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FDA Approves First RSV Vaccine for Pregnancy FDA Approves First RSV Vaccine for Pregnancy
The vaccine can be given after 32 weeks of pregnancy and is designed to protect infants from respiratory syncytial virus from birth to 6 months of age.Medscape Medical News
Source: Medscape Allergy Headlines - August 23, 2023 Category: Allergy & Immunology Tags: Infectious Diseases News Alert Source Type: news
FDA Approves Pfizer ’ s New RSV Vaccine for Older Adults
After decades of having no vaccines to fight respiratory syncytial respiratory (RSV), the U.S. now has two—both aimed at protecting older adults.
On May 31, the U.S. Food and Drug Administration (FDA) approved the second RSV vaccine in the world. The first, from the pharmaceutical company GSK, gained FDA approval earlier in May for adults age 60 and older. The newest vaccine, made by Pfizer, will also target people in the same age group.
RSV causes respiratory disease that can affect everyone, but elderly adults and young babies typically experience the most severe illness. Between 60,000 and 160,000 American seniors...
Source: TIME: Health - May 31, 2023 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized Drugs healthscienceclimate Source Type: news
Why It Took So Long to Finally Get an RSV Vaccine
Respiratory syncytial virus (RSV) can dangerously compromise breathing, especially for infants and the elderly. But there has been no vaccine to prevent it—until today. On May 3, the U.S. Food and Drug Administration (FDA) approved the first vaccine against RSV, from GlaxoSmithKline (GSK), to prevent respiratory disease in people ages 60 and older. The Centers for Disease Control’s vaccine committee will make formal recommendations in June about who should receive the vaccine, but GSK says it currently has enough doses to vaccinate eligible people beginning this fall.
In studies involving 25,000 people that GSK...
Source: TIME: Health - May 3, 2023 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized Drugs healthscienceclimate Source Type: news
Over 90% of Childhood BCG Vaccine-Induced Keloids in Japan Occur in Women
ConclusionTo our knowledge, this is the largest report in the literature on childhood-onset keloids. There was overall female predominance in childhood-onset keloids, and even more significant female predominance in BCG-induced keloids.
Source: Dermatology and Therapy - May 1, 2023 Category: Dermatology Source Type: research
Over 90% Percent of Childhood BCG Vaccine-Induced Keloids in Japan Occur in Women
ConclusionTo our knowledge, this is the largest report in the literature on childhood-onset keloids. There was overall female predominance in childhood-onset keloids, and even more significant female predominance in BCG-induced keloids.
Source: Dermatology and Therapy - March 23, 2023 Category: Dermatology Source Type: research
New STELARA ® (ustekinumab) Long-Term Data Support its Established Safety Profile in Inflammatory Bowel Disease and Durable Efficacy in Ulcerative Colitis
SPRING HOUSE, PENNSYLVANIA, March 4, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced final pooled long-term safety results for STELARA® (ustekinumab) through five years in adults with moderately to severely active Crohn’s disease (CD) and four years in adults with moderately to severely active ulcerative colitis (UC), as well as final four-year clinical and endoscopic outcomes from the UNIFI long-term extension (LTE) study evaluating the efficacy of STELARA for the treatment of adults with moderately to severely active UC.1,2 These data are a part of Janssen’s 22 oral and poster ...
Source: Johnson and Johnson - March 4, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Science ’s 2022 Breakthrough of the Year: A telescope’s golden eye sees the universe anew
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Source: ScienceNOW - December 15, 2022 Category: Science Source Type: news
Correlates of Protection Against Respiratory Syncytial Virus Infection in Infancy
AbstractThe highest morbidity and mortality from respiratory syncytial virus (RSV) infection occurs in young infants. Immunization of expectant mothers during pregnancy has the potential to substantially reduce the burden of RSV disease in a majority of infants. Correlates of protection (COP) are important in guiding the development of maternal RSV vaccines and the design of maternal RSV vaccine trials, as immune response to candidate vaccines should mirror protective RSV immunity at birth. Here, we review the literature reporting correlations between RSV immune measures at birth and clinical RSV outcomes during infancy. L...
Source: Clinical Reviews in Allergy and Immunology - December 1, 2022 Category: Allergy & Immunology Source Type: research
‘Extremely satisfying’: Scientist’s insight powers new RSV vaccine for infants
Barney Graham, a former scientist at the U.S. National Institute of Allergy and Infectious Diseases (NIAID), was thrilled yesterday when
Pfizer announced encouraging results
from an experimental vaccine that could protect against a major childhood killer. In a press release, the company said immunizing pregnant women
*
with its vaccine against respiratory syncytial virus (RSV) protected their babies from severe disease for 6 months. If the full results of its clinical trial bear out that promise, the vaccine could spare millions of infants worldwide from RSV-related hospitalization, reduce lasting lung damage f...
Source: Science of Aging Knowledge Environment - November 2, 2022 Category: Geriatrics Source Type: research
Antibody weapon against malaria shows promise in Africa
A new way to prevent malaria that showed promise in 9 U.S. volunteers deliberately exposed to parasite-laden mosquitoes last year has now shown its mettle in a real-world situation in Africa. A study published today in the
New England Journal of Medicine
showed that
a single dose
of lab-produced monoclonal antibodies can protect recipients from infection for up to 6 months during Mali’s intense malaria season.
Monoclonal antibodies are expensive to produce and can be cumbersome to administer if they are infused straight into the bloodstream. That makes some researchers skeptical that the new ones to thwa...
Source: ScienceNOW - November 1, 2022 Category: Science Source Type: news
STELARA ® (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Through Four Years in Adults with Moderately to Severely Active Ulcerative Colitis
SPRING HOUSE, PENNSYLVANIA, October 10, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced final data from the long-term extension (LTE) of the Phase 3 UNIFI study demonstrating efficacy and safety of STELARA® (ustekinumab) through four years of treatment in adult patients with moderately to severely active ulcerative colitis (UC).1 Among all patients who had achieved clinical responsea with STELARA during induction, 64.9 percent were in symptomatic remissionb after 44 weeks of maintenance. At week 200 (four years), this proportion of patients was 55.2 percent; the majority (96.4 percen...
Source: Johnson and Johnson - October 10, 2022 Category: Pharmaceuticals Source Type: news
STELARA ® (ustekinumab) Approved by the U.S. Food and Drug Administration to Treat Pediatric Patients with Active Psoriatic Arthritis
HORSHAM, PENNSYLVANIA, August 1, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved STELARA® (ustekinumab) for the treatment of pediatric patients six years of age and older with active psoriatic arthritis (PsA). This rare disease that resembles adult PsA affects five to eight percent of children and adolescents with chronic inflammatory arthritis.*1-7 Two of the four indications for STELARA now include pediatric patients, further expanding its treatment profile since the first approval in 2009 for adults living with moderate...
Source: Johnson and Johnson - August 1, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news
Correlates of Protection Against Respiratory Syncytial Virus Infection in Infancy
AbstractThe highest morbidity and mortality from respiratory syncytial virus (RSV) infection occurs in young infants. Immunization of expectant mothers during pregnancy has the potential to substantially reduce the burden of RSV disease in a majority of infants. Correlates of protection (COP) are important in guiding the development of maternal RSV vaccines and the design of maternal RSV vaccine trials, as immune response to candidate vaccines should mirror protective RSV immunity at birth. Here, we review the literature reporting correlations between RSV immune measures at birth and clinical RSV outcomes during infancy. L...
Source: Clinical Reviews in Allergy and Immunology - June 11, 2022 Category: Allergy & Immunology Source Type: research
Janssen Presents Study Results Showing Clinical Efficacy for TREMFYA ® (guselkumab) and Long-Term Safety Profile for STELARA® (ustekinumab) for Patients Living with Inflammatory Bowel Disease at Digestive Disease Week® 2022
SPRING HOUSE, PENNSYLVANIA, May 24, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the Phase 2 GALAXI 1 clinical trial of TREMFYA® (guselkumab) in adult patients with moderately to severely active Crohn’s disease (CD), and from three separate long-term pooled analyses of adult patients with ulcerative colitis (UC) and CD treated with STELARA® (ustekinumab).1,2,3,4 These data are being presented as oral and poster presentations and are among 29 Janssen abstracts presented during the Digestive Disease Week® (DDW) meeting taking place in person and virtually in San Di...
Source: Johnson and Johnson - May 24, 2022 Category: Pharmaceuticals Source Type: news
