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%) against severe/critical COVID-19, at least 14 days post-booster vaccination. Also part of the submission is Phase 1/2a data showing that when a booster of the Johnson &Johnson COVID-19 vaccine was given six months after the single shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster. The vaccine, when given as a booster or primary dose, was generally well-tolerated.“Our clinical program has found that a booster of our COVID-19 vaccine increases levels of protection for those who have received our single-shot vaccine to 94 percent. We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research &Development, Johnson &Johnson. “...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news

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Conclusions Although patients with a history of COVID-19 had worse function at time of admission to acute rehabilitation, inpatient rehabilitation significantly improved their function to comparable levels as patients who did not have COVID-19. To Claim CME Credits Complete the self-assessment activity and evaluation online at http://www.physiatry.org/JournalCME CME Objectives Upon completion of this article, the reader should be able to: (1) Identify how characteristics of patients with COVID-19 admitted to acute rehabilitation differ from those with similar admission codes but without COVID-19; (2) Desc...
Source: American Journal of Physical Medicine and Rehabilitation - Category: Rehabilitation Tags: CME Article . 2021 Series . Number 12 Source Type: research
Conclusions The COVID-19 pandemic acutely affected patient care and overall institutional operations. The research consortium of New York and New Jersey rehabilitation institutions responded dynamically to bed expansions/contractions, staff deployment, and innovations that facilitated safe and effective patient care.
Source: American Journal of Physical Medicine and Rehabilitation - Category: Rehabilitation Tags: SPECIAL SECTION on COVID-19 and PM&R Source Type: research
Objectives The aims of the study were to describe an interdisciplinary inpatient rehabilitation program for patients recovering from COVID-19 and to evaluate functional outcomes. Design This is an analysis of retrospective data captured from the electronic health record of COVID-19 patients admitted to the rehabilitation unit (N = 106). Rehabilitation approaches are described narratively. Functional gain was evaluated using the Activity Measure for Postacute Care 6 Clicks, basic mobility and daily activities. Results Interdisciplinary approaches were implemented to address the medical, physical, communica...
Source: American Journal of Physical Medicine and Rehabilitation - Category: Rehabilitation Tags: SPECIAL SECTION on COVID-19 and PM&R Source Type: research
We present five models of care in varying degrees of development and compare processes and adaptations to address the unique needs of each center and their unique patient populations. Forging a path to recovery will necessitate a multidisciplinary team with physiatry involvement to meet the distinctive needs of patients with postacute sequelae of SARS-CoV-2. Furthermore, it is imperative that there be equitable access to this care and commitment from healthcare institutions to provide resources for these programs.
Source: American Journal of Physical Medicine and Rehabilitation - Category: Rehabilitation Tags: SPECIAL SECTION on COVID-19 and PM&R Source Type: research
The long-term sequelae after SARS-CoV-2 infections in children is unknown. Guidance is needed on helpful models of care for an emerging subset of pediatric patients with postacute/long COVID who continue to experience persistent symptoms after initial COVID-19 diagnosis. Here, we describe a pediatric multidisciplinary post–COVID-19 rehabilitation clinic model as well as a case series of the initial cohort of patients who presented to this clinic. A consecutive sample of nine patients (pediatric patients
Source: American Journal of Physical Medicine and Rehabilitation - Category: Rehabilitation Tags: SPECIAL SECTION on COVID-19 and PM&R Source Type: research
The purpose of this observational study was to report the experience of a 1-yr home training with functional electrical stimulation cycling of a person with T4 American Impairment Scale A paraplegia for 9 yrs, homebound due to the COVID-19 health crisis. The 40-yr-old participant had a three-phase training: V1, isometric stimulation; V2, functional electrical stimulation cycling for 3 sessions/wk; and V3, functional electrical stimulation cycling for 2–4 sessions/wk. Data on general and physical tolerance, health impact, and performance were collected. Borg Scale score relating to fatigue was 10.1 before training and...
Source: American Journal of Physical Medicine and Rehabilitation - Category: Rehabilitation Tags: SPECIAL SECTION on COVID-19 and PM&R Source Type: research
Conclusions This study demonstrated a limited role of continuous passive motion in patients operated with total knee arthroplasty. Thus, there is at this stage no indication for continuous passive motion procedures in patients operated with total knee arthroplasty as a standard postoperative care.
Source: American Journal of Physical Medicine and Rehabilitation - Category: Rehabilitation Tags: Original Research Articles Source Type: research
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...
Source: Johnson and Johnson - Category: Pharmaceuticals Source Type: news
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 - Category: Pharmaceuticals Tags: Latest News Source Type: news
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 &J...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
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