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Just In | The Hill 

The Food and Drug Administration (FDA) said on Friday that AstraZeneca’s preventative monoclonal antibody treatment for COVID-19 is likely ineffective against the XBB.1.5 omicron subvariant due to its similarity to other mutations of the virus that are also not neutralized by the treatment.

In a statement, the FDA said it “does not anticipate that Evusheld will neutralize XBB.1.5.”

“This means that Evusheld may not provide protection against developing COVID-19 for individuals who have received Evusheld and are later exposed to XBB.1.5,” said the agency. “However, we are awaiting additional data to verify that Evusheld is not active against XBB.1.5. We will provide further updates as new information becomes available.”

Evusheld is a combination of two monoclonal antibodies that has been authorized as a pre-exposure prophylaxis to prevent COVID-19 infections in those who are moderately to severely immunocompromised.

The treatment was also recommended for use in people who may not be good candidates for coronavirus vaccination or those who have history of developing adverse reactions to COVID-19 shots. The Centers for Disease Control and Prevention also previously recommended Evusheld to be administered in immunocompromised people who have been vaccinated as a supplement the vaccine’s protection.

Evusheld is currently the only authorized available option for pre-exposure prophylaxis in immunocompromised individuals who may not develop a strong enough immune response from vaccination alone.

The FDA advised health care providers to inform their patients of the increased risk of COVID-19 infection due to variants that are not neutralized by Evusheld.

The XBB.1.5 subvariant accounts for about 2 percent of COVID-19 cases in the U.S. as of this week, with most cases in the Northeast now attributed to this mutation. Health officials have stated that XBB.1.5 appears to evade immune protection better than previous subvariants, with some calling it the most transmissible subvariant that has been detected so far.

While Evusheld is likely ineffective against preventing infection from XBB.1.5, officials from the White House have said that the bivalent COVID-19 booster dose as well as the antivirals like Paxlovid are likely still effective at treating cases brought on by the subvariant as well as reducing the chances of severe illness.

​Healthcare, AstraZeneca, fda, omicron subvari Read More 

Just In | The Hill 

The University of Maryland St. Joseph Medical Center violated federal law when it refused to provide gender-affirming surgical care to a transgender man because of his gender identity, a federal court ruled Friday.

Jesse Hammons, a transgender man diagnosed with gender dysphoria, was denied a hysterectomy to remove his uterus in 2020 after his scheduled surgeon discovered Hammons was transgender, citing a hospital policy that prohibits medical personnel from providing gender-affirming health care to transgender individuals.

St. Joseph Medical Center, now part of the University of Maryland Medical System (UMMS), was, up until 2012, owned and operated as a Catholic hospital by Catholic Health Initiatives. As a condition of its purchase agreement, UMMS pledged to continue operating St. Joseph “in a manner consistent with Catholic values and principles.”

That includes complying with a “formal reporting mechanism” to ensure the hospital is held accountable for its Catholic identity. The National Catholic Bioethics Center (NCBC) audits the hospital every two years to assess its adherence to a set of religious directives for Catholic health services set by the United States Conference of Catholic Bishops.

While the directives themselves – known as the Ethical and Religious Directives for Catholic Health Services – state that medical procedures that induce sterility “are permitted when their direct effect is the cure or alleviation of a present and serious pathology,” guidelines for transgender health care set by the NCBC are much more stringent.

“Gender transitioning should never be performed, encouraged, or positively affirmed as a good in Catholic health care,” reads a guidance document issued by the group. It adds that government mandates “do not alter the immorality of gender transitioning interventions” and Catholic hospitals should seek religious exemptions.

“Litigation may be appropriate in response to unjust legal coercion,” the document states.

On Friday, District Court Judge Deborah K. Chasanow ruled that UMMS and St. Joseph Medical Center had violated Section 1557 of the Affordable Care Act – which prohibits discrimination in health care on the basis of sex – in denying Hammons a hysterectomy simply because he is transgender.

“The undisputed facts establish that the decision to cancel Mr. Hammons’ hysterectomy pursuant to a policy that prohibits gender-affirming care was discrimination on the basis of his sex,” Chasanow wrote.

“Defendants have not identified evidence that suggests that Mr. Hammons’s surgery was cancelled for any other reason,” she added. “Therefore, Defendants’ position that the denial of Mr. Hammons’s surgery had nothing to do with his sex or gender identity is simply not supported by any evidence.”

UMMS had tried to remove itself as a defendant in Hammons’ case, arguing that only the funding recipient for the “specific discriminatory program” – which in this case is St. Joseph Medical Center – is liable under Section 1557.

Chasanow on Friday denied that claim, arguing that UMMS is “undoubtedly” engaged in the business of providing health care through its network of hospitals.

“A plain reading of the statute supports a conclusion that UMMS could be held liable under Section 1557 for discrimination that occurs in any of its hospitals,” she wrote in the ruling.

Hammons in a statement released by his attorneys at the American Civil Liberties Union (ACLU) said Friday’s win was an important step toward ensuring transgender people are no longer denied equal treatment because of who they are.

“All I wanted was for UMMS to treat my health care like anyone else’s, and I’m glad the court recognized how unfair it was to turn me away,” Hammons said. “I’m hopeful UMMS can change this harmful policy and help more transgender people access the care they need.”

In a statement to The Hill, a UMMS spokesperson said the hospital system is “carefully reviewing” Chasanow’s ruling and disagrees with “many of the conclusions that were reached in this decision.”

“This legal claim stems directly from, and is traceable to, a surgeon mistakenly scheduling a procedure that could not be performed at UM SJMC,” the spokesperson said. “Although our offer to perform gender affirming surgery at a different location was declined by Mr. Hammons, the University of Maryland Medical System remains committed to meeting the unique medical needs of transgender individuals and patients who are routinely scheduled by physicians for appointments and procedures at UMMS member organizations.”

​Court Battles, ACLU, Affordable Care Act, transgender health coverage Read More 

Just In | The Hill 

A majority of the House is 218 members — but that number is not always required to elect a Speaker.

The Speaker is elected by a majority of all members present and voting for a candidate — not counting “present” votes and absences.

With 434 incoming members and one vacancy, that number is 218 if all members vote. But if one member votes “present” or is absent, that number is lowered to 217. If three members are absent or vote “present,” that number lowers to 216.

Former Speakers Nancy Pelosi (D-Calif.) and John Boehner (R-Ohio) were each elected with only 216 votes in 2021 and 2015, respectively.

Three members were absent during the 12th Speaker ballot on Friday morning, meaning the number to win would have been 216. And with Rep. Kevin McCarthy (R-Calif.) flipping 13 of his 20 detractors to support him in that ballot, he got up to 213 votes, just three votes shy of getting the gavel.

Rep. David Trone (D-Md.) was absent on Friday for the 12th Speaker ballot due to a previously scheduled surgery, his spokesperson said in a statement. But he was back at the Capitol by 2 p.m. for the next ballot, he said in a tweet.

Trone’s move to rush back to the Capitol illustrates the importance of the Speaker math. His return to the Capitol for the 13th vote ticked the majority threshold up to 217.

Those two other absences are GOP McCarthy supporters. Rep. Ken Buck (Colo.) reportedly flew to Colorado for a medical procedure on Thursday, and Rep.-elect Wesley Hunt (Texas) flew to Texas to be with his family after his son was born prematurely a few days ago.

Some reports said Buck is expected to be back in Washington later this evening. But even if both Buck and Hunt return to vote for McCarthy, he will need to either flip two of the six GOP holdouts or convince several of them to vote “present.”

If the House extends voting until Saturday, McCarthy could lose another supporter due to absence. Rep. Kevin Hern (R-Okla.) will be attending a funeral for his mother.

​House, News Read More