Court Asked To Block Punishment Of All Navy Members Seeking Religious Exemptions From Mandate

 by Zachary Stieber via The Epoch Times (emphasis ours),

A federal court that blocked punishment of 35 Navy members seeking religious exemptions to the military’s COVID-19 vaccine mandate should widen the ruling to cover any Navy personnel seeking an exception, lawyers said in a filing on Monday.

The complaint in the case, U.S. Navy SEALS 1-3 et. al v. Lloyd Austin et. al, was amended to a class-action effort.

That means the judge presiding over the case could widen the block of the mandate to the nearly 4,000 Navy active-duty or reserve members who are seeking religious exemptions.

“Our clients are boldly leading the fight against the vaccine mandate, but no service member should face discipline or punishment for following their faith,” Mike Berry, general counsel for First Liberty Institute, which is representing Navy personnel in the case, said in a statement.

“The fact that the military continues to demonstrate hostility to anyone who expresses religious objection to the vaccine mandate shows that the Biden Administration does not care about religious freedom. The lawsuit seeks to protect as many service members as possible from further punishment. We have to put a stop to this before any more harm is done to our national security,” he added.

The Navy has approved zero religious exemptions, and only two have been approved by the entire U.S. military. That runs afoul of federal law, including the Religious Freedom Restoration Act, plaintiffs asserted.

U.S. Judge Reed O’Connor, a George W. Bush nominee, agreed, ruling last month that the Navy does provide a process to apply for religious accommodations “but by all accounts, it is theater.”

“The Navy has not granted a religious exemption to any vaccine in recent memory. It merely rubber stamps each denial,” he added.

A Navy spokesperson told The Epoch Times in an email shortly after the ruling that the branch “supports and respects the beliefs and religious practices of our Sailors.”

“Waivers for immunizations are balanced with operational readiness, unit cohesion, good order, discipline, health and safety,” the spokesperson said. “When this interferes with a member’s right to practice their faith according to the dictates of their conscience, the Navy works with the member to find ways to accommodate religious practice that are the least burdensome way possible for the member. All requests for religious accommodation, to include the COVID vaccine mandate, are handled in the same manner.”

Twenty-two Navy members have been discharged for refusing to get vaccinated as of Jan. 19.

The branch has only granted a single religious accommodation request since the beginning of 2015, according to documents filed in a different case challenging the military mandate, which was imposed by Austin, the secretary of defense, with support from President Joe Biden.

The amended complaint comes several days after Biden administration lawyers asked the U.S. Court of Appeals for the Fifth Circuit to overturn O’Connor’s preliminary injunction, which blocks punishment against the 35 Navy personnel as the case is decided by the courts.

The administration hasn’t yet submitted its argument as to why the injunction should be lifted. It was ordered by the court to provide certain information by Feb. 7, according to the docket.

https://www.zerohedge.com/covid-19/court-asked-block-punishment-all-navy-members-seeking-religious-exemptions-mandate

Herpes Zoster Vaccine Can Save Your Patients' Eyesight

 The first vaccine for shingles in the United States — Zostavax — was approved by the US Food and Drug Administration in 2006. The landmark study, published in the The New England Journal of Medicine in 2005, involved over 38,000 adults aged 60 years or older and found that the vaccine reduced the incidence of herpes zoster by 51%.^[1] Because the FDA study only included individuals who were 60 years or older, it was only approved for that group. Plus, this vaccine was a live attenuated virus, so it was contraindicated in most immunocompromised individuals. In 2011, FDA approval was expanded to include persons aged 50 years or older.

A 50% reduction, admittedly, is not great, but as a corneal specialist and having seen firsthand the devastation that herpes zoster can do to the eye (this is called herpes zoster ophthalmicus [HZO]), I got this vaccine as soon as I was eligible and encouraged all of my relatives, friends, and patients who were eligible to do the same.

In 2017, a recombinant subunit herpes zoster vaccine (Shingrix) was FDA approved. The clinical trial leading to that FDA approval involved more than 15,000 participants aged 50 years or older, and the vaccine's effectiveness proved to be over 96% in all age groups.^[2] Obviously, 96% is a lot better than 51%, plus this vaccine is not a live attenuated virus and therefore could be used in immunocompromised individuals. Because it had been many years since I received my original shingles vaccine, I got this new vaccine as soon as I could from my doctor's office (there were availability issues for the first year or two after FDA approval) and again encouraged all of my relatives, friends, and patients who were eligible to do the same.

We all know that results in clinical trials are not always duplicated in the real world, and we also know that these trials looked at herpes zoster in general and not HZO. So, does this new shingles vaccine really prevent HZO?

Lu and colleagues used a large insurance database that included over 4.8 million individuals over the 2-year period from 2018 to 2019 to answer this question. They found that the recombinant zoster vaccine is 89% effective against HZO. Pretty damn good in real life! However, they also found that a woefully low 3.7% of eligible patients received two valid doses of the vaccine.^[3] That's not totally surprising because they state that only 31% of adults aged 60 years or older had received the original zoster vaccine almost a decade after FDA approval.

As ophthalmologists, we understand how terrible HZO can be. My former partner in practice at Wills Eye Hospital, Dr Elisabeth Cohen, has stated publicly that one of the reasons she had to stop clinical practice was because of poor vision that resulted from her own case of HZO. She is now at New York University running a large multicenter trial to determine the efficacy of suppressive antiviral treatment for HZO.

What can we as eye care professionals do? We should be asking all of our patients who are 50 years or older whether they have had a shingles vaccine and encourage them all to get one! In my experience, that question is much less politically charged than asking about COVID vaccination. I'm in the process of customizing our EHR system to require the technician to ask every patient who is over 50 years old whether and when they were vaccinated for zoster. I can then easily see who is not vaccinated and encourage them to get the shingles vaccine. We have to do a better job!

https://www.medscape.com/viewarticle/966888

AIM ImmunoTech: Positive Results from Phase 1/2 Ovarian Cancer Study

 Chemokine-modulating IP chemo-immunotherapy combination demonstrated to be well tolerated, and associated with interferon stimulated gene changes that favor cytotoxic T lymphocytes chemoattraction and function

Strength of data support advancement into Phase 2 clinical study

Phase 2 study will be conducted to evaluate immunologic and clinical efficacy of tumor loaded αDC1 vaccine in conjunction with the cisplatin/chemokine modulatory combination regimen

AIM ImmunoTech Inc. (NYSE: American AIM) (“AIM” or the “Company”), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, today announced the publication of positive data from a Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer. The manuscript titled, “Phase I trial combining chemokine-targeting with loco-regional chemo-immunotherapy for recurrent, platinum-sensitive ovarian cancer shows induction of CXCR3 ligands and markers of type 1 immunity1” was published in the American Association for Cancer Research publication, Clinical Cancer Research.

The Phase 1/2 study being conducted by the University of Pittsburgh School of Medicine is designed to evaluate the immunologic and potential clinical effectiveness of intensive locoregional sequential intraperitoneal (IP) cisplatin (IPC) with intravenous (iv) paclitaxel followed by peritoneal infusion of a chemokine modulatory (CKM) regimen composed of a cocktail of IP rintatolimod and interferon-alpha (IFNα) for patients with advanced stage ovarian cancer (III-IV) at primary neoadjuvant setting. AIM ImmunoTech provided rintatolimod (Ampligen®, a dsRNA acting as TLR3 agonist), for the Phase 1/2 study.

“These results represent an important extension of prior studies using human tumor explants that showed Ampligen’s potentially important role as a TLR3 agonist acting synergistically with high-dose IFNα and celecoxib to selectively enhance Teff cell-attractants while suppressing Treg-attractants in the tumor microenvironment with a concomitant increase in the Teff/Treg ratio. This current study shows that similar findings are seen combining Ampligen with chemokine-targeting and chemo-immunotherapy in patients being treated for recurrent ovarian cancer. The importance of boosting the Teff/Treg ratio in the tumor microenvironment is that it is associated with the conversion of ‘cold’ tumors into ‘hot’ tumors, which have an increased sensitivity to chemo-immunotherapy and an improved chance of showing tumor regression. This, of course, creates the potential for a positive survival advantage,” stated David Strayer, MD, Chief Medical Officer, Chief Scientific Officer of the Company and Board Certified in Medical Oncology.

https://finance.yahoo.com/news/aim-immunotech-announces-publication-positive-130000265.html

ResMed gets 2 upgrades

 To Overweight from Neutral at JP Morgan

To Neutral from Underperform at B of A; target to $250 from $239

https://finviz.com/quote.ashx?t=RMD

Should we be worried about Omicron ‘stealth variant’ BA.2?

 With healthcare systems around the world labouring under the strain of dealing with the Omicron wave of COVID-19 infections, attention is already turning to a new sub-variant that is starting to emerge in some countries, including the UK, India and Denmark.

Dubbed BA.2, the sub-variant of Omicron (BA.1) hasn’t been classed as a variant of concern (VoC) by the World Health Organisation (WHO) yet, but is under investigation by the UK’s Health Security Agency with more than 400 cases detected in England so far.

Some scientists have given it the nickname ‘stealth variant’, because it is more difficult to detect than BA.1 and doesn’t share the genetic deletion on the spike protein that has been used to monitor the spread of Omicron and distinguish it from Delta, which fuelled the last wave of COVID-19 cases.

There are signs that BA.2 may be out-competing Omicron in the countries it has been detected, according to some media reports, although the UKHSA is taking a cautious stance on the new strain.

Early analyses suggest an increased growth rate compared to BA.1, it said, while cautioning that growth rates have a low level of certainty early in the emergence of a variant. So far, BA.2 has been seen in around 40 countries worldwide.

There are also concerns that it may be being under-detected, as its changed signature could lead to false negatives on PCR testing.

“It is the nature of viruses to evolve and mutate, so it’s to be expected that we will continue to see new variants emerge as the pandemic goes on,” said Dr Meera Chand, COVID-19 Incident Director at UKHSA.

“Our continued genomic surveillance allows us to detect them and assess whether they are significant,” she added. “So far, there is insufficient evidence to determine whether BA.2 causes more severe illness than Omicron BA.1, but data is limited and UKHSA continues to investigate.”

One expert, epidemiologist Prof Tobias Kurth of the Charite Hospital in Berlin, told German broadcaster Deutsche Welle think that the virus isn’t likely to be sufficiently different from Omicron to threaten the effectiveness of vaccines.

There is however already evidence that the currently-used shots are less effective against preventing transmission of Omicron than earlier COVID-19 variants, although early signs they still afford protection against severe disease.

“It’s really up to us to get vaccinated to stop the spread of the virus on the global level,” said Kurth.

https://pharmaphorum.com/news/should-we-be-worried-about-omicron-stealth-variant-ba-2/

Does Omicron Pose as Much of a Blood Clot Threat?

 The first wave of the pandemic brought a sharp, unexpected rise in fatal blood clot complications in COVID-19 patients, such as pulmonary embolism, breakthrough clots clogging dialysis lines, and even emergent strokes in the young and healthy.

Now with Omicron dominating U.S. cases, clotting complications appear to have declined. Although it's still too early to know for sure whether Omicron has altered thromboembolism risk compared with other variants, Omicron may cause less severe disease and therefore carry lower risk of clots.

Anecdotally, clinicians contacted by MedPage Today universally reported seeing fewer deep vein thrombosis/pulmonary embolism (DVT/PE) cases in recent months.

"We have not seen, particularly with this surge, the same level of blood clotting complications that we had been during that initial wave," said Peter Faries, MD, a vascular surgeon at Mount Sinai in New York.

Looking at studies from the initial waves of the pandemic, a systematic review and meta-analysis published in Radiology in February 2021 found that 16.5% of all COVID patients examined had PE and 14.8% had DVT. Those admitted to the ICU had a higher risk of PE than those who were not (24.7% vs 10.5%, respectively).

Additionally, another meta-analysis published in Thrombosis Journal last March found that the overall venous thromboembolism incidence was 9% overall among hospitalized COVID-19 patients and 21% among those admitted to the ICU.

While patients in critical care still appear to be at a high risk of clotting, Michael Streiff, MD, medical director of the Johns Hopkins Special Coagulation Laboratory in Baltimore, said that he hasn't seen any recent patients return with PE/DVT after hospitalization, which had happened in earlier waves. "It seems like the clot risk is a little bit less, but we don't know," Streiff said.

"Almost all of the clotting complications we've seen are really in the more acute phase," Faries agreed.

What's Different About Omicron?

The risk of clotting may have changed for a number of reasons, Faries told MedPage Today, such as less severe illness with Omicron, the availability of vaccines, or widespread use of anticoagulation therapy among at-risk patients.

Also, previous strains of SARS-CoV-2 caused an inflammatory response in the body that increased risk of blood clots – one that has yet to be seen as frequently with Omicron, said Alex Spyropoulos, MD, director of anticoagulation and clinical thrombosis services at Northwell Health in new Hyde Park, New York.

The majority of pulmonary embolisms during the first and second waves of the pandemic were in situ lung clots rather than clots that broke off and traveled to the lungs, Spyropoulos noted. Some evidence shows that Omicron may be more limited to the upper respiratory airway, meaning it would be less likely to cause clots directly in the lungs.

"Anecdotally, we're not seeing the amount of in situ pulmonary embolus that we know we saw in the first wave of the pandemic," Spyropoulos told MedPage Today.

However, he cautioned: "Let's not downplay the importance of the Omicron variant as a cause for decompensation of an otherwise very comorbid and sick patient." It could push such patients to a "tipping point" in which they could develop more severe COVID-19 and face a greater risk of clotting, he suggested.

Prevention and Treatment

Monitoring patients who might be at an increased risk of blood clots remains critical with Omicron.

It's important to avoid a "false sense of security" with Omicron, especially when case numbers are so high and could be driving a greater number of severe cases, said Behnood Bikdeli, MD, MS, a cardiologist with Brigham and Women's Hospital in Boston who has been involved in COVID-19 clot prophylaxis trials.

Some factors that may put patients at a greater risk of blood clots include advanced age, a history of cardiopulmonary disease, a history of cancer, immobility, and a history of sepsis or severe infection, Spyropoulos said. Also, a patient with Omicron who presents with D-dimer levels that are extremely elevated, he said, should be monitored closely due to elevated risk of thrombosis and death.

Another factor is vaccination status, Faries noted, as patients who are unvaccinated present with more severe illness, and thus are more prone to blood clots.

Even if clotting shows up less often in this wave of the pandemic, the protocols for prophylaxis haven't changed at most centers, Streiff said. Identifying patients at risk, conducting routine D-dimer tests, and administering anticoagulation therapy has remained in place, he said.

The NIH recommends prophylactic dosing of anticoagulation medication for patients who are hospitalized with COVID-19. Among critically ill patients, low molecular weight heparin or unfractionated heparin is preferred over oral anticoagulants, because they have shorter half-lives, can be administered intravenously or subcutaneously, and have fewer interactions with other drugs.

Considering that Omicron may cause less severe illness, it may be time to reassess the use of full-dose anticoagulants -- and their inherent bleeding risk -- in moderately sick hospitalized patients, said Stephan Moll, MD, of the division of hematology at the University of North Carolina at Chapel Hill. But more epidemiological studies and prospective trials will be needed to evaluate the risks and benefits of those therapies.

"I think it's enough to know that we have seen blood clots in patients who have Omicron," said Bikdeli "Now the question of, do we see more of it or less of it? And when we see it, are [patients] having more ominous outcomes or not? Those questions need adjusted analyses."

"So for now, I'm thinking of it more or less along the same lines of prior variants until we get more high quality data to inform us," he added.

White House: Biden does not look at stock market to judge economy

 U.S. President Joe Biden does not look at the stock market as a way to judge the strength or weakness of the U.S. economy, White House press secretary Jen Psaki said on Monday, as markets plunged on fears of a Russian attack on Ukraine.

“Unlike his predecessor the president does not look at the stock market as a means by which to judge the economy,” Psaki said, adding the market was up 15% since Biden took office.

https://finance.yahoo.com/finance/news/white-house-biden-does-not-191315520.html