Remdesivir and interferon fall flat in WHO’s megastudy of COVID-19 treatments – Science Magazine

Remdesivir and interferon fall flat in WHO’s megastudy of COVID-19 treatments – Science Magazine

Halloween and COVID-19: Best activities, safety ranked – Grand Forks Herald

Halloween and COVID-19: Best activities, safety ranked – Grand Forks Herald

October 18, 2020

SIOUX FALLS, S.D. The COVID-19 pandemic has disrupted many of our social lives and upended our usual schedule of life events, including major changes to how we celebrate holidays.

But shouldn't Halloween, which by long tradition involves people wearing masks, be an easy one to navigate in the time of COVID-19? Not so much. In fact, Halloween comes with a unique set of challenges if you want to keep you and your family, friends and neighbors safe.

The Centers for Disease Control and Prevention recently released a set of guidelines for Halloween safety, ones echoed by state health departments, including the Minnesota Department of Health, which helpfully ranked activities according to risk.

The easiest set of general guidelines should be familiar ones:

Here are somes Halloween-specific things to do, some things to avoid, and a list of activities ranked by potential risk of catching or spreading COVID-19:

A good rule to follow even without COVID -- only pass out and accept wrapped candy. Pixabay


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Cytokine elevation in severe and critical COVID-19: a rapid systematic review, meta-analysis, and comparison with other inflammatory syndromes – The…
Words cannot describe: Family loses 3 of 5 members to COVID-19 within days – WSAV-TV

Words cannot describe: Family loses 3 of 5 members to COVID-19 within days – WSAV-TV

October 18, 2020

by: Kimberly Cheng and Sareen Habeshian and Nexstar Media Wire

RIVERSIDE COUNTY, Calif. (KTLA) A family of five from California lost three family members to COVID-19 within 10 days of one another.

John Albert Carrillo and his brother, Xavier Carrillo, laid their mother, father and sister to rest this week.

I lost three not just one, but three family members, John Carrillo said.

Johns father, 93-year-old John Carrillo Sr., died on Sept. 15; his sister, 65-year-old Letecia Chavez, on Sept. 23; and his mother, 90-year-old Sally Carrillo, on Sept. 24.

Xavier Carrillo was the first to catch the virus back in August and believes he got it from friends at work. It quickly spread to his family.

While Xavier recovered, members of his family were hospitalized and within weeks, they passed away.

John Carrillo says he wants people to remember his family by the lives they lived and not just as statistics.

The brothers say their father was an army veteran, the first Mexican American drafted out of Riverside to the Korean War. They described their mother as a generous woman who loved to cook. And their sister, who was a mother and a grandmother, worked for Riverside City College until retirement.

Words cannot describe my sister, John Carrillo said. Our leader, our backbone.

John Carrillo had bid farewell to his mother over the phone but was able to say goodbye to his dad in person.

I started crying and I told him, If you want to leave dad, its okay. Were all fine, he said in tears. That was it.

More than 218,000 Americans have died from the novel coronavirus since the beginning of the pandemic. On Friday, the U.S. surpassed 8 million confirmed cases.


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Words cannot describe: Family loses 3 of 5 members to COVID-19 within days - WSAV-TV
Albany Med Nurses speak-out with new COVID-19 resurgence plan – NEWS10 ABC

Albany Med Nurses speak-out with new COVID-19 resurgence plan – NEWS10 ABC

October 18, 2020

ALBANY, N.Y (NEWS10) Albany Medical Center Nurses sounded the alarm about PPE and protocol problems at the hospital on Sunday. They outlined steps that the hospital should take to protect the communitys help.

Albany Med Nurses, community supporters, including Reverend Peter Cook, New York State Council of Churches, United Church of Christ, Dr. Brenda Robinson, Black Nurses Coalition and the Capital District Labor Federation gathered in front of the hospital highlighting the continued lack of preparation and safety protocols at Albany Med.

Nurses say after 7 months they are speaking out about PPE being reused and the need for greater transparency from Albany Med leadership.

Dr. Brenda Robison says the time is now to make these changes for the nurses.

Albany Med has an obligation to keep patients and our nurses safe by providing PPE. When nurses and other staff come to work to care for their patients it should not be a game of hide the medical masks. I want to stress that disposal means disposal, and single use means single use, said she.

On Sunday, they released a 5-step COVID Resurgence Plan to ensure the safety and health of staff, patients and the community.

The plan includes environmental controls that will save lives. Nurses want all postiive COVID-19 patients to bee in separate units and all patients must be tested upon entering the facility.

The nurses want to take steps to COVID from spreading outside the hospitals doors. They are demanding the need for the highest PPE standards in the US. Nurses say their staffing rations and levels must be restored now. They are asking for complete transparency and collaboration with the Albany Med leadership.

Albany Med Leadership sent this statement to News10 regarding Sundays speak-out.

The health and safety of our patients, students and staff remain Albany Meds top priorities. We continue adhering to guidance from the Centers for Disease Control and Prevention regarding all safety measures, and we do so in close collaboration with our colleagues. We are prepared to care for all members of our community regardless of their needs, as we have been since the start of the pandemic, as we have done for 181 years.


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Albany Med Nurses speak-out with new COVID-19 resurgence plan - NEWS10 ABC
White House Touts Document Calling for Herd-Immunity Approach to Covid-19 Crisis – The Wall Street Journal

White House Touts Document Calling for Herd-Immunity Approach to Covid-19 Crisis – The Wall Street Journal

October 18, 2020

A group of scientists is pushing back on renewed calls for a herd-immunity approach to Covid-19, calling the method of managing viral outbreaks dangerous and unsupported by scientific evidence.

Eighty doctors and public-health and medical researchers called the herd-immunity approach a dangerous fallacy in a letter published Wednesday in the Lancet. The researchers noted that it is still unknown how long recovered patients might be immune from the virus. Since the letter was published, more than 2,000 others have signed...


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Baltimore Ravens place Brandon Williams on reserve/COVID-19 list – ESPN

Baltimore Ravens place Brandon Williams on reserve/COVID-19 list – ESPN

October 18, 2020

OWINGS MILLS, Md. -- Baltimore Ravens starting nose tackle Brandon Williams was placed on the reserve/COVID-19 list on Saturday.

Williams was placed on the list after coming in close contact with someone who has COVID-19, a source confirmed to ESPN. He did not test positive, the source said. Per NFL/NFLPA protocol, Williams must isolate for five days after the initial exposure.

The Ravens, who made the trip to Philadelphia on Saturday afternoon, are now expected to be without two starting defensive linemen for Sunday's game against the Eagles. Defensive end Derek Wolfe (neck/concussion) is listed as doubtful.

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Williams has been a key figure in the Ravens' run defense. With him in the lineup since 2017 (47 games), Baltimore has held teams to 87.2 yards rushing per game and 3.9 yards per carry. In six games without Williams over that span, the Ravens have given up 160.3 yards rushing per game and 4.6 yards per carry.

Williams did not practice Thursday and Friday for non-injury related reasons. After Friday's practice, coach John Harbaugh said Williams had "a personal excused absence."

On Thursday and Friday, Ravens players were spotted wearing masks while walking out to the practice field, which is not something they previously did.

When asked a little over two weeks ago about what it will take to avoid COVID-19, Williams said: "Do as much as you possibly can to protect you and the family and the people that you love. Sometimes if you catch it, you catch it. Sometimes, it just is what it is and it's inevitable."

Justin Ellis is expected to replace Williams and make his first start since 2018. Jihad Ward or Justin Madubuike could fill in for Wolfe.

Williams becomes only the second Ravens player to be put on the reserve/COVID-19 list and the first since training camp officially started.

The Ravens' defense currently leads the NFL in fewest points allowed, giving up 15.2 points per game.


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New COVID-19 Vaccine Targeting Both B and T Cells – Contagionlive.com

New COVID-19 Vaccine Targeting Both B and T Cells – Contagionlive.com

October 18, 2020

Covaxx has developed its investigational vaccine and is currently in a phase 1/2 trial.

While it typically takes several years for a vaccine to be developed and approved, Covaxx Co-CEO Mei Mei Hu says with the rise of COVID-19, the pace of development has sped up tremendously.

Hu has worked in the past on animal vaccines and oversaw the launch of one of the first endobody vaccines in the world.

Her current company, Covaxx, is a Hauppauge, NY-based spinout of the UBI group of companies founded in 1985. UBI and its healthcare subsidiaries have been involved in antibody diagnostics and vaccine development and manufacturing for chronic and infectious diseases for more than 30 years.

They have developed a unique platform using a multi-antigen peptide approach to create their investigational COVID-19 vaccine, UB-612. With it, this becomes the first multitope peptide-based vaccine activating both B and T cells.

UB-612 has shown immunogenicity and a robust antibody response. During in vitro testing, antibodies have bound the target COVID-19 spike protein antigen, blocked binding to the hACE2 receptor, and neutralized the virus from replication.

Previously, the platform has been used to develop a vaccine for hand, foot and mouth disease, and was shown to be safe and well tolerated in 4 human clinical trials.

For UB-612, Covaxx began a phase 1 study in Taiwan back in August, and is planning a phase 1/2 study in the US this fall.

Hu spoke to Contagion about vaccine safety, provided some insider insights about vaccine development and manufacturing, and discussed their COVID-19 investigational vaccine.


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COVID-19 vaccine will take a year or more to distribute to all Kentuckians, official says – Courier Journal

COVID-19 vaccine will take a year or more to distribute to all Kentuckians, official says – Courier Journal

October 18, 2020

Kentucky is expecting to receive its first federal shipment ofthe COVID-19 vaccine in in late 2020 or early 2021 but it will likely take a year or more to get that vaccine to the Bluegrass State's 4.4 million residents, the commissioner of the state's Department for Public Health said Friday.

Dr. Steven Stack announced that Kentucky submitted an initial comprehensive draft to theCenters for Disease Control and Prevention Friday on how the state plans todistribute the COVID-19 vaccine to local health departments and health care organizations.

The first phase of the plan will help ensure those most at risk certain health care workers and first responders have access to the vaccination, Stack said. The plan will accommodate vaccinating these essential workers in every county across the commonwealth.

Whenever the vaccine is approved, supplies will be "limited at first," which is why the commonwealth will have a phased approach to distributing the vaccine, Stack said.

The vaccine will be shipped to Kentucky from the U.S. Department of Health and Human Services and the U.S. Department of Defense when it becomes available.

'An unbelievable chain of oppression': America's history of racism was a preexisting condition for COVID-19

Kentucky Gov. Andy Beshear said the federal government provided a plan for how states should distribute the vaccine once it becomes available, and that Kentucky's plan "closely mimics their recommendation."

Protecting the health and lives of our Kentucky families remains our top priority as we battle COVID-19 and as vaccines arrive," Beshear said.

As of Saturday afternoon, close to 87,000 Kentuckians have been diagnosed with COVID-19 since the onset of the pandemic in March. The deadly virus has claimed the lives of 1,312people in the Bluegrass State.

Eric Friedlander,secretary of the Kentucky Cabinet for Health and Family Services, said in a statement that it is imperative for Kentuckians to get the COVID-19 vaccine as well as all other recommended vaccines.

"Vaccines are the best way we have to prevent infectious disease," Friedlander said. "A successful immunization program depends on the cooperation of every person.

State officials are continuing to encourage everyone toobserve social distancing, weara mask and practicehand hygiene.

A full copy of Kentucky's COVID-19 vaccine distribution plan is posted toto kycovid19.ky.gov. You can read it here.

Contact Ben Tobin at bjtobin@gannett.comand502-377-5675 or follow on Twitter @Ben__Tobin.

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Bioethics in Practice: The Bioethics of Developing a COVID-19 Vaccine  From Vaccine Trials to Distribution – The Commentator

Bioethics in Practice: The Bioethics of Developing a COVID-19 Vaccine From Vaccine Trials to Distribution – The Commentator

October 18, 2020

As the novel coronavirus, SARS-CoV-2, continues to rapidly spread around the globe, scientists and researchers have been rushing to develop a vaccine to halt this deadly pandemic. With over 38 million cases and one million deaths worldwide, the need to create a safe and effective coronavirus vaccine as quickly as possible is of utmost importance. While vaccines ordinarily take 10 to 15 years to develop and bring to market, researchers hope to have this vaccine ready for distribution in far less time than any vaccine previously made. However, under the pressure to create this extremely complex vaccine in such a short time span, it is important not to lose sight of the numerous bioethical challenges researchers must overcome in creating this vaccine.

Developing a vaccine is a complex process which is made up of a series of carefully planned stages. Of these stages, perhaps the most significant is the clinical development stage, where three recurring phases of vaccine trials on human subjects of increasing sample size are conducted. Due to the large number and diversity of individuals affected by COVID-19, one of the greatest bioethical challenges to be overcome in vaccine trials is making sure that individuals of all ages, genders and ethnicities are properly represented among vaccine trial participants. This strong need for diversity in the vaccine trial samples is vital in ultimately ensuring that the vaccine will be effective in vaccinating the maximum number of individuals across all demographics. Yet, despite the numerous federal guidelines in place to establish diversity in vaccine trials, recent studies suggest that many of the coronavirus vaccine candidates currently in development lack this necessary diversity.

The population most at risk for complications and death by COVID-19 are elderly individuals, with those above the age of 65 comprising over 80% of COVID-19 deaths. And yet, numerous studies suggest that COVID-19 vaccine trials lack an adequate representation of elderly participants. One such study published in JAMA Internal Medicine on Sept. 28, 2020, found that elderly people were excluded from more than 50% of COVID-19 clinical trials and 100% of vaccine trials. One possible explanation for the exclusion of elderly study participants could be that their inclusion in coronavirus vaccine trials is itself a controversial bioethical issue, with many arguing that elderly individuals should not be included due to the increased health risks they may face from participating in these trials. However, others contend that the inclusion of healthy elderly individuals in these trials is necessary to ensure that the vaccine will be effective in this more vulnerable population.

In addition to a lack of elderly participants in COVID-19 vaccine trials, studies also suggest that there is insufficient representation of ethnic minorities in many vaccine trials in the United States. According to the CDC, Hispanic and Black Americans comprise a disproportionately large number of COVID-19 cases and are nearly twice as likely to die from COVID-19 complications than their white, non-Hispanic American counterparts. Despite this, many vaccine trials failed to obtain a representative sample of these minorities, particularly in the earlier vaccine trial phases of many of the vaccine candidates currently under development.

Ensuring that the sample of participants tested in COVID-19 vaccine trials accurately represents the population of individuals affected by COVID-19 is a highly significant bioethical issue, as having this diversity in vaccine trials ensures that all individuals affected by this virus, regardless of demographics, can look forward to equal benefits from this vaccine. Fortunately, measures are being taken to improve the diversity of COVID-19 vaccine trials going forward.

Equity in the development of a vaccine for COVID-19 is one bioethical concern; equity in the distribution of that vaccine is of equal importance. Once a COVID-19 vaccine is deemed safe and effective, the vaccine will need to be distributed on both a national and international level. On a national level, due to the limited number of vaccines that can be produced at a time, some groups of people will be prioritized in receiving the vaccine over others. The CDC recently released its plan for COVID-19 vaccine distribution, stating that first responders, health care workers, those with underlying health conditions, elderly individuals and essential workers will be prioritized in vaccine distribution. This decision on which populations to prioritize is a delicate bioethical issue, with the ultimate goal being to maximize the number of lives saved.

On an international level of vaccine distribution, perhaps the most significant bioethical challenge to be dealt with will be ensuring equal access to COVID-19 vaccines by all individuals, regardless of demographics, such as socioeconomic status or geographic location. There are currently several existing proposals on how to ethically distribute COVID-19 vaccines globally, all of which seek to establish a system through which individuals in poorer, less developed countries will have equal access to vaccines, though the majority of these proposals tend to inadvertently prioritize wealthier, more developed countries.

Developing and distributing a COVID-19 vaccine will involve overcoming a multitude of unique and complex bioethical challenges, from making sure that COVID-19 vaccine trials contain samples representative of the large, diverse populations of individuals affected by COVID-19, to ensuring that COVID-19 vaccines are allocated fairly and equitably to individuals of all demographics. COVID-19 has united individuals of all ages, ethnicities, and socioeconomic statuses across the globe through mutual feelings of fear, grief, and uncertainty; we can only hope that all of these individuals around the world will have an equal opportunity to once again be united, but this time, finding solidarity in the mutual feelings of hope and relief that an ethically designed and fairly distributed COVID-19 vaccine will bring.

Photo Caption: Scientists and researchers have been rushing to develop a vaccine to halt this deadly pandemic.Photo Credit: Pixabay


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Once a COVID-19 vaccine is ready for prime time, how will people get it? – Crain’s Detroit Business

Once a COVID-19 vaccine is ready for prime time, how will people get it? – Crain’s Detroit Business

October 18, 2020

Four COVID-19 vaccines have begun Phase 3 human clinical trials in the U.S. and a fifth is expected to be announced this month by Novavax. Two coronavirus vaccines are under development by Pfizer at the Michigan Center for Medical Research in Rochester and by Moderna at Henry Ford Health System in Detroit.

Johnson & Johnson/Janssen and AstraZeneca clinical trials, which had been underway at the University of Michigan, have been paused in the U.S. over safety concerns. The AstraZeneca trial has been paused for more than a month after two people became sick. The J&J trial was paused last week when one person came down with an unexplained illness.

Still, the CEOs of Pfizer and Moderna say their vaccines could be mass produced on a limited scale by the end of the year. The other drug makers say their vaccines are showing promise, but some experts believe mass production is more than six months away.

Pfizer's mRNA-based vaccine now requires ultra cold storage of -70 degree Celsius, rendering administration by doctor's offices, clinics and retail pharmacies virtually impossible.

Moderna's vaccine, also using the newer mRNA-based technology, currently requires -20 Celsius temperature, allowing for greater storage flexibility. The company also said its vaccine can be kept in normal vaccine refrigerators for up to seven days.

Novavax has said its vaccine can be stored at 2 to 8-degree Celsius temperatures in an unfrozen, liquid formulation that can be kept in a standard vaccine refrigerator. The Maryland-based drugmaker is taking a more traditional approach to vaccine development. It is using viral proteins rather than an mRNA genetic code approach to train the body against the coronavirus infection.

Merck and Sanofi, two veteran vaccine makers that got into the vaccine race this summer, are said to be close to beginning Phase 3 trials.

Once one or more vaccines are approved by the FDA, likely through an emergency use authorization, the companies will begin mass production.

Chaz Calitri, Pfizer's vice president of operations for sterile injections, said the drug company has been packaging the filled vaccine doses in Kalamazoo for its Phase 3 trial since earlier this year. More than 300 workers have been hired for the coronavirus vaccine effort, he said.

"If the vaccine is successful and we launch it, we expect to hire up to 700 people" in Kalamazoo, Calitri said. The plant has about 3,000 employees now.

Pfizer's COVID-19 clinical trials have been expanded to more than 44,000 people, including adding more minorities and teenagers and youth as young as age 12, officials said.

"What we will do is have the vials (of vaccine) packed in small pizza-shaped boxes and placed in a container packed in dry ice. It will be like a container in a container that will have a tracker," or a sensor that will monitor location and temperatures, Calitri said.

Doctors have asked Pfizer whether the company will develop a way to store the vaccines at temperatures greater than -70 degree Celsius. Pfizer said it was working on a plan to store its vaccines for up to 24 hours at standard refrigeration.

"They are still running tests to see if there can be less storage time and higher temperatures," Calitri said.

Another question is whether the vaccines will be a one-dose shot, like the proposed Johnson & Johnson/Janssen or Merck vaccines, or two-dose shots like the Pfizer, Moderna and others. Two doses will require careful tracking of people and appointment callbacks, similar to the vaccine for shingles.

Experts also are concerned that the hundreds of millions of vaccine doses will also require ramping up production of syringes and pharmaceutical-grade glass vials needed to transport and administer the vaccines. Operation Warp Speed has awarded major contracts to companies to build up inventories.

Julie Swann, a professor of industrial and systems engineering and department chair at North Carolina State University in Raleigh, said there are a number of logistical challenges in transporting and distributing COVID-19 vaccines, especially the Pfizer vaccine that appears the furthest along toward approval.

"It's not like the vaccines that you know, the seasonal flu vaccine that you might get at a Target or CVS, or your doctor's office. It's different than that," said Swann, who is a vaccine supply chain expert. "It has it has much greater perishability and needs to be kept at a much colder temperature. There's also going to need to be supplies of dry ice through the supply chain."

The Pfizer vaccine, for example, needs to be shipped in containers with dry ice that hold 975 doses.

"So you're going to send this specialized box of 1,000 doses to a hospital and you're only allowed to open it once a day because it will be frozen and you have to take out enough for those people," Swann said.

Vaccines with smaller doses per box, such as Moderna's, which is planned to be released with orders of 100 doses, can be shipped to physician offices, clinics and retail pharmacies, Swanson said.

"If it happens to be the Pfizer vaccine, with the ultra-cold requirements, it is likely to be shipped directly from the drug company to the hospital or large clinic," Swanson said.

CVS Health spokesman Mike DeAngelis said its Minute Clinic sites are well-positioned to administer COVID-19 vaccines.

"We look forward to playing a significant role in the vaccine distribution process, and our experience of providing millions of flu vaccinations each year is helping inform our plans," DeAngelis said in an email.

Most pharmacies and doctor offices have regular freezers and would only be able to store vaccines with lower temperature requirements for short periods of time.


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