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
Guinea: Hundreds of People Vaccinated Against Ebola
[RFI] More than 200 people in Guinea have been vaccinated against Ebola, just days after the arrival of some 11,000 doses of the Merck vaccine and just over a week since the West African country declared its first Ebola outbreak since the deadly epidemic from 2014 to 2016. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - February 26, 2021 Category: African Health Source Type: news
Guinea: Vital Ebola Vaccines Arrive After Dust Storm Delay
[RFI] Health officials are heading directly to Guinea's southeast region on Tuesday, after a special plane with 11,000 doses of Ebola vaccine landed late Monday night. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - February 23, 2021 Category: African Health Source Type: news
Guinea: Threat of Double Epidemic Worries Guineans As Ebola Vaccines Dispatched
[RFI] Some 11,000 vaccines for the Ebola virus are expected to arrive in Guinea this weekend, as a new outbreak has left five people dead and almost 200 contact cases. The stark reminder of the last West African outbreak comes with added complications of the Covid-19 crisis, which is already creating new challenges for health workers. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - February 20, 2021 Category: African Health Source Type: news
Johnson & Johnson Announces Submission to World Health Organization for Emergency Use Listing of Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
NEW BRUNSWICK, N.J., February 19, 2021– Johnson & Johnson (NYSE: JNJ) (the Company) announced that Janssen-Cilag International N.V. has submitted for Emergency Use Listing (EUL) to the World Health Organization (WHO) for the investigational single-dose Janssen COVID-19 vaccine candidate. The data package delivered today includes interim efficacy and safety results from the Phase 3 ENSEMBLE clinical trial. The Company’s rolling submission of clinical data to WHO is now complete.“Our filing with the World Health Organization marks another important step in our effort to combat COVID-19 and also in our unwavering co...
Source: Johnson and Johnson - February 19, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
Johnson & Johnson Announces Submission of European Conditional Marketing Authorisation Application to the EMA for its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
NEW BRUNSWICK, N.J., February 16, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that Janssen-Cilag International N.V., has submitted a conditional Marketing Authorisation Application (cMAA) to the European Medicines Agency (EMA) seeking authorisation for its investigational single-dose Janssen COVID-19 vaccine candidate. The submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial.“Throughout Europe, there remains an urgent need for additional COVID-19 vaccines, and today’s submission is a significant step forward in ensuring the European Union has anot...
Source: Johnson and Johnson - February 16, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
Guinea Declares Ebola Epidemic as Neighboring Countries Act to Prevent Further Spread
DAKAR, Senegal — Guinea has officially declared it has an Ebola epidemic after at least three people have died and four others have been infected in the West African nation.
Neighboring Sierra Leone and Liberia have put their citizens on high alert as the three West African nations battled the world’s deadliest Ebola outbreak from 2014 to 2016, which began in Guinea and in which more than 11,300 people died.
Sierra Leone’s President Julius Maada Bio has flown to consult with Guinean President Alpha Conde.
Guinea’s new Ebola outbreak occurred in N’Zerekore, in southern Guinea, where health offi...
Source: TIME: Health - February 16, 2021 Category: Consumer Health News Authors: CARLEY PETESCH / AP Tags: Uncategorized Source Type: news
Guinea tracks potential Ebola contacts as vaccination campaign begins in Congo
Guinea is tracking down people who potentially came in contact with Ebola patients after three people died of the disease, Health Minister Remy Lamah said on Monday. Meanwhile, the WHO said an Ebola vaccination campaign has begun in the Congolese city of Butembo. (Source: CBC | Health)
Source: CBC | Health - February 15, 2021 Category: Consumer Health News Tags: News/World Source Type: news
Africa: Organisations Announce Global Ebola Vaccine Stockpile for Quick Response
[WHO] The four leading international health and humanitarian organizations announced today the establishment of a global Ebola vaccine stockpile to ensure outbreak response. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - February 14, 2021 Category: African Health Source Type: news
COVID-19 Pandemic has Shown Humanity at its Best – & at its Worst
A health worker at a local health centre in Kinshasa, Democratic Republic of the Congo, prepares a vaccine injection. The dispatch of millions of COVID-19 vaccines to Africa started in February. Credit: UNICEF/Sibylle DesjardinsBy Tedros Adhanom GhebreyesusGENEVA, Feb 11 2021 (IPS) WHO and UNICEF have a long, deep and very special relationship. Neither of us could do what we do without the other.
UNICEF’s success is WHO’s success, and we are proud to be your partner on so many issues: Ebola, polio, maternal health, nutrition, infection prevention and control, primary health care – the list is long.
Never has our pa...
Source: IPS Inter Press Service - Health - February 11, 2021 Category: International Medicine & Public Health Authors: Tedros Adhanom Ghebreyesus Tags: Development & Aid Education Global Globalisation Headlines Health Inequity Poverty & SDGs TerraViva United Nations 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
NIH Director Francis Collins Is Fighting This Coronavirus While Preparing for the Next One
In May 2020, Dr. Francis Collins, the longtime head of the National Institutes of Health (NIH), was called to the White House to meet with Jared Kushner, the then President’s son-in-law and adviser, and Dr. Deborah Birx, the head of the White House Coronavirus Task Force. A few weeks earlier, Congress had given the NIH $1.5 billion to try to speed up the process of developing new diagnostic tests for COVID-19, and the White House, which was dubious about increasing the rate of testing, wanted to know more about what the NIH was doing.
Collins is technically the boss of Dr. Anthony Fauci, but during the pandemic he ha...
Source: TIME: Health - February 4, 2021 Category: Consumer Health News Authors: Belinda Luscombe Tags: Uncategorized COVID-19 feature Magazine 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 sever...
Source: Johnson and Johnson - January 29, 2021 Category: Pharmaceuticals Tags: Our Company 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-19, with co...
Source: Johnson and Johnson - January 29, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
Antibody highs and lows in survivors of Ebola
(University of Liverpool) A high proportion of survivors of Ebola experienced a resurgence in antibody levels nearly a year after recovery, a new University of Liverpool study has found. Published today in Nature, the finding hints that hidden reservoirs of virus could exist long after symptoms ease and has implications for monitoring programmes and vaccine strategies. (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - January 27, 2021 Category: Infectious Diseases Source Type: news
