What is VITT, the other blood clotting condition linked to AstraZeneca’s COVID-19 vaccine? – Firstpost

What is VITT, the other blood clotting condition linked to AstraZeneca’s COVID-19 vaccine? – Firstpost

What is VITT, the other blood clotting condition linked to AstraZeneca’s COVID-19 vaccine? – Firstpost

What is VITT, the other blood clotting condition linked to AstraZeneca’s COVID-19 vaccine? – Firstpost

May 17, 2024

AstraZeneca's COVID-19 vaccine has been linked to Vaccine-induced Immune Thrombotic Thrombocytopenia, a rare but potentially fatal condition. Reuters File Photo

British-Swedish pharma giant AstraZeneca has remained in the headlines after reports surfaced that it admitted its COVID-19 vaccine can cause a rare side effect of blood clotting. Now, Australian researchers have found a link between vaccine-induced immune thrombocytopenia and thrombosis (VITT), a rare complication associated with AstraZenecas COVID-19 jabs, and an uncommon but potentially fatal blood disease contracted by some who had a cold.

According to Adelaides Flinders University, the antibodies from VITT and an adenovirus VITT-like disorder share nearly identical molecular signatures or fingerprints.

Advertisement

These findings, using a completely new approach for targeting blood antibodies developed at Flinders University, indicate a common triggering factor on virus and vaccine structures that initiates the pathological PF4 antibodies, the universitys Professor Tom Gordon was quoted as saying by 9news.com.au.

Researchers said these findings will have implications for vaccine development and safety.

What is VITT? Is it different from TTS? How is it linked to AstraZeneca s COVID-19 vaccine? Lets take a closer look.

What is VITT?

VITT is a rare condition found in some people who got adenoviral vector COVID-19 vaccines such as AstraZenecas Vaxzevria and the Johnson & Johnsons Janssen shots.

The adverse effect led to blood clots and low platelet count in healthy young adults.

VITT is marked by venous or arterial thrombosis, particularly at unusual sites including cerebral sinus venous thrombosis (CSVT)/splanchnic thrombosis; mild to severe thrombocytopenia (low platelet count); and positive PF4-heparin ELISA (HIT ELISA), according to American Society of Hematology.

HIT stands for Heparin-induced thrombocytopenia which is an immune complication that can occur in patients exposed to heparin products.

Thrombosis refers to a blood clot within blood vessels that restricts the flow of the red-hued body fluid.

The symptoms of VITT include persistent headaches, shortness of breath, abdominal pain, easy bruising or bleeding, nausea and vomiting.

People who have VITT, their immune response gets compromised and they make antibodies that can stick to one of the bodys own proteins called platelet factor 4 (PF4), as per The Conversation.

Advertisement

TTS and VITT

AstraZeneca has accepted in court documents in the United Kingdom that its COVID-19 vaccine, in rare cases, can cause Thrombosis with Thrombocytopenia Syndrome (TTS).

TTS is a broader category that can be triggered by vaccine or it can be non-immune mediated. As per ScienceDirect, VITT can be considered as one of several entities that fall under the umbrella of immune-mediated TTS.

A 2022 study in Lancet Global Health revealed that AstraZeneca had reported rates of 8.1 TTS cases per million who got the first dose of its COVID-19 vaccine and 2.3 cases per million after people got the second jab. The highest number of these cases were found in Nordic countries 17.6 per million doses and the lowest in Asian nations 0.2 per million doses.

Advertisement

In India, at least one young woman is believed to have died from VITT after taking Covishield .

Rithaika Sri Omtri, 18, got the first dose of Covishield in May 2021 in Hyderabad. As per a Scroll report, within five days of being vaccinated, she experienced a prickling sensation in her fingers and, later, a high fever.

As her fever did not subside for a few days, a doctor suggested her a blood test which revealed her platelets had dropped to a dangerous low of 40,000 per cubic millimetre, compared to a normal range between 1.5 lakh and 4 lakh.

Over 10 days later, Rithaika started vomiting and could not walk. An MRI scan of her brain showed that she had multiple blood clots and a haemorrhage in the right frontal region, Scroll reported.

Advertisement

Despite efforts to save her, she was declared brain dead, two weeks after her vaccination.

Rithaika had suffered a vaccine-induced (immune) thrombotic thrombocytopenia, Scroll reported.

AstraZeneca under scanner

The pharma giant has been under scrutiny since its admission came to light. People who took its COVID-19 vaccine started questioning its safety. However, experts said the side effects appeared within the first few weeks of taking the vaccine and there was no need to worry now.

Recently, AstraZeneca said its COVID-19 vaccine, which was manufactured by the Serum Institute of India (SII) and sold as Covishield in India, has been removed from the markets for commercial reasons.

Advertisement

With inputs from agencies

Find us on YouTube


See original here: What is VITT, the other blood clotting condition linked to AstraZeneca's COVID-19 vaccine? - Firstpost
Rare but deadly blood clots tied to Johnson & Johnson and AstraZeneca Covid-19 vaccines: scientists report to journal | Mint – Mint

Rare but deadly blood clots tied to Johnson & Johnson and AstraZeneca Covid-19 vaccines: scientists report to journal | Mint – Mint

May 17, 2024

Rare but deadly blood clots tied to Johnson & Johnson and AstraZeneca Plcs Covid-19 vaccines were caused by an autoimmune reaction that some people are predisposed to, researchers have found. This discovery is expected to influence the development of future vaccines, Bloomberg reported.

Adenovirus-based vaccines, like the J&J and AstraZeneca shots that were later pulled from the market, contain a component that can trigger blood clots in genetically susceptible individuals, scientists reported Wednesday in a letter to the New England Journal of Medicine. Researchers are now aiming to identify the specific component and attempt to remove it through genetic engineering, the report said.

Its not known how many people may be susceptible to the complication," said Tom Gordon, head of immunology at Flinders University in South Australia, whose molecular investigation led to the finding. The immune reaction linked to the shot is a new disease," he stated in an interview. I think as haematologists and intensive care specialists become more familiar with these conditions, more cases will be described," the scientists Bloomberg.

Out of more than 18 million people who received the single-dose J&J vaccine, 60 cases of the clotting disorder were reported, resulting in nine deaths, according to the Yale School of Medicine, Bloomberg reported.

A small number of clot-related deaths linked to the AstraZeneca vaccine led to its withdrawal or restriction in Denmark, Norway, and other countries in 2021. The complication occurred in about 2-3 people per 100,000 vaccinated with the AstraZeneca shot under age 60 in Australia, where it hasnt been available since March 2023. The European Commission withdrew the marketing authorization for the vaccine in March 2024, the Bloomberg report said.

AstraZeneca welcomes any further examination of the possible underlying mechanism of thrombosis with thrombocytopenia syndrome (TTS), given that, despite extensive investigation, we do not yet understand the mechanism that can in very rare cases be a trigger for TTS," a spokesperson for the company said, as per the report.

J&J also expressed support for research that helps guide the development of safe and effective vaccines. More data are needed to fully understand potential factors that may be associated with this rare event, including its potential relationship with adeno- and other viruses, to draw appropriate conclusions about the underlying pathogenesis," the company said in an email.

Both vaccines played a crucial role in early pandemic vaccine programmes. An analysis found the AstraZeneca vaccine saved an estimated 6.3 million lives in 2021.

The mRNA vaccines made by the Pfizer Inc.-BioNTech SE partnership and Moderna Inc. were later found to be more effective at protecting against Covid and have been updated to tackle more recent virus variants.

(With Inputs from Bloomberg)

Unlock a world of Benefits! From insightful newsletters to real-time stock tracking, breaking news and a personalized newsfeed - it's all here, just a click away! Login Now!


See more here: Rare but deadly blood clots tied to Johnson & Johnson and AstraZeneca Covid-19 vaccines: scientists report to journal | Mint - Mint
Now, AstraZeneca’s Covid vaccine linked to VITT blood clotting disorder: Report – The Week

Now, AstraZeneca’s Covid vaccine linked to VITT blood clotting disorder: Report – The Week

May 17, 2024

AstraZeneca coronavirus vaccine, which was sold in India as Covishield, is linked to a rare blood clotting disorder called Vaccine-Induced Immune Thrombocytopenia and Thrombosis (VITT), researchers have found.

Pharmaceutical company AstraZeneca earlier this month had announced the worldwide withdrawal of its Covid-19 vaccines. Although "surplus of available updated vaccines" that target new variants of the virus was cited as the reason for the withdrawal, the decision came days after the company acknowledged in court papers that the vaccine carried serious side effects, known as thrombosis with thrombocytopenia, or TTS, in some people. This also follows the AstraZeneca's decision to withdraw its European Union marketing authorisation. On May 6, Monday, the European Medicines Agency issued a notice that the vaccine is no longer authorised for use.

It was scientists of South Australia's Flinders University that revealed in a study VITT emerged in 2021 during the Covid-19 pandemic, particularly after the use of the Oxford-AstraZeneca vaccine. The jab was based on adenovirus vectors, India Today said in a report.

ALSO READ | Why AstraZeneca decided to withdraw Covid-19 vaccine globally

According to the researchers, VITT is caused by a harmful blood autoantibody targeting a protein called platelet factor 4 (PF4), the report said. Another research last year had revealed a similar fatal disorder linked to natural adenovirus infections involving the same PF4 antibody.

PF4 antibodies in vaccine-related VITT and natural adenovirus infections reportedly share identical molecular signatures.

Understanding "autoantibody"

US-based National Cancer Institute describes "autoantibody" as an antibody produced by the immune system that attacks the body's own proteins. Autoantibodies can directly destroy cells that have substances on them or can make it easier for other white blood cells to destroy them.

This can cause to autoimmune diseases, where the immune system harms healthy cells and tissues. Affected people are likely to develop blood clots in unusual places including the brain, India Today said. The patients may also have high levels of a substance called D-dimer in their blood, the report said.

The new study reportedly found that a common factor in viruses and vaccines triggers these harmful antibodies.

However, VITT is likely to occur four to forty-two days after taking the vaccine. As people are no longer taking the vaccine, the study offers vaccinated people no reason to bother, the report added.


Read more from the original source: Now, AstraZeneca's Covid vaccine linked to VITT blood clotting disorder: Report - The Week
Genetics linked to rare blood clots from J&J and AstraZeneca Covid vaccines, researchers claim – WION

Genetics linked to rare blood clots from J&J and AstraZeneca Covid vaccines, researchers claim – WION

May 17, 2024

Researchers discovered that the rare but deadly blood clots associated with Johnson & Johnson and AstraZeneca Plc's COVID-19 vaccines were triggered by an autoimmune response that some people may have a genetic predisposition to. This finding is expected to influence the development of future vaccines.

COMMERCIAL BREAK

SCROLL TO CONTINUE READING

According to scientists who wrote a letter to the New England Journal of Medicine on Wednesday (May 15), said that adenovirus-based vaccines such as the J&J and AstraZeneca shots, which were withdrawn from the market, include a component capable of inducing blood clots in people with a genetic vulnerability. Researchers said they will try to narrow down the component and then try to eliminate it through genetic modification, as reported by Bloomberg.

Tom Gordon, head of immunology at Flinders University in South Australia, whose investigative work led to the discovery, said that the extent of susceptibility to this complication remains unknown. He described the immune reaction associated with the vaccine as "a new disease" stressing on the likelihood of more cases being documented as hematologists and intensive care specialists become more used to these conditions.

According to the Yale School of Medicine, out of over 18 million recipients of the single-dose J&J vaccine, there were 60 reported cases of the clotting disorder, resulting in nine deaths.

Also read | Plea filed inIndiastop court seeking investigation into Covid vaccine Covishield's sideeffects

Following a small number of clot-related deaths associated with the AstraZeneca vaccine, it was withdrawn or restricted in Denmark, Norway, and other nations in 2021. In Australia, where the AstraZeneca shot has not been available since March 2023, the complication occurred in approximately 2-3 people per 100,000 vaccinated individuals under the age of 60. The European Commission revoked the marketing authorisation for this vaccine in March 2024.

AstraZeneca welcomes any further examination of the possible underlying mechanism of thrombosis with thrombocytopenia syndrome (TTS), given that, despite extensive investigation, we do not yet understand the mechanism that can in very rare cases be a trigger for TTS, a spokesperson for the company told Bloomberg.

J&J also said that it is open to research that helps in the development of safe and effective vaccines.

More data are needed to fully understand potential factors that may be associated with this rare event, including its potential relationship with adeno- and other viruses, to draw appropriate conclusions about the underlying pathogenesis, the company said in an email sent to Bloomberg.

Also read | AstraZeneca Covid vaccine: Court case, rare side effects, admission of guilt, and more. All you need to know

Both vaccines were crucial in vaccine campaigns in the initial phases of the pandemic. An assessment indicated that the AstraZeneca vaccine potentially saved around 6.3 million lives in 2021. However, the mRNA vaccines produced by Pfizer Inc.-BioNTech SE and Moderna Inc. were subsequently discovered to offer higher effectiveness against Covid and have been modified to address more recent virus variants.

(With inputs from agencies)


Read the original: Genetics linked to rare blood clots from J&J and AstraZeneca Covid vaccines, researchers claim - WION
Watch: Baroness Arlene Foster appears before the Covid-19 Inquiry – BBC.com

Watch: Baroness Arlene Foster appears before the Covid-19 Inquiry – BBC.com

May 15, 2024

UK Covid Inquiry in Northern Irelandpublished at 09:29 09:29

Baroness Arlene Foster is set to appear before the UK Covid Inquiry in Belfast today.

She was Northern Ireland first minister from January 2016 to January 2017 and during the pandemic from January 2020 until she resigned on 14 June 2021.

You can watch a stream of the inquiry by clicking the play button above.


Original post:
Watch: Baroness Arlene Foster appears before the Covid-19 Inquiry - BBC.com
Judge in civil case over covid-19 fight in Little Rock restaurant chastises defense over evidence submissions … – Arkansas Online

Judge in civil case over covid-19 fight in Little Rock restaurant chastises defense over evidence submissions … – Arkansas Online

May 15, 2024

Advertisement Advertisement

May 14, 2024 at 8:54 p.m.

by Dale Ellis

Sparks flew Tuesday in federal court as Chief U.S. District Judge Kristine G. Baker threatened to sanction attorneys defending Saltgrass Arkansas in a lawsuit filed by a Little Rock couple claiming the restaurant was negligent in failing to head off a June 2020 brawl that broke out over covid-19 restrictions.

The...


Original post:
Judge in civil case over covid-19 fight in Little Rock restaurant chastises defense over evidence submissions ... - Arkansas Online
Nursing Homes Wield Pandemic Immunity Laws To Duck Wrongful Death Suits – Kaiser Health News

Nursing Homes Wield Pandemic Immunity Laws To Duck Wrongful Death Suits – Kaiser Health News

May 15, 2024

By Fred Schulte May 14, 2024

In early 2020, with reports of covid-19 outbreaks making dire headlines, Trever Schapers worried about her fathers safety in a nursing home in Queens.

She had delighted in watching her dad, John Schapers, blow out the candles on his 90th birthday cake that February at the West Lawrence Care Center in the New York City borough. Then the home went into lockdown.

Soon her father was dead. The former union painter spiked a fever and was transferred to a hospital, where he tested positive for covid, his daughter said, and after two weeks on a ventilator, he died in May 2020.

But when Trever Schapers sued the nursing home for negligence and wrongful death in 2022, a judge dismissed the case, citing a New York state law hastily passed early in the pandemic. It granted immunity to medical providers for harm or damages from an act or omission in treating or arranging care for covid. She is appealing the decision.

I feel that families are being ignored by judges and courts not recognizing that something needs to be done and changed, said Schapers, 48, who works in the medical field. There needs to be accountability.

The nursing home did not return calls seeking comment. In a court filing, the home argued that Schapers offered no evidence that the home was grossly negligent in treating her father.

More than four years after covid first raged through many U.S. nursing homes, hundreds of lawsuits blaming patient deaths on negligent care have been tossed out or languished in the courts amid contentious legal battles.

Even some nursing homes that were shut down by health officials for violating safety standards have claimed immunity against such suits, court records show. And some families that allege homes kept them in the dark about the health of their loved ones, even denying there were cases of covid in the building, have had their cases dismissed.

Schapers alleged in a complaint to state health officials that the nursing home failed to advise her that it had admitted covid-positive patients from a nearby hospital in March 2020. In early April, she received a call telling her the facility had some covid-positive residents.

The call I received was very alarming, and they refused to answer any of my questions, she said.

About two weeks later, a social worker called to say that her father had a fever, but the staff did not test him to confirm covid, according to Schapers complaint.

The industry says federal health officials and lawmakers in most states granted medical providers broad protection from lawsuits for good faith actions during the health emergency. Rachel Reeves, a senior vice president with the American Health Care Association, an industry trade group, called covid an unprecedented public health crisis brought on by a vicious virus that uniquely targeted our population.

In scores of lawsuits, however, family members allege that nursing homes failed to secure enough protective gear or tests for staffers or residents, haphazardly mixed covid-positive patients with other residents, failed to follow strict infection control protocols, and brazenly misled frightened families about the severity of covid outbreaks among patients and staff.

They trusted these facilities to take care of loved ones, and that trust was betrayed, said Florida attorney Lindsey Gale, who has represented several families suing over covid-related deaths.

The grieving process people had to go through was horrible, Gale said.

A Deadly Toll

KFF Health News found that more than 1,100 covid-related lawsuits, most alleging wrongful death or other negligent care, were filed against nursing homes from March 2020 through March of this year.

While theres no full accounting of the outcomes, court filings show that judges have dismissed some suits outright, citing state or federal immunity provisions, while other cases have been settled under confidential terms. And many cases have stalled due to lengthy and costly arguments and appeals to hash out limits, if any, of immunity protection.

In their defense, nursing homes initially cited the federal Public Readiness and Emergency Preparedness Act, which Congress passed in December 2005. The law grants liability protection from claims for deaths or injuries tied to vaccines or medical countermeasures taken to prevent or treat a disease during national emergencies.

The PREP Act steps in once the secretary of Health and Human Services declares a public health emergency, which happened with covid on March 17, 2020. The emergency order expired on May 11, 2023.

The law carved out an exception for willful misconduct, but proving it occurred can be daunting for families even when nursing homes have long histories of violating safety standards, including infection controls.

Governors of at least 38 states issued covid executive orders, or their legislatures passed laws, granting medical providers at least some degree of immunity, according to one consumer groups tally. Just how much legal protection was intended is at the crux of the skirmishes.

Nursing homes answered many negligence lawsuits by getting them removed from state courts into the federal judicial system and asking for dismissal under the PREP Act.

For the most part, that didnt work because federal judges declined to hear the cases. Some judges ruled that the PREP Act was not intended to shield medical providers from negligence caused by inaction, such as failing to protect patients from the coronavirus. These rulings and appeals sent cases back to state courts, often after long delays that left families in legal limbo.

These delays have been devastating, said Jeffrey Guzman, a New York City attorney who represents Schapers and other families. He said the industry has fought tooth and nail trying to fight these people getting their day in court.

Empire State Epicenter

New York, where covid hit early and hard, is ground zero for court battles over nursing home immunity.

Relatives of residents have filed more than 750 negligence or wrongful death cases in New York counties since the start of the pandemic, according to court data KFF Health News compiled using the judicial reporting service Courthouse News Service. No other area comes close. Chicagos Cook County, a jurisdiction where private lawyers for years have aggressively sued nursing homes alleging poor infection control, recorded 121 covid-related cases.

Plaintiffs in hundreds of New York cases argue that nursing homes knew early in 2020 that covid would pose a deadly threat but largely failed to gird for its impact. Many suits cite inspection reports detailing chronic violations of infection control standards in the years preceding the pandemic, court records show. Responses to this strategy vary.

Different judges take different views, said Joseph Ciaccio, a New York lawyer who has filed hundreds of such cases. Its been very mixed.

Lawyers for nursing homes counter that most lawsuits rely on vague allegations of wrongdoing and boilerplate claims that, even if true, dont demonstrate the kind of gross negligence that would override an immunity claim.

New York lawmakers added another wrinkle by repealing the immunity statute in April 2021 after Attorney General Letitia James noted the law could give nursing homes a free pass to make financially motivated decisions to cut costs and put patients at risk.

So far, appeals courts have ruled lawmakers didnt specify that the repeal should be made retroactive, thus stymying many negligence cases.

So these cases are all wasting the courts time and preventing cases that arent barred by immunity statutes from being resolved sooner and clogging up the court system that was already backlogged from COVID, said attorney Anna Borea, who represents nursing homes.

Troubled Homes Deflect Suits

Some nursing homes that paid hefty fines or were ordered by health officials to shut down at least temporarily because of their inadequate response to covid have claimed immunity against suits, court records show.

Among them is Andover Subacute and Rehabilitation nursing home in New Jersey, which made national headlines when authorities found 17 bodies stacked in a makeshift morgue in April 2020.

Federal health officials fined the facility $220,235 after issuing a critical 36-page report on covid violations and other deficiencies, and the state halted admissions in February 2022.

Yet the home has won court pauses in at least three negligence lawsuits as it appeals lower court rulings denying immunity under the federal PREP Act, court records show. The operators of the home could not be reached for comment. In court filings, they denied any wrongdoing.

In Oregon, health officials suspended operations at Healthcare at Foster Creek, calling the Portland nursing home a serious danger to the public health and safety. The May 2020 order cited the homes consistent inability to adhere to basic infection control standards.

Bonnie Richardson, a Portland lawyer, sued the facility on behalf of the family of Judith Jones, 75, who had dementia and died in April 2020. Jones was among dozens of covid-related deaths at that home.

It was a very hard-fought battle, said Richardson, who has since settled the case under confidential terms. Although the nursing home claimed immunity, her clients wanted to know what happened and to understand why. The owners of the nursing home provided no comment.

No Covid Here

Many families believe nursing homes misled them about covids relentless spread. They often had to settle for window visits to connect with their loved ones.

Relatives of five patients who died in 2020 at the Sapphire Center for Rehabilitation and Nursing in the Flushing neighborhood in Queens filed lawsuits accusing the homes operators of keeping them in the dark.

When they phoned to check on elderly parents, they either couldnt get through or were told there was no COVID-19 in the building, according to one court affidavit.

One woman grew alarmed after visiting in February 2020 and seeing nurses wearing masks below their noses or under their chin, according to a court affidavit.

The woman was shocked when the home relayed that her mother had died in April 2020 from unknown causes, perhaps from depression and not eating, according to her affidavit.

A short time later, news media reported that dozens of Sapphire Center residents had died from the virus her 85-year-old mother among them, she argued in a lawsuit.

The nursing home denied liability and won dismissal of all five lawsuits after citing the New York immunity law. Several families are appealing. The nursing homes administrator declined to comment.

Broadening Immunity

Nursing home operators also have cited immunity to foil negligence lawsuits based on falls or other allegations of substandard care, such as bedsores, with little obvious connection to the pandemic, court records show.

The family of Marilyn Kearney, an 89-year-old with a history of dementia and falls, sued the Watrous Nursing Center in Madison, Connecticut, for negligence. Days after she was admitted in June 2020, she fell in her room, fracturing her right hip and requiring surgery, according to court filings.

She died at a local hospital on Sept. 16, 2020, from sepsis attributed to dehydration and malnutrition, according to the suit.

Her family argued that the 45-bed nursing home failed to assess her risk of falling and develop a plan to prevent that. But Watrous fired back by citing an April 2020 declaration by Connecticut Gov. Ned Lamont, a Democrat, granting health care professionals or facilities immunity from any injury or death alleged to have been sustained because of the individuals or health care facilitys acts or omissions undertaken in good faith while providing health care services in support of the states COVID-19 response.

Watrous denied liability and, in a motion to dismiss the case, cited Lamonts executive order and affidavits that argued the home did its best in the throes of a public health crisis, the likes of which had never been seen before. The operators of the nursing home, which closed in July 2021 because of covid, did not respond to a request for comment. The case is pending.

Attorney Wendi Kowarik, who represents Kearneys family, said courts are wrestling with how much protection to afford nursing homes.

Were just beginning to get some guidelines, she said.

One pending Connecticut case alleges that an 88-year-old man died in October 2020 after experiencing multiple falls, sustaining bedsores, and dropping more than 30 pounds in the two months he lived at a nursing home, court records state. The nursing home denied liability and contends it is entitled to immunity.

So do the owners of a Connecticut facility that cared for a 75-year-old woman with obesity who required a lift to get out of bed. She fell on April 26, 2020, smashing several teeth and fracturing bones. She later died from her injuries, according to the suit, which is pending.

I think it is really repugnant that providers are arguing that they should not be held accountable for falls, pressure sores, and other outcomes of gross neglect, said Richard Mollot, executive director of the Long Term Care Community Coalition, which advocates for patients.

The government did not declare open season on nursing home residents when it implemented COVID policies, he said.

Protecting the Vulnerable

Since early 2020, U.S. nursing homes have reported more than 172,000 residents deaths, according to Centers for Medicare & Medicaid Services data. Thats about 1 in 7 of all recorded U.S. covid deaths.

As it battles covid lawsuits, the nursing home industry says it is struggling to recover due to ongoing labor shortages, inflation, and chronic government underfunding, according to Reeves, the trade association executive.

She said the American Health Care Association has advocated for reasonable, limited liability protections that defend staff and providers for their good faith efforts during the pandemic.

Caregivers were doing everything they could, Reeves said, often with limited resources and ever-changing information, in an effort to protect and care for residents.

But patients advocates remain wary of policies that might bar the courthouse door against grieving families.

I dont think we want to continue to enact laws that reward nursing homes for bad care, said Sam Brooks, of the Coalition for the Protection of Residents of Long-Term Care Facilities, a patient advocacy group.

We need to keep that in mind if, God forbid, we have another pandemic, Brooks said.

Bill Hammond, a senior fellow at the Empire Center for Public Policy, a nonpartisan New York think tank, said policymakers should focus on better strategies to protect patients from infectious outbreaks, rather than leaving it up to the courts to sort out liability years later.

There is no serious effort to have that conversation, Hammond said. I think thats crazy.

We encourage organizations to republish our content, free of charge. Heres what we ask:

You must credit us as the original publisher, with a hyperlink to our kffhealthnews.org site. If possible, please include the original author(s) and KFF Health News in the byline. Please preserve the hyperlinks in the story.

Its important to note, not everything on kffhealthnews.org is available for republishing. If a story is labeled All Rights Reserved, we cannot grant permission to republish that item.

Have questions? Let us know at KHNHelp@kff.org


Excerpt from: Nursing Homes Wield Pandemic Immunity Laws To Duck Wrongful Death Suits - Kaiser Health News
Secretory IgA and course of COVID-19 in patients receiving a bacteria-based immunostimulant agent in addition to … – Nature.com

Secretory IgA and course of COVID-19 in patients receiving a bacteria-based immunostimulant agent in addition to … – Nature.com

May 15, 2024

Hoffmann, M. et al. SARS-CoV-2 cell entry depends on ACE2 and TMPRSS2 and is blocked by a clinically proven protease inhibitor. Cell. 181, 271280. https://doi.org/10.1016/j.cell.2020.02.052 (2020).

Article PubMed PubMed Central Google Scholar

Chuchalin, A. G., Svitich, O. A., & Kostinov, M. P. Mucosal immunity in patients with COVID-19: treatment and rehabilitation. Monograph. 128 (Moscow, MDV Group, 2022)

Schaad, U. B. Prevention of pediatric respiratory tract infections: emphasis on the role of OM-85. Eur. Respir. Rev. 14, 7477. https://doi.org/10.1183/09059180.05.00009506 (2005).

Article Google Scholar

Korovkina, E. S. & Kostinov, M. P. immunopathological mechanisms of community-acquired pneumonia and chronic obstructive pulmonary disease caused by the infectious pathology of these diseases, and ways of possible immunocorrection. ZHMEI. 2, 100109 (2019).

Google Scholar

Kostinov, M. P., Tatevosov, V. R., Protasov, A. D., Gajnitdinova, V. V. & Sizov, A. V. Vaccination against Staphylococcus aureus and some representatives of the Enterobacteriaceae family in the complex treatment of community-acquired pneumonia of mild course in new recruits. Medicinskij vestnik MVD. CXV(6), 2329 (2021).

Kostinov, M. P., Zorin, N. A., Kazharova, S. V. & Zorina, V. N. Comparative effect of immunomodulators on concentrations of hydrolase inhibitors and lactoferrin in community-acquired pneumonia in adults. Med. Immunol. 22(4), 791798 (2020).

Article Google Scholar

Kostinov, M. P. et al. The influence of immunomodulators on various markers of the acute phase of inflammation in patients with non-severe community-acquired pneumonia. Tuberculosis Lung Dis. 99(4), 3643 (2021).

Article Google Scholar

Chang, S. Y., Ko, H. J. & Kweon, M. N. Mucosal dendritic cells shape mucosal immunity. Exp. Mol. Med. 46, e84 (2014).

Article CAS PubMed PubMed Central Google Scholar

Chuchalin, A.G. Respiratornaya meditsina. Rukovodstvo 2nd Ed. [Respiratory medicine. Guidelines], vol. 2, 544 (Moscow, Litterra Publ, 2017).

Nikulin, B. A. Otsenka i korrektsiya immunnogo statusa (Assessment and correction of immune status) in Assessment and management of the immune status disorders. 376 (Moscow, GEOTAR-Media Publ., 2007).

Protasov, A. D. et al. The effect of complex vaccination against pneumococcal, hemophilic type b infections and influenza in patients with chronic obstructive pulmonary disease. J. Mikrobiologii, Epidemiologii i Immunobiologii 4, 8084 (2011).

Google Scholar

Ryzhov, A. A., Kostinov, M. P. & Magarshak, O. O. The use of vaccines against pneumococcal and hemophilic type b infections in patients with chronic pathology. Epidemiologiya i Vaktsionoprofilaktika 6(19), 2427 (2004).

Google Scholar

Kostinov, M. P., & Chuchalin, A. G. Clinical immunology guide to respiratory medicine. 2nd ed. 304 (Moscow, Gruppa MDV Publ., 2018).

Avdeev, S. N. et al. Clinical efficacy of mechanical bacterial lysate in the prevention of infectious exacerbations of chronic obstructive pulmonary disease. Terapevticheskiy Arkhiv 92(4), 5763 (2020).

Article CAS Google Scholar

Svitich, O. A. et al. The level of sIgA in nasal secretions and the incidence of complications in hospitalized patients with COVID-19 against an immunotropic drug. ERJ Open Res. 8, 258. https://doi.org/10.1183/23120541.LSC-2022.258 (2022).

Article Google Scholar

Svitich, O. A. et al. Hydrogen effect on the mechanisms of mucosal immunity in patients with COVID-19. Terapevticheskii Arkhiv. 94(3), 372377. https://doi.org/10.26442/00403660.2022.03.201398 (2022).

Article CAS PubMed Google Scholar

Carlo, C. et al. Systemic and mucosal antibody responses specific to SARS-CoV-2 during mild versus severe COVID-19. J. Allergy Clin. Immunol. 147(2), 545557 (2021).

Article Google Scholar

Sterlin, D. et al. IgA dominates the early neutralizing antibody response to SARS-CoV-2. Sci. Transl. Med. 13(577), 2223 (2021).

Article Google Scholar

Kostinov, M. et al. Changes in nasal, pharyngeal and salivary secretory IgA levels in patients with COVID-19 and the possibility of correction of their secretion using combined intranasal and oral administration of a pharmaceutical containing antigens of opportunistic microorganisms. Drugs Contexts. 12, 1. https://doi.org/10.7573/dic.2022-10-4 (2023).

Article Google Scholar

Chuchalina, A. G., & Yasnecov, V. V. Federal guidelines on the use of medicines (formulary system). Vipusk.XVI., 1016 (Moskow., 2015).

Tajima, Y., Suda, Y. & Yano, K. A case report of SARS-CoV-2 confirmed in saliva specimens up to 37 days after onset: proposal of saliva specimens for COVID-19 diagnosis and virus monitoring. J. Infect. Chemother. 26, 10861089 (2020).

Article CAS PubMed PubMed Central Google Scholar

To, K.K.-W. et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: An observational cohort study. Lancet Infect. Dis. 20, 565574 (2020).

Article CAS PubMed PubMed Central Google Scholar

Chen, J.H.-K. et al. Evaluating the use of posterior oropharyngeal saliva in a point-of-care assay for the detection of SARS-CoV-2. Emerg. Microbes Infect. 9, 13561359 (2020).

Article ADS CAS PubMed PubMed Central Google Scholar

Bates, D., Maechler, M., Bolker, B. & Walker, S. Fitting linear mixed-effects models using lme4. J. Stat. Softw. 67(1), 148 (2015).

Article Google Scholar

Hartig, F. DHARMa: Residual diagnostics for hierarchical (multi-level/mixed) regression models. R package version 0.4.5. https://CRAN.R-project.org/package=DHARMa (2022).

Kuznetsova, A., Brockhoff, P. B. & Christensen, R. H. B. lmerTest package: Tests in linear mixed effects models. J. Stat. Softw. 82(13), 126 (2017).

Article Google Scholar

Yoav, B., Krieger, A. M. & Yekutieli, D. Adaptive linear step-up procedures that control the false discovery rate. Biometrika. 93(3), 491507 (2006).

Article MathSciNet Google Scholar

Hassan, A. O. et al. A single-dose intranasal ChAd vaccine protects upper and lower respiratory tracts against SARS-CoV-2. Cell. 183, 169184 (2020).

Article CAS PubMed PubMed Central Google Scholar

Krammer, F. SARS-CoV-2 vaccines in development. Nature. 586, 516527 (2020).

Article ADS CAS PubMed Google Scholar

Mudgal, R., Nehul, S. & Tomar, S. Prospects for mucosal vaccine: Shutting the door on SARS-CoV-2. Hum. Vaccines Immunother. 16, 29212931. https://doi.org/10.1080/21645515.2020.1805992 (2020).

Article CAS Google Scholar

Cao, Y. et al. Imprinted SARS-CoV-2 humoral immunity induces convergent omicron RBD evolution. Nature. 614, 521529 (2023).

ADS CAS PubMed Google Scholar

Zhuang, Z. F. et al. Safety and immunogenicity of a live-attenuated influenza virus vector-based intranasal SARS-CoV-2 vaccine in adults: Randomised, double-blind, placebo-controlled, phase 1 and 2 trials. Lancet Respir. Med. 10, 749760 (2022).

Article PubMed PubMed Central Google Scholar

ZhuShoujie, F. et al. Safety and efficacy of the intranasal spray SARS-CoV-2 vaccine dNS1-RBD: A multicentre, randomised, double-blind, placebo-controlled, phase 3 trial November 2023. Lancet Respir. Med. 11(12), S2213-2223. https://doi.org/10.1016/S2213-2600(23)00349-1 (2023).

Article Google Scholar

Tuksin, J. et al. Intranasal administration of RBD nanoparticles confers induction of mucosal and systemic immunity against SARS-CoV-2 vaccines (Basel). 9(7), 768 (2021).

Suloeva, S. V., Kostinov, M. P. & Esman, V. N. Preventive and clinical effect of the use of IRS 19 in children born to HIV-positive women. Epidemiologiya i vakcinoprofilaktika. 1(20), 5456 (2005).

Google Scholar

Kostinov, M. P., Suloeva, S. V., Tarasova, A. A. & Lukushkina, E. F. Mucosal immunity in children with HIV infection and the possibility of its correction. ZHurnal mikrobiologii, epidemiologii i immunobiologii. 2, 7577 (2006).

Google Scholar

Ilenko, L. I. et al. Immunization with vaccines for the prevention of pneumococcal, hemophilic infection and influenza in frequently and long-term ill children with chronic and often recurrent nonspecific infectious pathology of the bronchopulmonary system. Voprosy sovremennoj pediatrii. 5(4), 2730 (2006).

Google Scholar

Foshina, E. P., Polishchuk, V. B., Kostinov, M. P. & Krasnoproshina, L. I. Correction of oral microbiocenosis disorders in children with chronic tonsillitis using topical bacterial lysate. Voprosy sovremennoj pediatrii 6(2), 107109 (2007).

Google Scholar

Chistyakova, E. G. et al. Profilaktika i lechenie ostryh respiratornyh infekcij nosoglotki u bolnyh yunosheskim artritom (Prevention and treatment of acute respiratory infections of the nasopharynx in patients with juvenile arthritis). Voprosy sovremennoj pediatrii 5(6), 4044 (2006).

Google Scholar

Kostinov, M. P. & Ababiya, I. I. Rukovodstvo po vakcinacii i immunoterapii pri LOR-patologii Guidelines for vaccination and immunotherapy in ENT pathology () (Ed. Kostinov, M.P., Ababiya, I.I.) 448 (Gruppa MDV, 2019).

Fbin, T. K., Fejrdy, P. & Csermely, P. Salivary genomics, transcriptomics and proteomics: The emerging concept of the oral ecosystem and their use in the early diagnosis of cancer and other diseases. Curr. Genomics. 9, 1121 (2008).

Article PubMed PubMed Central Google Scholar

Kryukova, N. O., Rakunova, E. B., Kostinov, M. P., Baranova, I. A. & Svitich, O. A. Cekretornyj immunoglobulin A respiratornoj sistemy i COVID-19 (Secretory immunoglobulin A of the respiratory system and COVID-19). Pulmonologiya 31(6), 792798. https://doi.org/10.18093/0869-0189-2021-31-6-792-798 (2021).

Article Google Scholar

Egorova, N. B. & Kurbatova, E. A. Immunotherapeutic concept of the use of microbial antigens in atopy and pathology associated with conditionally pathogenic microflora (using the example of the multicomponent Immunovak-VP-4 vaccine). Med. Immunol. 10(1), 1320. https://doi.org/10.15789/15630625-2008-1-13-20 (2008).

Article Google Scholar

Isho, B. et al. Persistence of serum and saliva antibody responses to SARS-CoV-2 spike antigens in COVID-19 patients. Sci. Immunol. 5(52), 5511. https://doi.org/10.1126/sciimmunol.abe5511 (2020).

Article Google Scholar

Fang, L., Zhou, L., Tamm, M. & Roth, M. OM-85 Broncho-Vaxom, a bacterial lysate, reduces SARS-CoV-2 binding proteins on human bronchial epithelial cells. Biomedicines. 9(11), 1. https://doi.org/10.3390/biomedicines9111544 (2021).

Article CAS Google Scholar


View original post here: Secretory IgA and course of COVID-19 in patients receiving a bacteria-based immunostimulant agent in addition to ... - Nature.com
FDA tells users to throw away Cue Health’s home COVID tests – Fierce Biotech

FDA tells users to throw away Cue Health’s home COVID tests – Fierce Biotech

May 15, 2024

The FDA is recommending that anyone who still has any home COVID tests left from Cue Health should throw them away.

According to the agency, its inspectors discovered that the diagnostics company had made undisclosed changes to its products in the time since receiving a green light from the FDA and that these changes reduced the reliability of the tests to detect SARS-CoV-2 virus.

Do not use any Cue Health COVID-19 Tests for Home and OTC Use that you may still have. Dispose of the entire test cartridge in the household trash, the FDA wrote in its notice to the public and urged users to take a different test if they previously received a negative result but still have symptoms.

The agency also handed Cue a warning letter late last week, which said the modifications the company made to its tests hardware and firmware could result in the device failing earlier than its nine-month expiration date.

Cue said in a May 13statementthat it is evaluating the letter and determining its response, with more information to follow in the next few days. The companys stock fell by about 15% on the news, down to about 12 cents.

Though the San Diego-based Cue was first founded in 2010 with the goal of providing an easier, more portable molecular screener for diseases such as influenza, the arrival of the COVID-19 pandemic kicked its operations into high gear.

The company, a former Fierce 15 winner, raised $100 million in venture capital cash through a June 2020 funding roundamid federal contracts worth hundreds of millions more to help juice its manufacturing capacity, and while inking deals to provide tests to the NBA and Major League Baseball.

The year after, it filed a $200 million Nasdaq IPO with a first-day high of over $22 per share and a valuation approaching $3 billion, with a pledge to expand its catalog far beyond COVID. The company aimed to become a full-service home diagnostic provider for diseases such as the flu and respiratory syncytial virus, as well as sexually transmitted conditions and more.

With its battery-powered, palm-sized reader and single-use PCR cartridges, Cue received emergency COVID authorizations from the FDA for both point-of-care testing by healthcare workers and for use in the home by the general public.

Last summer, it claimed a full de novo clearance from the FDA for its over-the-counter coronavirus testmarking the first at-home test for any respiratory disease, and one celebrated by agency leadership as a trailblazer in a new era of consumer access to diagnostic tests.

However, Cue shortly came under investor pressure, as its share price continued to decline alongside the publics demand for home testsor COVID tests of any kind. Last August, Tarsadia Investments, representing a group of family stockholders that had backed Cue during its pre-pandemic series B round, called on the companys board to launch a strategic review of its business before Cue ran out of money.

In March, the company reported $70.9 million in 2023 revenues, alongside a net loss of $148.4 million.

Earlier this month, the company disclosed in a Securities and Exchange Commission filing the latest in a series of layoffs since January 2023: Cue plans to cut its global workforce by about half, letting go of 230 employees.

Prior to that, the company saw the departure announcements of its co-founder and long-time CEO, Ayub Khattak, in March, followed by its chief financial officer Aasim Javed. Co-founder and Chief Product Officer Clint Sever now serves as CEO.

Cue had previously scheduled its 2024 first-quarter earnings release for May 13, but it has been delayed; its annual general meeting is scheduled for today, May 14.


Read more: FDA tells users to throw away Cue Health's home COVID tests - Fierce Biotech
Former West Virginia health official gets probation in COVID-19 payment investigation – The Associated Press

Former West Virginia health official gets probation in COVID-19 payment investigation – The Associated Press

May 15, 2024

CHARLESTON, W.Va. (AP) A former West Virginia state health official was sentenced Monday to one year of probation for lying about whether or not he verified vendor invoices from a company claiming to have conducted COVID-19 tests for the state.

Timothy Priddy was sentenced in federal court for his guilty plea to making a false statement to investigators.

An indictment filed in October charged Priddy with lying to federal agents in August 2022 when he said he verified a vendors invoices for performing COVID-19 tests as part of a back-to-school program before approving them. Priddy knew his statements were false because he made no such verification efforts, according to prosecutors.

Priddy, 49, of Buffalo, West Virginia, had faced up to five years in prison and a $250,000 fine.

Priddy, who held various managerial positions with the state Bureau for Public Healths Center for Threat Preparedness, left his job the day the indictment was announced.

Prosecutors said federal investigators were trying to determine whether one or more vendors providing COVID-19 tests and mitigation services to the state overbilled or otherwise received federal payments they shouldnt have through the state Department of Health and Human Resources. Investigators focused on a vendor that submitted invoices approved by Priddy for payments exceeding $34 million.

Prosecutors said the vendor reported the results of about 49,000 COVID-19 tests between October 2020 and March 2022 but submitted invoices reflecting the cost of about 518,000 test kits. The indictment did not name the vendor but said the company was from out of state and provided test kits, laboratory analysis and held community testing events throughout West Virginia.

Vendors were required to report test results so officials would have accurate information about the number of COVID-19 infections and any geographical hot spots, the indictment said.

The West Virginia Health Department has said that a contract with the company ended in October 2022 and that the agency cooperated fully with federal investigators.

U.S. Attorney Will Thompson said significant questions remain concerning the legitimacy of the vendors invoices but there is no evidence that Priddy lied to protect the vendor or further its business.

Instead, it appears that Mr. Priddy lied to hide his own dereliction of duty, Thompson said.


Read more here:
Former West Virginia health official gets probation in COVID-19 payment investigation - The Associated Press