The FDA Is Slowing Down COVID-19 Vaccine Approval. That Could Be Good for Public Health

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 on Nov. 3, as President Donald Trump has repeatedly pushed for. Despite reports to the contrary, White House representatives told ABC News they never tried to block the FDA’s policy. Still, Trump tweeted his displeasure on Tuesday night. “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day,” he wrote, tagging FDA Commissioner Dr. Stephen Hahn. “Just another political hit job!” New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job! @SteveFDA — Donald J. Trump (@realDonaldTrump) October 7, 2020 Also on Oct. 6, Moncef Slaoui, co-chair of the Trump Administration’s Operation Warp Speed vaccine development project, said the group urged pharmaceutical companies not to apply for emergency-use auth...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Source Type: news

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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
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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
NEW BRUNSWICK, N.J., September 23, 2020 – Johnson &Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial follows positive interim results from the Company’s Phase 1/2a clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development. These results have been submitted to medRxiv and are due to be published online im...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news
Body count has long been the yardstick by which we measure calamity. There were the 58,000 U.S. lives lives lost in the Vietnam war; the 1,496 souls who perished on the Titanic. In the hours after the September 11 attacks, when the death toll was not known, then-New York Mayor Rudy Giuliani famously said, “The number of casualties will be more than any of us can bear, ultimately.” We are, once again, trying to bear the unbearable as the U.S. today surpassed 200,000 deaths caused in the still-rampaging COVID-19 pandemic. We remain, as we have long been, the world’s hardest-hit country, with just 4% of the ...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Source Type: news
Wondering when to get your flu shot? The best time is before influenza (flu) starts circulating widely. For most people, September or October is ideal for protection through the whole flu season, as the immune response from the vaccine wanes over time. And while changes and restrictions due to COVID-19 may make getting a flu vaccine less convenient for some this year, the pandemic makes it more important than ever. Why do I need to get a flu vaccine yearly? Influenza A and Influenza B cause most cases of flu in humans. Both have many strains that constantly change, accumulating genetic mutations that disguise them from the...
Source: Harvard Health Blog - Category: Consumer Health News Authors: Tags: Cold and Flu Coronavirus and COVID-19 Vaccines Source Type: blogs
AbstractObjectives: The Bacille Calmette-Gu érin (BCG) vaccine against tuberculosis is associated with non- specific protective effects against other infections, and significant reductions in all-cause morbidity and mortality have been reported. We aim to test whether BCG vaccination may reduce susceptibility to and/or the severity of COVID- 19 and other infectious diseases in health care workers (HCW) and thus prevent work absenteeism.The primary objective is to reduce absenteeism due to illness among HCW during the COVID-19 pandemic. The secondary objectives are to reduce the number of HCW that are infected with S...
Source: Trials - Category: Research Source Type: clinical trials
ConclusionThe MESV developed in this study is capable of generating immune response against COVID-19. Therefore, if designed MESV further investigated experimentally, it would be an effective vaccine candidate against SARS-CoV-2 to control and prevent COVID-19.
Source: Infectious Diseases of Poverty - Category: Infectious Diseases Source Type: research
The cleverest of enemies thrive on surprise attacks. Viruses—and coronaviruses in particular—know this well. Remaining hidden in animal hosts for decades, they mutate steadily, sometimes serendipitously morphing into more effective and efficient infectious agents. When a strain with just the right combination of genetic codes that spell trouble for people makes the leap from animal to human, the ambush begins. Such was the case with SARS-CoV-2, the coronavirus behind COVID-19, and the attack was mostly silent and insidious at first. Many people infected with SARS-CoV-2 remained oblivious as they served as the v...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Magazine Source Type: news
AstraZeneca, the U.K.-based pharmaceutical company behind one of the world’s most promising COVID-19 vaccine candidates, has paused its trials due to “a single event of an unexplained illness that occurred in the UK Phase III trial,” the company announced Sept. 9. The news is disappointing, but it shows the development process is happening as it should. It is not uncommon for drug or vaccine trials to hit snags, even at advanced stages. Indeed, part of the reason vaccines go through multiple phases of testing, with increasingly large numbers of patients, is to catch rare but potentially serious side effec...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Source Type: news
This story has been updated to reflect AstraZeneca’s vaccine trial resuming. AstraZeneca, the U.K.-based pharmaceutical company behind one of the world’s most promising COVID-19 vaccine candidates, has resumed its U.K. trial after pausing it due to “a single event of an unexplained illness,” the company announced Sept. 12. While AstraZeneca did not initially specify the nature of the study participant’s “unexplained illness,” an anonymous source told the New York Times that a trial participant in the U.K. was recently diagnosed with an inflammatory condition that affects the spinal...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Source Type: news
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