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NIH Trial Underway for Universal Flu Vaccine
WEDNESDAY, July 13, 2022 -- The National Institutes of Health Clinical Center has begun a phase I trial of a potential universal influenza vaccine, according to an announcement by the agency. The National Institute of Allergy and Infectious...
Source: Drugs.com - Pharma News - July 13, 2022 Category: Pharmaceuticals Source Type: news

Assessment of COVID-19 vaccines acceptance in the Lebanese population: a national cross-sectional study
ConclusionsOur findings support the need to improve knowledge about COVID-19 infection and vaccination through education and awareness programs. Specifically residents of rural areas should be targeted to optimize COVID-19 vaccine acceptance among the Lebanese population.
Source: Journal of Pharmaceutical Policy and Practice - January 11, 2022 Category: Pharmaceuticals Source Type: research

Janssen Announces Phase 2b Data Demonstrating its Investigational RSV Adult Vaccine Provided 80% Protection against Lower Respiratory Infections in Older Adults
RARITAN, N.J., October 2, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that its investigational respiratory syncytial virus (RSV) vaccine candidate was highly effective in protecting against lower respiratory tract disease (LRTD) caused by RSV, demonstrating vaccine efficacy of 80 percent (CI, 52.2-92.9%) in adults aged 65 and older. The study results were presented as a late-breaking abstract at the virtual IDWeek 2021 conference on October 2.“The findings from our CYPRESS study are very encouraging as we seek to deliver a long-awaited preventive vaccine to stave off the severe ...
Source: Johnson and Johnson - October 2, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Announces Start of Phase 3 Trial for Investigational Respiratory Syncytial Virus (RSV) Vaccine in Older Adults
RARITAN, N.J., September 29, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the initiation of its Phase 3 EVERGREEN study. The study will evaluate the efficacy, safety and immunogenicity of Janssen’s investigational adult vaccine against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV), when compared with placebo in approximately 23,000 adults aged 60 years and older throughout North America and a selection of countries across Europe, Asia and the Southern Hemisphere.The EVERGREEN study was initiated based on positive results from the Phase 2b CYPR...
Source: Johnson and Johnson - September 29, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Positive New Data for Johnson & Johnson Single-Shot COVID-19 Vaccine on Activity Against Delta Variant and Long-lasting Durability of Response
NEW BRUNSWICK, N.J., July 1, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced data that demonstrated its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants. In addition, the data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date. The two preprint study summaries have been submitted today to bioRxiv. “Today’s newly announced studies reinforce the ability of the Johnson & Johnson COVID-19 vaccine to help prot...
Source: Johnson and Johnson - July 1, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Single-Shot COVID-19 Vaccine Phase 3 Data Published in New England Journal of Medicine
NEW BRUNSWICK, N.J., April 21, 2021 – Johnson & Johnson (the Company) today announced publication in the New England Journal of Medicine of primary data from the Phase 3 ENSEMBLE clinical trial for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). The publication of the primary analysis follows the topline efficacy and safety data announced in January, showing the trial met all primary and key secondary endpoints, and found that the Johnson & Johnson single-dose COVID-19 vaccine prevented hospitalization and death across all study participants ...
Source: Johnson and Johnson - April 21, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Expands Phase 2a Clinical Trial of COVID-19 Vaccine Candidate to Include Adolescents
New Brunswick, NJ (April 2, 2021) – Johnson & Johnson (the Company) has begun vaccinating adolescent participants in the ongoing Phase 2a clinical trial for its COVID-19 vaccine candidate, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. “The COVID-19 pandemic has had a profound impact on adolescents, not just with the complications of the disease, but with their education, mental health, and wellbeing,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “It is vital that we develop vaccines for everyone, everywher...
Source: Johnson and Johnson - April 2, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Announces U.S. CDC Advisory Committee Recommends First Single-Shot COVID-19 Vaccine for Adults 18 and Older in U.S.
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 today’s re...
Source: Johnson and Johnson - February 28, 2021 Category: Pharmaceuticals Source Type: news

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 ...
Source: Johnson and Johnson - February 28, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee
NEW BRUNSWICK, N.J., February 26, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend Emergency Use Authorization (EUA) for the Company’s single-shot COVID-19 vaccine candidate for adults 18 and older, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. The vote was based on a totality of scientific evidence provided by the Company, including efficacy and safety data from the Phase 3 ENSEMBLE trial. “We are extremely gratefu...
Source: Johnson and Johnson - February 26, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
NEW BRUNSWICK, N.J., February 4, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. The Company’s EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints. The Company expects to have product available to ship immediately following autho...
Source: Johnson and Johnson - February 4, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial
NEW BRUNSWICK, N.J., January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19. The Phase 3 ENSEMBLE study is designed to evaluate the efficacy and safety of the Janssen COVID-19 vaccine candidate in protecting moderate to severe COVID-...
Source: Johnson and Johnson - January 29, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

With $90M contract, Duke aims to accelerate flu/MRSA research
The Duke Clinical Research Institute could receive up to $90 million as one of three national sites chosen to run early clinical trials of new anti-infection therapies. The institute received a 10-year contract from the National Institute of Allergy and Infectious Diseases to find treatments for diseases like influenza, Methicillin-resistant Staphylococcus aureus (MRSA) and drug-resistant tuberculosis. The first clinical trials at Duke will likely start later this year, after infrastructure is…
Source: bizjournals.com Health Care:Pharmaceuticals headlines - January 15, 2015 Category: Pharmaceuticals Authors: Jason deBruyn Source Type: news