COVID-19 Vaccine Standards Questioned at FDA Advisory Meeting COVID-19 Vaccine Standards Questioned at FDA Advisory Meeting

FDA advisers on Thursday heard calls for changes in how the agency plans to review applications for clearance of COVID-19 vaccines.Medscape Medical News
Source: Medscape Allergy Headlines - Category: Allergy & Immunology Tags: Infectious Diseases News Source Type: news

Related Links:

In a Phase 1 trial of 191 healthy participants ages 18-59, vaccination with the group's experimental shot based on inactivated virus showed no severe adverse reactions, its researchers said in a paper not yet peer-reviewed.Reuters Health Information
Source: Medscape Allergy Headlines - Category: Allergy & Immunology Tags: Infectious Diseases News Source Type: news
Conditions:   Corona Virus Infection;   Flu Vaccine;   Immunity Intervention:   Biological: Flu shot Sponsors:   Stanford University;   National Institute of Allergy and Infectious Diseases (NIAID) Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
New U.S. Food and Drug Administration (FDA) guidance means a COVID-19 vaccine likely will not be approved by Election Day—which could actually be a good thing for public health. On Oct. 6, the agency posted an industry guidance document on its website asking pharmaceutical companies applying for emergency-use authorization of a COVID-19 vaccine to monitor study subjects for at least two months after vaccination, so they can look for side effects that may arise over time and get a better sense of the shot’s efficacy. That means it’s unlikely any manufacturer will receive authorization before Election Day o...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Source Type: news
The COVID-19 pandemic has had a worldwide effect for what seems like an eternity. After shelter-in-place orders became more prevalent in March,  most people probably didn’t think they’d still be wearing masks in October. So the question remains, when will the pandemic end?  It turns out there are quite a few factors that contribute to the rise and fall of a pandemic, some within our control, some that are not. An outbreak becomes a pandemic when it meets two criteria, first, it spreads rapidly and widely, and second, it must qualify as a severe disease. If either of these factors change, it is no long...
Source: Conversations with Dr Greene - Category: Child Development Authors: Tags: Dr. Greene's Blog Coronavirus COVID COVID-19 COVID-19 Feature Source Type: blogs
We need one million more citizens to volunteer for the COVID-19 vaccine trials. Almost half a million Americans have signed up to be part of the clinical trials, but in order to complete the study, the COVID-19 Prevention Network—formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. National Institutes of Health—will need more volunteers, and especially more volunteers from diverse backgrounds. The sooner the clinical trials finish accruing patients the sooner we will have results of the vaccine studies. I am a cancer doctor, but like many doctors and researchers have been call...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Source Type: news
A Phase 1 trial of an investigational mRNA vaccine to prevent SARS-CoV-2 infection has shown that the vaccine is well-tolerated and generates a strong immune response in older adults. A report published today in the New England Journal of Medicine describes the findings from the study, which was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
Source: World Pharma News - Category: Pharmaceuticals Tags: Featured EMA Regulatory Affairs Source Type: news
cbsoptanon.onScriptsReady(function(cmp){cmp.ot.targetingAllowed(function(a){if(a) AnvatoPlayer("p0").init({"mcp":"cbs","width":"100%","height":"100%","video":"4749412","autoplay":false,"titleVisible":false,"accessKey":"EZqvRyKE7qmqDflDPXIw6U7kKZEA0Vx7","accessControl":{"preview":false},"pInstance":"p0","plugins":{"heartbeat":{"account":"cbslocal-global-unified","publisherId":"cbslocal","jobId...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - Category: Consumer Health News Authors: Tags: Boston News Covid-19 Boston, MA Health Healthcare Status Healthwatch Syndicated Local Coronavirus Dr. Mallika Marshall Source Type: news
Johnson&Johnson has advanced its one-shot COVID-19 vaccine into phase 3 testing. The National Institute of Allergy and Infectious Diseases describes this as the fourth candidate to reach this stage.Medscape Medical News
Source: Medscape FamilyMedicine Headlines - Category: Primary Care Tags: Infectious Diseases News Source Type: news
Johnson &Johnson announced today (Sept. 23) that it is launching a large-scale Phase 3 test of its COVID-19 vaccine candidate, which was developed based on science supported by the National Institutes of Health. The vaccine, being tested through the company’s Janssen Pharmaceuticals arm, will be the fourth to enter late stage studies, following candidates from Moderna, Pfizer-BioNTech and AstraZeneca. Unlike those vaccine candidates, which all require two shots, J&J’s vaccine involves a single injection. That means it could require half the number of doses to immunize the same number of people. J&J’s ...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Source Type: news
cbsoptanon.onScriptsReady(function(cmp){cmp.ot.targetingAllowed(function(a){if(a) AnvatoPlayer("p1").init({"mcp":"cbs","width":"100%","height":"100%","video":"4730668","autoplay":false,"titleVisible":false,"accessKey":"EZqvRyKE7qmqDflDPXIw6U7kKZEA0Vx7","accessControl":{"preview":false},"pInstance":"p1","plugins":{"heartbeat":{"account":"cbslocal-global-unified","publisherId":"cbslocal","jobId...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - Category: Consumer Health News Authors: Tags: Boston News Covid-19 Boston, MA Health Healthcare Status Beth Israel Deacones Medical Center Coronavirus Johnson & Johnson Source Type: news
More News: Allergy | Allergy & Immunology | COVID-19 | Infectious Diseases | Vaccines