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2nd COVID-19 Vaccine Trial Paused Over Unexplained Illness | Business News

NEW BRUNSWICK, N.J. (AP) — A late-stage study of Johnson & Johnson’s COVID-19 vaccine candidate has been paused while the company investigates whether a study participant’s “unexplained illness” is related to the shot.

The company said in a statement Monday evening that illnesses, accidents and other so-called adverse events “are an expected part of any clinical study, especially large studies,” but that its physicians and a safety monitoring panel would try to determine what might have caused the illness.

The pause is at least the second such hold to occur among several vaccines that have reached large-scale final tests in the U.S.

The company declined to reveal any more details about the illness, citing the participant’s privacy.

Temporary stoppages of large medical studies are relatively common. Few are made public in typical drug trials, but the work to make a coronavirus vaccine has raised the stakes on these kinds of complications.

Companies are required to investigate any serious or unexpected reaction that occurs during drug testing. Given that such tests are done on tens of thousands of people, some medical problems are a coincidence. In fact, one of the first steps the company said it will take is to determine if the person received the vaccine or a placebo.

The halt was first reported by the health news site STAT.

Final-stage testing of a vaccine made by AstraZeneca and Oxford University remains on hold in the U.S. as officials examine whether an illness in its trial poses a safety risk. That trial was stopped when a woman developed severe neurological symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord, the company has said. That company’s testing has restarted elsewhere.

Johnson & Johnson was aiming to enroll 60,000 volunteers to prove if its single-dose approach is safe and protects against the coronavirus. Other vaccine candidates in the U.S. require two shots.

Copyright 2020 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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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

Coronavirus live updates: Czech Republic sees record rise in cases for 2nd straight day

An internal memo from the Federal Emergency Management Agency obtained by ABC News on Wednesday night shows that the number of new COVID-19 cases recorded in the United States and the nationwide usage of intensive care units are both on the rise in week-over-week comparisons.

There were 306,965 new cases confirmed during the period of Sept. 30-Oct. 6, a 4.8% increase from the previous week. There were also 4,860 coronavirus-related fatalities recorded during the period of Sept. 30-Oct. 6, a 4.6% decrease compared with the week prior, according to the memo.

Meanwhile, the national positivity rate for COVID-19 tests increased from 4.5% to 5.4% in week-to-week comparisons. Currently, 23% of hospitals across the country have more than 80% of beds full in their intensive care units. That figure was 17-18% during the summertime peak, the memo said.

The memo, which is circulated to the highest levels of the federal government and is used to determine daily priorities for the agencies working on COVID-19 response, shows that 32 U.S. states and territories are in an upward trajectory of infections, while 8 jurisdictions are at a plateau and 16 others are in a downward trend.

In Florida, 75% of ICU beds statewide are occupied. The number of new COVID-19 deaths doubled in Duval County in week-to-week comparisons, while Sumter County recently reported a single-day positivity rate for COVID-19 tests of over 20%, according to the memo.

Kentucky reported its highest single-day rise in COVID-19 cases on Oct. 3. Nearly half of current cases in northern Kentucky are patients younger than 40, and approximately 40% of them are under 30. The total number of COVID-19 hospitalizations has been increasing statewide since the end of September, the memo said.

The seven-day COVID-19 hospitalization rate continues to rise in Minnesota, reaching its highest since June 1 at 9.8 per 100,000 population, according to the memo.

In Ohio, the number of new COVID-19 cases has more than doubled in Muskingum County between the weeks ending Sept. 27 and Oct. 4. Outbreaks have been discovered at four social clubs there, according to the memo.

Wisconsin’s seven-day COVID-19 death rate has increased 139% from Sept. 27 to Oct. 4. The seven-day COVID-19 hospitalization rate also continues to climb, with Wisconsin reporting a peak of 16.4 per 100,000 population on Oct. 4. The state saw a record high of 782 COVID-19 hospitalizations on Oct. 5, more than double the amount a month earlier. As of Oct. 4, 84% of ICU beds statewide were in use. Local health departments in the counties of Fox Valley, Door and Manitowoc report seeing so many new cases that they are unable to conduct tests or

Battered by 1st wave, Madrid hospital staff stretched by 2nd

TORREJÓN DE ARDOZ, Spain (AP) — With speed and determination, nurses, doctors and caretakers move in and out of glassed rooms with beds hooked up to tubes, cables and monitors. The cadence of beeps serves as a soundtrack to their workday, underpinned by a constant chatter of voices at half pitch and the snapping of rubber gloves as they’re removed by staff ending their shifts.

It’s another day at the intensive care ward at the Torrejón de Ardoz University Hospital, on the outskirts of the European capital that has so far seen the worst of the second wave of the pandemic. Still, hospital staff count themselves lucky: Despite having had to add nine intensive care beds to the usual 16, the hospital hasn’t had to postpone treatment for any other patients.

Many others in the region have.

Hospitals and their workers have been stretched to their limits again in Madrid, where the surging number of COVID-19 patients in September forced an expansion of critical care beds into gymnasiums and surgery rooms. But as the number of incoming patients started to ease last week, health professionals are dismayed at what they see as official acceptance of a situation that is far from normal.

“It can’t be that we fall into a dynamic of a virus wave followed by a lockdown, and then the next wave in winter and lockdown again in winter,” said Carlos Velayos, an intensivist who has seen a slight decrease in new patients with coronavirus-related symptoms arriving at his Fuenlabrada hospital, also in suburban Madrid.

At the peak of the first wave, ICU wards were given over to haste, desperation and even cluelessness about what to do. Now, a well-oiled machinery saves some lives and loses others to COVID-19, but without the doomsday atmosphere of March and April.


“It’s no longer like being in a war zone field hospital,” said Velayos. “But the reality is that we are working way over our normal capacity. This is a situation that is absolutely exceptional and that we shouldn’t have reached under any scenario.”

As many professionals are still coming to terms with the emotional impact of the first wave, they are now struggling to understand why Spain has not prepared better for new outbreaks of a virus that has left more than 825,000 infected in the country and at least 32,000 deaths.

Treatment has improved, although the time that COVID-19 patients spend under intensive care can still stretch for weeks or even months, taking up desperately-needed hospital resources, said Dr. María José García Navarro, medical director of the Torrejón de Ardoz University Hospital, where 49 patients are now being treated, 35 in normal beds and 14 in ICUs.

“We have learned to quickly identify the symptoms and what treatment to apply, which are the drugs that are useful and which aren’t, even if that narrowed down our options,” García Navarro said. Corticosteroids that were experimented with at the onset of the pandemic have now discarded on behalf of Remdesivir, the

New Zealand eliminates COVID-19 for a 2nd time; cases surge in Europe

Oct. 7 (UPI) — New Zealand on Wednesday announced it has eliminated local transmission of the coronavirus for a second time as cases surge in Europe.

New Zealand’s Health Minister Chris Hipkins said there were no more active community cases of COVID-19 in the country after the last patients had recovered from a recent outbreak of the virus.

“This is a big milestone,” he said. “New Zealanders have once again through their collective actions squashed the virus.”

Prime Minister Jacinda Ardern announced in early June that the archipelago Oceania nation had eliminated the virus, lifting the country from weeks of strict lockdown measures in doing so.

But after going more than 100 days without reporting local transmission of the virus, the country was placed back under lockdown in August as four new cases were confirmed among a single Auckland family with no known source of transmission.

In total, 186 community cases of COVID-19 — 179 of which were connected to the Auckland cluster — were diagnosed, but all of them have since been discharged from hospitals. The so-called Auckland cluster will be officially considered “closed” after two incubation periods have elapsed.

“While having stamped out COVID-19 in our community for the second time is a real achievement that New Zealanders should be proud of, there is an ongoing risk that further community cases will emerge in the future,” he said. “I urge New Zealanders to remain vigilant and to not let complacency creep in.”

New Zealand has been internationally lauded for its suppression of the coronavirus, having reported only 25 deaths and fewer than 1,600 confirmed cases of the virus that was first diagnosed in the country in late February.

On Wednesday, health officials reported three new imported cases in New Zealand, and they have been isolated in quarantine, lifting its total number of confirmed cases to 1,505 and 1,861 confirmed and probable cases.

Auckland, which has been under Alert Level 2 lockdown since August, will move to the less restrictive Alert Level 1 at 11:59 p.m. Wednesday.

In Europe, however, cases have been surging since Septemeber.

On Wednesday, health officials in the Czech Republic announced a record high 4,457 cases, trumping its previous high of 3,796 infections diagnosed late last week.

The central European country has been battling skyrocketing cases since late August, lifting its total number of infections to 90,022, nearly half of which were still active by Wednesday morning.

The Czech Republic also recorded a record high of 36 deaths in the last 24 hours for a total of 794.

A state of emergency went into effect on Monday that will last at least 30 days, enforcing strict social distancing, closing secondary schools where clusters are reported and banning spectators from sporting events, among other actions.

According to the European Center for Disease Prevention and Control, 27 European nations, including the Czech Republic, have experienced high levels or sustained increases in 14-day COVID-19 case rates compared to the previous week.

Europe over Tuesday added more than 82,000

Battered by 1st wave, Madrid hospital staff blench at 2nd

Hospitals and their workers have been stretched to their limits again in Madrid, where the surging number of COVID-19 patients in September forced an expansion of critical care beds into gymnasiums and surgery rooms

TORREJÓN DE ARDOZ, Spain — With speed and determination, nurses, doctors and caretakers move in and out of glassed rooms with beds hooked up to tubes, cables and monitors. The cadence of beeps serves as a soundtrack to their workday, underpinned by a constant chatter of voices at half pitch and the snapping of rubber gloves as they’re removed by staff ending their shifts.

It’s another day at the intensive care ward at the Torrejón de Ardoz University Hospital, on the outskirts of the European capital that has so far seen the worst of the second wave of the pandemic. Still, hospital staff count themselves lucky: Despite having had to add nine intensive care beds to the usual 16, the hospital hasn’t had to postpone treatment for any other patients.

Many others in the region have.

At the peak of the first wave, ICU wards were given over to haste, desperation and even cluelessness about what to do. Now, a well-oiled machinery saves some lives and loses others to COVID-19, but without the doomsday atmosphere of March and April.

“It’s no longer like being in a war zone field hospital,” said Velayos. “But the reality is that we are working way over our normal capacity. This is a situation that is absolutely exceptional and that we shouldn’t have reached under any scenario.”

Treatment has improved, although the time that COVID-19 patients spend under intensive care can still stretch for weeks or even months, taking up desperately-needed hospital resources, said Dr. María José García Navarro, medical director of the Torrejón de Ardoz University Hospital, where 49 patients are now being treated, 35

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

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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

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Mark Farrah Associates Assessed 2nd Quarter Health Insurance Enrollment Trends

Mark Farrah Associates (MFA), www.markfarrah.com, released a mid-year 2020 health insurance segment enrollment update. Based on membership data filed with statutory financial reports from the NAIC (National Association of Insurance Commissioners), the CA DMHC (California Department of Managed Health Care), and data from MFA’s ASO estimates, insurance companies provided medical coverage for 274 million people, as of June 30, 2020. This number is up from 268.2 million or approximately 5.8 million members, from a year ago.

  • Second quarter enrollment trends indicated membership gains for Individual, Medicare Advantage (MA), Managed Medicaid, and Employer-Group ASO (administrative services only for self-funded plans) business, while the Employer-Group risk segment experienced a year-over-year decline.

  • Over 15.3 million people are currently enrolled in Individual, Non-Group medical plans, representing a 2.8% increase between 2Q19 and 2Q20.

  • Managed Care Organizations (MCOs) now provide coverage for approximately 52.8 million beneficiaries, representing 6% growth, year-over-year. According to CMS reports, nearly 73.5 million people rely on Medicaid as their source of health insurance coverage.

  • Second quarter membership in Medicare Advantage (MA) plans increased to over 24.8 million, from 22.2 million in the prior year.

To read the FREE full text of “Mid-Year Trends in Health Insurance Enrollment and Segment Performance“, visit the Analysis Briefs library on Mark Farrah Associates’ website.

About Mark Farrah Associates (MFA)

Mark Farrah Associates (MFA) is a leading data aggregator and publisher providing health plan market data and analysis tools for the healthcare industry. Our product portfolio includes Health Coverage Portal™, County Health Coverage™, 5500 Employer Health Plus, Medicare Business Online™, Medicare Benefits Analyzer™, and Health Plans USA™. For more information about these products, refer to the informational videos and brochures available under the Our Products section of the website or call 724-338-4100. MFA will continue to monitor enrollment changes and competitive shifts across all healthcare segments.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201006005781/en/

Contacts

Mark Farrah Associates
Ann Marie Wolfe, [email protected]

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