? Given the adverse consequences of COVID-19 during pregnancy and the increasing data supporting a favorable safety profile of mRNA-1273 in pregnancy, WHO recommends the use of mRNA-1273 in pregnant individuals. WHO does not recommend pregnancy testing prior to vaccination. WHO does not recommend...

    This vaccine is authorized for use for those aged 6 months and above, with an adjustment in the recommended dosage in those aged 6 months – 4 years, and those aged 5-11 years. WHO recommends that countries should consider using the vaccine in children aged 6 months to 17 years only when high vaccine coverage with 2 doses has been achieved in the hi...

    On 30 April 2021, WHO listed the Moderna vaccine for emergency use. WHO’s Emergency Use Listing (EUL) assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX Facility vaccine supply. TheGlobal Advisory Committee on Vaccine Safety, a group of experts that provides independent and authoritative guidance to the W...

    The Moderna vaccine after two doses and a first booster dose has been shown to have very high effectiveness against severe disease, hospitalizations and death, and modest effectiveness against symptomatic illness.

    For adults aged 17 and above, SAGE recommends the use of the Moderna mRNA-1273 vaccine at a schedule of two doses (100 µg, 0.5 ml each) 8 weeks apart. For adolescents aged 12 to 17 years, SAGE recommends 2 doses (100 µg, 0.5 ml each), given intramuscularly, 4 weeks apart. For children aged 6 to 11 years, SAGE recommends 2 doses (50µg in 0.25 ml eac...

    The first booster dose is recommended for the highest priority-use groups (e.g. older adults, persons with moderate to severe immunocompromising conditions, and health workers), 4-6 months after the completion of the primary series. If more than 6 months have elapsed since completion of the primary series, the booster dose should be given at the ea...

    SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series. For countries considering heterologous schedules, (e.g. using different COVID-19 vaccine platforms), WHO has made the following recommendations: 1. Either of the WHO EUL COVID-19 vectored vaccine (Janssen or AstraZeneca Vaxzervia/COVISHIELD) can be used a...

    There is only modest impact on preventing mild infections and transmission, particularly in the context of Omicron. Immunity persists for several months, but the full duration is not yet known. A booster dose restores vaccine effectiveness against Omicron, in particular against severe disease. In the meantime, we must maintain public health measure...

    The vaccine remains effective against virus variants, though for the Omicron variant, vaccine effectiveness against severe and mild disease after two doses is lower compared to Delta, and waning is more rapid. Therefore, a third dose (first booster) is recommended for all adults, and a second booster for the highest priority-use groups.

    It is impossible to compare vaccines head-to-head due to the different approaches taken in designing the respective studies, but overall, all of the vaccines that have achieved WHO Emergency Use Listing are highly effective in preventing severe disease and hospitalization due to COVID-19. This webpage was updated on 18 August 2022 to reflect the la...

  5. Sep 11, 2023 · In June 2023, the U.S. FDA advised that COVID-19 vaccines should be updated to a monovalent XBB.1.5 composition for the 2023 - 2024 vaccination season. At the June VRBPAC, Moderna presented clinical data showing that its updated vaccine resulted in robust immune responses across multiple XBB sublineages, including XBB.1.5 and XBB.1.16.

  6. Nov 1, 2023 · Moderna COVID-19 Vaccine (2023-2024 Formula) Authorized For Individuals 6 Months through 11 Years of Age. On September 11, 2023, the Food and Drug Administration amended the emergency use ...

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