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March 6, 2021
Johnson & Johnson Announces U.S. CDC Advisory Committee Recommends First Single-Shot COVID-19 Vaccine for Adults 18 and Older in the U.S.
NEW BRUNSWICK, N.J., March 6, 2021 — Johnson & Johnson has announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended its first single-shot COVID-19 vaccine. The committee has prescribed it for individuals 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. Food and Drug Administration (FDA).
“For more than 130 years, Johnson & Johnson has come to the aid of people during times of crisis. 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, M.D. He is 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.”
The Company’s single-shot COVID-19 vaccine received EUA from the FDA on February 27, 2021. The terms of the EUA allow the use of the vaccine while more data gets gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.
“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 expects to deliver enough single-shot vaccines by 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 vaccines 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.,” the company stated.
Johnson & Johnson also recently announced its submission of a European Conditional Marketing Authorisation Application to the European Medicines Agency and its filing for an Emergency Use Listing with the World Health Organization (WHO) for its COVID-19 vaccine candidate. Also, rolling submissions for the single-dose COVID-19 vaccine candidate have been initiated in several countries worldwide.
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°F (-20°C), and a maximum of three months at routine refrigeration at temperatures of 36-46°F (2 to 8°C), the company said.
The company’s Janssen COVID-19 vaccine leverages the AdVac® vaccine platform. The program had used this proprietary technology to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines.
Johnson & Johnson’s Janssen COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but FDA has allowed its Emergency Use Authorization (EUA).
Source: Johnson & Johnson
|GlobalGiants.Com|
Edited & Posted by the Editor | 12:59 PM | View the original post
Miss Universe Competition to air live from Seminole Hard Rock Hotel & Casino in Hollywood, Florida, Sunday, May 16, at 8.00 PM ET.
Photo: Comedian/Writer Nick Teplitz introduces the 2015 Miss Universe contestants during the Welcome Event at Planet Hollywood Resort & Casino on Monday, December 7, 2015. Photographer: Matt Petit. Image provided by & copyright © The Miss Universe Organization, New York. [File Photo]
Photo: Pia Alonzo Wurtzbach, Miss Universe Philippines 2015, poses for a photo inside Planet Hollywood on Wednesday, December 9, 2015. Photographer: Matt Petit. Image provided by & copyright © The Miss Universe Organization, New York. [File Photo]
Photo: Catriona Gray, Miss Universe Philippines 2018, is congratulated by fellow contestants after being crowned Miss Universe after a three-hour special programming event on FOX on Sunday, December 16, 2018, Bangkok, Thailand. Photographer: Amorn Pitayanant. Image provided by & copyright © The Miss Universe Organization, New York. [File Photo]
NEW YORK, NY, March 4, 2021 — The Miss Universe Organization today announced that the 69th MISS UNIVERSE Competition would air from the Seminole Hard Rock Hotel & Casino Hollywood on Sunday, May 16, 2021. The competition will broadcast LIVE around the world from 8:00 to 11:00 PM ET.
“We have spent months planning and preparing safety precautions to develop this edition of MISS UNIVERSE—one that will be memorable, special, and innovative,” said Paula M. Shugart, president of the Miss Universe Organization. “I look forward to seeing this work come to fruition and crowning a new Miss Universe in May.”
The three-hour event will feature women representing dozens of countries competing in multiple categories, including the personal statement, swimsuit, evening gown, and interview. The event would end with Zozibini Tunzi crowning her successor.
“I always knew that my reign as Miss Universe would be unlike any other,” said Tunzi. “While it was nothing like what I had imagined my year to be, this year has opened doors for me I could never have imagined. I am so grateful for the opportunity to connect virtually with people worldwide and elevate the causes I care most about.”
Seminole Hard Rock’s Safe & Sound protocols follow similar guidelines as enacted successfully during the 2020 MISS USA Competition, produced in Memphis, Tennessee, in November. These policies include mask usage, social distancing, quarantining upon arrival, and rigorous testing in coordination with health officials.
The show will air in over 160 countries and territories across the globe.
Source: The Miss Universe Organization
|GlobalGiants.Com|
Edited & Posted by the Editor | 3:28 AM | View the original post
