FDA says yes to MSD’s 21-valent adult pneumococcal jab

 The rivalry between Pfizer and MSD in pneumococcal vaccines has dialled up a notch with the FDA approval of MSD’s new shot Capvaxive, the first to be aimed specifically at adults.

The 21-valent product – formerly known as V116 – covers a wider range of Streptococcus pneumoniae serotypes than any of MSD’s earlier vaccines and eight that are not covered by any other approved pneumococcal vaccine.

The approval is the strongest challenge yet to Pfizer’s pneumococcal vaccine franchise, led by its 20-valent Prevnar 20 shot, which generated $6.4 billion in sales last year from use for prevention of IPD in infants, children, and adults.

MSD’s current jab Vaxneuvance – which covers 15 serotypes – is also approved for use in infants, children, and adults and made $665 million in worldwide sales last year.

With Capvaxive, MSD (known as Merck & Co in the US and Canada) is aiming to carve out a niche in the over-50s, positioning it as the go-to vaccine used to prevent invasive pneumococcal disease (IPD) in this group.

All told, Capvaxive encompasses the serotypes responsible for around 84% of IPD cases in adults aged 50 and over, compared to around 52% with Prevnar 20, according to data from the Centers for Disease Control and Prevention (CDC). The eight serotypes unique to MSD’s vaccine account for more than a quarter (27%) of IPD cases in adults 50 and older.

The CDC’s Advisory Committee on Immunization Practices (ACIP) is scheduled to meet on Thursday 27th June to discuss and make recommendations for the use of Capvaxive in adults. All eyes are on that meeting, as the wording of the ACIP’s recommendations will give the clearest view of how competitive the new shot will be in the US market.

The CDC currently recommends pneumococcal vaccination for all adults age 65 and older and for younger adults who are immunocompromised or have certain other risk factors. If Capvaxive is recommended for the over-50s bracket, it could unlock a lucrative new category in the market, and that age-targeted approach is central to MSD’s targeted pneumococcal vaccine strategy.

It is also deploying its age-targeted serotype selection approach to V117, a paediatric vaccine that is currently in phase 3 testing.

There are around 100 different pneumococcal serotypes, causing non-invasive disease like pneumonia confined to the lungs and invasive disease where the infection can spread to the bloodstream or tissues in the central nervous system. It is estimated that more than 150,000 adults are hospitalised from pneumococcal pneumonia each year in the US.

MSD also sells an older shot called Pneumovax 23, which covers 23 serotypes, but is based on an older polysaccharide technology that does not stimulate the immune response as strongly as the newer conjugate vaccines. It brought in $412 million in 2023, down from more than $600 million in the prior year.

https://pharmaphorum.com/news/fda-says-yes-msds-21-valent-adult-pneumococcal-jab

Judge blocks Biden’s transgender student protections in 6 more states

 A federal judge on Monday temporarily blocked a Biden administration rule expanding federal nondiscrimination protections for LGBTQ students. 

The decision by U.S. District Judge Danny C. Reeves halts enforcement of changes to Title IX — the federal civil rights law preventing sex discrimination in schools and education programs that receive government funding — that were finalized in April by the Education Department in Kentucky, Indiana, Ohio, Tennessee, Virginia and West Virginia.

The new rule, which covers discrimination based on sexual orientation and gender identity for the first time, had been set to take effect later this summer. 

Reeves, an appointee of former President George W. Bush, wrote in his ruling that the plaintiffs — the six GOP-led states, an association of Christian educators and a 15-year-old girl — will “suffer immediate and irreparable harm” if the rule is allowed to take effect. 

“As [the plaintiffs] correctly argue, the new rule contravenes the plain text of Title IX by redefining ‘sex’ to include gender identity, violates government employees’ First Amendment rights, and is the result of arbitrary and capricious rulemaking,” Reeves wrote. 

His ruling comes days after another federal judge temporarily blocked the administration’s rule from taking effect in Idaho, Louisiana, Mississippi and Montana, after the states sued the Biden administration in April. Lawsuits challenging the rule in more than a dozen other Republican-controlled states are still pending. 

Although Title IX is a federal law, each administration takes a different approach to enforcing its regulations, which schools are then required to follow as a condition of receiving funding from the government. 

The Biden administration’s changes to Title IX are slated to take effect nationwide on Aug. 1, except in states where they have been blocked. Disapproval resolutions filed this month by House and Senate Republicans aim to strike down the rule before its enforcement date. 

Monday’s ruling in Kentucky was celebrated by the state’s Republican Attorney General Russell Coleman, who said the challenge brought against the new rule is part of a larger effort “to protect our women and girls from harm.” 

“We’re grateful for the court’s ruling, and we will continue to fight the Biden Administration’s attempts to rip away protections to advance its political agenda,” Coleman said in a statement. 

Republicans have largely balked at the Biden administration’s Title IX changes, which they say undermine federal nondiscrimination protections for students who are not transgender. The new rule, they argue, also incorrectly applies the reasoning of a 2020 Supreme Court decision that protects employees from discrimination based on sexual orientation and gender identity to Title IX. 

Conservative leaders claim the latest update to how Title IX is enforced will allow transgender women and girls to compete on female school sports teams, invalidating laws passed in 24 GOP-led states that prohibit transgender student-athletes from competing in accordance with their gender identity. Enforcement of four of those laws is already blocked by federal court orders. 

The Education Department has yet to finalize a separate rule governing athletics eligibility, however. The proposal unveiled last year would prohibit schools from adopting polices that categorically ban transgender student-athletes from sports teams that match their gender identity. 

Education Secretary Miguel Cardona in June denied reports that the athletics rule is being deliberately delayed because of the presidential election. 

In a statement to The Hill, an Education Department spokesperson said the department is reviewing Monday’s ruling in Kentucky and the Thursday ruling in Louisiana preventing the administration’s new rule from taking effect. 

“The Department crafted the final Title IX regulations following a rigorous process to realize the Title IX statutory guarantee,” the spokesperson wrote in an email. “The Department stands by the final Title IX regulations released in April 2024, and we will continue to fight for every student.” 

https://thehill.com/regulation/court-battles/4726114-judge-blocks-bidens-transgender-student-protections-in-6-more-states/

'Groups urge FEMA to recognize extreme heat, wildfire smoke as a ‘major disaster’'

 A coalition of environmental, labor and healthcare groups called on the Federal Emergency Management Agency (FEMA) to classify extreme heat and wildfire smoke as “major disasters” to unlock federal funding for states during these weather events.

The petition, filed on Monday by dozens of groups across several states, seeks to assist states and local regions struggling to financially recover from the surge of extreme heat and wildfire smoke amid climate change.

“It’s urgent that FEMA treats intensifying heat waves and wildfire smoke as the major climate disasters they are,” Jean Su, energy justice director and senior attorney at the Center for Biological Diversity, the petition’s lead author, said in a statement. “It’s past time for FEMA to address the climate emergency head-on.”

Should FEMA include extreme heat and wildfire smoke in the regulatory category of a “major disaster,” funding could be given to state, local and Tribal governments for community solar and storage, cooling centers, air filtration systems and community resilience hubs, per the petition.

Last year marked the hottest year ever recorded, with average land and ocean temperatures reaching 2.12 degrees Fahrenheit above the 20th-century average, the National Oceanic Atmospheric Administration confirmed earlier this year.

Experts predict the extreme heat, fueled by climate change, will likely continue to some extent in the coming years.

The Center for Biological Diversity, the environmental group and lead author on the petition, pointed to a National Weather Service statistic that found heat is the leading disaster-related killer in the U.S. and has killed more individuals than hurricanes, tornadoes and floods combined.

As for wildfires, the average U.S. resident breathed in more wildfire smoke than in any year since 2006, the Center for Biological Diversity said.

The American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), one of the petition’s signatories, pointed to the need for more labor protections for those called in to assist with these weather events.

“Too many workers are exposed to extreme heat and wildfire smoke on the job without adequate safety measures in place. Not only do we need to develop strong worker protection standards to meet the demand of the changing environment and intensifying climate disasters, we need the federal government to take action now to release resources,” Liz Shuler, president of AFL-CIO, said in a statement.

The Hill reached out to FEMA for further comment.

https://thehill.com/policy/energy-environment/4726763-groups-fema-extreme-heat-wildfire-smoke-major-disaster/mlite/

'Biden issues massive immigration relief, seeking balance after border crackdown'

 The Biden administration will allow certain undocumented immigrants married to U.S. citizens to stay in the country and work legally, expanding a program that’s currently used to provide papers to immediate family of military servicemembers.

The Tuesday morning announcement comes amid the 12-year anniversary celebration of the Deferred Action for Childhood Arrivals (DACA) program, which President Biden will celebrate at the White House later in the day with immigrant advocacy and Latino leaders.

Biden’s move comes weeks after the administration adopted a crackdown on asylum at the U.S.-Mexico border that angered the same groups the new measure is designed to please.

Neither measure came as a surprise: For months, immigration advocates had been dreading the border security initiative and eagerly awaiting the relief measure.

“The announcement to be made by the Biden administration today is the most significant positive immigration policy change in the last 12 years,” said Rep. Jesús “Chuy” García (D-Ill.), one of Congress’s most active pro-immigrant advocates.

“One child out of every ten in Illinois has an undocumented parent. These moms and dads have built lives in our country and have contributed to the economy, but live in constant fear of deportation.”

The expansion of parole in place, as the regularization program is known, will be paired with measures to make the work visa application easier for undocumented immigrants — particularly DACA beneficiaries — who have graduated from U.S. colleges.

Beneficiaries won’t receive new privileges — existing paths to regularize the migratory status of undocumented immigrants will be streamlined under the new rules.

For spouses of U.S. citizens, undocumented college graduates and holders of so-called “liminal” statuses such as DACA, the process to straighten out their papers currently involves risky trips abroad that can result in yearslong or permanent separations from their families and communities in the United States.

“The purpose of this process is to facilitate the adjustment of status process domestically, to avoid people having to travel abroad and be separated from their family if they are otherwise eligible to adjust,” an administration official told reporters Monday.

The parole in place measure will allow undocumented immigrants who are married to U.S. citizens or who are the adoptive children of U.S. citizens to apply for a case-by-case assessment of their parole request.

Without the parole, applicants who did decide to leave the country to apply for permanent residency from abroad could be subject to mandatory three- or ten-year waits, on top of an already uncertain resolution.

To be eligible, prospective parolees must have been in the United States for 10 years as of Monday.

Approved applicants will be given three years to apply for permanent residency and meanwhile will receive a three-year work permit and deferral from deportation

The administration and advocates estimate that about half a million non-citizen spouses will be eligible, as will about 50,000 non-citizen children.

There are currently an estimated 1 million undocumented immigrants part of mixed-status families in the United States, but about half of them have more difficult cases that can make them ineligible to apply for permanent residency.

Immigration law poses different bureaucratic barriers to foreign nationals, depending on factors such as the number of illegal entries, whether they’ve overstayed a visa and how long they have been in the country illegally.

Depending on individual cases, many of those people will be ineligible for the new program, as will other longtime undocumented immigrants who are not married to U.S. citizens.

“Providing relief and peace of mind to mixed-status families, and to the 45,000 DACA recipients in my state, is a step in the right direction to make our immigration system more fair and just. Still, many of my constituents won’t benefit from today’s announcement, and I will continue to push for work permits for our long-term immigrants who have waited for relief for decades,” said García.

Biden’s action targeted at Dreamers will also benefit a subset of that population, granting undocumented college graduates certainty that they will receive a necessary waiver if they apply for a work visa.

Most foreign nationals can apply for work visas if they have a job offer in the United States and fulfill requirements like a four-year college degree.

Undocumented applicants can also apply using that process, but they must be granted a waiver by consular officers reviewing their visa applications — a risky prospect since that consular review needs to happen while the applicant is abroad.

By removing some of that risk, the application process should become more palatable for eligible undocumented immigrants who would otherwise avoid leaving the United States for fear of being unable to return.

“The idea is just to reflect that we recognize that there is a national interest element to making sure that people who have been educated in the United States are able to put their education and skills to use for the benefit of our country,” an administration official told reporters.

The measure is also galvanizing immigrant advocates who fear the new streamlined processes would be done away with in a potential second Trump administration.

They are giving full-throated support to the measure, sending a message both to Biden and to immigration restrictionists that they expect it to receive substantial political support.

While the asylum crackdown generally polled well, it was panned from the right as too little too late — and improbably, as a form of amnesty — and from the left as a humanitarian and legal non-starter.

Pro-Trump super PAC MAGA Inc. on Monday also panned the new plan as an “amnesty.”

But the relief measure means national Latino and immigrant leaders are all but certain to give Biden the sort of enthusiastic political praise that’s so far eluded him.

“We should all be saying that with our chest, because this is not the fight the anti-immigrant groups want to have. I think this is really great policy and great politics,” said Todd Schulte, president of FWD.us, an immigration reform advocacy organization.

And pro-immigrant advocacy groups are already sharpening their political knives, keen to show Biden they will take the fight to Republicans.

“An overwhelming majority of Americans agree that humane solutions for Dreamers and spouses of U.S. citizens are good for the economy and good for families. It would be absurd for Republicans to demonize something that benefited two of President Trump’s wives,” said Rebecca Shi, executive director of the American Business Immigration Coalition.

https://thehill.com/latino/4726536-biden-immigration-southern-border-crackdown-daca-dreamers-deportation/

AstraZeneca's breast cancer drug combination fails in late-stage trial

 AstraZeneca said on Tuesday its breast cancer drug, Truqap, in combination with chemotherapy agent, paclitaxel, did not meet its main goals in a late-stage trial to improve overall survival of patients with a type of breast cancer.

Triple-negative breast cancer remains one of the most challenging forms of disease to treat due to the lack of known actionable biomarker targets, and chemotherapy-based regimens continue to be the mainstay of treatment, AstraZeneca said.

The trial, known as CAPItello-290, was testing whether the drug combination improved overall survival in patients with inoperable or metastatic triple-negative breast cancer versus the older and cheaper chemotherapy agent, paclitaxel, in combination with a placebo.

The study failed to achieve its goals in both the overall trial population and in a sub-group of patients with tumours harbouring specific biomarker alterations, the drugmaker said.

"While we are disappointed in the CAPItello-290 outcome, these results will further our understanding of the role of the PI3K/AKT pathway in breast cancer," said Susan Galbraith, executive vice president, oncology R&D, AstraZeneca.

https://www.yahoo.com/news/astrazenecas-breast-cancer-drug-combination-070602195.html

Live Fire Incident: Casualties Reported After North Korean Soldiers Cross Military Demarcation Line

 Something big is happening on the heavily militarized Korean border, following several days of soaring tensions which has included North Korea flying hundreds of trash and feces-filled balloons into the south.

There are several reports of dozens of North Korean soldiers having briefly crossed the border, and soon retreating, after warning shots were fired by South Korean border troops, according to South Korea's Yonhap news agency.

Per Reuters, citing Yonhap at about 11:00am local time: "South Korea's military fired warning shots after North Korean soldiers crossed the Military Demarcation Line near the border, the Yonhap news agency reported on Tuesday citing the country's Joint Chiefs of Staff."

A Yonhap wire has further said "Korea military suffers 'multiple casualties' in landmine explosion near border."

While details of exactly what is happening are still emerging, this comes one week after a live fire incident occurred along the border. Last Tuesday, South Korean border forces fired warning shots after troops on the other side 'accidentally' crossed the border in the south. 

Here is what happened exactly one week ago:

"There were no unusual movements other than the North Korean army immediately moving north after our warning shots," South Korea’s Joint Chiefs of Staff spokesman, Col. Lee Sung-jun, told a briefing.

He generally downplayed the incident which happened Sunday, and suggested there was no indication the enemy troops were seeking to invade territory.

"The South Korean military is closely monitoring the movements of the North Korean military and taking necessary measures."

If casualties among DPRK troops are confirmed, this could be the start of a major live fire incident between the two historic enemies, also as Kim Jong-Un has been warning he could restart nuclear tests.

US state-funded Stripes reported yesterday:

North Korean troops have been observed creating anti-tank barriers, reinforcing roads and carrying out other military projects within the Demilitarized Zone, according to the South’s military on Monday. South Korean intelligence agencies spotted the improvements near the border in recent days, army Col. Lee Seong-jun, a spokesman for the country’s Joint Chiefs of Staff, said during a news conference Monday.

Lee declined to elaborate on the North’s activities at the border and said the South’s military was still analyzing its operations. North Korean troops were also observed building walls and roads between the Military Demarcation Line — the actual border between the two Koreas — and the Demilitarized Zone, an unidentified military source said in a Yonhap News report Saturday. The 2½-mile-wide DMZ spans 150 miles across the Korean Peninsula from coast to coast.

Nuclear saber-rattling has been coming out of Pyongyang since last summer, when the US Navy parked a nuclear submarine in South Korea for the first time in years.

South Korea’s Ministry of National Defense: North Korean inside the Demilitarized Zone that divides the Korean Peninsula last year.

Pyongyang has also reportedly deployed extra troops the border amid the escalating tit-for-tat.

developing...

https://www.zerohedge.com/geopolitical/live-fire-incident-casualties-reported-after-north-korean-soldiers-cross-military

House committee demands answer on eight Tajik border crossers arrested for terror plot

House Republicans are demanding answers after an FBI counterterrorism sting in three major US cities reportedly rolled up eight Tajik nationals who’d crossed the US Southwest Border and were planning a terrorist bombing.

In a new letter, House Homeland Security Committee Mark Green and several subcommittee leaders are demanding that Alejandro Mayorkas, secretary of Homeland Security, disclose whether border agencies could have known of terrorism connections when the Tajik Eight first crossed, and how those agencies handled the immigrants after their releases through to the moment the FBI alerted them about plot.

At least some of the Tajik Eight crossed more than a year prior to their early June 2024 arrests by ICE. And the undercover FBI sting operation was underway for quite some time, according to media reporting.

House Republicans sent a letter to Homeland Security Secretary Alejandro Mayorkas demanding answers after eight terror suspects from Tajikistan were arrested after crossing the border.Al Drago – Pool via CNP / MEGA

Their letter points to an NBC news report that ICE in the first week of June arrested the Tajik Eight on immigration-related charges only “after the FBI alerted them that the men possessed a connection to the terrorist group ISIS.”The lawmakers are investigating whether overwhelmed border agency personnel are able to properly screen terrorists and other criminals.

View this document on Scribd

The committee cites my report listing seven accidental terror suspect releases – each a counterterrorism intelligence failure – and its call for forceful congressional intervention and concerted government investigation.

“Unfortunately, the unacceptable security failures that have allowed individuals with terrorist ties to enter the United States through the Southwest Border have become an alarming pattern under the administration,” the letter states.

The committee, which holds special oversight responsibility for all homeland security-related government activity, wants the immigration files on all eight suspects, communications between the FBI and US Immigration and Customs Enforcement that would reveal how the eight arrested immigrants were handled after their border crossings, and all derogatory information in the terrorist watch list database about them.

They want a briefing by June 27 and the documents and records later.

But if history is any indication, Mayorkas is likely to ignore this reasonable public interest request.

Mayorkas has already blown off an April 3, 2024 committee information request about two of the DHS accidental releases of border-crossing suspected terrorists on the FBI watch list “due to errors within ICE’s internal database.”

An especially egregious security failure happened with the accidental border release of Afghan national Mohammad Kharwin, who was already on the FBI’s terrorism watch list for his associations with the US-designated terrorist organization Hezb-e-Islami.

Border Patrol released him into ICE custody into the so-called “Alternatives to Detention (ATD) program on March 12, 2023 after his illegal crossing from Mexico into California. He remained free for nearly a year until his arrest in San Antonio.

“The Department’s prioritization of catch, process, and release, presents a grave danger to national security,” the letter said. “The Committee has repeatedly and forcefully highlighted the security vulnerabilities inherent in the massive influx of illegal aliens at our border. The Biden Administration and the Department, however, continue to hide their heads in the sand, ignoring the ‘blinking red lights’ everywhere.”

Todd Bensman, a senior national security fellow at the Center for Immigration Studies, is the author of “America’s Covert Border War” (2021).

https://nypost.com/2024/06/17/us-news/house-committee-demands-answer-on-eight-tajik-border-crossers-arrested-for-terror-plot/