{"id":446497,"date":"2021-02-28T16:42:58","date_gmt":"2021-02-28T21:42:58","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=446497"},"modified":"2021-02-28T16:42:58","modified_gmt":"2021-02-28T21:42:58","slug":"johnson-johnson-announces-u-s-cdc-advisory-committee-recommends-first-single-shot-covid-19-vaccine-for-adults-18-and-older-in-u-s","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/johnson-johnson-announces-u-s-cdc-advisory-committee-recommends-first-single-shot-covid-19-vaccine-for-adults-18-and-older-in-u-s\/","title":{"rendered":"Johnson & Johnson Announces U.S. CDC Advisory Committee Recommends First Single-Shot COVID-19 Vaccine for Adults 18 and Older in U.S."},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n NEW BRUNSWICK, N.J.<\/span>, Feb. 28, 2021<\/span> \/PRNewswire\/ —\u00a0Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the first single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, for individuals 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. Food and Drug Administration (FDA). <\/p>\n

“For more than 130 years, Johnson & Johnson has come to the aid of people during times of crisis, and we believe today’s recommendation from the CDC to begin use of our vaccine as part of the U.S. national immunization program will add a critical tool in the fight against COVID-19,” said Paul Stoffels<\/span>, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “This recommendation follows the FDA’s decision to grant an Emergency Use Authorization for our single-shot vaccine, which has the potential to play a pivotal role in helping to end the COVID-19 pandemic.” <\/p>\n

ACIP is a body of independent health experts that advises the CDC on the types of populations and circumstances for which vaccines should be used. The ACIP recommendation will be forwarded to the Director of the CDC and the U.S. Department of Health and Human Services (HHS) for review and adoption.<\/p>\n

The Company’s single-shot COVID-19 vaccine received EUA from the FDA<\/a>\u00a0on February 27, 2021<\/span>. \u00a0The terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021. <\/p>\n

Johnson & Johnson is committed to making its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. The Company has begun shipping its COVID-19 vaccine and\u00a0expects to deliver enough single-shot\u00a0vaccines\u00a0by the end of March to enable the full vaccination of more than 20 million people in the U.S. The Company plans to deliver 100 million single-shot\u00a0vaccines to the U.S. during the first half of 2021. The U.S. government will manage allocation and distribution of the vaccine in the U.S. <\/p>\n

Johnson & Johnson also recently announced\u00a0its submission<\/a>\u00a0of a European Conditional Marketing Authorisation Application to the European Medicines Agency as well as its filing for an Emergency Use Listing <\/a>with the World Health Organization for its COVID-19 vaccine candidate. In addition, rolling submissions for the single-dose COVID-19 vaccine candidate have been initiated in several countries worldwide.<\/p>\n

\n Manufacturing and Supply Chain <\/b>
\n Information
<\/b>The Johnson & Johnson COVID-19 single-dose vaccine is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas. The vaccine is estimated to remain stable for two years at -4\u00b0F (-20\u00b0C), and a maximum of three months at routine refrigeration at temperatures of 36-46\u00b0F (2 to 8\u00b0C). The Company will ship the vaccine using the same cold chain technologies it uses today to transport treatments for cancer, immunological disorders and other medicines. The COVID-19 vaccine should not be re-frozen if distributed at temperatures of 36\u00b0F\u201346\u00b0F (2\u00b0-8\u00b0C).<\/p>\n

\n Johnson & Johnson’s COVID-19 Vaccine Candidate
<\/b>The\u00a0Company’s Janssen COVID-19 vaccine leverages the AdVac\u00ae<\/sup>\u00a0vaccine platform<\/a>, a unique and proprietary technology\u00a0that was also used to\u00a0develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines. <\/p>\n

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 the FDA through an Emergency Use Authorization (EUA).<\/p>\n

The FDA EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and full EUA Prescribing Information are available here<\/a>.<\/p>\n

For more information on the single-dose Janssen COVID-19 vaccine, visit: www.janssencovid19vaccine.com<\/a>. <\/p>\n

\n Phase 3 ENSEMBLE Study Design
<\/b>The Phase 3 ENSEMBLE<\/a><\/u> study is a randomized, double-blind, placebo-controlled clinical trial in individuals 18 years of age and older.\u00a0The study was designed to evaluate the safety and efficacy of the Company’s vaccine candidate in protecting against both moderate and severe COVID-19 disease,\u00a0with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints. The study enrolled a total of 43,783 participants.<\/p>\n

The trial, conducted in eight countries across three continents, includes a diverse and broad population including 34 percent of participants over age 60.<\/p>\n

The study enrolled 44 percent of participants in the United States<\/span>. Seventy-four percent of participants in the U.S. are White\/Caucasian; 15 percent are Hispanic and\/or Latinx; 13 percent are Black\/African American; 6 percent are Asian and 1 percent are Native American.<\/p>\n

Forty-one percent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19.<\/p>\n

Research and development activities for the Company’s COVID-19 vaccine, including the ENSEMBLE clinical trial and the delivery of doses for the U.S., have been funded in part with federal funds from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201700018C, and in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at the U.S. Department of Health and Human Services (HHS).\u00a0<\/p>\n

Johnson & Johnson has worked with BARDA since 2015 on innovative solutions for influenza, chemical, biological, radiation and nuclear threats and emerging infectious diseases such as Ebola. <\/p>\n

For more information on the Company’s multi-pronged approach to helping combat the pandemic, visit: www.jnj.com\/coronavirus<\/a>.<\/u><\/p>\n

\n Authorized Use
<\/b>The Janssen COVID-19 vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.<\/p>\n

\n Important Safety Information<\/b>\n <\/p>\n

\n WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE JANSSEN COVID-19 VACCINE?
<\/b>Tell the vaccination provider about all of your medical conditions, including if you:<\/p>\n