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Friday, April 1, 2022

More Evidence Hybrid Immunity Confers Highest Level of COVID Protection

 Hybrid immunity from a COVID-19 infection plus a vaccine provided an immune boost against symptomatic disease, as well as severe outcomes, Brazilian researchers found.

Among people who survived a COVID infection from Feb. 24, 2020 to Nov. 11, 2021, vaccine effectiveness against symptomatic disease at least 14 days after series completion was 44.0% (95% CI 31.5-54.2) for Johnson & Johnson's vaccine and 64.8% (95% CI 54.9-72.4) after two doses of Pfizer's vaccine, reported Julio Croda, MD, PhD, of Universidade Federal de Mato Grosso do Sul in Brazil, and colleagues.

Moreover, vaccine effectiveness against COVID-related hospitalization or death was 57.7% (95% CI -2.6 to 82.5) for Johnson & Johnson's vaccine, and 89.7% (95% CI 54.3-97.7) for Pfizer's, the authors wrote in Lancet Infectious Diseases.

While four COVID vaccines in total were evaluated (including AstraZeneca's vaccine and CoronaVac), only Johnson & Johnson's and Pfizer's are authorized for use in the U.S.

"There has been ongoing public debate about whether previously infected individuals need to be vaccinated," said Croda in a statement. "Our results suggest that vaccine benefits far outweigh any potential risk and support the case for vaccination, including the full vaccine series, among individuals with prior SARS-CoV-2 infection."

However, the authors noted that this analysis was done prior to the emergence of the Omicron variant.

Using national data, Croda and team identified 30,910 people (5.4% of the total 213,457 individuals who tested positive for COVID at least 90 days after the start of the vaccination program) who had a subsequent positive test "consistent with reinfection"; 22,566 were matched with 68,426 controls who tested negative.

Median age of the matched population was 36, and about 60% were women. Median time between first infection and a subsequent positive test was 216 to 223 days. About 65% of cases and 57% of controls were unvaccinated. Overall, 39,717 people were vaccinated -- about 80% were vaccinated with either AstraZeneca's vaccine or CoronaVac, 15% were vaccinated with Pfizer's vaccine, and 2% with Johnson & Johnson's.

Of the four examined vaccines, only Pfizer's vaccine showed a significant increase in effectiveness against symptomatic disease when given 180 days after the first infection versus 91 to 180 days (70.7% vs 35.3%, P=0.011).

An accompanying editorial by Pramod Kumar Garg, MBBS, MD, and Ramachandran Thiruvengadam, MD, of the Translational Health Science and Technology Institute in Faridabad, India, noted that the vaccine effectiveness estimates in this study are "generally lower than those in naive populations reported earlier," but added that these "estimates were for additional protection provided by vaccination over and above that offered by immunity resulting from natural infection."

This study "challenges the concept of population-level herd immunity through natural infection alone" and suggests that "vaccinating individuals who were previously infected provides further protection, particularly against severe disease," they noted.

"Understanding the duration and effectiveness of immunity for those vaccinated with a previous COVID-19 diagnosis becomes increasingly important as ... surges in new cases ... occur as a result of more transmissible variants," Croda said in a statement. "Further research on the need for vaccination for those with a previous COVID-19 infection is a vital step to pandemic policy intervention."

Even Sweden Finds Hybrid Immunity Is Best

A second study in Lancet Infectious Diseases found the lowest number of reinfections and hospitalizations among those with hybrid immunity.

Two-dose vaccination plus prior immunity resulted in a 66% lower risk of COVID reinfection versus infection alone (adjusted HR 0.34, 95% CI 0.31-0.39, P<0.001), with a non-significant trend towards attenuation after 9 months (P=0.07), reported Peter Nordström, MD, PhD, of Umeå University in Sweden, and colleagues.

In addition, two-dose hybrid immunity was linked with a significantly lower risk of COVID hospitalization compared with infection alone (aHR 0.10, 95% CI 0.04-0.22, P<0.001).

One dose of vaccine had similar results, albeit on a smaller scale. Hybrid immunity with one-dose vaccination resulted in a 58% lower risk of reinfection (aHR 0.42, 95% CI 0.38-0.47, P<0.001), with significant attenuation after 9 months. One-dose hybrid immunity also resulted in a lower risk of hospitalization (aHR 0.06, 95% CI 0.03-0.12, P<0.001).

Nordström and team examined data from Swedish nationwide registries, looking at infections from March 20, 2020 to Oct. 4, 2021, and hospitalizations with COVID from March 30, 2020 to Sept. 5, 2021. Cohort 1 included 2,039,106 unvaccinated individuals with prior infection who were matched with unvaccinated individuals without prior infection. Cohort 2 included 2,962,318 individuals with prior infection and one vaccine dose and cohort 3 included 567,810 individuals with prior infection and two vaccine doses, both matched to individuals with "natural immunity." Median age in all cohorts was 38 to 40.

Compared with unvaccinated individuals without infection, prior infection was associated with a 95% lower risk of reinfection at 3 months and a 87% lower risk of COVID hospitalization for up to 20 months of follow-up, the authors said.

During a mean follow-up of 66 days, 438 people with two-dose hybrid immunity were reinfected with COVID versus 808 with natural immunity. After a median follow-up of 52 days, there were 639 reinfections among those with one-dose hybrid immunity versus 1,662 reinfections in those with natural immunity.

Due to Omicron plus varying recommendations for boosters, hybrid immunity may result from "vaccination followed by infection," rather than vice-versa, noted Hyon-Xhi Tan, PhD, and Jennifer A. Juno, PhD, of the University of Melbourne in Australia, in an accompanying editorial.

However, they cited research that indicated that regardless of the order of infection and vaccination, "the quantity, quality, and breadth of the humoral immune response were vastly improved."

"This finding further supports the notion that infection histories should be an important consideration in determining whether individuals are protected against SARS-CoV-2," Tan and Juno wrote.


Disclosures

Cerqueira-Silva and colleagues were supported by the Brazilian National Research Council, Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro, Oswaldo Cruz Foundation, JBS, Instituto de Salud Carlos III, Spanish Ministry of Science and Innovation, and Generalitat de Catalunya.

Co-authors disclosed support from the Fazer o Bem Faz Bem programme from JBS, Bristol Myers Squibb, Regeneron, Serimmune, and Tata Medical Devices.

Croda and several co-authors are employees of Fiocruz, a federal public institution, which manufactures Vaxzevria (ChAdOx1 nCoV-19 vaccine) in Brazil through a full technology transfer agreement with AstraZeneca.

Garg and Thiruvengadam disclosed no conflicts of interest.

Nordström and colleagues disclosed no conflicts of interest.

Tan and Juno disclosed no conflicts of interest.

New research hints at why COVID brain fog may persist

 New research released today suggested that an over-stimulated immune system -- possibly triggered by ongoing vascular injury and repair -- may be behind persistent post-COVID cognitive changes.

In preliminary work that will be presented at the American Academy of Neurology annual meeting, researchers led by Joanna Hellmuth, MD, MHS, of the University of California San Francisco, found an "inflammatory signature" in the cerebrospinal fluid of 13 people who had lingering cognitive problems 10 months after they had their first COVID symptoms.

People with persistent cognitive problems after mild COVID-19 had higher levels of two inflammatory markers in their spinal fluid -- C-reactive protein and serum amyloid A -- compared with those who had COVID and no cognitive symptoms, Hellmuth and co-authors reported. Vascular endothelial growth factor markers were also higher in these people, with some measures specific to people who experienced cognitive changes soon after being infected.

"This is an important observation," said Avindra Nath, MD, clinical director of the National Institute of Neurological Disorders and Stroke at the NIH, who wasn't involved with the study. "It suggests vascular injury and repair in the brain may set up the inflammation," he told MedPage Today.

"Many millions of people experience persistent cognitive issues after SARS-CoV-2 infection, which can impact even young, healthy adults who had a mild case of COVID," Hellmuth noted. "However, there are not yet effective laboratory tests or treatments for COVID-associated cognitive changes, in part because we do not understand the underlying biology."

This is a very small study, Hellmuth acknowledged, but the findings, if true, imply that inflammation within the brain may contribute to cognitive changes after COVID, and COVID infection could trigger immunovascular dysregulation through endothelial activation and dysfunction.

Changes in the Brain

Earlier research found damage caused by thinning and leaky blood vessels in brain tissue samples of people who died with COVID, but did not link those changes and resulting inflammation with post-COVID cognition.

Other studies established that post-COVID cognitive changes were similar to symptoms seen after other viral infections like HIV or Ebola, or after chemotherapy.

"The symptoms of cognitive impairment after COVID-19 infection -- impaired attention, concentration, memory, speed of information processing, and executive function -- bear striking clinical similarities to the symptoms of cancer therapy-related cognitive impairment," Stanford University researcher Michelle Monje, MD, PhD, told MedPage Today. "Given these clinical similarities between 'chemo-fog' and 'COVID-fog,' we asked if there were also neurobiological similarities."

In preprint research awaiting journal publication, Monje and co-authors found parallels between the type of cell dysregulation that happens after chemotherapy and mild COVID-19. "We found the same pattern of white matter-predominant microglial reactivity in the brains of people with COVID-19 that we found in the people after chemotherapy," Monje said.

Recent research has shown that people with mild COVID had a greater decline in executive function -- notably in their ability to perform complex tasks -- that dovetailed with brain changes seen before and after COVID on MRI. In a U.K. Biobank study, 401 COVID patients showed a greater loss of gray matter volume and more brain tissue damage an average of 4.5 months after infection compared with people who never were infected.

"The U.K. Biobank study shows the first truly compelling data of a measurable change in the brain structure in people with COVID-19," said Serena Spudich, MD, a Yale University neurologist specializing in nervous system infections, who wasn't involved with the research.

"A key aspect of this study is its focus on people with mild COVID-19," Spudich told MedPage Today. "Only 4% of patients were hospitalized during their bout of acute COVID-19, so the findings come from a population that parallels the experience of most people worldwide who've been infected."

What Drives Cognitive Symptoms?

What drives post-COVID cognitive changes is still a mystery. "The mechanisms have not been very well studied," Nath said. "The indications are that there's at least a subset of persistent immune activation. Now the question is, what type of immune activation are we seeing?"

"My guess is that we're seeing largely macrophage activation, or what I call markers of innate immune response," he added. "What we see in the brain at autopsy is activation of microglia. Once those cells get turned on, they're very hard to turn off. Persistent symptoms are likely to come from that kind of immune activation."

A clinical trial could help move treatment forward while shedding light on what causes post-COVID brain changes, Nath suggested. "We have a lot of drugs that affect the immune system in various ways," he said. "We may be able to figure out what part of the immune system is really impaired and what is not, what is responding to treatment and what is not, and how that is corresponding to recovery."

The NIH plans to start a treatment trial of people with post-COVID cognitive problems, testing intravenous high-dose corticosteroids, intravenous immunoglobulin, and placebo soon, he noted.

"People say you need to know the mechanism behind this," Nath said. "And I would say, yes, that's absolutely true: you don't want to rush because you don't want to cause harm."

"But an argument I would make is that with COVID, you're dealing with a very different beast," he pointed out. "You've got billions of people infected. It takes years to figure out mechanisms. Can we really afford to wait that long?"

https://www.medpagetoday.com/neurology/generalneurology/97981

Thursday, March 31, 2022

Sanofi to list drug ingredients business on May 6

 Sanofi (SASY.PA) expects to list its drug ingredients business EUROAPI on May 6, having received approval from French stock market regulator, the pharmaceutical giant said on Friday.

The listing is set to take place shortly after a May 3 shareholder meeting, at which Sanofi's stakeholders will vote on the listing.

Sanofi said the new shares will be distributed to its shareholders at one EUROAPI share per 23 Sanofi shares.

The company confirmed plans to conserve a 30% stake in the business after the listing while the French state will buy a 12% stake through EPIC Bpifrance for up to 150 million euros ($166 million).

L'Oreal (OREP.PA), Sanofi's largest shareholder with a more than 9% stake, and EUROAPI Chief Executive Karl Rotthier have both agreed to a one-year lock-up period after the listing, it added.

EUROAPI makes active pharmaceutical ingredients (APIs) for medicines and will be based from six production sites in Italy, Germany, Britain, France and Hungary.

Sanofi, which last year accounted for half EUROAPI's revenue, said in January that it expects the business to become the world's second-biggest API player with about 1 billion euros in revenue forecast for this year.

The bulk of EUROAPI's share capital, 58%, will be distributed to Sanofi shareholders through a dividend in kind, in addition to a previously proposed 3.33 euros per share cash payout.

https://www.reuters.com/business/healthcare-pharmaceuticals/sanofi-list-drug-ingredients-business-may-6-2022-04-01/

How a Seagen cancer drug with Nobel Prize science might also work in diabetes

 Some diabetes therapies work by ramping up the body’s secretion of insulin to counteract high blood sugar levels. But a team of scientists at the Karolinska Institute believe preserving insulin-producing pancreatic beta cells—rather than overloading them—would be a better diabetes treatment strategy over the long term.

Following that thinking, the team showed that an experimental cancer drug made by Seagen dubbed PX-478 could improve the function of beta cells and restore blood sugar balance in diabetic mice. The results are published in the journal Science Translational Medicine.

Because PX-478 has already been tested in a clinical trial as an anti-cancer drug and was well tolerated in these patients, the Karolinska researchers hope they could quickly move the drug into clinical trials of diabetes after additional animal tests.

PX-478 is an inhibitor of the hypoxia-inducible factor 1-alpha (HIF-1alpha) protein. The 2019 Nobel Prize in physiology or medicine went to three scientists for their discoveries of HIF’s role in how cells respond to low oxygen levels, or hypoxia.

In Type 2 diabetes, continuous insulin resistance sends pancreatic beta cells into overdrive as the cells try to maintain normal blood sugar levels, eventually wearing the cells out. Previous studies have linked the metabolic dysfunction with hypoxia and HIF-1alpha, given the high energy, oxygen-dependent demands of insulin secretion.

Under normal circumstances, HIF-1alpha is quickly degraded. But in diabetic mouse models, HIF-1alpha was stabilized and accumulated in the animals’ pancreatic islets amid hypoxia caused by an increase in metabolic workload, the Karolinska team found.

The researchers treated the diabetic mice with PX-478. In a mouse model of “extreme” Type 2 diabetes marked by early loss of beta cell function, PX-478 prevented the rise of blood glucose. Mice treated with the drug kept plasma insulin concentration elevated, suggesting their beta cells were still working to release insulin to compensate for insulin resistance. By contrast, untreated mice saw their insulin concentration drop.

In another mouse model with reduced functional beta cells, PX-478 treatment brought blood sugar levels under control, whereas hyperglycemia persisted in nontreated mice.

Pancreatic islets isolated from PX-478-treated mice showed hallmarks of improved beta cell function including an increase in insulin content and expression of genes involved in beta cell function and maturity as well as the formation of insulin granules similar to those of nondiabetic control mice.

The drug also showed similar benefits in organoids of human pancreatic cell islets. It cooled the human beta cells down by reducing basal insulin secretion and increasing a response to high blood sugar, the researchers found.

Hypoxia has broad implications in various diseases. And this is not the first time that scientists have found the repurposing potential of PX-478 in a disease beyond cancer. A research team at Yale University previously discovered that PX-478 held promise for lupus nephritis, because it could reduce kidney inflammation from kidney-infiltrating T cells. 

Because insulin production declines during diabetes, therapeutic strategies have so far mainly focused on improving beta cells' insulin production. Other research efforts that have also focused on the preservation of beta cell function, including targeting the protein TXNIP by scientists at the University of Alabama at Birmingham.

“Current therapies targeting beta cells have only a temporary positive effect on insulin secretion,” Per-Olof Berggren, the current study’s co-senior author, said in a statement. “In the long-term, these drugs lead to beta-cell exhaustion.”

Next up, the Karolinska team aims to test PX-478’s effect on human pancreatic beta cell function in a “humanized” mouse model in which immunosuppressed mouse is transplanted with human islets.

https://www.fiercebiotech.com/research/how-seagen-cancer-drug-might-also-work-diabetes

After FDA hold, CytoDyn will appeal for pharma partnerships to save leronlimab

 With CytoDyn's lead drug on FDA clinical hold, the troubled biotech will go searching for partners to rescue key programs and keep afloat.

Meanwhile, the board is actively searching for a new CEO to replace Nader Pourhassan, Ph.D., who was ousted in January.

The company provided a sweeping corporate update in a conference call Thursday morning, after announcing at market close the day before that the FDA had placed two separate clinical holds on leronlimab. The regulatory shutdown includes a partial hold on CytoDyn’s HIV work and a full hold on the COVID-19 program, according to an after-market release issued Wednesday.

"We will be focused on setting up the company for future success by restoring credibility and determining our most advantageous path forward with the goal of maximizing shareholder value," said Antonio Migliarese, CFO and interim president, on the call.

Migliarese then listed the priorities, which were many: "We plan on doing this by strengthening our clinical operations and prioritizing patient safety, addressing the concerns noted in the partial clinical hold letter received for HIV and the full clinical hold letter received for COVID-19, enhancing leadership with the board, CEO and Scientific Advisory Board, addressing legal and financial issues."

Not to mention analyzing new data in HIV, revamping the timeline for a biologics license application in the indication, releasing results in non-alcoholic steatohepatitis and finding new partnerships with pharmaceutical companies to fund all this work. All that for a company that does not currently have a CEO.

CytoDyn has touted leronlimab as having potential in multiple indications, but the therapy has struggled in the clinic against COVID, and the company has equally faced difficulties in getting regulatory submissions locked down for HIV. The company said in announcing the holds that clinical trials underway in the COVID program in Brazil would be paused pending results from the data safety monitoring committee.

Chief Medical Officer and Head of Business Development Scott Kelly said the company decided to pause the Brazilian trials in COVID because of two cardiac events. The studies feature very sick patients with cardiac and pulmonary manifestations of the disease, he added.

The study remains blinded, meaning CytoDyn does not know whether the patients who suffered the cardiac events received leronlimab or placebo. 

"We discussed this in depth with the physician investigators in Brazil who have extensive pulmonary and critical care expertise, and they believe the events were consistent with the natural course of COVID and nothing out of the ordinary of their experience and prior COVID-19 trials," Kelly said. 

CytoDyn opted to pause the program "out of an abundance of caution," knowing that the data safety monitoring committee would be meeting anyway in April. 

"I want to be clear that this was our decision. We thought it was the right thing to do," Kelly said. Once the committee clears the trial to continue, CytoDyn plans to resume clinical activities.

As for the holds, Kelly said the agency wants aggregated safety data from all the indications leronlimab has been tested in before any further work can be done in the U.S. He called this a "solvable problem," and pledged to complete the work on an eight- to 10-week timeline. Kelly stressed that the company is not enrolling in the U.S. for the COVID program, and the HIV program at issue is a long-term extension study that has wrapped up. 

For the HIV program, CytoDyn said Wednesday that "these patients will be transitioned to other available therapeutics and no clinical studies can be initiated or resumed until the partial clinical hold is resolved." While the company works with the FDA to resolve the holds, no new studies may be started in the COVID-19 program.

The company will also re-evaluate a biologics license application in HIV, which will mean a "delay in clinical activities," according to Chris Recknor, M.D., senior executive VP of clinical operations. The submission will be on hold while the safety data is compiled for the FDA with a new CRO. 

Regarding the search for a new CEO, Board Chair Tanya Urbach said a search committee has been formed. 

"We are excited about the overall quality of the candidate pool and will continue in our efforts to identify the company's next chief executive officer," she said. 

CytoDyn also provided a broad update to its clinical programs, including plans to advance leronlimab in NASH. The company has also been contacted by multiple academic institutions for access to the drug to conduct preclinical studies in glioblastoma multiforme, Alzheimer's disease and others, according to Kelly. Another study could someday look at using leronlimab in COVID long haulers, and there's been interest in combining the therapy with CAR-T treatments in cancer, he said.

All of these indications have confounded major drugmakers for decades, even companies that specialize in diseases like NASH or Alzheimer's. 

For all or most of these initiatives, CytoDyn needs help. Kelly, and other executives said over and over that they would be seeking partnerships to move programs forward. This will help CytoDyn "advance our development efforts and value creation with minimal investment," according to Migliarese.

"As we all know, in clinical trials, it's very costly, but we believe we can leverage the experience of others that are experts in each chosen field," Kelly said. 

He declined to name names, but said, "We have companies under NDA right now and we are advancing those discussions for multiple different applications for leronlimab." 

Another issue that received scant mention is CytoDyn's many legal battles, which include an investigation from the Department of Justice and the Securities and Exchange Commission. Migliarese said the company is fully cooperating with the investigators and "doing our best to expeditiously wrap up the various other legal matters of the company." That includes a spat with a former contract research organization. 

CytoDyn's remaining leadership has a tough to-do list. But the conference call was markedly more sane compared to those previously held when Pourhassan was in charge. In May last year, he begged investors to stop trashing the FDA after the agency's public smackdown of the company over its leronlimab claims. Pourhassan took a barrage of questions from angry investors. But on today's call, Kelly and the team took pre-screened written questions, mostly those surrounding clinical trial updates or the pharma partnerships. 

https://www.fiercebiotech.com/biotech/cytodyns-leronlimab-slapped-fda-holds-covid-19-hiv-programs

Missouri House slated to pass sweeping new abortion bill

 The Republican-led Missouri House is set to pass legislation to defund Planned Parenthood, criminalize mail-order abortion medications, and allow wrongful death lawsuits in rare cases when infants are born alive after an abortion attempt and the infant then dies or is injured.

House lawmakers earlier this week blocked an attention-grabbing amendment to make it illegal to “aid or abet” abortions that violate Missouri law, even if they occur out of state.

Instead, the GOP swapped in another amendment that would make it a crime to provide abortion-inducing medications to women. Doctors could still provide those medicines.

Republican Rep. Brian Seitz, who sponsored the medication abortion bill, said the issue with the proposal to penalize helping women travel out of state for abortions was that it has not been vetted through a committee like his measure has.

If Roe v. Wade is overturned and abortion is banned in Missouri, Seitz’s change would prohibit telemedicine abortions through medications.

“It’s very important that states, especially typically pro-life states, have legislation already in place for the possible overturn of Roe v. Wade,” Seitz said.

House members packed the abortion policies together in an omnibus bill Tuesday in hopes of passing the proposals by lawmakers mid-May deadline despite ongoing GOP infighting that’s causing work in the Senate to move at a glacial pace.

Advocates of Planned Parenthood of the St. Louis Region and Southwest Missouri spokeswoman Bonyen Lee-Gilmore in a statement called the legislation “a kitchen-sink approach to banning reproductive freedom in Missouri.”

“It unlawfully blocks Medicaid patients from preventive care at Planned Parenthood, it spreads inflammatory rhetoric, and seeks to ban common medications used for miscarriages, labor and delivery, and abortion,” she said.

Under the amended bill, family members could also file wrongful death suits if infants born alive after an abortion attempt are injured or later die as a result of the attempted abortion. If the pregnancy is the result of rape, the bill would not allow the rapist to sue.

Republican Rep. Hannah Kelly, who sponsored a bill banning fetal tissue donations onto which the other abortion amendments were added, told colleagues during House floor debate Tuesday that the born-alive provision represents a chance for justice.

Democratic Rep. Keri Ingle warned that the threat of lawsuits would pit families against each other.

Instances of babies being born alive after an induced pregnancy termination are extremely rare.

A review by the U.S. Centers for Disease Control and Prevention of infant mortality data from 2003 and 2014 showed 143 deaths were of infants that displayed signs of life after an induced termination. That was a tiny fraction of the 315,000 infant deaths during those 12 years, a period that also included 49 million live births.

In a majority of those cases, the abortion was induced due to a maternal complication or congenital anomaly in the fetus.

Mary Ziegler, a Florida State University law professor, said current homicide laws could already offer protections for infants born alive after abortions.

She said similar proposals nationally and in other state have mostly been used as a way for Republicans to show their opposition to abortion while forcing Democrats to argue against bills with the stated intent of cracking down on infanticide.

“What they’ve been historically designed to do is to frame the debate around issues that are really uncomfortable for supporters of abortion rights,” Ziegler said of similar proposals.

The Missouri measure also includes yet another attempt by Republican lawmakers to strip Planned Parenthood of any public funding, including clinics that do not provide abortions.

Lawmakers were able to stop money from going to Planned Parenthood in the 2019 fiscal year by forgoing some federal funding to avoid requirements that the clinics be reimbursed if low-income patients go there for birth control, cancer screenings and other preventative care. Missouri instead used state money to pay for those services.

But the Missouri Supreme Court in 2020 ruled that lawmakers violated the constitution by making the policy change through the state budget, forcing the state to reimburse Planned Parenthood for health care provided to Medicaid patients.

It’s unclear whether blocking funding through a policy bill instead of the budget will work, but Republican lawmakers have said they’re hopeful enough to try again.

A vote to send the sweeping bill to the GOP-led Senate could come as early as next week.

https://apnews.com/article/abortion-business-health-lawsuits-missouri-b795a9cf11a28488b875f774c3b414c2

Jayapal: Federal protections for trans kids ‘cannot wait any longer’

 Rep. Pramila Jayapal (D-Wash.), who is a mother to a transgender child, penned an op-ed published by Teen Vogue on Thursday, International Transgender Day of Visibility, calling for federal protections for transgender children.

“Like hundreds of thousands of parents with transgender kids across the country, I want to do everything I can to support my daughter as she strives to embrace who she is and live as her most authentic self,” Jayapal wrote.

“But I also worry deeply that the world we live in now doesn’t receive her in the same way — that she will face violence and barriers that we know are there for too many transgender people.”

The congresswoman noted the higher degree of harassment and mental illness that transgender children face and accused Republicans of worsening these problems by using transgender youth as a “political wedge issue.”

She pointed to the bill recently passed in Texas that classified gender-affirming care for children as child abuse. Jayapal called the legislation “unconstitutional” and “openly discriminatory and hostile to the well-being of these children.” The bill was halted by a Texas appeals court earlier this month.

The congresswoman also noted a similar bill in Idaho that would make gender-affirming youth health care a felony. The measure was passed in the Idaho state House of Representatives earlier this month, but Idaho Senate Republicans declined to vote on it on the basis that it undermined parental rights and allows the government to interfere in parents’ decisions for their children.

“Both of these bills are fueled by a cocktail of ignorance, transphobia, and malice for trans kids, their parents, and the doctors and the communities who want to help them. The bills are an outrageous violation of human rights,” Jayapal wrote. “That’s why today, as we celebrate Transgender Day of Visibility, I stand with every single trans child and the parents who support them.”

“The suffering of transgender children is not inevitable. It is our job — as leaders, as parents, as legislators — to push back on the attacks and to move us forward again toward true equality and justice,” she added.

https://thehill.com/news/house/3255919-jayapal-federal-protections-for-trans-kids-cannot-wait-any-longer/