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Total 71 results found since Jan 2013.
With the Decongestant SNAFU, the FDA Tries Something New
It’s easy to understand how a medicine like phenylephrine got onto pharmacy shelves in the first place. The common decongestant, used most often as an ingredient in multidrug cold medications like DayQuil and Sudafed PE, was initially designated as “safe and effective” by the Food and Drug Administration (FDA) in 1976, when the agency was newly—and less stringently than today—greenlighting drugs that had been on the market for years before the agency had established any efficacy standards. After a full review of 14 studies (12 unpublished and two published) from pharmaceutical companies—...
Source: TIME: Health - September 14, 2023 Category: Consumer Health News Authors: Haley Weiss Tags: Uncategorized healthscienceclimate Source Type: news
Companies won ’t share COVID-19 shots, stalling future vaccine research
The U.S. government has tens of millions of unused doses of messenger RNA (mRNA) COVID-19 vaccines, regularly trashing shots as they pass their expiration dates. It’s a dismal reflection on recent vaccine uptake, but it’s also a serious roadblock for scientists testing and developing vaccines that could protect against future variants of SARS-CoV-2—and the next pandemic. Developers need existing vaccines as a benchmark to compare with new candidates. But government contracts with the vaccinemakers, and the companies’ own policies, prohibit the use of the vaccines for research purposes.
“At this stage of the ...
Source: ScienceNOW - May 30, 2023 Category: Science 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
News at a glance: Earth ’s top geological sites, cameras on sharks, and China’s space station
NATURAL HISTORY
Science society lists Earth’s top ‘geoheritage’ sites
The International Union of Geological Sciences last week marked its 60th anniversary by announcing
a list of 100 “geoheritage” sites that have substantially influenced understanding of Earth’s deep history
. The global list, released in collaboration with UNESCO, is meant to foster conservation and tourism. The sites include familiar ones, such as the Grand Canyon’s “great unconformity,” a billion-year gap in the rock record erased by erosion. More exotic examples include limestones in Germany that preserve
Arc...
Source: Science of Aging Knowledge Environment - November 3, 2022 Category: Geriatrics 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
A New Lab-Made COVID-19 Virus Puts Gain-of-Function Research Under the Microscope
On October 14, a team of scientists at Boston University released a pre-print study reporting that they had created a version of SARS-CoV-2 combining two features of different, existing strains that boosted its virulence and transmissibility. Scientists and the public raised questions about the work, which refocused attention on such experiments, and prompted the U.S. government to investigate whether the research followed protocols for these kinds of studies.
The concerns surround what is known as gain-of-function studies, in which viruses, bacteria, or other pathogens are created in the lab—either intentionally or ...
Source: TIME: Science - October 27, 2022 Category: Science Authors: Alice Park Tags: Uncategorized COVID-19 Source Type: news
Was a study that created a hybrid COVID-19 virus too risky?
The objective was to tease apart whether Omicron’s spike protein explains why it is less pathogenic (meaning it causes less severe disease). The answer could lead to improved COVID-19 diagnostic tests and better ways to manage the disease, the preprint authors say.
Somewhat surprisingly, the hybrid virus killed eight of 10 infected mice, whereas mice infected with Omicron got sick but did not die. This suggests the mutations that make Omicron less pathogenic must involve changes in proteins other than the spike protein, the authors say.
What are critics of the study saying?
They question the scientific val...
Source: Science of Aging Knowledge Environment - October 18, 2022 Category: Geriatrics Source Type: research
Almost everything Tucker Carlson said about Anthony Fauci this week was misleading or false
Tucker Carlson, a political commentator on Fox News, has long assailed Anthony Fauci for his role in the U.S. government’s response to the COVID-19 pandemic during both former President Donald Trump’s and President Joe Biden’s administrations. But on 22 August, when Fauci announced he would be retiring from his jobs as director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and chief medical adviser to the president at the end of year, the
Tucker Carlson Tonight
host laid into him like never before.
Carlson asserted Fauci had committed “very serious crimes” and said he “app...
Source: ScienceNOW - August 25, 2022 Category: Science Source Type: news
News at a glance: New gene therapy, Europe ’s drought, and a black hole’s photon ring
ARCHAEOLOGY
Drought exposes ‘Spanish Stonehenge’ for study
Scientists are rushing to examine a 7000-year-old stone circle in central Spain that had been drowned by a reservoir for decades and was uncovered after the drought plaguing Europe lowered water levels. Nicknamed the “Spanish Stonehenge”—although 2000 years older than the U.K. stone circle—the Dolmen of Guadalperal (above) was described by archaeologists in the 1920s. The approximately 100 standing stones, up to 1.8 meters tall and arranged around an oval open space, were submerged in the Valdecañas reservoir after the construction of a ...
Source: Science of Aging Knowledge Environment - August 25, 2022 Category: Geriatrics Source Type: research
What to Know About the Latest Advances in Managing Severe Asthma
Graphs and charts don’t always tell the whole story. Numbers can be deceiving. But anyone who looks at U.S. trends in asthma mortality can see, without squinting, that things are moving in the right direction.
A 2019 analysis in the American Journal of Respiratory and Critical Care Medicine found that from 1999 to 2015, asthma mortality fell by 43%. “The decrease in asthma-related mortality was consistent in both sexes and in all race groups, with the largest decrease in patients older than 65 years,” the authors concluded. Figures from the U.S. Centers for Disease Control and Prevention indicate that the...
Source: TIME: Health - June 23, 2022 Category: Consumer Health News Authors: Markham Heid Tags: Uncategorized Disease freelance healthscienceclimate Source Type: news
Allergy evaluation of messenger RNA vaccine reactions is crucial, with a specific role for polyethylene glycol testing
The US Food and Drug Administration granted emergency authorization to both Pfizer-BioNTech's BNT162B2 messenger RNA (mRNA) and Moderna's mRNA-1273 coronavirus disease 2019 (COVID-19) vaccines in December 2020. Uncommon (2.5-4.7 events per million) anaphylactic reactions were observed that had not been reported in phase III studies which excluded individuals with a history of an allergy to a vaccine or components of the mRNA vaccines. From that moment on, allergists have played a crucial role in the vaccine rollout and have clarified a very specific role for polyethylene glycol (PEG) testing.
Source: Annals of Allergy, Asthma and Immunology - June 16, 2022 Category: Allergy & Immunology Authors: Pragya Shrestha, Cosby Allen Stone Tags: Perspective Source Type: research
Moderna Seeks Emergency Use Authorization For COVID Vaccine For Kids 5 And Under
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Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - April 28, 2022 Category: Consumer Health News Authors: Health – CBS Boston Tags: Boston News COVID-19 Covid-19 Boston, MA Health Healthwatch Syndicated CBSN Boston Coronavirus Moderna Source Type: news
A001 mrna covid-19 vaccine adverse events following immunization: should you recommend the second dose?
We describe the evaluation and outcome of patients referred to an Allergy Clinic for AEFI to the mRNA COVID-19 vaccines.
Source: Annals of Allergy, Asthma and Immunology - November 1, 2021 Category: Allergy & Immunology Authors: B. St. Clair, D. Hoffman, R. Lee, J. Montgomery Tags: Adverse Drug Reactions, Insect Reactions, Anaphylaxis 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
Specific antibody response of common variable immunodeficiency patients to BNT162b2 COVID-19 vaccination
On March 11, 2020, the World Health Organization declared that coronavirus disease 2019 (COVID-19) was a pandemic.1 Since then, the disease has reached a 1% to 3% estimated overall mortality rate.2 COVID-19 severity ranges from asymptomatic to acute respiratory distress syndrome and possible death due to multiorgan failure.2 Therefore, to ameliorate the resultant poor health and social and economic consequences, prophylactic vaccines were developed. On December 11, 2020, the U.S. Food and Drug Administration issued the first emergency use authorization of Pfizer-BioNTech mRNA vaccine (BNT162b2) for COVID-19 prevention.
Source: Annals of Allergy, Asthma and Immunology - August 2, 2021 Category: Allergy & Immunology Authors: Nizar Abo-helo, Emad Muhammad, Sondus Ghaben-amara, Josef Panasoff, Shai Cohen Tags: Letters Source Type: research
