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Wednesday, August 23, 2023

Don’t believe doomsayers — new COVID outbreak is mild, and masks don’t help

 COVID-19 cases are expected to rise this fall as new variants become more prevalent. And, as unfortunately expected, it’s already triggered demands by some of our more zealous public health enforcers, not to mention some teachers’ unions, to reinstate mitigation measures including mandatory masking. 

Some researchers are already recommending that when cases go up, people will need to wear masks indoors again.

Epidemiologist Katelyn Jetelina, author of the widely read newsletter “Your Local Epidemiologist,” predicts COVID-19  “is going to be disruptive this winter, and it will cause a number of people to die,” and added, “That’s just not acceptable to the public health world, especially since it’s preventable.” In a recent “PBS Newshour” interview, she suggested “wearing masks in crowded areas, especially during a surge” and “certainly at home, it works, if you want to reduce household transmission.” 

About 100 colleges and universities still require students to be vaccinated. A smaller number of schools including Rutgers, Georgetown, and Morris Brown College in Atlanta have reinstated mask mandates on campus.

Grade schools may be next. The Biden administration recently appointed teachers’ union boss and long-time school closure advocate Randi Weingarten to a new Department of Homeland Security school safety advisory council tasked with recommending “preparedness measures” and “safety and security” in schools.

New Yorkers seen masking up again, Brooklyn August 22, 2023.
COVID-19 cases are expected to rise this fall as new variants become more prevalent.
Paul Martinka

None of this incipient hysteria is warranted.

The SARS-CoV-2 virus that causes COVID-19 is, as expected, continuing to mutate. The EG.5 variant is the most common US strain now, making up an estimated 21% of new infections in the two-week period ending August 19. The next-most common, at 13%, is the FL.1.5.1 variant.

EG.5 and FL.1.5.1 share a common spike protein mutation — F456L — which appears to help them spread more easily than earlier variants, possibly because the mutation decreases susceptibility to antibodies in previously vaccinated and/or infected people

But neither variant seems to cause more severe disease than earlier Omicron strains which were themselves less virulent than the pre-Omicron variants.

New Yorkers seen masking up again, Brooklyn August 22, 2023.
New Yorkers were seen masking up in Brooklyn on Tuesday.
Paul Martinka
New Yorkers seen masking up again, Brooklyn August 22, 2023.
The EG.5 variant, the most common US strain, accounts for an estimated 21% of new infections in the two-week period ending August 19.
Paul Martinka

Lurking in the background is a new, highly mutated strain called BA.2.86, which has thus far only been detected in seven cases in four countries — Denmark, Israel, the United Kingdom, and a US case in Michigan. BA.2.86 is worrisome because it has 35 mutations on the spike protein relative to the XBB.1.5 variant targeted by the forthcoming revised vaccines. This is as big an evolutionary jump as Omicron was from the original Wuhan strain.

The fact that the genetic sequences in all seven cases were close and that BA.2.86 has been found around the world suggests that it may be spreading beneath the radar. Nevertheless, while BA.2.86 may prove to be highly transmissible, there is nothing yet to suggest it will cause more severe illness.

The fact is, nearly everyone has some degree of immunity to COVID-19 that will protect them against severe disease and mortality. Blood bank data showed that as of September 2022, about 96% of people 16 and older have immunity resulting from vaccination (26%), infections (23%), or both (48%). The numbers should be higher a year later.

New Yorkers seen masking up again, Brooklyn August 22, 2023.
Data showed that as of September 2022, about 96% of people 16 and older have some immunity.
Paul Martinka

Moreover, many of the revised mandates are directed at low-risk populations. School-age children, ages 5-14, accounted for less than one-tenth of a percent of total COVID-19 deaths. High school and university ages, 15-24, were a quarter of a percent.

Finally, there is little evidence that masking works for either students or teachers. In Sweden, which kept schools open without mask mandates, there was no increase in childhood cases and teachers had no increased risk of severe COVID-19 infection compared to other occupations.

Multiple studies have failed to document a benefit from masks. But masks do interfere with social interactions and are particularly damaging to the psychosocial and educational development of schoolchildren.

New Yorkers seen masking up again, Brooklyn August 22, 2023.
Should cases rise dramatically, those at increased risk from COVID will need to exercise caution.
Paul Martinka

Should cases rise dramatically, those at increased risk from COVID — the elderly (more than three-quarters of deaths), the immunocompromised, and people with multiple underlying medical conditions — will need to exercise caution, just as they should during any annual flu season.

But the time for widespread COVID-19 mandates is over.

Dr. Joel Zinberg is a senior fellow at the Competitive Enterprise Institute and director of the Paragon Health Institute’s Public Health and American Well-Being Initiative.

https://nypost.com/2023/08/23/new-covid-outbreak-is-mild-and-masks-dont-help/

AstraZeneca facing two London lawsuits over COVID-19 vaccines

 AstraZeneca is facing two London lawsuits, including one from the husband of a woman who died after receiving the Anglo-Swedish drugmaker's COVID-19 vaccine, in the first of potentially dozens of cases brought in England.

Britain was the first country to roll out the at-cost AstraZeneca COVID-19 vaccine in early 2021, although it later restricted the use of it among under 40s due to the small risk of blood clots.

Anish Tailor, whose wife Alpa died in March 2021 after receiving her first dose of the vaccine, filed a product liability claim against AstraZeneca at London's High Court on Aug. 4, according to court records.

His lawyer Peter Todd, from the law firm Scott-Moncrieff & Associates, told Reuters that he has nearly 50 other clients who will formally sue AstraZeneca in the coming months.

AstraZeneca declined to comment on active legal cases. A spokesperson said in a statement: "Patient safety is our highest priority and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines.

"Our sympathy goes out to anyone who has lost loved ones or reported health problems."

AstraZeneca is facing a similar lawsuit from Jamie Scott, who was diagnosed with vaccine-induced thrombotic thrombocytopenia, which can cause fatal blood clotting, after receiving the AstraZeneca vaccine.

Scott filed a product liability lawsuit against AstraZeneca on Monday, according to court records. No filings or further details about the case were immediately available.

Hausfeld, the law firm representing Scott, said it represents around 40 other individuals or bereaved families.

Sarah Moore, a lawyer at Hausfeld, said in a statement that Scott had "suffered life-changing injuries which have severely impacted not only him, but those close to him".

She said Scott will argue AstraZeneca is "liable to compensate him for what he has suffered so that he can rebuild his life as far as possible and ensure the security of his family".

The two cases are the first lawsuits brought in England and Wales over an adverse reaction to a COVID-19 vaccine, according to publicly-available court records.

https://finance.yahoo.com/news/astrazeneca-facing-two-london-lawsuits-151515532.html

Wagner chief Yevgeny Prigozhin presumed dead after Russia plane crash

 Wagner boss Yevgeny Prigozhin was on the passenger list of a jet which crashed killing all on board, Russia's civil aviation authority has said.

Earlier, Wagner-linked Telegram channel Grey Zone reported the Embraer aircraft was shot down by air defences in the Tver region, north of Moscow.

The private jet, which was flying from Moscow to St Petersburg, was carrying seven passengers and three crew.

Prigozhin led a failed mutiny against the Russian armed forces in June.

Grey Zone said local residents heard two bangs before the crash and saw two vapour trails.

Tass news agency said the plane, an Embraer Legacy belonging to Prigozhin, caught fire on hitting the ground.

The aircraft had been in the air for less than half an hour, it said.

An investigation has been launched into the crash and emergency services are searching the site.

Another news agency, Ria, said eight bodies had been recovered.

Grey Zone reports that a second business jet owned by Prigozhin landed safely in the Moscow region.

The 62-year-old mercenary boss headed the mutiny on 23-24 June, moving his troops from Ukraine, seizing the southern Russian city of Rostov on Don, and threatening to march on Moscow.

The move came after months of tension with Russian military commanders over the Ukraine conflict.

The stand-off was settled by a deal which allowed Wagner troops to move to Belarus or join the Russian army.

Prigozhin himself agreed to relocate to Belarus but has apparently been able to move freely, making public appearances in Russia and releasing a video of him purportedly in Africa.


But several Russia watchers have described him as a "dead man walking" since the mutiny.

President Putin's initial reaction to his challenge to Russia's defence establishment was vitriolic, calling it a betrayal and a stab in the back in a video message on 24 June.

The deal did not mean he was safe.

"Revenge," commented CIA director William Burns, "is a dish Putin prefers served cold" - or words to that effect.

None of this, of course, is proof that Prigozhin and his entourage were deliberately targeted.

But given the circumstances any claims that his demise, if confirmed, was an accident will see a lot of eyebrows raised.


https://www.bbc.com/news/world-europe-66599733

Biogen's Leqembi set for strong uptake based on Baird physician survey

 Leqembi, Biogen's Alzheimers drug that recently won full US FDA approval, is set to capture significant market share, according to a new physician survey from Baird.

https://seekingalpha.com/news/4005683-biogen-leqembi-alzheimers-strong-uptake-baird-physician-survey

Orphan Drug Designation for Immix Biopharma NXC-201 as Treatment for Multiple Myeloma

 FDA Orphan Drug Designation (“ODD”) qualifies NXC-201 for:

  • 7 years of U.S. market exclusivity after approval

  • Tax credits for qualified clinical testing

  • Waiver of the Prescription Drug User Fee (currently at almost $3 million for a new drug)

  • The $13.9 billion Multiple Myeloma market in 2017 is expected to reach $28.7 billion in 2027 according to Wilcock, et al. Nature Reviews

 Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio” or the “Company”), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) designation for NXC-201 for the treatment of a life-threatening form of blood cancer, multiple myeloma. NXC-201, a next generation CAR-T cell therapy, is currently being evaluated in a Phase 1b/2a clinical trial NEXICART-1 (NCT04720313).

The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to 7 years of market exclusivity in the U.S. upon regulatory approval.

https://finance.yahoo.com/news/u-food-drug-administration-approves-123700882.html

Gingrich Says Biden Behavior In Maui 'Just Plain Frightening' As MSM Triggered Over 'Nodgate'

 by Steve Watson via Summit News (emphasis ours),

Former Speaker of the House Newt Gingrich encapsulated Joe Biden’s jaw droppingly disastrous fly by of Maui on Monday, calling it “beyond just being heartless.”