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The Pfizer-BioNTech vaccine explained: Whats in it and how does it work – KELOLAND.com

Posted: October 16, 2021 at 2:11 am

SIOUX FALLS, S.D. (KELO) Since the start of the COVID-19 pandemic, the world has seen remarkable strides made in the swift development of safe and effective vaccines to protect against the illness. At the time of writing one of these vaccines, the Pfizer-BioNTech vaccine, has been granted FDA approval for those age 16 and older.

However, questions and concerns still swirl around the vaccine, including what it contains, who made it and the outcomes that can result from its use. KELOLAND News gathered the facts to lay out the answers to these questions.

Who makes the Pfizer-BioNTech vaccine?

The Pfizer-BioNTech vaccine is manufactured by Pfizer, Inc., and BioNTech.

Pfizer is a multinational pharmaceutical and biotechnology company that produces products such as Xanax, Robitussin, Advil and Viagra.

BioNTech is a German biotech and immunotherapy company that had pioneered tech using messenger RNA (more on this later) joined with Pfizer in 2018 to jointly develop an mRNA-based flu vaccine prior to the onset of the COVID-19 pandemic.

According to their website, BioNTechs collaboration with Pfizer allowed them to utilize Pfizers broad expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network while BioNTech and its partners provided a clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.

Pfizer-BioNTech/COMIRNATY

Some confusion has been caused by the appearance of the vaccine marketed as COMIRNATY, which has led some to claim that the Pfizer-BioNTech vaccine has not been granted FDA approval. This is false. The vaccine received FDA approval on August 23, 2021, for individuals 16 years of age and older.

The confusion appears to stem from the fact that once FDA approval has been granted, companies are then allowed to market the vaccines under brand names. COMIRNATY is the brand name for the Pfizer-BioNTech COVID-19 Vaccine.

Due to the fact that the vaccine has only received full authorization for those aged 16 and up, the name Pfizer-BioNTech will still be used for those in the 12-15 year age range. While the names are different, the makeup of the vaccines is identical, and no change has been made.

The name Pfizer-BioNTech will be used for the remainder of this article.

What is the Pfizer-BioNTech vaccine?

The Pfizer-BioNTech vaccine is an mRNA vaccine. What this means is that as opposed to many other vaccines which insert a weakened or inactive germ/virus into our bodies, mRNA COVID-19 vaccines contain no actual sample of the COVID-19 virus.

Instead, mRNA in the vaccine functions as an instructional guide for bodies cells to create a harmless piece of the spike protein that the COVID-19 virus uses to enter our cells. According to the CDC, once the cells produce the spike protein, the messenger RNA is no longer needed and is broken down by the cell. It is important to note that while RNA (ribonucleic acid) is similar to DNA (deoxyribonucleic acid), mRNA does not enter the nucleus of our cells where our DNA is stored. This means that the mRNA does not affect and cannot change our genetic material.

Following the creation of this dummy spike protein, the cell displays the spike on its surface, allowing it to be noticed by our immune system, which then begins building an immune response and producing antibodies, just as it would in the event of an exposure to the actual COVID-19 virus, but without the risk of actually catching the virus.

While mRNA vaccines are a new technology, the research on it goes back decades. According to Johns Hopkins University, mRNA was discovered in the 1960s and research into its application to human cells was developed in the 1970s.

One of the biggest barriers to the application of mRNA in the early years of study was the speed with which it is broken down by the human body, leading to its destruction before it ever had the chance to deliver to the cells the info which it was carrying.

The solution to this problem came from advances in nanotechnology: the development of fatty droplets (lipid nanoparticles) that wrapped the mRNA like a bubble, which allowed entry into the cells.

Johns Hopkins states that the first use of mRNA vaccines using this method of delivery was developed to counter the Ebola virus, but due since the virus was only found in a handful of African countries, the vaccine had no commercial development in the U.S., where only four patients were ever diagnosed with the illness.

The CDC notes that mRNA vaccines have also been studied for flu, Zika, rabies, and cytomegalovirus. They also report that cancer research has used mRNA to trigger the immune system to target specific cancer cells.

What ingredients are in the vaccine?

mRNA:

Lipids: Lipids are fatty, waxy or oily compounds that are able to be dissolved in organic solvents such as those found in the body. According to the Connecticut Department of Public Health (CDPH), lipids protect the mRNA and provide a greasy exterior that helps the mRNA slide inside cells.

Salts, sugars and buffers: The CDPH explains that salts, sugars and other buffers are used in the vaccine to help balance acidity in the body and to assist the molecules in keeping their shape while frozen for storage and transportation. Sodium chloride is basic table salt, while Sucrose is just sugar.

You can view a full list of the ingredients in all three vaccines authorized for use in the U.S. here.

The Pfizer-BioNTech vaccine does not contain eggs, preservatives, latex or metals of any kind.

How effective is the vaccine?

According to the CDC, based on evidence from clinical trials in people 16 years and older, the Pfizer-BioNTech vaccine was 95% effective at preventing laboratory-confirmed infection with the virus that causes COVID-19 in people who received two doses and had no evidence of being previously infected.

The vaccine has also been highly effective in the prevention of COVID-19 infection in adolescents 1215 years old, and the immune response in people 1215 years old was at least as strong as the immune response in people 1625 years old.

What are the known side effects?

Possible side effects of the vaccine include pain, redness and swelling at the site of the injection. Tiredness, headaches, muscle pain, chills, fever and nausea have all been reported as well. These side effects are not signs of illness caused by the vaccine, but rather the effect of our bodies immune systems reacting to the spike protein and working to build an immune response.

Side effects generally can be expected within the first two days after vaccination, and generally, go away within a few days.

Adverse effects to the vaccine

Serious adverse effects to the Pfizer-BioNTech vaccine are rare, but possible. The CDC gathers reports of adverse events through its Vaccine Adverse Event Reporting System (VAERS).

Anaphylaxis: Anaphylaxis is a severe allergic reaction leading to skin rash, nausea, vomiting, difficulty breathing, and shock. It can be fatal. Anaphylaxis following COVID-19 vaccination is rare, and according to CDC data has occurred in around 2-5 people per million vaccinated in the U.S. Severe allergic reactions of this sort can occur after any vaccination.

Thrombosis with thrombocytopenia syndrome (TTS): TTS is a rare syndrome in which the formation of blood clots combines with low blood platelet levels which can lead to long-term disability or death if not treated. The CDC and FDA have identified 47 confirmed reports of TTS in those who have received a dose of the J&J/Janssen COVID-19 vaccine, which has been administered to nearly 15 million Americans.

To date, there have been two reported cases of TTS in people who have received the Moderna vaccine, which has been administered to more than 376 million people in the U.S. So far, there do not appear to be any reports of TTS in those who have received the Pfizer-BioNTech vaccine in the U.S.

Myocarditis and pericarditis: Myocarditis isinflammation of the heart muscle, and pericarditis is inflammation of the outer lining of the heart. These conditions are rare following COVID-19 vaccination. As of Sept. 29, VAERS had received 1,590 reports of myocarditis or pericarditis among people ages 30 and younger who received the COVID-19 vaccine.

Most cases have been reported after mRNA COVID-19 vaccination (Pfizer-BioNTech or Moderna), particularly in male adolescents and young adults. Through follow-up, including medical record reviews, CDC and FDA have confirmed 906 reports of myocarditis or pericarditis.

It is not yet known whether there is a relationship between these instances of myocarditis and pericarditis and the COVID-19 vaccines, but the CDC says the matter is being investigated.

Death: More than 396 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through October 4, 2021, according to the CDC.

Through this time, VAERS received 8,390 reports of death (0.0021%) among people who had received a COVID-19 vaccine. It is extremely important to understand that these are reports of people who died and were also vaccinated, and not people who died because they were vaccinated.

Understanding VAERS data

The Vaccine Adverse Event Reporting System is an early warning system used to monitor adverse events that happen after vaccination. The purpose of the system is to allow vaccine safety experts to study any and all potential adverse effects of a vaccine. Due to this, when a health problem is reported to VAERS, it does not necessarily mean that the vaccine caused the problem.

The FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if its unclear whether the vaccine was the cause. Due to this, a person killed in a car crash who also happened to be vaccinated would be included in this statistic.

Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem.

The CDC states that a review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines.

It should also be noted that VAERS is not a closed system. Anyone can submit areport to VAERS, including patients, parents or caregivers, healthcare providers, and vaccine manufacturers.

Vaccine safety experts review all reports of serious adverse events submitted to VAERS, which include permanent disability, hospitalization or an extended hospital stay (if vaccinated while in the hospital), life-threatening illness, birth defects (congenital anomalies) and death.

When VAERS staffmembers follow-up on a report of a serious adverse event, they ask forthe patients medical recordsrelated to the event to learn more about what happened.

The CDC emphasizes that VAERS reports alone generally cannot be used to determine if a vaccine caused or contributed to an adverse event or illness.

Some reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. VAERS reports often lack contextual information, such as total vaccinations given or information on unvaccinated groups for comparison. Most reports to VAERS are voluntary, which means they may be subject to biases. Data from VAERS reports should always be interpreted with these limitations in mind.

Due to these factors, any claim citing VAERS data that attempts to state that the vaccine has resulted in thousands of deaths is inaccurate, misleading and unsubstantiated.

Black box warnings

Black box warnings are the strongest form of warning required by the FDA for prescription drugs, and are meant to alert patients and health care providers to increased risk of serious adverse reactions with a medication or restrictions to using the particular drug.

Courtney Feist, a Clinical Pharmacist for Lewis Drug explained to KELOLAND News via email that the Pfizer-BioNTech vaccine does not carry a black box warning. There are warnings/precautions, but not a specific black box warning, she said. Like I mentioned there are warnings and precautions with the Pfizer vaccine, which can be found in the patient and provider fact sheets thatare available.

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COVID SCIENCE-Coronavirus may have reached U.S. last December; some cancer therapies may prolong infectiousness – Reuters

Posted: December 3, 2020 at 2:57 am

Dec 2 (Reuters) - The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

New coronavirus may have reached the U.S. last December

The new coronavirus may have been circulating in the United States last December, well before the first COVID-19 case was diagnosed on Jan. 19, a new analysis of donated blood reveals. Researchers at the U.S. Centers for Disease Control and Prevention looked for COVID-19 antibodies in archived samples of blood donations collected by the American Red Cross from Dec. 13, 2019 to Jan. 17 from non-identifiable donors in nine states (California, Connecticut, Iowa, Massachusetts, Michigan, Oregon, Rhode Island, Washington, and Wisconsin). Of the 7,389 blood donors, 106 had antibodies specific to the new virus. There were samples found with COVID-19 antibodies from all nine states, according to a report of the study published on Tuesday in Clinical Infectious Diseases. The findings suggest the virus may have been present in western states as early as Dec. 13 and in eastern states as early as Dec. 30, according to a press statement from Dr. Susan Stramer, vice president of Scientific Affairs at the American Red Cross. It is not possible from these findings to determine whether these potential early COVID-19 infections were due to community spread or were travel related, she said. (bit.ly/33C401l)

Some cancer therapies may prolong COVID-19 infectiousness

COVID-19 patients who received cancer treatments that suppress their immune system may remain contagious and able to spread the coronavirus for two months or more, according to a study published on Tuesday in The New England Journal of Medicine. The U.S. Centers for Disease Control and Prevention (CDC) currently recommends that COVID-19 patients with compromised immune systems be isolated for up to 20 days after symptoms appear. In the new study, researchers analyzed sputum and swab samples from 20 immunosuppressed cancer patients infected with the new coronavirus. They found that three were contagious for more than three weeks after their symptoms began, including one who remained contagious for 61 days. The three patients had received either a stem-cell transplant or therapy with genetically engineered immune cells called CAR T-cells within the previous six months. Current public health recommendations for COVID-19 patients with weak immune systems are based on limited data and may need to be revised, the researchers said. While only a small proportion of cancer patients with COVID-19 are likely to remain contagious for prolonged periods, "it's a residual risk that we need to address," said coauthor Mini Kamboj from Memorial Sloan Kettering Cancer Center. "We need to keep an open mind about how (much) longer immunocompromised patients could pose an infection risk to others." (bit.ly/3lsx6Gv)

Lingering pain after COVID-19 may be nerve injuries

Patients with lingering pain after COVID-19 may have nerve injuries, according to a report published on Tuesday in Radiology. The researchers said lingering pain in COVID-19 survivors can be due to nerve dysfunction caused by the virus itself or it may be a side effect of treatment received in the hospital. These could include nerve issues arising from being positioned in a way that helped the lungs recover but put pressure on other body parts, or from pressure on a nerve from blood that pooled after blood clot prevention. High-tech imaging methods like magnetic resonance and ultra high-resolution ultrasound can help identify the location and extent of nerve damage, the researchers found when they reviewed earlier study reports. "Clinicians should (suspect nerve injury) in COVID patients who are left with chronic pain and weakness, particularly since early diagnosis and appropriate treatment is crucial to prevent irreversible damage," coauthor Dr. Swati Deshmukh of Northwestern University in Evanston, Illinois told Reuters. During the pandemic, Deshmukh added, when patients come in with unexplained new nerve and muscle symptoms, doctors should consider testing them for COVID-19. (bit.ly/37tP2LS)

Open tmsnrt.rs/3a5EyDh in an external browser for a Reuters graphic on vaccines and treatments in development.

Reporting by Nancy Lapid, Marilynn Larkin, and Manas Mishra; Editing by Bill Berkrot

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Yale New Haven Health Docs: Interpreting the Uptick in Covid-19 Cases – Greenwich Free Press

Posted: October 31, 2020 at 11:56 pm

At a press conference this week, doctors from Yale New Haven Health System gave a snapshot of the Covid-19 uptick in Connecticut.

On Tuesday the System had 90 inpatients, more than 3-1/2 times the number at the end of September.

In the past two weeks the System had seen a 50% increase from 64 on Oct 13th to 92 cases on Monday.

A month ago there were only two Covid patients in the Systems ICUs. On Tuesday there were 22 with eight on ventilators. That was after many days with no ventilated Covid-positive patients.

While the numbers represent an uptick, they are still well below the peak of 800 cases last spring.

But it doesnt feel very good, said CEO Marna Borgstron. People are tired. Tired of the pandemic. Tired of social distancing. Tired of wearing masks.

As of Tuesday, the 90 Covid-19 cases across the System were as follows:

51 at Yale New Haven Hospital 16 at Bridgeport Hospital 11 at Lawrence and Memorial Hospital in New London 5 at Greenwich Hospital 6 at Westerly Hospital.

Dr. Tom Balcezak, Chief Medical Officer for the System, and Yale New Haven Hospital Infectious Disease Specialist Dr. Onyema Ogbuagu, who is working on the Pfizer trial for a vaccination and is deeply involved in care for Covid-19 patients, talked about the recent uptick.

We didnt know that (mask wearing) worked in the first part of this pandemic, Balcezak said. There is now scientific certainty that mask wearing and social distancing does work.

How Bad Will It Get?

Balcezak said it was impossible to forecast numbers or predict when a peak might come.

He said a wastewater sampling model showed the Greenwich area was seeing some slow growth, and the hot spot area to watch was eastern Connecticut.

As for Thanksgiving and Halloween, Balcezak said, We all have families and desire to reconnect with out families and friends, but this is not the time to be doing that.

Implications for Flu Season

Balcezak said with the arrival of fall, there was the potential for a flu pandemic in addition to Covid-19. He urged residents to get flu shots to avoid a twindemic of flu and Covid-19.

Dr. Ogbuagu said there was concern about how the flu would mimic Covid-19.

Balcezak agreed, adding the challenge wold be to sort out flu patients from Covid patients, who need different therapies and cohorting.

Balcezak said the southern hemisphere foreshadows what might be in store for Connecticut.

It appears the southern hemisphere had a very light flu season this year, he said. But we need to do everything we can to lock that in. That means getting your flu shot this year. We dont need our emergency departments and doctors offices clogged with folks that have respiratory illness.

Vaccine Trial at Yale New Haven Hospital with Pfizer

Dr. Ogbuagu said there are 300 people in the trial in New Haven. The target number is 44,000, which they are approaching, as the trial is multinational.

Enrollment is going well. Up to 70% of participants have already received the second of two vaccines. (The second vaccine comes three weeks after the first.)

I think the earliest a vaccine would receive approval would be end of December or January 2021, at best, Dr. Ogbuagu said.

Its been incredible to watch the speed with which our science has moved with this pandemic, Balcezak said. Were already talking about novel therapeutics and hopefully will have a vaccine approved in the next couple of months.

Balcezak added that when the first vaccine becomes available, it might not be the best vaccine, and wont prevent the virus.

He explained when the Covid-19 virus enters the body through the respiratory system, the immunity will stop it replicating, but the vaccine will not prevent infection. It will prevent symptoms but vaccinated people could still be contagious.

We may have to wait for a vaccine that prevents infection, he said. Even if you have got the vaccine, you will still be infectious. Therefore, mask wearing will still be the standard.

Dr. Ogbuagu said the Pfizer trial has already gone through phases 1 and 2, and the phase 3 trials are advanced. The trials are randomized. Half the people receive the vaccine and the others receive a placebo.

Dr. Ogbuagu said the study has a diverse enrollment, and not only enrolls adults and elderly individuals, but also enrolls pediatric age participants from age 12 +, and immune-compromised patients including HIV patients. Over half the people enrolled in the trial identify as racial minorities.

Asked about the use of embryonic stem cells in some vaccine trials, Dr. Ogbuagu said that scenario was not unique to Covid vaccines.

There were vaccines long before Covid, like Rubella, which is German measles, and shingles vaccines, which have utilized human embryonic cells to advance development, he said.

Dr. Balcezak said it was important to note that these are tissues have been grown over many years.

They are involved in early development, he said. But for large scale mass production of these vaccines, theyre going to use traditional manufacturing methodologies that dont involve stem cells.

Why are Covid-19 Illnesses Less Severe than in the Spring?

Dr. Balcezak said much had been learned about treating Covid-19 patients.

Were more liberal with the use of steroids than we were early on, he said. And we have figured out what medications do not work.

Theres been a lot of negative studies whether it be Hydroxychloroquine, or Azithromycin weve stopped the utilization of those drugs, Balcezak said.

We continue to use Rendesivir, which seems to have a small benefit, at least in terms of length of hospitalization.

He said theyd also learned more about non therapeutic therapies.

Its putting patients on their bellies, or proning them. Its how you manage the ventilator and how you use oxygen and high flow oxygen, he said. Weve seen mortality rates fall substantially.

Balcezak cautioned, Doing better was far from perfect, and while the System is seeing a small number of deaths compared to the spring, theyd like to see the number fall to zero.

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Stem Cell Therapy Connecticut – Boston Stem Cell Center

Posted: October 24, 2020 at 8:59 pm

Physicians and researchers have studied stem cells as alternatives in curing joint injuries and musculoskeletal conditions naturally. Stem cells have regenerative properties that can be used for treating joint pain and injuries.

Today, your own stem cells can be used for treatments with the help of science and technology. This treatment is called stem cell therapy. We are now using this option to treat patients who want a fast and effective recovery.

At The Boston Stem Cell Center, we only treat orthopedic, joint, muscular, soft tissue, ligament and tendon disorders. Despite that, scientific organizations are praising the healing capabilities of stem cells. Many people in the scientific community believe that there is no extent to what stem cells could cure in the future. According to them, it may even cure diseases that may not have any formal treatment yet. Stem cells are important to a persons body due to their ability to regenerate and replace other cells.

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Buzzing to Rebuild Broken Bone: Its Electric! – UConn Today

Posted: July 2, 2020 at 7:43 pm

Healing broken bones could get easier with a device that provides both a scaffold for the bone to grow on and electrical stimulation to urge it forward, University of Connecticut engineers reported on June 27 in the Journal of Nano Energy.

Although minor bone breaks usually heal on their own, large fractures with shattered or missing chunks of bone are more difficult to repair. Applying a tiny electrical field to the site of the fracture to mimic the bodys natural electrical field helps the cells regenerate. But the medical devices that do this are usually bulky, rely on electrical wires or toxic batteries, require invasive removal surgery, and cant do much for serious injuries.

Now, a group of biomedical engineers from UConn have developed a scaffold of non-toxic polymer that also generates a controllable electrical field to encourage bone growth. The scaffold helps the body bridge large fractures. Although many scientists are exploring the use of scaffolding to encourage bone growth, pairing it with electrical stimulation is new.

The team demonstrated the device in mice with skull fractures.

The electrical voltage the scaffold generates is very small, just a few millivolts. And uniquely for this type of device, the voltage is generated via remotely-controlled ultrasound. The ultrasound vibrates the polymer scaffolding, which then creates an electrical field (materials that create electricity from vibration, or vice versa, are called piezoelectric.) To help heal a thigh fracture, for example, the polymer scaffold can be implanted across the broken bone. Later, the person with the broken bone can wave the ultrasound wand over their own thigh themselves. No need for batteries, and no need for invasive removal surgery once the bone is healed.

The electrical field relates to the natural signal generated by your body at the injury location. We can sustain that voltage, on demand and reversible, for however long is needed using ultrasound, says UConn biomedical engineer Thanh Nguyen. The piezoelectric polymer Nguyen and his colleagues use to build the scaffold is called poly(L-lactic acid), or PLLA. In addition to being non-toxic and piezoelectric, PLLA gradually dissolves in the body over time, disappearing as the new bone grows.

The electric field created by the piezoelectric PLLA scaffold seems to attract bone cells to the site of the fracture, and promote stem cells to evolve into bone cells. This technology can possibly be combined with other factors to facilitate regeneration of other tissues, like cartilage, muscles, or nerves, says Ritopa Das, a graduate student in Nguyen group and the first author of the published paper.

Currently, Nguyen and his colleagues are working to make the polymer more favorable to bone growth, so that it heals a large fracture more quickly. They are also trying to understand why electrical fields encourage bone growth at all. Bone itself is somewhat piezoelectric, generating a surface charge when the bone is stressed by everyday life activities. That surface charge encourages more bone to grow. But scientists dont know whether its because it helps cells stick to the surface of the bone, or whether it makes the cells themselves more active.

Once we understand the mechanism, we can devise a better way to improve the material and the whole approach of tissue stimulation, Nguyen says.

This work was supported by the National Institutes of Health.

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Connecticut governor seeks 3rd party review of nursing homes – Thehour.com

Posted: June 13, 2020 at 4:47 pm

Susan Haigh, Associated Press

HARTFORD, Conn. (AP) Gov. Ned Lamont on Monday ordered an independent, third-party review of how Connecticut's nursing homes and assisted living centers prepared for and responded to the coronavirus pandemic, noting the findings could be helpful if the state faces a second wave this fall.

The Democrat said proposals will soon be solicited from third-party experts. In the meantime, he expects to meet with state lawmakers to determine the full scope of the review, which will include input from the operators of the long-term care facilities, unions representing the workers, patients, health experts and others.

Obviously that was the tragic center for our state and the other 49 states, in terms of fatalities," said Lamont, referring to the nursing homes. If there's a chance that there could be a second surge later on this summer, more likely in the fall, we want to be ready.

Lamont said a strong outside group will be able to focus on things like infection protocols, adequate supplies of personal protective equipment and what nursing homes might look like in the long-term.

To date, there have been more than 2,500 resident deaths from COVID-19 in nursing homes across Connecticut, a number that represents more than 60% of the state's total deaths, which grew to 4,084 on Monday.

Connecticut took various steps to try and stem the spread of the cononavirus in nursing homes, including halting visitations, eventually testing all residents and creating so-called COVID-recovery facilities where COVID-positive patients discharged from the hospital and moved from other homes could recuperate.

Representatives of Connecticut's two nursing home associations said they support Lamont's call for an independent investigation, but recommended it take into account how guidance changed from the U.S. Centers for Disease Control, the inadequate supply of PPE, delays in testing, and the prevalence of COVID-19 in the communities where the nursing homes and assisted living facilities are located.

On Monday, a national group representing assisted living centers across the U.S. called for $5 billion in emergency federal assistance. Josh Geballe, Lamont's COO, said state officials are monitoring the needs of assisted living centers in Connecticut, but noted nursing homes have been more financially precarious, requiring state assistance.

For most people, the virus causes mild or moderate symptoms, such as fever and cough. For some, especially older adults and people with existing health problems, it can cause more severe illness or lead to death.

In other coronavirus news in Connecticut:

____

MORE BUSINESSES REOPENING

Lamont said about 95% of the state's economy will be reopened as of June 17, so long as Connecticut's infection numbers remain low. That's when lodging, outdoor amusement parks, libraries, tattoo parlors, nail salons, gyms, pools, bowling alleys, and movie theaters will be allowed to open at limited capacities. Certain smaller outdoor events will also be allowed.

A third reopening is planned in July. Lamont said that's when bars may reopen, as well as indoor events.

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INMATE SETTLEMENT

A settlement has been reached in a federal lawsuit that sought to better protect Connecticut prison inmates from the coronavirus. Announced over the weekend, it requires the Department of Correction to prioritize elderly and medically vulnerable prisoners who qualify for early release programs.

It also requires the department to provide prisoners better access to antiseptic cleaning supplies and allow those isolated after testing positive to have regular access to showers.

The American Civil Liberties Union of Connecticut had been seeking the widespread release of inmates, many of whom are housed in dormitory settings where social distancing is difficult. But the state had argued that a widespread release of inmates would jeopardize public safety.

The draft agreement notes the Department of Correction has begun the voluntary testing of all prisoners. It has also required the wearing of masks by staff and inmates outside their cells and has increased cleaning to limit spread of the disease.

The settlement must still be approved by a U.S. District Court judge.

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STATE CAMPGROUNDS REOPENING

The Department of Energy and Environmental Protection plans to reopen campgrounds for summer camping beginning July 8. Campers with recreational vehicles or RVs will be able to keep their reservations starting July 1. Anyone with reservations before those dates will be provided refunds.

New reservations for the season can be made online beginning July 20.

DEEP is hiring and training staff to clean bathrooms and other facilities to maintain standards required by health officials during the coronavirus pandemic. The agency has also obtained protective gear and made safety changes to camp office buildings.

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Associated Press Writer Pat Eaton-Robb contributed to this report.

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The Growing Prison Pandemic Wasn’t Inevitable, and It’s Not Too Late to Fight It – brennancenter.org

Posted: April 9, 2020 at 4:49 am

The Covid-19 outbreaksnow surgingthrough many of the nations prisons and jails werent just predictable, they were predicted. And not just by theprisoners themselvesand theirfamily membersinincreasingly desperate tonesoverthe past monthbut also by some sheriffs andjailersandcorrections officialsand theirunion representatives. And not just by those behind bars but bylawyersanddoctorsandcriminal justice advocatesand professors,hundreds of them, in every nook and cranny of the country, all of whom understood how dangerous and deadly the pandemic would be once itfound its wayinto cramped, dirty, overcrowded cells.

These personalcries for help,these warnings, thesepersonal essays from prisons, these reasoned arguments to release vulnerable prisoners especially those whose sentences are about to expire and those in pretrial detention accused of nonviolent offenses sounded everywhere. And they were all a variation of the same theme: that prisons and jailswere obvious breeding grounds for the virus, that it could not be contained behind bars, that theinevitable outbreakswouldnt just take or endanger the lives of prisoners but would kill prison staff and their extended families; in other words, that preventing the pandemic in prison would save lives on the outside.

To theireternal credit, some officials have heard the call anddone the right thing. Thousands of men and women were released fromprisonsand jailsover the past monthand many more should be released soon. But in too many other places,politiciansand prosecutors waitedfor the virus to enter their facilitiesbeforeacting to save prisoners. And in some places eventhe spread of the virusand its obvious threat to everyone in or near a prisonhasnt been enoughto convincesome officialsthat there aremore important public safety interestsat stake than continuing to imprison at-risk people in the name of justice.

Like so much else about Americas criminal justice systems, a prisoners fate amid the pandemic is an arbitrary affair, largely determined by jurisdiction. If you were released from confinement in the past month its largely because you happened to have an enlightened jailer,or compassionate judge, or broad-minded prosecutor, or because you had particularlyferocious advocatesfighting for you. Or maybe the laws of your state happened to have a little more ambiguity. Or maybe you had a governor willing to say, on the record, that public safety in these circumstances includes the idea of fewer prisoners.

Even still, there are no guarantees. Officials at the Cook County Jail in Illinois, for example, reduced their population by 16 percent in the last month to try to help bend the curve but still are suffering from a terrible outbreak. As of this weekend, nearly300 prisoners and staff have tested positivethere,nearly 4 percent of the entire states numberof confirmed cases. How much worse would the outbreak have been there had that 16 percent remained behind bars? How many fewer cases of the virus will stem from the social distancing these lucky men and women now can practice?

There is a growing outbreak, too, at the jail in Washington, DC, wherefour more prisoners were confirmed positiveover the weekend. There,as attorney Greg Lipper pointed out, lawyers for the Districts attorney general opposed the release of prisoners by arguing, incredibly, that they had not met their burden of proof. Although complete social distancing and isolation is not possible in DOC facilities,the lawyers wrote, plaintiffs have not shown that the risk posed by DOCs practices raises plaintiffs risk of exposure substantially over the risk experienced by the outside community. Fewer sentences in the annals of American law deserve more opprobrium than that one.

The federal response was equallytardyand tragic. As my colleagues at The Marshall Projectreported last week, the chief public health official at the Bureau of Prisons ordered a staff member at FCI Oakdale, in Louisiana, to return to work behind bars even though he had been exposed to those who had tested positive for Covid-19. Not only did this advice contradict the guidance offered by the Centers for Disease Control, it also came at a time when Justice Department officials were downplaying the potential consequences of a prison outbreak, with federal prosecutors going so far as to write briefsopposingreasonable release requests.

Today? At leasteight federal prisoners have died from Covid-19and over 300 other prisoners and staff have tested positive, and there is no way to tell how far the coronavirus has spread into the families of the prison guards and others who work there. FCI Oakdale is not alone. There isalso a COVID-19outbreak at the low-security federal prison in Danbury, Connecticut. The Justice Department waited until these outbreaks occurred andthenswiftly ordered the release of prisoners there. We will never know how many lives are lost, behind bars and beyond them,because of these inexcusable delays. Wedont even know for surethat the Bureau of Prisons will zealously implement the new plan.

These corrections officials and sheriffs and judges and prosecutors and legislators didnt have to wait until it was too lateto protect prisoners.But they waited anyway. They waited to release prisoners who had not been convicted. They waited to release prisoners who were slated for release within 60 or 90 days. They argued that elderly prisoners, if released, would start a crime wave. They argued that carrying out duly imposed sentences were more important than saving lives. They argued they had it all under control evenwhen the rest of usknew they didnt. And if theydidrelease some prisonersit was a paltry few. Far too few.

Its negligence at best,deliberate indifference at worst. Robert Ferguson, the author and professor, years ago described the reasons why America has always beenso spectacularly harsh in its treatment of prisoners. Never hasthat theory been proven more clearlythan it has been in the past month. Except the cruelty shown the prisoners who have been kept locked up as the virus spreads doesnt just end with them. It attaches to the staff who guard them, and to their families, their lawyers, and to everyone who interacts with them. All of these non-prisoners, as well as those behind bars, may soon suffer from the virus, a form of retributive justice neither retributive nor just.

The views expressed are the authors own and not necessarily those of the Brennan Center.

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Yiviva Announces Dosing of First Patient in Phase 2b Study of First-Line YIV-906 Plus Sorafenib Combination Therapy in the Treatment of Hepatocellular…

Posted: April 6, 2020 at 11:51 pm

- First-in-class oncology therapeutic candidate YIV-906 applies an integrative systems biology approach -- Global study to evaluate efficacy, safety, and quality of life in patients with hepatitis B-positive hepatocellular carcinoma -

NEW YORK and SHANGHAI, China, April 06, 2020 (GLOBE NEWSWIRE) -- Yiviva today announced that the first patient has been dosed in a Phase 2b study of YIV-906 in combination with sorafenib in the treatment of patients with hepatitis B-positive hepatocellular carcinoma (HCC). YIV-906 is a novel, proprietary therapeutic candidate based on molecular profiling of extracts identified from use in traditional botanical medicine. YIV-906 has demonstrated that it can potentiate the anti-tumor activity of sorafenib, enhance innate and adaptive immune function in the tumor microenvironment, protect cells of the gastrointestinal tract by reducing inflammation mediated by IL-6, NF-kappaB, COX2, iNOS, and accelerate regeneration of damaged gastrointestinal tissue by promoting progenitor and stem cell growth via the Wnt signaling pathway.

Patients and providers are eager to have evidence-based systemic treatment options for cancer, such as YIV-906, commented Edward Chu, M.D., Chief of the Division of Hematology and Oncology, Deputy Director at the UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine and senior advisor to Yiviva. YIV-906 applies a novel systems biology approach that has been shown in preclinical and preliminary clinical studies to enhance immune function in the tumor microenvironment and protect gastrointestinal tissue. Observations of the effects of YIV-906 in proof of concept clinical studies provide a compelling rationale for conducting this large global study in the first-line treatment setting. In addition, patients with hepatitis B-positive HCC represent a population with particularly limited treatment options where the YIV-906 approach could have a particularly significant impact on care.

The development of YIV-906 is a state-of-the-art approach using modern science, bioinformatics, and current GMP manufacturing to develop a precisely engineered botanical medicine, commented Yun Yen, M.D., Ph.D., Co-Global PI Coordinator of the YIV-906 study and former President of Taipei Medical University. The components of YIV-906 have been selected for their expected effects across multiple targets when administered as a complex mixture in combination. Given the major need for better treatments for patients with liver cancer, and the safety and efficacy profile of YIV-906 as seen to date, we look forward to the results of this global study. This could lead to new therapeutic strategies to treat cancer patients holistically.

The randomized, placebo-controlled Phase 2b study of YIV-906 is evaluating efficacy, safety, and quality of life in patients with hepatitis B-positive HCC. The clinical study is designed to enroll approximately 125 patients at 20 sites in the U.S., mainland China, Hong Kong, and Taiwan, including Memorial Sloan Kettering Cancer Center, Taipei Medical University, Queen Mary Hospital in Hong Kong and the China National Cancer Center in Beijing. Patients will be randomized 2:1 to either the study arm (YIV-906 plus sorafenib) or control arm (placebo plus sorafenib). The primary endpoint of the study is an evaluation of progression free survival. Secondary endpoints include safety and quality of life assessments and additional measures of clinical efficacy, including time to progression, overall survival, objective response rate and disease control rate. Change of quality of life will be assessed according to HCC18 and EORTC QLQ-C30 assessments. Additional information is available at https://clinicaltrials.gov/ct2/show/NCT04000737.

About YIV-906

YIV-906 (also PHY906 or KD018) is a therapeutic candidate comprised of a proprietary cGMP botanical extract of four herbs inspired by a traditional Chinese medicine formulation used for over a millennium. YIV-906 has the potential to be developed as a platform oncology therapeutic when administered in combination with chemotherapy, immunotherapy and radiation therapies, in multiple cancer indications. YIV-906 has been shown to enhance immune function in the tumor microenvironment (by polarizing M1 macrophages and activating T cells), protect the gastrointestinal tract (by inhibiting inflammation via IL-6, NF-kappa-B, COX2, and iNOS pathways) and promote intestinal tissue repair (by increasing activity and expression of components of the Wnt signaling pathway). YIV-906 has been observed to enhance the anti-tumor activity of sorafenib in preclinical models of hepatocellular carcinoma and has shown promise in preliminary clinical studies in liver, pancreatic, colorectal and rectal cancers. YIV-906 has been granted Orphan Drug designations from the U.S. Food and Drug Administration (FDA) for development of YIV-906 in the treatment of hepatocellular carcinoma and pancreatic cancer. Yiviva holds worldwide intellectual property for YIV-906 including 32 patents related to methods of use, manufacturing and quality control. YIV-906 is being developed for approval under the U.S. FDA Botanical Drug regulatory pathway.

About Yiviva

Yiviva is a clinical stage biotechnology company developing multi-target botanical therapeutics using a systems biology approach, focused on cancer, inflammatory and chronic diseases. The Yiviva STAR (signal transduction, activity and response) discovery platform accelerates the identification of botanical therapeutics that influence immune function, inflammatory responses, cell growth and metabolic functions and hormone activity. Yiviva applies patented, mechanism-based quality control linked to biological activity to satisfy established regulatory requirements for complex products. The company was launched with Yale University as a co-founder and co-founders include Yung-Chi Cheng, Ph.D., with teams in New York, New Haven, Connecticut and Shanghai. For further information, please visit https://yiviva.com.

Contact:Tel: +1 646-883-3906Email: hello@yiviva.com

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Stem cells that can grow new bone discovered by researchers – Drug Target Review

Posted: March 7, 2020 at 3:52 pm

A new population of stem cells that can generate bone has been revealed by researchers, which they say could have implications in regenerative medicine.

A population of stem cells with the ability to generate new bone has been newly discovered by a group of researchers at the University of Connecticut (UConn) School of Dental Medicine, US.

The researchers present a new population of cells that reside along the vascular channels that stretch across the bone and connect the inner and outer parts of the bone.

This is a new discovery of perivascular cells residing within the bone itself that can generate new bone forming cells, said lead investigator Dr Ivo Kalajzic. These cells likely regulate bone formation or participate in bone mass maintenance and repair.

Stem cells for bone have long been thought to be present within bone marrow and the outer surface of bone, serving as reserve cells that constantly generate new bone or participate in bone repair. Recent studies have described the existence of a network of vascular channels that helped distribute blood cells out of the bone marrow, but no research has proved the existence of cells within these channels that have the ability to form new bones.

In this study, Kalajzic and his team are the first to report the existence of these progenitor cells within cortical bone that can generate new bone-forming cells osteoblasts that can be used to help remodel a bone.

To reach this conclusion, the researchers observed the stem cells within an ex vivo bone transplantation model. These cells migrated out of the transplant and began to reconstruct the marrow cavity and form new bone.

While this study shows there is a population of cells that can help aid formation, more research needs to be done to determine the cells potential to regulate bone formation and resorption, say the scientists.

According to the authors of the study: we have identified and characterised a novel stromal lineagerestricted osteoprogenitor that is associated with transcortical vessels of long bones. Functionally, we have demonstrated that this population can migrate out of cortical bone channels, expand and differentiate into osteoblasts, therefore serving as a source of progenitors contributing to new bone formation.

The results are published inSTEM CELLS.

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University of Connecticut Reverses Prader-Willi Syndrome in Lab by Restoring Silent Genes – Gilmore Health News

Posted: January 5, 2020 at 4:33 am

Discovery by UConn Health Researchers Could Mean Much for Prader-Willi Syndrome Treatment

Stem cell researchers at the University of Connecticut Health Center (UConn Health) have made a discovery that may significantly improve the treatment of people with Prader-Willi syndrome.

A child with PraderWilli Syndrome

In research published in Human Molecular Genetics, scientists reported that they were able to reverse this genetic disorder in brain cells growing in the lab. They achieved this by turning on genes that are usually silent in patients.

Read Also: Cessation of HGH Therapy Leads to Increased Fat Mass in Adults with PWS

Prader-Willi syndrome is typically the result of certain genes losing their functions. It develops when there is a deletion of a section of a chromosome a baby inherits from his father.

The disorder occurs in around one of every 15,000 births. It is the leading genetic cause of life-threatening obesity and has no cure.

Prader-Willi syndrome is not due to a defective gene. It is rather the outcome of a healthy gene that refuses to perform its role having been silenced. The gene becomes silent if only the copy inherited from the mother is present in a child.

The UConn Health researchers got rid of a protein responsible for the silencing in this study. As a result, there was an improvement in Prader-Willi syndrome.

The scientists observed that a particular protein caused the gene to become silent. This compound referred to as ZNF274 also plays a part in blocking some other gene types from expressing themselves.

Read Also: University of Utah: Understanding Hibernation Mechanisms Could Help Overcome Obesity

However, the protein appears to work alone in the case of this genetic disorder. It often acts together with another protein to silence other types of genes.

To find a way around the silencing of the gene inherited from a mother, the UConn Health researchers got stem cells from some Prader-Willi patients. They then proceeded to delete the ZNF274 protein from the area of the DNA involved in this disorder.

After the deletion, the research team stimulated the stem cells to grow into neurons or nerve cells. The neurons grew as normal to the expectation of the scientists. Most importantly, they expressed the silent gene inherited from the mother.

This discovery provides a direction for future research aimed at finding a cure for this genetic disorder. Studies have mostly focused on finding a treatment for certain symptoms linked to it.

Read Also: A Vaccine Could Prevent Obesity, Crohns and Diabetes

Symptoms associated with Prader-Willi syndrome include increased appetite and obesity, which can pose a serious threat to health. Short stature and intellectual disability are among other possible signs.

Interventions that can help to control these unpleasant symptoms can make so much difference in the life of a patient.

According to the UConn Health researchers, there are some other questions yet to answer regarding this discovery. For instance, it is not yet clear whether this approach can achieve the same effect directly in human brain cells. There is also a need to find out if it will work only in embryos, among other things.

Maeva Langouet, one of the UConn Health researchers, said there was still a need to find out whether deleting ZNF274 could lead to unwanted effects.

The post-doctoral fellow did express the hope that their findings may prove helpful to children with Prader-Willi syndrome in the future.

https://academic.oup.com/hmg/article/27/3/505/4708236

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