Moderna COVID-19 Vaccine EUA Letter of Authorization
Jan 31, 2022 · vaccine in individuals 18 years of age or older who have undergone solid organ transplantation, or individuals 18 years of age or older who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise, FDA reviewed safety and effectiveness data reported in two manuscripts on solid organ transplant recipients.
Tags:
Solid, Argon, Transplantation, Solid organ, Solid organ transplantation
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document:
Documents from same domain
Vaccination Provider Fact Sheet | EUA | Moderna COVID-19 ...
www.modernatx.comPrimary Series: Each primary series dose of the Moderna COVID-19 Vaccine is 0.5 mL. The Moderna COVID-19 Vaccine is administered as a primary series of two doses (0.5 mL each) ... See this Fact Sheet for instructions for preparation and administration. This Fact Sheet may have . Revised: Dec/9/2021 2
CLINICAL STUDY PROTOCOL - Moderna
www.modernatx.comThe synopsis of Amendment 3 has been modified to correspond to changes in the body of the protocol. ... and clinical conduct. Study Design and Methodology: This is a Phase 3, randomized, stratified, observer-blind, placebo-controlled study …
Study, Clinical, Protocol, Synopsis, Clinical study protocol
COVID-19 Vaccine (mRNA-1273) - Moderna
www.modernatx.comNov 16, 2020 · Pediatric respiratory syncytial virus (RSV) vaccine Future respiratory combo Worldwide mRNA-1189 Epstein-Barr virus (EBV) vaccine Worldwide mRNA-1851 Influenza H7N9vaccine ... Presentation of older adults Phase 1 data October 22, 2020 Phase 3 COVE study completed enrollment of 30,000 participants Sept 29, 2020 Publication of older adults …
Virus, Adults, Respiratory, Older, Syncytial, Older adults, Respiratory syncytial virus
Storage Handling - Moderna
www.modernatx.comStorage and Handling The information in this Fact Sheet supersedes the information on the vial and carton labels. During storage, minimize exposure to room light. The Moderna COVID-19 Vaccine multiple-dose vials are stored frozen between -50º to -15ºC (-58º to 5ºF). Store in the original carton to protect from light.
WHITE PAPER mRNA Vaccines - Moderna
www.modernatx.comsyringe Investment decisions in production facility (3-5yr lead time) Standardized (mg scale) Standardized (kg scale) Standardized multiproduct facility (kg scale) mRNA vaccine DNA vaccine: Bespoke facility ($100mm-$1bn) (tonne scale) Specialized delivery system Standard needle &
US00000010898574B220210126
www.modernatx.comTitle: US00000010898574B220210126 Subject: 00780001 Created Date: 20210106010406Z
IMPORTANT PRESCRIBING INFORMATION Booster Dose …
www.modernatx.comreport vaccine administration errors to the Vaccine Adverse Event Reporting System (VAERS). See the Fact Sheet for Vaccination Providers for reporting instructions. Additional Resources To access the most recent Moderna COVID-19 Vaccine Fact Sheets, please scan the QR code or
Administration, Vaccine, Errors, Vaccine administration errors
Vaccine Recipient Fact Sheet | EUA | Moderna COVID-19 …
www.modernatx.comEMERGENCY USE AUTHORIZATION (EUA) OF THE MODERNA COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) IN INDIVIDUALS 18 YEARS OF AGE AND OLDER You are being offered the Moderna COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2. This Fact Sheet contains information to …
Reimbursement for the Moderna COVID-19 Vaccine
www.modernatx.comcharge for administration. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured recipients).
Administration, Vaccine, Covid, Covid 19 vaccine, Covid 19 vaccine administration
Hoja informativa para receptores de la vacuna | EUA ...
www.modernatx.comLa vacuna contra la COVID-19 de Moderna es una vacuna no aprobada. En ensayos clínicos, aproximadamente 15,400 personas de 18 años en adelante han recibido al menos 1 dosis de la vacuna contra la COVID-19 de Moderna. Millones de personas han recibido la vacuna en virtud
Related documents
Evidence check - Immunocompromised patients and …
aci.health.nsw.gov.auimmunocompromised patients have a weaker anti-SARS-CoV-2 antibody response after vaccination.(2, 3, 7) o A study of solid organ transplant recipients observed expected, typically mild, minimal peri vaccine reactogenicity after the first dose, similar to reported rates in non-organ transplant recipients.(3)
Patients, Solid, Antibody, Argon, Solid organ, Immunocompromised, Immunocompromised patients and
HIGHLIGHTS OF PRESCRIBING INFORMATION …
www.regeneron.comcan occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection.
A2018ReferenceGuidetotheBanffClassification of Renal ...
banfffoundation.orgfrom solid organ transplants. Since its initial conception in 1991 for renal transplants, it has undergone review every 2 years, with attendant updated publications. The rapidexpansion of knowledge in the field has led to numerous revisionsofthe classification.
Immune Globulins Therapy
static.cigna.comimmunosuppression, antiviral treatment) in cancer or solid organ transplant recipients. HIV-infected Children ONE of the following criteria is met: • Primary prophylaxis of bacterial infections when hypogammaglobulinemia (serum IgG < 400 mg/dL) is present • Secondary prophylaxis of frequent recurrent serious bacterial infections