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  1. Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use - First Single-Shot Vaccine in Fight Against Global Pandemic Data demonstrated protection against COVID-19 related hospitalization and death, across countries with different variants

    • Overview
    • Reporting of Vaccine Adverse Events
    • References

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    Table 1

    FDA requires that immunization providers report vaccine administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death after administration of COVID-19 vaccine under an EUA.***** Adverse events that occur after receipt of any COVID-19 vaccine should be reporte...

    1.Food and Drug Administration. Janssen COVID-19 vaccine emergency use authorization. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2021. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/Janssen-covid-19-vaccineexternal icon

    2.Oliver SE, Gargano JW, Scobie H, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Janssen COVID-19 vaccine—United States, February 2021. MMWR Morb Mortal Wkly Rep 2021;70:329–32. https://doi.org/10.15585/mmwr.mm7009e4external icon PMID:33661860external icon

    3.MacNeil JR, Su JR, Broder KR, et al. Updated recommendations from the Advisory Committee on Immunization Practices for use of the Janssen (Johnson & Johnson) COVID-19 vaccine after reports of thrombosis with thrombocytopenia syndrome among vaccine recipients—United States, April 2021. MMWR Morb Mortal Wkly Rep 2021;70:651–6. https://doi.org/10.15585/mmwr.mm7017e4external icon PMID:33914723external icon

    4.Gargano JW, Wallace M, Hadler SC, et al. Use of mRNA COVID-19 vaccine after reports of myocarditis among vaccine recipients: update from the Advisory Committee on Immunization Practices—United States, June 2021. MMWR Morb Mortal Wkly Rep 2021;70:977–82. https://doi.org/10.15585/mmwr.mm7027e2external icon PMID:34237049external icon

    5.Rosenblum HG, Hadler SC, Moulia D, et al. Use of COVID-19 vaccines after reports of adverse events among adult recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna): update from the Advisory Committee on Immunization Practices—United States, July 2021. MMWR Morb Mortal Wkly Rep 2021;70:1094–9. https://doi.org/10.15585/mmwr.mm7032e4external icon PMID:34383735external icon

    6.Greinacher A, Thiele T, Warkentin TE, Weisser K, Kyrle PA, Eichinger S. Thrombotic thrombocytopenia after ChAdOx1 nCov-19 vaccination. N Engl J Med 2021;384:2092–101. https://doi.org/10.1056/NEJMoa2104840external icon PMID:33835769external icon

  2. Jan 6, 2022 · The Johnson & Johnson COVID-19 vaccine demonstrated a profile that showed durability of effectiveness up to 6 months for hospitalizations and ICU admissions across the study period, with a modest increase in breakthrough infections starting in month 4.

  3. Apr 19, 2024 · Quick Summary. Vaccine name: Ad26.COV2.S. Design type: Adenovirus viral vector. Dose number: 1 dose, with a “booster” dose recommended for all adults at least two months later. At least two...

  4. May 5, 2022 · Johnson & Johnson, in close coordination with the U.S. Food and Drug Administration (FDA), has updated its U.S. COVID-19 Vaccine Fact Sheet to increase awareness about the risk of thrombosis with thrombocytopenia syndrome (TTS), a rare but potentially life-threatening condition.

  5. Johnson & Johnson is testing a coronavirus vaccine known as JNJ-78436735 or Ad26.COV2.S. Clinical trials showed that a single dose of the vaccine had an efficacy rate of 72 percent in the...

  6. Apr 13, 2021 · As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a...

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