Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use

NEW BRUNSWICK, N.J., February 27, 2021 – Johnson &Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson &Johnson, to prevent COVID-19 in individuals 18 years of age and older. This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination. The 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. “This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public,” said Alex Gorsky, Chairman and Chief Executive Officer at Johnson &Johnson. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”“We believe the Johnson &Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across ...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news

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"I think the biggest challenge for the health care field in the next decade will be determining the next course of action in the face of the gaps exposed throughout the pandemic," Mona Veiseh said.
Source: bizjournals.com Health Care News Headlines - Category: Health Management Authors: Source Type: news
The $500 million project targets mRNA vaccines for COVID-19 and other viral infections
Source: Chemical and Engineering News - Category: Chemistry Authors: Source Type: research
"I think the biggest challenge for the health care field in the next decade will be determining the next course of action in the face of the gaps exposed throughout the pandemic," Mona Veiseh said.
Source: bizjournals.com Health Care:Biotechnology headlines - Category: Biotechnology Authors: Source Type: news
Ohio ranks among the least safe states during the Covid-19 pandemic, according to a new study. The Buckeye State ranks No. 47 in personal finance website Wallethub’s report “Safest States During Covid-19," which was released Oct. 14. Researchers compared the 50 states and District of Columbia across five key metrics (based on data available as of 12:30 p.m. Oct. 13). Here is how Ohio f ared in each category: Vaccination rate: No. 42 Positive testing rate: No. 43 Hospitalization rate: No. 44 Death…
Source: bizjournals.com Health Care News Headlines - Category: Health Management Authors: Source Type: news
ConclusionThe national birth prevalence for omphalocele in Sweden is 1/10,000 newborn, with high termination rates. Over half of the pregnancies with prenatally diagnosed omphalocele will be terminated. Among those who continue the pregnancy, 1-year survival rates are high.Type of studyNational register studyLevel of evidenceIII.
Source: Pediatric Surgery International - Category: Surgery Source Type: research
ConclusionIn the follow-up of children and adolescents with CCM during the first UK lockdown using telemedicine we found that over half had stable health conditions. Patients needing additional care could not be predicted by the severity of their disease or their bowel function alone.
Source: Pediatric Surgery International - Category: Surgery Source Type: research
ConclusionThere is no association between early initiation of adjuvant chemotherapy and post-operative complications including wound healing. Early initiation of chemotherapy ( ≤ 7 days) is feasible in unilateral WT or high-risk neuroblastoma patients who are otherwise doing well without resulting in a preponderance of wound healing complications.
Source: Pediatric Surgery International - Category: Surgery Source Type: research
Conclusions Higher CRF associated with decreased probability of clinical HBP, lower insulin resistance, and improved liver function in children with EA. Yet blood pressure percentiles and kidney function improved with increasing CRF irrespective of adiposity status.
Source: Medicine and Science in Sports and Exercise - Category: Sports Medicine Tags: CLINICAL SCIENCES Source Type: research
Introduction Radiation therapy increases the risk of secondary malignancy and morbidity in cancer survivors. The role of obesity and exercise training in modulating this risk is not well understood. As such, we used a preclinical model of radiation-induced malignancy to investigate whether diet-induced obesity and/or endurance exercise training altered lifelong survival, cancer incidence, and morbidity. Methods Male CBA mice were randomly divided into control diet/sedentary group (CTRL/SED), high-fat diet (45% fat)/sedentary group (HFD/SED), control diet/exercise group (2–3 d·wk−1; CTRL/EX), o...
Source: Medicine and Science in Sports and Exercise - Category: Sports Medicine Tags: BASIC SCIENCES Source Type: research
NEW BRUNSWICK, N.J., February 28, 2021 – Johnson &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). “For more than 130 years, Johnson &Johnson has come to the aid of people during times of crisis, and we believe tod...
Source: Johnson and Johnson - Category: Pharmaceuticals Source Type: news
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