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Johnson & Johnson Announces Positive CHMP Opinion for a Booster Shot of its COVID-19 Vaccine
NEW BRUNSWICK, N.J., December 15, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a Positive Opinion for use of the Company’s COVID-19 vaccine as a booster for adults aged 18 and older at least two months after primary vaccination with a single-shot of the Johnson & Johnson COVID-19 vaccine, and as a ‘mix and match’ booster following primary vaccination with an approved two-shot mRNA COVID-19 vaccine regimen (known as heterologous boosting). “We are pleased with today’s Positiv...
Source: Johnson and Johnson - December 15, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety
AbstractTo date, four vaccines have been authorised for emergency use and under conditional approval by the European Medicines Agency to prevent COVID-19: Comirnaty, COVID-19 Vaccine Janssen, Spikevax (previously COVID-19 Vaccine Moderna) and Vaxzevria (previously COVID-19 Vaccine AstraZeneca). Although the benefit –risk profile of these vaccines was proven to be largely favourable in the general population, evidence in special cohorts initially excluded from the pivotal trials, such as pregnant and breastfeeding women, children/adolescents, immunocompromised people and persons with a history of allergy or p revious SARS...
Source: Drug Safety - November 5, 2021 Category: Drugs & Pharmacology Source Type: research

Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.
This study compared approximately 390,000 people who received the Company’s single-shot COVID-19 vaccine versus approximately 1.52 million unvaccinated people matched on age, sex, time, three-digit zip code, and comorbidities and predictors for COVID-19 infection severity.This study is a longitudinal cohort design, using robust propensity matching methods to create a comparator cohort to assess real-world VE. All analyses were performed using the Aetion Evidence Platform, which is a scientifically validated software that is also used by regulators, payers, and health technology assessment bodies to assess the safety, eff...
Source: Johnson and Johnson - September 21, 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

The Covid Pandemic: Broadening the Discourse
Thailand’s COVID-19 response an example of resilience and solidarity: a UN Resident Coordinator’s BlogBy Asoka BandarageCOLOMBO, Sri Lanka, Nov 10 2020 (IPS) SARS-CoV-2, the corona virus that causes COVID-19, has been spreading exponentially across the world over the last ten or so months. As of November 6th, according to the Center for Systems Science at Johns Hopkins University, there have been 49,195,581 cases of COVID-19, including 1,241,031 deaths. More than a third of the global population has been placed on lockdown. The global economy is experiencing the deepest global recession since World War 2 and massive n...
Source: IPS Inter Press Service - Health - November 10, 2020 Category: International Medicine & Public Health Authors: Asoka Bandarage Tags: Featured Global Headlines Health Human Rights Humanitarian Emergencies Peace TerraViva United Nations Source Type: news

Johnson & Johnson Announces European Commission Approval for Janssen ’s Preventive Ebola Vaccine
Discussions with the U.S. Food and Drug Administration (FDA) have taken place to define the required data set for filing US licensure. About Janssen’s Ebola Vaccine Regimen The Janssen preventive Ebola vaccine regimen, Ad26.ZEBOV and MVA-BN-Filo, utilizes a non-replicating viral vector strategy in which viruses – in this case adenovirus serotype 26 (Ad26) and Modified Vaccinia Virus Ankara (MVA) – are genetically modified so that they cannot replicate in human cells. In addition, these vectors carry the genetic code of several Ebola virus proteins in order to trigger an immune response.Janssen’s vaccine regimen ori...
Source: Johnson and Johnson - July 1, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news