Showing: 1 - 7 of 7 RESULTS

J&J vaccine trial hits pause as US doubles down on antibody therapies

Johnson & Johnson (JNJ) announced late Monday it was pausing shots in its late-stage coronavirus vaccine trial due to an adverse event, but plans to continue enrolling patients and stick to the current manufacturing timeline.

It is still unknown if the participant was receiving a placebo or the vaccine, a point that will be determined by an independent advisory group, known as the Data Safety Monitoring Board (DSMB). Another vaccine using similar technology from AstraZeneca (AZN) is still on hold after a serious adverse event from a trial participant triggered a halt in September. The trial has continued in the U.K., but remains on hold in the U.S.

“Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies,” J&J said statement late Monday, reiterating that “studies may be paused if an unexpected serious adverse event (SAE)” occurs that may or may not be related to the trials. The company promised a “careful review of all of the medical information before deciding whether to restart the study.”

Mathai Mammen, head of research and development at Janssen, J&J’s pharmaceutical arm, said the information is kept confidential from the company until the DSMB reviews it.

“It will be a few days at minimum for the right set of information to be gathered and evaluated,” Mammen said during an investor call Tuesday.

The two frontrunner candidates in the U.S., Moderna (MRNA) and Pfizer (PFE) with BioNTech (BNTX), are using technology that has never been approved, but have so far not hit any significant adverse events.

Meanwhilel, Pfizer’s non-peer-reviewed data showed some side effects, but nothing that would trigger a halt. Pain at the point of injection and fatigue are considered normal vaccine side effects — seen frequently after flu shots.

Monoclonal antibodies

There are over 7.6 million cases in the U.S. (Graphic: David Foster/Yahoo Finance)
There are over 7.6 million cases in the U.S. (Graphic: David Foster/Yahoo Finance)

The experimental treatment used by President Donald Trump while he was at Walter Reed Military Medical Center is gaining momentum as the country awaits a vaccine by the end of the year.

Monoclonal antibody treatments, which are lab-produced antibodies from a sample of recovered patients, has been seen as a bridge between standard treatments and a vaccine, as well as an alternative for those who cannot be given a vaccine. That is because it can both treat and defend against the virus.

Trump received a high dose of Regeneron’s (REGN) antibody cocktail, which sparked the company and Eli Lilly (LLY), which is also developing an antibody treatment, to apply for emergency use authorizations (EUA). The U.S. Food and Drug Administration (FDA) has yet to provide an update on these filings from last week, but analysts have anticipated authorizations following Trump’s treatment.

Meanwhile, Operation Warp Speed announced a collaboration with AstraZeneca to test and produce a monoclonal antibody cocktail, which would be provided for free once authorized by the FDA.

Adding to the portfolio of candidates, the National Institutes of Health (NIH) announced Tuesday it

Lesson not learned: Europe unprepared as 2nd virus wave hits

ROME — Europe’s second wave of coronavirus infections has struck well before flu season even started, with intensive care wards filling up again and bars shutting down. Making matters worse, authorities say, is a widespread case of “COVID-fatigue.”

Record high daily infections in several eastern European countries and sharp rebounds in the hard-hit west have made clear that Europe never really crushed the COVID-19 curve as hoped, after springtime lockdowns.

Spain this week declared a state of emergency for Madrid amid increasing tensions between local and national authorities over virus containment measures. Germany offered up soldiers to help with contact tracing in newly flaring hotspots. Italy mandated masks outdoors and warned that for the first time since the country became the European epicenter of the pandemic, the health system was facing “significant critical issues” as hospitals fill up.

The Czech Republic’s “Farewell Covid” party in June, when thousands of Prague residents dined outdoors at a 500-meter (yard) long table across the Charles Bridge to celebrate their victory over the virus, seems painfully naive now that the country has the highest per-capita infection rate on the continent, at 398 per 100,000 residents.

“I have to say clearly that the situation is not good,” the Czech interior minister, Jan Hamacek, acknowledged this week.

Demonstrators protesting the Czech government’s restrictions on restaurants and bars march across the Old Town Square as the spread of the coronavirus disease (COVID-19) continues in Prague, Czech Republic, October 5, 2020. Photo by David W Cerny/Reuters.

Epidemiologists and residents alike are pointing the finger at governments for having failed to seize on the summertime lull in cases to prepare adequately for the expected autumn onslaught, with testing and ICU staffing still critically short. In Rome this week, people waited in line for 8-10 hours to get tested, while front-line medics from Kiev to Paris found themselves once again pulling long, short-staffed shifts in overcrowded wards.

“When the state of alarm was abandoned, it was time to invest in prevention, but that hasn’t been done,” lamented Margarita del Val, viral immunology expert with the Severo Ochoa Molecular Biology Center, part of Spain’s top research body, CSIC.

“We are in the fall wave without having resolved the summer wave,” she told an online forum this week.

Tensions are rising in cities where new restrictions have been re-imposed, with hundreds of Romanian hospitality workers protesting this week after Bucharest once again shut down the capital’s indoor restaurants, theaters and dance venues.

“We were closed for six months, the restaurants didn’t work and yet the number of cases still rose,” said Moaghin Marius Ciprian, owner of the popular Grivita Pub n Grill who took part in the protest. “I’m not a specialist but I’m not stupid either. But from my point of view it’s not us that have the responsibility for this pandemic.”

FILE PHOTO: Restaurants and bars owners hold signs as they attend a demonstration to protest against the new sanitary measures by the French government to stop a second wave

Lesson Not Learned: Europe Unprepared as 2nd Virus Wave Hits | World News

By NICOLE WINFIELD, Associated Press

ROME (AP) — Europe’s second wave of coronavirus infections has struck well before flu season even started, with intensive care wards filling up again and bars shutting down. Making matters worse, authorities say, is a widespread case of “COVID-fatigue.”

Record high daily infections in several eastern European countries and sharp rebounds in the hard-hit west have made clear that Europe never really crushed the COVID-19 curve as hoped, after springtime lockdowns.

Spain this week declared a state of emergency for Madrid amid increasing tensions between local and national authorities over virus containment measures. Germany offered up soldiers to help with contact tracing in newly flaring hotspots. Italy mandated masks outdoors and warned that for the first time since the country became the European epicenter of the pandemic, the health system was facing “significant critical issues” as hospitals fill up.

The Czech Republic’s “Farewell Covid” party in June, when thousands of Prague residents dined outdoors at a 500-meter (yard) long table across the Charles Bridge to celebrate their victory over the virus, seems painfully naive now that the country has the highest per-capita infection rate on the continent, at 398 per 100,000 residents.

“I have to say clearly that the situation is not good,” the Czech interior minister, Jan Hamacek, acknowledged this week.

Epidemiologists and residents alike are pointing the finger at governments for having failed to seize on the summertime lull in cases to prepare adequately for the expected autumn onslaught, with testing and ICU staffing still critically short. In Rome this week, people waited in line for 8-10 hours to get tested, while front-line medics from Kiev to Paris found themselves once again pulling long, short-staffed shifts in overcrowded wards.

“When the state of alarm was abandoned, it was time to invest in prevention, but that hasn’t been done,” lamented Margarita del Val, viral immunology expert with the Severo Ochoa Molecular Biology Center, part of Spain’s top research body, CSIC.

“We are in the fall wave without having resolved the summer wave,” she told an online forum this week.

Tensions are rising in cities where new restrictions have been re-imposed, with hundreds of Romanian hospitality workers protesting this week after Bucharest once again shut down the capital’s indoor restaurants, theaters and dance venues.

“We were closed for six months, the restaurants didn’t work and yet the number of cases still rose,” said Moaghin Marius Ciprian, owner of the popular Grivita Pub n Grill who took part in the protest. “I’m not a specialist but I’m not stupid either. But from my point of view it’s not us that have the responsibility for this pandemic.”

As infections rise in many European countries, some — including Belgium, Netherlands, the United Kingdom, Spain and France — are diagnosing more new cases every day per capita than the United States, according to the seven-day rolling averages of data kept by Johns Hopkins University. On Friday, France, with a population of about 70 million, reported a record 20,300 new

Europe unprepared as 2nd virus wave hits

ROME (AP) — Europe’s second wave of coronavirus infections has struck well before flu season even started, with intensive care wards filling up again and bars shutting down. Making matters worse, authorities say, is a widespread case of “COVID-fatigue.”

Record high daily infections in several eastern European countries and sharp rebounds in the hard-hit west have made clear that Europe never really crushed the COVID-19 curve as hoped, after springtime lockdowns.

Spain this week declared a state of emergency for Madrid amid increasing tensions between local and national authorities over virus containment measures. Germany offered up soldiers to help with contact tracing in newly flaring hotspots. Italy mandated masks outdoors and warned that for the first time since the country became the European epicenter of the pandemic, the health system was facing “significant critical issues” as hospitals fill up.

The Czech Republic’s “Farewell Covid” party in June, when thousands of Prague residents dined outdoors at a 500-meter (yard) long table across the Charles Bridge to celebrate their victory over the virus, seems painfully naive now that the country has the highest per-capita infection rate on the continent, at 398 per 100,000 residents.

“I have to say clearly that the situation is not good,” the Czech interior minister, Jan Hamacek, acknowledged this week.


Epidemiologists and residents alike are pointing the finger at governments for having failed to seize on the summertime lull in cases to prepare adequately for the expected autumn onslaught, with testing and ICU staffing still critically short. In Rome this week, people waited in line for 8-10 hours to get tested, while front-line medics from Kiev to Paris found themselves once again pulling long, short-staffed shifts in overcrowded wards.

“When the state of alarm was abandoned, it was time to invest in prevention, but that hasn’t been done,” lamented Margarita del Val, viral immunology expert with the Severo Ochoa Molecular Biology Center, part of Spain’s top research body, CSIC.

“We are in the fall wave without having resolved the summer wave,” she told an online forum this week.

Tensions are rising in cities where new restrictions have been re-imposed, with hundreds of Romanian hospitality workers protesting this week after Bucharest once again shut down the capital’s indoor restaurants, theaters and dance venues.

“We were closed for six months, the restaurants didn’t work and yet the number of cases still rose,” said Moaghin Marius Ciprian, owner of the popular Grivita Pub n Grill who took part in the protest. “I’m not a specialist but I’m not stupid either. But from my point of view it’s not us that have the responsibility for this pandemic.”

As infections rise in many European countries, some — including Belgium, Netherlands, the United Kingdom, Spain and France — are diagnosing more new cases every day per capita than the United States, according to the seven-day rolling averages of data kept by Johns Hopkins University. On Friday, France, with a population of about 70 million, reported a record 20,300 new infections.

Experts say Europe’s high

Gov’t Bows to Vax Makers’ Demands? 2nd Wave Hits Europe; FDA Wants Makena Pulled

Note that some links may require registration or subscription.

The White House is blocking new FDA guidelines that would stiffen requirements for authorizing COVID-19 vaccines, after manufacturers reportedly objected to the guidance. (New York Times, Politico)

White House Press Secretary Kayleigh McEnany and Pastor Greg Laurie of the Harvest Christian Fellowship megachurch were the latest attendees at a recent White House event to report a positive coronavirus test. MedPage Today has a running list here.

Perhaps the most at risk White House staffers, however, are the 100 members of the White House’s residence staff. (The Atlantic)

Finally: the CDC acknowledges the potential for airborne SARS-CoV-2 transmission.

As of 8:00 a.m. ET Tuesday, the estimated U.S. COVID-19 toll reached 7,459,102 cases and 210,196 deaths — up 40,364 and 462, respectively, since the same time Monday.

The Northeast and Midwest are experiencing surges, and new cases have risen for at least two weeks in a row in 21 states. (Reuters)

Lockdown measures make a comeback in Europe. (The Guardian)

WHO official said roughly 1 in 10 people worldwide have been infected with COVID-19 and that we are now heading into a “difficult period.” (Reuters)

Three doctors met with HHS Secretary Alex Azar and Trump advisor Scott Atlas, MD, to push the herd immunity hypothesis. (The Hill)

European drug regulators are investigating reports of acute kidney injury in some COVID-19 patients who were on remdesivir. (Becker’s Hospital Review)

Moderna failed to enroll enough people of color in its vaccine trial and slowed enrollment to ensure more minority volunteers were recruited. (Reuters)

Trump issued an executive order establishing a Coronavirus Mental Health Working Group to respond to “mental-health conditions induced or exacerbated by the pandemic, including issues related to suicide prevention.”

Texas universities have plenty of tests, but participation rates are far lower than expected, prompting one school to offer prizes to students volunteering to be tested. (Texas Tribune)

PBS is airing a segment tonight on the nationwide scramble for personal protective equipment in the first wave of the pandemic.

In other news:

  • author['full_name']

    Elizabeth Hlavinka covers clinical news, features, and investigative pieces for MedPage Today. She also produces episodes for the Anamnesis podcast. Follow

Source Article

DCH Hits Highest COVID-19 Inpatient Total Since Aug. 21

TUSCALOOSA, AL. — The number of inpatient COVID-19 cases for DCH Health System across its three hospitals has hit its highest mark in more than a month, according to Monday’s update from DCH.

As of 4 p.m. Monday, DCH reported 69 inpatient COVID-19 cases, which is up from 50 two weeks ago and represents the most patients being treated in the hospital after testing positive for the coronavirus since the system reported 69 cases on Aug. 21.

The number of COVID-19 patients being treated in the hospital’s intensive care units (ICUs) as of Monday afternoon — 25 — is also the same number seen on Aug. 21 and a total increase of five over the last two weeks.

While inpatient totals at DCH have been on a steady climb since Labor Day weekend and the beginning of in-person instruction for local schools and colleges, Monday’s inpatient figures are still well-short of a surge brought on by the Fourth of July holiday that saw the hospital top triple-digit totals for its COVID-19 inpatients.

An increase worth noting could also be seen in the number of patients being treated on ventilators, which climbed to 11 as of Monday, compared to “five or fewer” reported on Sept. 21.

According to Monday’s update of the Alabama Department of Public Health’s COVID-19 dashboard, Tuscaloosa has confirmed a cumulative total of 6,606 COVID-19 cases. Of those cases, 1,938 were confirmed over the last 14 days.

Since Aug. 21, the hospital has also reported 49 deaths of inpatients at DCH who tested positive for COVID-19. To date, 195 inpatients who tested positive have died at DCH, 107 of whom were Tuscaloosa residents.

In its latest update, DCH did say the volume at its remote site in the Laundry Lot just west of DCH Regional Medical Center in Tuscaloosa has been on a gradual decline, prompting the system to reduce the number of days and changing the hours of operation.

Starting this week, DCH says the site will be open Monday, Wednesday and Friday from, 8 a.m. until noon.

This article originally appeared on the Tuscaloosa Patch

Source Article

Fitness coach Lauren Simpson, 30, hits back at trolls who accused her of being ‘fake’ on Instagram

‘Don’t be a hater’: Fitness coach, 30, claps back at trolls with a red hot bikini snap after she was accused of being ‘fake’ in her social media pictures

  • A trainer has hit back at trolls who accused her of being fake on Instagram  
  • Lauren Simpson asked her 1.9million followers to ask questions on her story
  • One person wrote: ‘Why do you pose in photos? You are so fake’
  • The fitness coach, from Sydney, replied that it’s simply part of her job
  • She urged women to post what they want and stop worrying about criticism

A fitness coach has clapped back at trolls with a picture showing off her incredible physique after she was accused of being ‘fake’ in her photos on social media.

When Lauren Simpson, 30, invited her 1.9million Instagram followers to ask questions on her story, one person wrote: ‘Why do you pose in your photos? You are so fake.’

In response, the personal trainer from Sydney posted a shot of herself in a red bikini with a caption explaining that she poses and flexes in some of her pictures because it’s simply part of her job.

Ms Simpson – who said she prides herself on being a ‘very genuine person’ online – encouraged women to post what they want and stop worrying about the opinions of others.

Sydney fitness coach Lauren Simpson posted this photo as a clap back to haters who accused her of being 'fake' on Instagram

Sydney fitness coach Lauren Simpson posted this photo as a clap back to haters who accused her of being ‘fake’ on Instagram

‘Honey, don’t be a hater. Yes I pose in my photos. Yes I flex in some of my photos,’ she began.

‘I do photoshoots. I am a bikini competitor – so I’ve learned over the years how to pose from top coaches for stage.

‘I create content for social media every day. It’s all part of it.’

Ms Simpson – who was crowned WBFF Bikini World Champion in 2018 – added that she enjoys showing herself off in ‘flattering angles’ and ‘nailing poses’ she knows work well for her body.

‘I mean, who doesn’t?’ she asked.

But the fitness star said she is equally comfortable posting candid, make-up free pictures where she’s not posing for the camera.

Ms Simpson - who said she prides herself on being a 'very genuine person' online - encouraged women to post what they want and stop worrying about the opinions of others

Ms Simpson – who said she prides herself on being a ‘very genuine person’ online – encouraged women to post what they want and stop worrying about the opinions of others

Ms Simpson was crowned WBFF Bikini World Champion in 2018

She said she enjoys showing herself off in 'flattering angles' and 'nailing poses' she knows work well for her body

Ms Simpson – who was crowned WBFF Bikini World Champion in 2018 – said she enjoys showing herself off in ‘flattering angles’ and ‘nailing poses’ she knows work well for her body

Lauren Simpson’s nutrition secrets

1. Calories in versus calories out is king. Ultimately the results you get is dictated by calories consumed versus calories burned. 

2. A calorie deficit is the only way to drop body fat. If you’re not losing weight on a certain amount of calories, it means you are not in a calorie deficit.