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FDA EUA Letter EUA Fact Sheet for HCPs EUA Fact Sheet for Recipients &
Caregivers
Janssen.com
Janssen.com
FDA EUA Letter EUA Fact Sheet for HCPs EUA Fact Sheet for Recipients &
Caregivers


JOHNSON & JOHNSON’S JANSSEN COVID-19 VACCINE: AUTHORIZED FOR EMERGENCY USE

The Janssen COVID-19 Vaccine has not been approved or licensed by the U.S. Food
and Drug Administration (FDA), but has been authorized by FDA through an
Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus
Disease 2019 (COVID-19) in individuals 18 years of age and older for whom other
FDA-authorized or approved COVID-19 vaccines are not accessible or clinically
appropriate, and in individuals 18 years of age and older who elect to receive
the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19
vaccine. The emergency use of this product is authorized only for the duration
of the declaration that circumstances exist justifying the authorization of the
emergency use of the medical product under Section 564(b)(1) of the FD&C Act,
unless the declaration is terminated or authorization revoked sooner.

FDA EUA Letter for the Janssen COVID-19 Vaccine

EUA FACT SHEET AND FULL EUA PRESCRIBING INFORMATION FOR VACCINATION PROVIDERS

EUA FACT SHEET FOR VACCINE RECIPIENTS AND CAREGIVERS

Reporting Vaccine Adverse Events

It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event
Reporting System (VAERS) all vaccine administration errors, all serious adverse
events, cases of Multisystem Inflammatory Syndrome (MIS) in adults, and
hospitalized or fatal cases of COVID-19 following vaccination with the Janssen
COVID-19 Vaccine. To the extent feasible, provide a copy of the VAERS form to
Janssen Biotech, Inc.

Visit VAERS for more information and to report adverse events
 * If you are unable to submit this form electronically, you may fax it to VAERS
   at 1-877-721-0366. If you need additional help submitting a report, you may
   call the VAERS toll-free information line at 1-800-822-79671-800-822-7967 or
   send an email to info@vaers.org
   or

 * Contact Janssen Biotech, Inc. at:
   
   US Toll Free: 1-800-565-40081-800-565-4008
   US Toll: 1-908-455-99221-908-455-9922

 * FDA EUA Letter
   
 * EUA Fact Sheet for HCPs
   
 * EUA Fact Sheet for Recipients & Caregivers
   

Janssen.com

For medical inquiries or
product-related questions:


US Toll Free: 1-800-565-40081-800-565-4008
US Toll: 1-908-455-9922 1-908-455-9922

© Janssen Therapeutics, Division of Janssen Products, LP 2023. All rights
reserved. 03/23 cp-201875v26.

This site is published by Janssen Therapeutics, Division of Janssen Products,
LP, which is solely responsible for its contents. The material on this site is
intended only as informational or as an educational aid and it is not intended
to be taken as medical advice. The ultimate responsibility for patient care
resides with a healthcare professional.

This information is intended for use of healthcare providers in the United
States and its territories only. Laws, regulatory requirements, and medical
practices for pharmaceutical products vary from country to country. The
Prescribing Information included here may not be appropriate for use outside the
United States and its territories.

Third-party trademarks used herein are trademarks of their respective owners.

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Accessibility StatementCompliance status

We firmly believe that the internet should be available and accessible to anyone
and are committed to providing a website that is accessible to the broadest
possible audience, regardless of ability.

To fulfill this, we aim to adhere as strictly as possible to the World Wide Web
Consortium’s (W3C) Web Content Accessibility Guidelines 2.1 (WCAG 2.1) at the AA
level. These guidelines explain how to make web content accessible to people
with a wide array of disabilities. Complying with those guidelines helps us
ensure that the website is accessible to blind people, people with motor
impairments, visual impairment, cognitive disabilities, and more.

This website utilizes various technologies that are meant to make it as
accessible as possible at all times. We utilize an accessibility interface that
allows persons with specific disabilities to adjust the website’s UI (user
interface) and design it to their personal needs.

Additionally, the website utilizes an AI-based application that runs in the
background and optimizes its accessibility level constantly. This application
remediates the website’s HTML, adapts its functionality and behavior for
screen-readers used by blind users, and for keyboard functions used by
individuals with motor impairments.

If you wish to contact the website’s owner please use the website's form

Screen-reader and keyboard navigation

Our website implements the ARIA attributes (Accessible Rich Internet
Applications) technique, alongside various behavioral changes, to ensure blind
users visiting with screen-readers can read, comprehend, and enjoy the website’s
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browse and operate your site effectively. Here’s how our website covers some of
the most important screen-reader requirements:

 1. Screen-reader optimization: we run a process that learns the website’s
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    combination. Screen-reader users also get automatic announcements to turn
    the Screen-reader mode on as soon as they enter the website.
    
    These adjustments are compatible with popular screen readers such as JAWS,
    NVDA, VoiceOver, and TalkBack.
    
    
 2. Keyboard navigation optimization: The background process also adjusts the
    website’s HTML and adds various behaviors using JavaScript code to make the
    website operable by the keyboard. This includes the ability to navigate the
    website using the Tab and Shift+Tab keys, operate dropdowns with the arrow
    keys, close them with Esc, trigger buttons and links using the Enter key,
    navigate between radio and checkbox elements using the arrow keys, and fill
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    the focus to drift outside.
    
    Users can also use shortcuts such as “M” (menus), “H” (headings), “F”
    (forms), “B” (buttons), and “G” (graphics) to jump to specific elements.

Disability profiles supported on our website
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   use the website by eliminating the risk of seizures resulting from flashing
   or blinking animations and risky color combinations.
 * Vision Impaired Profile: this profile adjusts the website so that it is
   accessible to the majority of visual impairments such as Degrading Eyesight,
   Tunnel Vision, Cataract, Glaucoma, and others.
 * Cognitive Disability Profile: this profile provides various assistive
   features to help users with cognitive disabilities such as Autism, Dyslexia,
   CVA, and others, to focus on the essential elements more easily.
 * ADHD Friendly Profile: this profile significantly reduces distractions and
   noise to help people with ADHD, and Neurodevelopmental disorders browse,
   read, and focus on the essential elements more easily.
 * Blind Users Profile (Screen-readers): this profile adjusts the website to be
   compatible with screen-readers such as JAWS, NVDA, VoiceOver, and TalkBack. A
   screen-reader is installed on the blind user’s computer, and this site is
   compatible with it.
 * Keyboard Navigation Profile (Motor-Impaired): this profile enables
   motor-impaired persons to operate the website using the keyboard Tab,
   Shift+Tab, and the Enter keys. Users can also use shortcuts such as “M”
   (menus), “H” (headings), “F” (forms), “B” (buttons), and “G” (graphics) to
   jump to specific elements.

Additional UI, design, and readability adjustments
 1. Font adjustments – users can increase and decrease its size, change its
    family (type), adjust the spacing, alignment, line height, and more.
 2. Color adjustments – users can select various color contrast profiles such as
    light, dark, inverted, and monochrome. Additionally, users can swap color
    schemes of titles, texts, and backgrounds with over seven different coloring
    options.
 3. Animations – epileptic users can stop all running animations with the click
    of a button. Animations controlled by the interface include videos, GIFs,
    and CSS flashing transitions.
 4. Content highlighting – users can choose to emphasize essential elements such
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We aim to support as many browsers and assistive technologies as possible, so
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possible. Therefore, we have worked very hard to be able to support all major
systems that comprise over 95% of the user market share, including Google
Chrome, Mozilla Firefox, Apple Safari, Opera and Microsoft Edge, JAWS, and NVDA
(screen readers), both for Windows and MAC users.

Notes, comments, and feedback

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needs, there may still be pages or sections that are not fully accessible, are
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solution to make them accessible. Still, we are continually improving our
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level of accessibility following technological advancements. If you wish to
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EUA FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION
PROVIDERS) INCLUDING THE FULL EUA PRESCRIBING INFORMATION


PLEASE SELECT A LANGUAGE TO VIEW:

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EUA FACT SHEET FOR RECIPIENTS
AND CAREGIVERS


PLEASE SELECT A LANGUAGE TO VIEW:

English

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FDA EUA LETTER FOR THE
JANSSEN COVID‑19 VACCINE


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