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Johnson & Johnson Updates U.S. COVID-19 Vaccine Fact Sheet
NEW BRUNSWICK, NJ, May 5, 2022 - Our number one priority is the safety and well-being of those who use the Johnson & Johnson COVID-19 vaccine. Johnson & Johnson, in close coordination with the U.S. Food and Drug Administration (FDA), has updated its U.S. COVID-19 Vaccine Fact Sheet to increase awareness about the risk of thrombosis with thrombocytopenia syndrome (TTS), a rare but potentially life-threatening condition. Language about the risk of TTS has been added to the first page of the Fact Sheet to increase its prominence. Following the update to the Fact Sheet, the Johnson & Johnson COVID-19 vaccine is now...
Source: Johnson and Johnson - May 5, 2022 Category: Pharmaceuticals Source Type: news
Real World Evidence Shows Johnson & Johnson COVID-19 Vaccine Demonstrates Durable Protection Against Breakthrough Infection, Hospitalization, and Intensive Care Unit Admission in the United States
NEW BRUNSWICK, N.J., January 6, 2022 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced new results from the largest study to date on the durability of COVID-19 vaccines in the United States (U.S.), showing that a single shot of the Johnson & Johnson COVID-19 vaccine resulted in long-lasting protection for up to six months against COVID-19 breakthrough infections, hospitalizations, and intensive care unit (ICU) admissions. The study was sponsored by the Janssen Pharmaceutical Companies of Johnson & Johnson and conducted in partnership with the Department of Science-Aetion, Inc, and the Division of ...
Source: Johnson and Johnson - January 6, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Johnson & Johnson COVID-19 Vaccine Demonstrates 85 Percent Effectiveness against Hospitalization in South Africa when Omicron was Dominant
NEW BRUNSWICK, N.J., December 30, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced new preliminary results from the South African Phase 3b Sisonke study which showed that a homologous (same vaccine) booster shot of the Johnson & Johnson COVID-19 vaccine (Ad26.COV2.S) demonstrated 85 percent effectiveness against COVID-19-related hospitalization. The study, conducted by the South African Medical Research Council (SAMRC), showed that the Johnson & Johnson booster reduced the risk of hospitalization from COVID-19 among healthcare workers in South Africa after Omicron became the dominant variant...
Source: Johnson and Johnson - December 30, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Johnson & Johnson Statement on its COVID-19 Vaccine Following CDC ACIP Meeting
NEW BRUNSWICK, N.J., December 16, 2021 – Johnson & Johnson remains confident in the overall positive benefit-risk profile of its COVID-19 vaccine. Studies have shown that the Johnson & Johnson COVID-19 vaccine generates strong antibody and cellular immune responses [i] and long-lasting immune memory[ii] and breadth of protection across variants. In addition, a growing body of evidence is revealing the strength of protection of our vaccine as a booster to either the Janssen COVID-19 vaccine or a different authorized or approved COVID-19 vaccine, both in terms of its efficacy and durability.[iii], [iv], [v], [vi], ...
Source: Johnson and Johnson - December 16, 2021 Category: Pharmaceuticals Source Type: news
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
World Health Organization Strategic Advisory Group of Experts (SAGE) Interim Recommendation Supports Use of Johnson & Johnson COVID-19 Vaccine as a Booster
NEW BRUNSWICK, N.J., December 9, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the interim recommendation by the Strategic Advisory Group of Experts on Immunization (SAGE) for the World Health Organization (WHO) supporting the use of the Johnson & Johnson COVID-19 vaccine as a booster shot in persons aged 18 years and above. The WHO recommend the booster shot should be administered two to six months after the primary vaccination. SAGE advises WHO on global vaccine and immunization policies, and its recommendations provide guidance on the use of vaccines supplied through the COVAX Facility, a ...
Source: Johnson and Johnson - December 9, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Johnson & Johnson COVID-19 Booster, Administered Six Months After Two-Dose Regimen of BNT162b2, Shows Substantial Increase in Antibody and T-cell Responses
NEW BRUNSWICK, N.J., DECEMBER 5, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced preliminary results from an independent study, including a subset of participants from the Janssen-sponsored COV2008 study, conducted by Dan Barouch, M.D., Ph.D., et al. of Beth Israel Deaconess Medical Center (BIDMC), which showed that a booster shot of the Johnson & Johnson COVID-19 vaccine (Ad26.COV2.S), administered at six months after a two-dose primary regimen of BNT162b2, increased both antibody and T-cell responses. These results demonstrate the potential benefits of heterologous boosting (mix-and-match). T...
Source: Johnson and Johnson - December 5, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Johnson & Johnson to Evaluate Its COVID-19 Vaccine Against New Omicron COVID-19 Variant
Since the emergence of the COVID-19 pandemic, Johnson & Johnson (the Company) has been closely monitoring newly emerging COVID-19 variants. In collaboration with academic groups in South Africa and around the world, the Company has been evaluating the effectiveness of its COVID-19 vaccine across variants, including now the new and rapidly spreading Omicron variant. The Company is testing blood serum from participants in completed and ongoing booster studies to look for neutralizing activity against the Omicron variant. In addition, the Company is pursuing an Omicron-specific variant vaccine and will progress it as need...
Source: Johnson and Johnson - November 29, 2021 Category: Pharmaceuticals Source Type: news
U.S. CDC Advisory Committee Unanimously Recommends Johnson & Johnson COVID-19 Vaccine as a Booster for All Eligible Individuals Who Receive Authorized COVID-19 Vaccines
NEW BRUNSWICK, N.J., October 21, 2021 – Johnson & Johnson (the Company) today announced that the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), has recommended its COVID-19 vaccine as a booster for all eligible individuals who receive an authorized COVID-19 vaccine. “Today’s recommendation supports the use of the Johnson & Johnson COVID-19 vaccine as a booster for eligible individuals in the U.S. regardless of which vaccine they initially receive,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Jo...
Source: Johnson and Johnson - October 21, 2021 Category: Pharmaceuticals Source Type: news
Johnson & Johnson COVID-19 Vaccine Booster Shot Authorized for Emergency Use by U.S. FDA
NEW BRUNSWICK, N.J., October 20, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for a booster dose of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older at least two months following primary vaccination with single-shot Johnson & Johnson COVID-19 vaccine; and for eligible individuals who received a different authorized or approved COVID-19 vaccine. The Johnson & Johnson booster shot will be the same formulation and dosage as the primary shot. The EUA follows a unanimous recommendat...
Source: Johnson and Johnson - October 20, 2021 Category: Pharmaceuticals Tags: Latest News Source Type: news
Johnson & Johnson COVID-19 Vaccine Booster Shot Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee
NEW BRUNSWICK, N.J., October 15, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted 19-0 to recommend Emergency Use Authorization (EUA) for a booster dose of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older at least two months following initial vaccination with the single-shot vaccine. The vote was based on findings from two Company clinical trials, including the Phase 3 ENSEMBLE 2 study, which evaluated a booster dose of the Johnson & Johnso...
Source: Johnson and Johnson - October 15, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Johnson & Johnson Announces Submission of Emergency Use Authorization Amendment to the U.S. FDA to Support Booster of its Single-Shot COVID-19 Vaccine
NEW BRUNSWICK, N.J., October 05, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) announced it has submitted data to the U.S. Food and Drug Administration (FDA) to support use of a booster shot of the Johnson & Johnson COVID-19 vaccine in individuals 18 years of age and older.The submission includes recent results from the Phase 3 ENSEMBLE 2 study that found a booster of the Johnson & Johnson COVID-19 vaccine given 56 days after the primary dose provided 94 percent protection against symptomatic (moderate to severe/critical) COVID-19 in the U.S. (CI, 58%-100%) and 100 percent protection (CI, 33%-100%) again...
Source: Johnson and Johnson - October 5, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
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
Johnson & Johnson Announces Data to Support Boosting its Single-Shot COVID-19 Vaccine
NEW BRUNSWICK, N.J., August 25, 2021 – Johnson & Johnson today announced data supporting the use of its COVID-19 vaccine as a booster shot for people previously vaccinated with the single-shot Johnson & Johnson vaccine. In July, the Company reported interim Phase 1/2a data published in the New England Journal of Medicine that demonstrated neutralizing antibody responses generated by the Johnson & Johnson single-shot COVID-19 vaccine were strong and stable through eight months after immunization. In anticipation of the potential need for boosters, the Company conducted two Phase 1/2a studies in individuals pre...
Source: Johnson and Johnson - August 25, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
Johnson & Johnson Statement on COVID-19 Vaccine (7/12)
NEW BRUNSWICK, N.J., July 12, 2021 – The safety and well-being of the people who use our products is our number one priority. Rare cases of the neurological disorder, Guillain-Barré syndrome have been reported following vaccination with the Janssen COVID-19 vaccine. Most occurred within 42 days after vaccination. While the chance of having this occur is very low, Johnson & Johnson has updated its COVID-19 Vaccine Factsheet to include important information about these rare cases and on the signs and symptoms of Guillain-Barré syndrome. Updates with this new information will be implemented in other regions of the wo...
Source: Johnson and Johnson - July 12, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
