Anaphylaxis – Parents Of Allergic Children http://parentsofallergicchildren.org/ Tue, 22 Nov 2022 21:36:00 +0000 en-US hourly 1 https://wordpress.org/?v=5.9.3 https://parentsofallergicchildren.org/wp-content/uploads/2021/06/icon-5.png Anaphylaxis – Parents Of Allergic Children http://parentsofallergicchildren.org/ 32 32 Blueprint Medicines Submits Supplemental New Drug Application to FDA for AYVAKIT® (avapritinib) for Treatment of Indolent Systemic Mastocytosis https://parentsofallergicchildren.org/blueprint-medicines-submits-supplemental-new-drug-application-to-fda-for-ayvakit-avapritinib-for-treatment-of-indolent-systemic-mastocytosis/ Tue, 22 Nov 2022 21:36:00 +0000 https://parentsofallergicchildren.org/blueprint-medicines-submits-supplemental-new-drug-application-to-fda-for-ayvakit-avapritinib-for-treatment-of-indolent-systemic-mastocytosis/ — Company to Present PIONEER Registration Trial Results at 2023 AAAA Annual Meeting — CAMBRIDGE, Mass., November 22, 2022 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC) today announced the submission of a Supplemental New Drug Application to the United States Food and Drug Administration (FDA) for AYVAKIT® (avapritinib) for the treatment adults with indolent systemic […]]]>

— Company to Present PIONEER Registration Trial Results at 2023 AAAA Annual Meeting —

CAMBRIDGE, Mass., November 22, 2022 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC) today announced the submission of a Supplemental New Drug Application to the United States Food and Drug Administration (FDA) for AYVAKIT® (avapritinib) for the treatment adults with indolent systemic mastocytosis (SM). AYVAKIT was designed to potently and selectively inhibit the KIT D816V mutant, the underlying cause of MS in approximately 95% of cases.

The submission includes data from the PIONEER registration trial, the largest randomized, placebo-controlled clinical study ever conducted in indolent SM. The FDA has granted Breakthrough Therapy Designation to AYVAKIT for the treatment of moderate to severe indolent SM.

“This regulatory submission for AYVAKIT marks an important step in addressing the medical needs of a large patient population with systemic mastocytosis, characterized by debilitating symptoms and a lifelong multi-organ disease burden,” said Becker Hewes, MD. , chief medical officer at Blueprint Medicines. “By targeting the primary driver of SM with AYVAKIT, we seek to transform treatment beyond symptom-focused therapy, alter the course of the disease, and ultimately make a meaningful difference in the Our filing with the FDA marks the first application for regulatory approval for the treatment of indolent SM, and we look forward to working closely with the agency to achieve our goal of bringing AYVAKIT to SM patients. indolent as quickly as possible.”

In addition, Blueprint Medicines today announced the acceptance of several abstracts highlighting registration data from the PIONEER trial for oral and poster presentation at the annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI), February 24-27, 2023. AAAAI plans to publish accepted abstracts on www.annualmeeting.aaaai.org on February 32023.

About AYVAKIT (avapritinib)

AYVAKIT (avapritinib) is an FDA-approved kinase inhibitor for the treatment of adults with advanced MS, including aggressive MS (ASM), MS with associated hematological neoplasm (SM-AHN), and mast cell leukemia ( MCL), and adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. For more information, visit AYVAKIT.com. This drug is approved in Europe (AYVAKYT®) for the treatment of adults with MSA, SM-AHN or MCL, after at least one systemic treatment, and adults with unresectable or metastatic GIST carrying the PDGFRA D842V mutation. Please click here to view the full US Prescribing Information for AYVAKIT, and click here to see the European Summary of Product Characteristics for AYVAKYT. AYVAKIT/AYVAKYT is not approved for the treatment of any other indication in the United States or Europe.

To learn more about ongoing or planned clinical trials, contact Blueprint Medicines at [email protected] or 1-888-BLU-PRNT (1-888-258-7768). Additional information is available at blueprintclinicaltrials.com Where clinicaltrials.gov.

About Systemic Mastocytosis

Systemic mastocytosis (MS) is a rare disease mainly caused by the KIT D816V mutation. The uncontrolled proliferation and activation of mast cells leads to chronic, severe, and often unpredictable symptoms in multiple organ systems. The vast majority of those affected have non-advanced (sluggish or smoldering) SM. A wide range of symptoms, including anaphylaxis, maculopapular rash, pruritus, diarrhea, brain fog, fatigue, and bone pain, frequently persist in patients with nonadvanced MS despite treatment with several symptom-based therapies. This disease burden can have a profound negative impact on quality of life. Patients often live in fear of severe and unexpected symptoms, have limited ability to work or perform daily activities, and self-isolate to protect themselves from unpredictable triggers. Currently, there are no approved therapies for the treatment of non-advanced MS.

A minority of patients have advanced SM, which encompasses a group of high-risk SM subtypes including ASM, SM-AHN, and MCL. In addition to symptoms of mast cell activation, advanced MS is associated with organ damage due to mast cell infiltration and poor survival.

About Blueprint Medications

Blueprint Medicines is a global precision therapy company inventing life-changing therapies for people with cancer and blood disorders. By applying a precise yet agile approach, we create drugs that selectively target genetic factors, with the goal of staying ahead through disease stages. Since 2011, we have leveraged our research platform, including our molecular targeting expertise and world-class drug design capabilities, to rapidly and reproducibly translate our scientific innovation into a wide range of approved precision therapies. and experimental studies aimed at treating hard-to-treat diseases. cancers and blood disorders. Today, we deliver our approved medicines to patients in the United States, Europe and other geographies ourselves or through our partners. In addition, we are globally advancing several programs for systemic mastocytosis, lung cancer, breast cancer and other genomically defined cancers, as well as cancer immunotherapy. For more information, visit www.BlueprintMedicines.com and follow us on Twitter (@BlueprintMeds) and LinkedIn.

Caution Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the submission of a Supplemental New Drug Application to the FDA for AYVAKIT for the treatment of indolent SM; plans and timing for presenting detailed data from the PIONEER trial of AYVAKIT in patients with non-advanced MS, and expectations regarding the potential benefits of AYVAKIT in the treatment of patients with non-advanced MS; statements regarding plans, strategies, timelines and expectations regarding interactions with the FDA and other regulatory authorities; statements regarding Blueprint Medicines’ current or future approved drugs and drug candidates’ plans and expectations; the potential benefits of any of Blueprint Medicines’ current or future approved drugs or drug candidates in treating patients; and the financial performance, strategy, objectives and planned milestones, business plans and direction of Blueprint Medicines. The words “aim”, “may”, “will”, “could”, “should”, “should”, “expect”, “plan”, “anticipate”, “intend”, ” believe”, “estimate”, “predict”, “project”, “potential”, “continue”, “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. ‘identification. All forward-looking statements contained in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and factors that may cause actual events or results to differ. differ materially from those expressed or implied by any forward-looking statement. statements contained in this press release, including, without limitation, the risks and uncertainties related to the impact of the COVID-19 pandemic on the business, operations, strategy, objectives and planned milestones of Blueprint Medicines, including Blueprint Medicines’ ongoing and planned research and discovery activities, ability to conduct ongoing and planned clinical trials, clinical delivery of current or future drug candidates, commercial delivery of current or future approved products, and launching, marketing and selling current or future approved products; Blueprint Medicines’ ability and plans to continue to establish and expand a commercial infrastructure, and to successfully launch, market and sell current or future approved products; Blueprint Medicines’ ability to successfully expand approved indications for AYVAKIT/AYVAKYT or obtain marketing approval for AYVAKIT/AYVAKYT in other geographies in the future; delay in any ongoing or planned clinical trials or development of Blueprint Medicines’ current or future drug candidates; advancing Blueprint Medicines from multiple early-stage efforts; the ability of Blueprint Medicines to successfully demonstrate the safety and efficacy of its drug candidates and to obtain approval of its drug candidates on a timely basis, if at all; preclinical and clinical results of Blueprint Medicines’ drug candidates, which may not support the further development of these drug candidates, whether as monotherapies or in combination with other agents, or may impact the expected timing of data or regulatory submissions; timing of initiation of clinical trials and trial cohorts at clinical trial sites and patient enrollment rates; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials; Blueprint Medicines’ ability to obtain, maintain and enforce patent and other intellectual property protections for AYVAKIT/AYVAKYT or any drug candidates it develops; Blueprint Medicines’ ability to develop and commercialize companion diagnostic tests for AYVAKIT/AYVAKYT or any of its current and future drug candidates; Blueprint Medicines’ ability to successfully expand its operations, research platform and pipeline of therapeutic candidates, as well as the timing and costs thereof; Blueprint Medicines’ ability to realize the expected benefits of its executive transition plan; and the success of Blueprint Medicines’ current and future collaborations, funding agreements, partnerships or licensing agreements. These and other risks and uncertainties are described in more detail in the section titled “Risk Factors” in Blueprint Medicines’ filings with the Securities and Exchange Commission (SEC), including Blueprint Medicines’ most recent annual report. Blueprint Medicines on Form 10-K, as supplemented by its most recent quarterly report on Form 10-Q and any other filings Blueprint Medicines has made or may make with the SEC in the future. All forward-looking statements contained in this press release represent the views of Blueprint Medicines only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Blueprint Medicines expressly disclaims any obligation to update forward-looking statements.

Trademarks

Blueprint Medicines, AYVAKIT, AYVAKYT and associated logos are trademarks of Blueprint Medicines Corporation.

SOURCE Blueprint Medicines Corporation

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Woman ‘could have died’ after McDonald’s failed to remove ingredient https://parentsofallergicchildren.org/woman-could-have-died-after-mcdonalds-failed-to-remove-ingredient/ Tue, 15 Nov 2022 05:00:00 +0000 https://parentsofallergicchildren.org/woman-could-have-died-after-mcdonalds-failed-to-remove-ingredient/ ]]>
ALLERGIES : Une femme (Image: Canva)” src=”https://s.yimg.com/ny/api/res/1.2/XAzJ._oKgfON9aHbiW0_6A–/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTY0MA–/https://media.zenfs.com/en/oxford_mail_251/7354a4fabe4edce5bcae73cfdf84ace” data- src=”https://s.yimg.com/ny/api/res/1.2/XAzJ._oKgfON9aHbiW0_6A–/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTY0MA–/https://media.zenfs.com/en/oxford_mail_251/7354a4fabe4edce5bcae72cfdf84ace/>

ALLERGIES: Woman ‘could have died’ after McDonald’s failed to remove ingredient (Image: Canvas)

‘This makes my blood boil,’ a dad says after McDonald’s mistakenly served his daughter a cucumber wrap she is ‘deathly allergic to’.

Ian Mathey and his daughter Sky had entrusted the fast food restaurant in Abingdonwhere they live, without cucumber on the crispy chicken wrap ordered at the drive-thru.

However, despite expressing the allergy twice, when the 20-year-old bit into the wrapper, she feared she would find the fruit inside.

READ MORE: 1990s mural discovered at Oxfordshire Primary School

Now Mr Mathey, a foodservice trader, is seeking compensation from the US chain after it offered him a ‘free burger’ as an apology.

“They value my daughter’s life in a free burger,” he said. “It makes my blood boil. I wasn’t looking for compensation, I just wanted a sincere apology.

The incident happened in July this year after Miss Mathey, who was returning from studying biochemistry at the University of Southampton, finished her shift at The Brewery Tap.

“She finished her work around 11 p.m.,” Mr Mathey said. “She asked if we could go to McDonalds, so I went to the window and asked for a crispy chicken wrap and said, ‘Make sure there’s no cucumber because she is deathly allergic” and I checked the screen and it said, “No cucumber”.

“I checked again when I got to the next window to pay and he reassured me there would be none.

“But on the way home, my daughter bit into the envelope and said, ‘Oh shit,’ and I said, ‘Are you kidding? Do you have an EpiPen?

READ MORE: Hotel near Kassam stadium used to house refugees sparks row with authorities

“She is allergic to cucumbers, apples, peaches, it’s because of a certain enzyme in the skin. If it’s cooked, it’s fine, but if it’s raw, it could cost him his life.

“She had EpiPens at home so I drove her to make sure she was ok. This involved waking us up every 30 minutes to make sure she was ok and had an EpiPen ready. because anaphylaxis can happen very quickly.

“She’s an adult but at the end of the day, she’s still our daughter.”

Mr Mathey phoned the store the next day and emailed head office before being offered a free burger.

He said: “I was getting furious at this point because no one had even asked if my daughter was okay.

“Finally I said I was going to get the environmental health officer (EHO) and the commercial standard because what made me lose my rag was they gave me a free burger .

“I’m really frustrated with the way McDonalds handled the situation.”

In a report by EHO, it was discovered that packaging from an earlier canceled order had been provided rather than the one without cucumbers.

READ MORE: Police search for CCTV footage after attempted burglary in Chalgrove

He said: “McDonalds has completed its own internal investigation and has assumed that the cause of the incorrect product given was due to human error.”

McDonalds was asked to make a statement.

Learn more about this author

This story was written by Gee Harland. She joined the team in 2022 as a senior multimedia reporter.

Gee covers Wallingford, Wantage and Didcot.

Get in touch with her by emailing: Gee.harland@newsquest.co.uk

Follow her on Twitter @Geeharland

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Canadian boy battles mystery illness in Phoenix hospital https://parentsofallergicchildren.org/canadian-boy-battles-mystery-illness-in-phoenix-hospital/ Fri, 11 Nov 2022 00:24:00 +0000 https://parentsofallergicchildren.org/canadian-boy-battles-mystery-illness-in-phoenix-hospital/ “It’s probably one of the hardest things I’ve had to do in my life,” said the boy’s father. PHOENIX – Doctors at a valley hospital are working around the clock to determine exactly what is ailing a 15-month-old boy – unexpectedly under medical care thousands of miles from home. “It’s probably one of the hardest […]]]>

“It’s probably one of the hardest things I’ve had to do in my life,” said the boy’s father.

PHOENIX – Doctors at a valley hospital are working around the clock to determine exactly what is ailing a 15-month-old boy – unexpectedly under medical care thousands of miles from home.

“It’s probably one of the hardest things I’ve had to do in my life,” said Matthew Schoeman.

Schoeman is the father of 15-month-old Eric Schoman. The elder Schoeman is stuck at home more than 1,500 miles away in British Columbia, Canada, while his wife comforts their young son in a hospital in Phoenix.

“They found him in his crib, stiff as a board and not breathing properly and drenched in sweat,” Schoeman said.

When Eric’s mother discovered her son in his crib on Tuesday evening, trying to cry but only able to do what they describe as barking, she called 911. Believing the boy’s symptoms were anaphylactic shock, an allergic reaction to venom such as a scorpion sting, doctors administered five doses of anti-venom. His condition did not improve.

“They’re just testing. Like crazy,” Schoeman said. “They don’t know what’s going on yet.”

Being from Canada, the Schoemans do not have US health insurance. While doctors are still trying to diagnose Eric, his father knows the medical bills could change his life.

“Yeah, we’re going to be responsible for that bill, which I don’t know how we’re going to totally pay, but I’m sure we can come up with something. I don’t know,” Schoeman said.

At this point, the family can only count on the perseverance of their doctors and on their faith.

“God is good. So. Sometimes it’s hard to see what his plan is, but I know he’s in control,” Schoeman said. “And that’s the only comfort I have right now. “

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Death of Kozhikode MCH not due to wrong injection, says Minister of Health https://parentsofallergicchildren.org/death-of-kozhikode-mch-not-due-to-wrong-injection-says-minister-of-health/ Fri, 28 Oct 2022 10:13:55 +0000 https://parentsofallergicchildren.org/death-of-kozhikode-mch-not-due-to-wrong-injection-says-minister-of-health/ Kozhikode: Kerala Health Minister Veena George on Friday dismissed claims that the administration of the wrong drug led to the death of a patient at the government medical college here. The minister’s statement came shortly after the preliminary report concluded that no medication had been wrongly administered to the patient. However, Veena requested a detailed […]]]>

Kozhikode: Kerala Health Minister Veena George on Friday dismissed claims that the administration of the wrong drug led to the death of a patient at the government medical college here.

The minister’s statement came shortly after the preliminary report concluded that no medication had been wrongly administered to the patient.

However, Veena requested a detailed report from hospital authorities.

KT Sindhu (45), who had been treated in hospital, collapsed moments after receiving an injection. His death was confirmed shortly thereafter.

Police had filed a complaint against the nurse who administered the injection on the complaint of the woman’s husband, Raghu.

He alleges that the nurse’s negligence resulted in the death of his wife. Hospital authorities have denied the allegations.

They said the nurse tested the drug – a dose of penicillin – for an allergic reaction on the woman’s arm before administering the full dose.

Anaphylaxis – a severe allergic reaction – is believed to be the cause of the woman’s death.

The autopsy report also suggested that side effects of the drug likely led to death. The woman’s internal organs were found to have been damaged as a result of the side effects.

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Democrats push Medicaid expansion for rural Georgia left behind https://parentsofallergicchildren.org/democrats-push-medicaid-expansion-for-rural-georgia-left-behind/ Sat, 22 Oct 2022 13:00:59 +0000 https://parentsofallergicchildren.org/democrats-push-medicaid-expansion-for-rural-georgia-left-behind/ ARLINGTON, Georgia — Nine years after the hospital closed in the southwestern Georgia city of Arlington, concern about health care lurks. Health insurance premiums are high, many residents are reporting poor health, and there’s no guarantee that Calhoun County’s only ambulance will arrive quickly if it takes a patient to a distant hospital. “If it’s […]]]>

ARLINGTON, Georgia — Nine years after the hospital closed in the southwestern Georgia city of Arlington, concern about health care lurks. Health insurance premiums are high, many residents are reporting poor health, and there’s no guarantee that Calhoun County’s only ambulance will arrive quickly if it takes a patient to a distant hospital.

“If it’s on a call, might as well throw them in the truck and try to get somewhere,” resident Sam Robinson said.

Arlington, home to 1,209, reflects rural Georgia’s health care struggles.

Democrats, including their gubernatorial candidate Stacey Abrams, are presenting these issues as they run for office this year, pushing Georgia to join 38 other states in expanding the Medicaid health insurance program to cover all able-bodied adults.

Abrams opened his campaign to oust Republican Brian Kemp at a hospital that closed in nearby Cuthbert, pointing to an issue that was at the center of his narrow loss to Kemp in 2018.

“We’re talking about someone who goes in for a checkup and they’re told they have stage one pancreatic cancer,” Abrams told reporters in a video news conference this month. “In Georgia, they don’t get a follow-up visit unless they can pay out of pocket.”

Experts predict that more than 450,000 uninsured Georgians would receive coverage if Medicaid were expanded. Many generally don’t qualify for subsidies to buy individual policies, leaving them in what experts call the “coverage gap.”

Medicaid expansion is also an issue elsewhere this year.

In South Dakota, voters will decide on an expansion referendum opposed by Republican Gov. Kristi Noem. In Kansas and Wisconsin, Democratic governors are seeking re-election after failing to persuade Republican legislatures to expand coverage.

In Georgia, Kemp has declined calls for expansion, instead offering coverage for a smaller group of people who meet work, education or volunteer requirements. In an Oct. 11 letter to Democratic members of the Georgia Congress, Kemp called the full expansion of Medicaid a “failed one-size-fits-all” policy.

But that refusal stings Arlington, which was once home to the 25-bed Calhoun Memorial Hospital. It had been decades since babies were born at Calhoun Memorial, and the facility struggled to afford the latest technology. Although services were limited, local residents relied on her for emergencies.

“I used the emergency room with my son,” Pam Conner said. “He was around 4 years old when he got his first ever wasp sting. It put him into anaphylaxis. I don’t know what we would have done without the hospital.”

Conner chairs the county hospital’s board of directors, nine years after the facility closed and 99 employees were laid off. With many patients uninsured, Conner said the hospital was providing more than $2 million a year in unpaid care when it closed.

The county government borrowed for a new roof in 2008, and it’s a local sore spot that taxpayers still owe nearly $500,000 on the building, now leased to a drug and alcohol rehabilitation center. Local officials have refused to raise property taxes to cover hospital deficits, unlike some counties in Georgia. The hospital sold its nursing home, raising funds but clouding the long-term financial outlook. Eventually, authorities decided to close, joining eight other rural hospitals in Georgia since 2008.

Now, Arlington residents rely on the county’s only ambulance, based 12 miles away in Morgan. Calhoun County projects it will spend $537,000 providing emergency medical services this year, more than one-eighth of its $4.2 million budget.

However, the health issues run deeper in southwest Georgia. Private health insurance is so expensive that Conner, whose family owns an insurance agency, buys coverage on the federal health insurance market instead. Robinson said he and his wife once paid $1,000 a month for the insurance.

Kemp succeeded in lowering insurance rates and encouraging more insurers to offer coverage outside of metro Atlanta with subsidies. But premiums remain high in southwest Georgia, with a large hospital in Albany dominating the market and residents often in poor health. Calhoun County has high rates of diabetes, obesity and teenage births, according to county health rankings data. Black residents are much more likely to have preventable hospital stays.

Sherrell Byrd of SOWEGA Rising, which is trying to improve wellness in southwest Georgia, said COVID-19 has exposed the region’s poor health and rickety health care system. At the start of 2020, Southwest Georgia captured national attention with one of the highest death rates from the respiratory virus.

“It really exposed how bad our health is,” Byrd said. “We had so many comorbidities here.”

Medicaid has also become an issue in Atlanta, where the WellStar system closed a hospital in suburban East Point and will close the 532-bed Atlanta Medical Center by Nov. 1. It is one of only five top trauma centers in Georgia. WellStar says Atlanta Medical Center was losing so much money that expanding Medicaid wouldn’t have helped, but Democrats persist in saying it could have made a difference in the long run.

President Barack Obama’s 2010 health care overhaul envisioned states providing Medicaid coverage to residents whose incomes reached up to 138% of the federal poverty level. But the United States Supreme Court ruled in 2012 that the federal government cannot force states to act, and many Republican-led states balked.

President Joe Biden’s administration tried to block Kemp’s plan for a partial Medicaid expansion, but a judge in August ruled Georgia could pursue the work requirement. Kemp calls his approach “a much better approach to increasing health care coverage than the ‘full’ expansion of Medicaid.”

Kemp notes that Medicaid expansion would force some people now eligible for Medicaid private health insurance subsidies. Because Georgia has set low Medicaid payments and some doctors aren’t taking Medicaid, Kemp says it would make things worse for those people while increasing competition for current Medicaid patients to find a doctor.

The governor also notes that 600,000 more Georgians are currently on Medicaid than when he took office, essentially saying that Medicaid expansion has already happened. However, many people are covered because the federal government blocked states from removing people from Medicaid during the COVID-19 pandemic. They could be removed once the federal public health emergency is over.

Democratic Sen. Raphael Warnock has tried to sweeten the deal, prompting lawmakers last year to increase the federal share of funding from 90% to 95% for the first two years of any new Medicaid expansion. Warnock, who is seeking re-election on Nov. 8, has long called for broader coverage. He was arrested during protests over the issue at the Georgia Capitol in 2014 and the United States Capitol in 2017 before becoming a senator.

“Unfortunately, the state left that money on the table and left hundreds of thousands of working Georgians in the void of coverage,” Warnock said Oct. 12 in Atlanta. “And I intend to keep fighting for them.”

Warnock’s opponent, Republican Herschel Walker, said last month he opposed the expansion.

“Right now Medicaid hasn’t been good,” he told reporters. “Right now, the expansion is going to keep bankrupting us. Everyone knows that.”

A key question underpinning the debate is the extent to which government is obligated to provide health care and seek better health outcomes. Democrats now widely believe that health care is a human right and a collective responsibility. Many Republicans still believe it’s an individual responsibility.

In Arlington, Conner says what really existed was a lag — with hospitals legally obligated to provide emergency care, but with no guarantee of payment.

“It makes me think that universal health care might actually be a right of our citizens,” Conner said. “It’s a right for them to go to the emergency room whether they can pay or not. But it’s not a right for the hospital to get the money to pay for it.”

___

Follow Jeff Amy at http://twitter.com/jeffamy

___

Follow AP’s Medicaid coverage at: https://apnews.com/hub/medicaid

Follow AP’s election coverage at: https://apnews.com/hub/2022-midterm-elections

Visit https://apnews.com/hub/explaining-the-elections to learn more about the issues and factors at play in the 2022 midterm elections.

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CDC clears Novavax monovalent COVID-19 boosters for adults 18 and older | CDC Online Newsroom https://parentsofallergicchildren.org/cdc-clears-novavax-monovalent-covid-19-boosters-for-adults-18-and-older-cdc-online-newsroom/ Wed, 19 Oct 2022 20:42:45 +0000 https://parentsofallergicchildren.org/cdc-clears-novavax-monovalent-covid-19-boosters-for-adults-18-and-older-cdc-online-newsroom/ Today, CDC Director Rochelle P. Walensky, MD, MPH, signed a decision memorandum authorizing Novavax Adult Monovalent COVID-19 Boosters. This action gives people aged 18 and over the option of receiving a monovalent Novavax booster instead of an updated (bivalent) Pfizer-BioNTech or Moderna booster if they have completed the primary vaccination but have not yet received […]]]>

Today, CDC Director Rochelle P. Walensky, MD, MPH, signed a decision memorandum authorizing Novavax Adult Monovalent COVID-19 Boosters.

This action gives people aged 18 and over the option of receiving a monovalent Novavax booster instead of an updated (bivalent) Pfizer-BioNTech or Moderna booster if they have completed the primary vaccination but have not yet received a COVID-19 booster – and if they can’t or won’t get mRNA vaccines.

Some may not be able to receive an mRNA vaccine due to an allergy to a component of a COVID-19 mRNA vaccine, or as a result of a history of severe allergic reaction (such as anaphylaxis) after a previous dose of a COVID-19 mRNA vaccine, or lack of availability of an mRNA vaccine. People aged 18 and over can also choose to receive a monovalent Novavax booster if they do not wish to receive mRNA vaccines and would not otherwise receive a booster dose.

The FDA’s authorization of monovalent COVID-19 boosters and the CDC’s recommendation for use are significant advances in our nation’s comprehensive immunization program — a program that has helped provide increased protection for all Americans against COVID-19. illness and death from COVID-19.

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Robbie Coltrane: new victim of a declaration of death by vaccine! https://parentsofallergicchildren.org/robbie-coltrane-new-victim-of-a-declaration-of-death-by-vaccine/ Sat, 15 Oct 2022 17:08:06 +0000 https://parentsofallergicchildren.org/robbie-coltrane-new-victim-of-a-declaration-of-death-by-vaccine/ Robbie Coltrane, who played Hagrid in the Harry Potter movies, is the latest victim of anti-vaccination campaigners who claim he was a victim of sudden vaccine death! Take a look at the viral claims and find out what the facts really are! To claim : Robbie “Hagrid” Coltrane has died of sudden vaccine-induced death! Hot […]]]>

Robbie Coltrane, who played Hagrid in the Harry Potter movies, is the latest victim of anti-vaccination campaigners who claim he was a victim of sudden vaccine death!

Take a look at the viral claims and find out what the facts really are!

To claim : Robbie “Hagrid” Coltrane has died of sudden vaccine-induced death!

Hot on the heels of news of Robbie Coltrane’s death at age 72, anti-vaccination campaigners immediately claimed that the actor who played Rubeus Hagrid in the Harry Potter films had died a sudden vaccine-induced death (SADS/ vids)!

Here is a selection of social media posts with links or articles about his death:

Was Robbie Coltrane’s relatively young death linked to a covid vaccine?

Robbie Coltrane dies from vaccine

The shot killed Robbie Coltrane. So sad. RIP Robbie #CovidVaccine

Recommended : Sara Lee: new victim of the allegation of sudden death of a vaccine!

Truth : No proof that Robbie Coltrane died of sudden death caused by a vaccine!

It’s now a tradition for anti-vaccination campaigners to immediately blame all celebrity deaths or illnesses on the COVID-19 vaccine.

This is yet another example of FAKE NEWS created and propagated by anti-vaccination activists, and here’s why, and what we know so far…

Fact #1: Robbie Coltrane’s cause of death is unknown

Robbie Coltrane (born Anthony Robert McMillan) OBE died at Forth Valley Royal Hospital in Larbert, Scotland on Friday October 14, 2022.

His agent, Belinda Wright, announced his death in a statement which read:

My client and friend Robbie Coltrane OBE passed away on Friday October 14th. Robbie was a unique talent, sharing the Guinness Book of Records award for winning three consecutive Best Actor Baftas.

He will probably be best remembered for decades as Hagrid in the Harry Potter films, a role that brought joy to children and adults everywhere, prompting a flood of fan letters every week for over 20 years. year.

For me personally, I will remember him as a loyal customer. Besides being a wonderful actor, he was forensically intelligent, brilliantly witty and after 40 years of proudly being called his agent, I will miss him.

He is survived by his sister Annie Rae, his children Spencer and Alice and their mother Rhona Gemmell. They would like to thank the medical staff at the Forth Valley Royal Hospital in Larbert for their care and diplomacy.

His agent didn’t mention a cause of death for Robbie Coltrane, but neither did she mention COVID-19 vaccines, let alone blame them for his death.

Just because Robbie Coltrane’s cause of death is currently unknown doesn’t mean he died from the COVID-19 vaccine. It just means that his cause of death is… UNKNOWN ours.

His family and doctors probably know the cause of his death. But just because they don’t reveal the cause of his death doesn’t mean anyone has the right to falsely claim that he died suddenly from the SADS/VIDS vaccine.

Robbie Coltrane: new victim of a declaration of death by vaccine!

Fact #2: Robbie Coltrane was in poor health

Robbie Coltrane had been in poor health for two years, saying he was in “constant pain all day” and disabled.

In 2016, he revealed that he suffered from osteoarthritis, which caused him severe pain and limited his mobility even at that time. He would end up using a cane and eventually a wheelchair in 2019 while waiting to undergo knee replacement surgery (arthroplasty) in the United States.

Osteoarthritis is a degenerative disease and is associated with an increased risk of falls, bone fractures and premature death.

Coltrane seemed to be aware of his mortality, reflecting on it in an HBO special for the 20th anniversary of the Harry Potter franchise:

The legacy of the movies is that my kids’ generation will show them to their kids, so you could watch them 50 years from now. I won’t be there unfortunately, but Hagrid will be.

Recommended : Gwen Casten: Cause of sudden death NOT vaccine!

Wheelchair for osteoarthritis Robbie Coltrane

Fact #3: It is not known if Robbie Coltrane has been vaccinated against COVID-19

It is currently unknown if Robbie Coltrane was vaccinated against COVID-19, so it would be wrong for anyone to claim that he died from side effects of the COVID-19 vaccine.

As far as we know, he may not even be vaccinated! The COVID-19 vaccine is not compulsory in the UK, despite what anti-vaccination campaigners may claim.

Fact #4: SADS is an inherited heart disease

It is ludicrous to claim that COVID-19 vaccines cause Sudden Arrhythmia Death Syndrome (SADS), because SADS was first documented in 1977 – long before COVID-19 vaccines were invented!

Despite what anti-vaccination activists may tell you – SADS is not a new vaccine-related syndrome.

SADS is a inherited problem with your heart’s electrical system, which produces an abnormal heartbeat resulting in cardiac arrest. This is why it can be prevented by implanting an automatic defibrillator.

SADS also occurs at a rate of 0.12 to 0.21 per 100,000 people every year. In other words, around 9,000 to 16,000 people die from SADS every year, before COVID-19 vaccines were invented.

The UK Office for National Statistics Data on sudden adult deaths from 2016 to 2020 also showed NO INCREASE in SADS cases, demonstrating that COVID-19 vaccines did not increase the prevalence of SADS.

To note : There is no 2021 data until December 2022. The 2020 data was not released until December 22, 2021.

Vaccination in the UK began on December 8, 2020, with over a million doses administered by the end of the month. Despite the (false) claims that vaccines cause SADS, this has not led to an increase in SADS cases.

Years Sudden death of an adult
Cases of syndromes
2016 116
2017 63
2018 53
2019 87
2020 115

Fact #5: Vaccine-induced death syndrome does not exist

After social media filters began cracking down on SADS, anti-vaccination activists coined a new term – Vaccine Induced Death Syndrome (VIDS or VDS).

There is no vaccine-induced death syndrome. It’s just a term they coined to blame every sudden death on the COVID-19 vaccine.

Despite what anti-vaccination activists claim, COVID-19 vaccines do not cause sudden deaths.

Read more : Robert Cormier: The cause of death IS NOT the SAD of vaccines!

Robbie Coltrane as Rubeus Hagrid

Fact #6: Vaccine side effects Appear within hours/days

Even if Robbie Coltrane was fully vaccinated against COVID-19, he would have received all of his vaccine doses several months ago.

He can’t have died from a side effect of the vaccine, because they appear within hours or days, not months later.

Mild side effects like injection site pain, fever, muscle aches, headache, lethargy develop minutes to hours after vaccination.

Anaphylaxis develops in a few minuteswhile other serious adverse effects like myocarditis and VITT develop within a few days.

The spike proteins produced by COVID-19 vaccines also don’t stick around for months. If these spike proteins are permanent (as antivaxxers claim), we would have lifelong immunity.

Your own immune system will identify the spike proteins as foreign, and destroy them within a few days, although some may last up to a few weeks. This is part of how vaccines teach your immune system to identify the enemy and destroy it.

Fact #7: Deaths/injuries caused by COVID-19 vaccines can be proven

Despite anti-vaccination campaigners blaming celebrity deaths on the vaccine; death or injury from rare vaccine adverse events such as anaphylaxis, myocarditis, and VITT can be proven.

Anaphylaxis (severe allergic reaction) from Pfizer or Moderna mRNA vaccines occurs in a few minutes. This is why people are asked to wait 15 to 30 minutes after receiving the vaccine. People who go into anaphylactic shock will need an injection of epinephrine for quick relief.

Vaccine-induced myocarditis has distinct histopathological findings that are different from typical myocarditis, so a pathologist will be able to determine if myocarditis was caused by vaccines or otherwise.

Vaccine-induced thrombotic thrombocytopenia (VITT) is highly specific to AstraZeneca and Johnson & Johnson vaccines. It is also easily differentiated by its unique combination of blood clots in large veins brain, abdomen and lungs, as well as low platelet count leading to bleeding tendencies.

Recommended : Did a vaccine injury force Justin Bieber to cancel his tour? !

Why Steve Kirsch is 100% wrong about Justin Bieber's paralysis!

Fact #8: Claims of celebrities injured by COVID-19 vaccine turned out to be false

This is yet another example of anti-vaccination activists misusing celebrity deaths/injuries to create and propagate FAKE NEWS on the safety and effectiveness of vaccines against COVID-19.

So far, claims of celebrity deaths/injuries due to COVID-19 vaccine have been proven to be false every moment.

Are these anti-vaccination activists going to apologize for lying to you? Nope! They’ll just move on to the next celebrity tragedy…

please help us FIGHT AGAINST FAKE NEWS by sharing this fact-checking article, and please SUPPORT our work !

Don’t forget to protect yourself and your family by getting vaccinated against COVID-19!

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Dr. Adrian Wong has been writing about technology and science since 1997, even publishing a book with Prentice Hall titled Crossing the BIOS Barrier (ISBN 978-0131455368) during his medical studies.

He continues to devote countless hours each day to writing about technology, medicine and science, in his quest for facts in a post-truth world.

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Moderna Receives FDA Clearance for Emergency Use of Bivalent COVID-19 Booster Vaccine Targeting Omicron for Children and Adolescents 6-17 Years Old https://parentsofallergicchildren.org/moderna-receives-fda-clearance-for-emergency-use-of-bivalent-covid-19-booster-vaccine-targeting-omicron-for-children-and-adolescents-6-17-years-old/ Wed, 12 Oct 2022 14:42:06 +0000 https://parentsofallergicchildren.org/moderna-receives-fda-clearance-for-emergency-use-of-bivalent-covid-19-booster-vaccine-targeting-omicron-for-children-and-adolescents-6-17-years-old/ Enter Wall Street with StreetInsider Premium. Claim your one week free trial here. mRNA-1273.222 targets Omicron variant BA.4/BA.5 strains Authorization is based on clinical and preclinical data of Moderna’s bivalent vaccine candidates CAMBRIDGE, MA/ACCESSWIRE/October 12, 2022/ Moderna, Inc. (NASDAQ: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has […]]]>

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mRNA-1273.222 targets Omicron variant BA.4/BA.5 strains

Authorization is based on clinical and preclinical data of Moderna’s bivalent vaccine candidates

CAMBRIDGE, MA/ACCESSWIRE/October 12, 2022/ Moderna, Inc. (NASDAQ: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has received Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) for its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222, in children and adolescents 6-17 years of age. Authorizations are based on a 25 ¼g booster dose for children 6-11 years old and a 50 ¼g booster dose for adolescents 12-17 years old, each after a complete primary series of one of the vaccines COVID-19 authorized or a previous booster. The mRNA-1273.222 booster doses each contain mRNA coding for the BA.4/BA.5 spike protein as well as mRNA coding for the original SARS-CoV-2 virus strain.

“We are proud to have received clearance for our updated bivalent COVID-19 booster for children and teens ages 6-17,” said Stephane Bancel, CEO of Moderna. “With bivalent boosters available for most age groups, families have access to updated tools as they head into the winter months and holiday gatherings. We are grateful to the FDA for its thorough and timely consideration.”

Last month, mRNA-1273.222, which targets Omicron’s BA.4/BA.5 subvariants, received EUA from the FDA for adults over 18. The pediatric and adolescent EUA application is based on clinical trial recall data for Moderna’s original vaccine, Spikevax, which was administered to more than a thousand participants in each cohort. In addition, the EUA application included preclinical data for mRNA-1273.222 as well as Phase 2/3 clinical trial data investigating mRNA-1273.214another bivalent booster vaccine targeting Omicron developed by Moderna.

Moderna is currently working to finalize its EUA app for children ages 6 months to 5 years old. The application is expected to be completed later this year.

About Moderna

In more than 10 years since its inception, Moderna has grown from a research-stage company advancing messenger RNA (mRNA) programs to a company with a diverse clinical portfolio of vaccines and therapeutics in seven modalities, a broad portfolio of intellectual property in areas such as mRNA and lipid nanoparticle formulation, and an integrated manufacturing facility that enables rapid clinical and commercial scale production. Moderna maintains alliances with a wide range of domestic and foreign government and commercial collaborators, which has enabled the pursuit of both breakthrough science and rapid scale-up of manufacturing. Most recently, Moderna’s capabilities have come together to enable the licensed use and approval of one of the oldest and most effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform leverages continuous advancements in basic and applied mRNA science, delivery technology and manufacturing, and has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named one of Science’s Top Biopharmaceutical Employers for the past seven years. To learn more, visit www.modernatx.com.

INDICATION (USA)

SPIKEVAX (COVID-19 vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in people aged 6 and over.

IMPORTANT SAFETY INFORMATION

  • Do not administer to persons with a known history of severe allergic reaction (eg, anaphylaxis) to any component of the vaccine.
  • Appropriate medical treatment to manage immediate allergic reactions should be immediately available in the event of an acute anaphylactic reaction following vaccine administration.
  • Post-marketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days of the second dose. The observed risk is higher in men under 40 than in women and older men. The observed risk is highest in men aged 18 to 24.
  • Syncope (fainting) may occur in association with the administration of injectable vaccines. Procedures must be in place to prevent injury from fainting.
  • Immunocompromised people, including people receiving immunosuppressive therapy, may have a diminished response to the vaccine.
  • The vaccine may not protect all vaccinees.
  • Adverse reactions reported in clinical trials following vaccine administration include injection site pain, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, swelling/ axillary tenderness, fever, injection site swelling and injection site erythema. site and rash.
  • The vaccinator is responsible for mandatory reporting of certain adverse events to the online Vaccine Adverse Event Reporting System (VAERS) at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967.
  • Please consult the Complete SPIKEVAX Prescribing Information. For more information on authorized emergency uses of the Moderna COVID-19 vaccine, please see the EUA Fact Sheet.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including with respect to: the potential US FDA approval of mRNA-1273.222 as a vaccination booster for children 6 months of age 5 years of age and time of submissions to the US FDA for emergency use authorization; and the potential of mRNA-1273.222 to provide protection in pediatric and adolescent populations against COVID-19. The forward-looking statements contained in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond within Moderna’s control and which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These risks, uncertainties and other factors include the other risks and uncertainties described under “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility to update or revise the forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.

Moderna Contacts

Media:

Elise Meyer
Senior Director, Corporate Communications
[email protected]

Investors:

Lavina Talukdar
Senior Vice President and Head of Investor Relations
617-209-5834
[email protected]

THE SOURCE: Moderna, Inc.

See the source version on accesswire.com:
https://www.accesswire.com/720084/Moderna-Receives-FDA-Authorization-for-Emergency-Use-of-Omicron-Targeting-Bivalent-COVID-19-Booster-Vaccine-for-Children-and-Adolescents- 6 to 17 years old

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Hypersensitivity to beta-lactams caused mainly by cephalosporins https://parentsofallergicchildren.org/hypersensitivity-to-beta-lactams-caused-mainly-by-cephalosporins/ Mon, 10 Oct 2022 17:10:47 +0000 https://parentsofallergicchildren.org/hypersensitivity-to-beta-lactams-caused-mainly-by-cephalosporins/ October 10, 2022 2 minute read ADD A SUBJECT TO EMAIL ALERTS Receive an email when new articles are published on Please provide your email address to receive an email when new articles are published on . ” data-action=subscribe> Subscribe We have not been able to process your request. Please try again later. If you […]]]>

October 10, 2022

2 minute read


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According to a study published in Annals of Allergy, Asthma and Immunology.

But the patterns differ between inpatients and outpatients, Yuda Chongpison, PhD, MS, MBA, epidemiologist and biostatistician from the Skin and Allergy Research Unit at Chulalongkorn University, Bangkok, and colleagues wrote.

Data are from Chongpison Y et al. Ann Allergy Asthma Immunol. 2022; doi:10.1016/j.anai.2022.09.011.

The study included 357 patients (mean age, 52.3 ± 18.8 years) with a presumed diagnosis of beta-lactam (HBL) hypersensitivity, including 223 (62.5%; mean age, 49.8 ± 18 years) in an outpatient setting and 134 (37.5%; mean age 56.3 ± 19.5 years) hospitalized. In addition to being older, the hospitalized group had more underlying malignancies and fewer allergic diseases than the outpatient group.

Natural and semi-synthetic penicillins were the most frequently implicated drugs in BLH in the outpatient group, while cephalosporins and carbapenems were the main drugs implicated in the hospitalized group.

In addition, 45.9% of reactions in the outpatient group and 14.5% of those in the hospitalized group reported a suspected IgE-mediated reaction to beta-lactam antibiotics.

Test results

There were 335 patients with 381 beta-lactam reactions who agreed to participate in further investigation, including skin testing, intradermal testing, skin testing, specific IgE antibody measurements, activation testing basophils, measurements of interferon-gamma releasing cells and drug challenge. examinations (DPT).

According to the researchers, 18.9% of all reactions were serious skin adverse reactions and 14.6% of combined skin and in vitro tests were positive.

Specifically, 14.6% of 41 participants with a history of immediate reaction to penicilloyl G and amoxicilloyl tested positive for sIgE antibodies to these drugs.

DPTs among 137 patients with 144 reactions yielded 14 (9.7%) positive results, including three patients with urticaria, two with fixed drug eruption, and two with maculopapular rashes, meaning that 90.3% of those who underwent TPD had their BLH demarked. Between 2 and 8 hours after the drug challenge, five patients developed anaphylaxis and two developed serum sickness-like reactions (SSLRs).

Of all 381 reactions, there was a 15.7% rate of positive results in combined in vivo and in vitro tests, including direct DPT, and 18.1% had their BLH confirmed.

Sixty-three patients with confirmed BLH presented 69 reactions, including 33 IgE-mediated and 26 cell-mediated, most often due to cephalosporins (34.8%), semi-synthetic penicillins (29%), natural penicillins ( 26.1%) and carbapenems (10.1%). %).

Predictors of BLH

Among 199 reactions in 185 patients whose BLH status was verified, BLH appeared to be significantly associated with newer generations of beta-lactams, including cephalosporins and carbapenems, hospitalization, allergic history of one year or less and underlying malignancies or autoimmune diseases.

BLH was 3.7 (95% CI, 1.8-7.3) times more likely in inpatients than in outpatients and 5.3 (95% CI, 1.3-21.3) times more likely in those with or without malignancy.

In reviewing 63 patients with 69 verified beta-lactam allergic reactions, researchers found an increased risk of type IV hypersensitivity reactions in the hospital setting compared to the outpatient setting (OR=9.7; 95% CI %, 3.1-30.3).

After adjusting for HIV infection status, researchers also found that patients with underlying autoimmune diseases had increased risks of non-Type 1 and IV reactions, including delayed anaphylaxis, and SSLR (adjusted OR = 5.3; 95% CI, 1-27.9) .

Based on these findings, the researchers concluded that newer generation cephalosporins and other beta-lactams were more likely to have an increased risk of BLH, with different patterns of hypersensitivity in hospital and outpatient settings.

They also concluded that current BLH demarking approaches are not applicable to high-risk patients with contraindications to DTP, whereas combined in vivo and in vitro techniques would be more appropriate in the hospital setting, although other new ways of identifying culprit drugs should also be explored.

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Treatment with its own cells offers hope for degenerative diseases https://parentsofallergicchildren.org/treatment-with-its-own-cells-offers-hope-for-degenerative-diseases/ Fri, 07 Oct 2022 14:30:32 +0000 https://parentsofallergicchildren.org/treatment-with-its-own-cells-offers-hope-for-degenerative-diseases/ Credit: Rost-9D/Getty Images Increasing the number and function of a certain type of white blood cell and returning it to the same patient may slow the progression of the degenerative disease amyotrophic lateral sclerosis (ALS), an early study has found. The phase IIa trial indicated that infusions of expanded autologous regulatory T cells (Tregs) increased […]]]>
Credit: Rost-9D/Getty Images

Increasing the number and function of a certain type of white blood cell and returning it to the same patient may slow the progression of the degenerative disease amyotrophic lateral sclerosis (ALS), an early study has found.

The phase IIa trial indicated that infusions of expanded autologous regulatory T cells (Tregs) increased their immunosuppressive function in ALS patients when used with low-dose interleukin (IL)-2, which helps regulate white blood cells of the immune system.

Acknowledging the challenges of conducting their small study during the COVID-19 pandemic, the researchers nevertheless note that taking Tregs from patients, increasing their numbers in a lab, and then returning them to the same patient was safe and well tolerated.

“We look forward to a much larger clinical trial that will allow proper evaluation of the clinical efficacy and further characterization of the long-term safety of this therapy,” said lead researcher Jason Thonhoff of Houston Methodist Neurological. Institute in Texas. “These initial results in a handful of patients are promising.”

The research is published in the journal Neurology: Neuroimmunology and Neuroinflammation.

The trial was originally designed as a randomized, placebo-controlled phase IIa trial with 12 participants with the rare neurological condition, which would be followed by an open-label trial.

But the impact of the coronavirus pandemic led to reduced enrollment, with seven participants eventually entering the double-blind trial and eight in the six-month open-label trial.

The first part, lasting six months, was designed to examine the biological activity, safety and tolerability of monthly intravenously increased Tregs (1 x 106 cells/kg) or inactive saline placebo administered intravenously plus subcutaneous injections of low dose IL-2 (2 × 105 IU/m2) or a saline placebo three times a week.

Six of the initial trial participants moved on to the second six-month open dose escalation extension, with two additional patients joining.

Participants received a single dose of Treg cells twice, at a frequency of once per month with three injections of IL-2 per week, followed by double and then triple the dose of Treg cells twice, with an injection of IL-2, all at the same frequency.

This was followed by a month-long safety follow-up visit after the last triple dose of Tregs and IL-2 injections.

The researchers note that due to low pandemic enrollment, the study had limited power to detect the primary and secondary endpoint of the trial.

Nonetheless, the primary endpoint of the trial, change in Treg suppressor function between screening and treatment week 24, was 26% higher in participants receiving Treg/IL-2 compared to placebo.

During the trial, active treatment was well tolerated, with only mild adverse events and mild, transient inflammation at IL-2 injection sites being common.

The researchers note that the unique anaphylactic reaction with a placebo has already been observed in other studies using vehicles containing albumin or dimethyl sulfoxide.

A post-hoc analysis of the extension study showed that six of the eight participants experienced intermediate to no disease progression, while the other two showed rapid progression while receiving Treg/IL-2 therapy. .

Six of the eight open-label extension participants changed an average of -2.7 points on the ALS Functional Rating Scale-Revised, while the other two changed an average of -10.5 points.

The two progressing patients had higher levels of pro-inflammatory cytokines IL-17F and IL-17C as well as higher oxidative stress markers OLR1 and ox-LDL than the other six.

The researchers say, “The elevated levels of inflammation and oxidative stress seen in these two participants might have limited the effectiveness of Tregs, resulting in shorter half-lives and negating their downstream suppressive effects.”

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