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Wednesday, August 9, 2023

Biden Admin Concedes No Evidence Behind Recommendation for 6 Annual COVID Booster Shots

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

President Joe Biden's administration concedes that there is no scientific evidence to support an apparent recommendation to receive as many as six COVID-19 booster shots in a year.

After Health Secretary Xavier Becerra, a Biden appointee, wrote in a social media post on Nov. 29, 2022, that people should get vaccinated “if it’s been over 2 months since your last dose,” the Functional Government Initiative (FGI) filed a Freedom of Information Act request for documents supporting the statements.

The watchdog organization then sued after the administration didn't comply with timelines laid out in the law.

FGI asked for, among other documents: "Any scientific support relied on by Secretary Becerra when approving or issuing the tweet recommending that all Americans receive a booster shot every two months" and "any study, synopsis, or similar statement or document of scientific, academic, or government research on whether a bi-monthly booster shot will effectively prevent the transmission or susceptibility to COVID-19 and known active variants as of November 2022."

It also asked for internal communications regarding Mr. Becerra's statements.

In a new response, the government said it had no evidence to support Mr. Becerra's recommendation.

"The department reviewed 1,263 pages of potentially responsive records captured in the agency’s search for this FOIA request. After a careful review of these records, I determined the 1,263 pages were not relevant to your request," Alesia Williams, an official in the Department of Health and Human Services (HHS), told FGI.

"The lack of a single of a single record supporting Secretary Becerra’s bold public health recommendation for six COVID boosters a year is a startling development," Pete McGinnis, a spokesman for FGI, said in a statement.

"It is tremendously irresponsible for the government’s chief health official to fire off tweets recommending frequent injections of a new vaccine booster apparently based on no academic or scientific support," Mr. McGinnis added.

"How can the public be assured that the agency is ‘following the science’ on other important public health matters when it demonstrates such clear disregard for basic scientific integrity standards on an issue as important as COVID vaccine shots?"

The group noted that Mr. Becerra, a lawyer by training, lacks a background in health. Doctors typically lead that department.

Booster Recommendations

As newer COVID-19 variants have emerged, the vaccines have performed increasingly worse. Federal officials inside HHS first cleared booster shots in 2021 due to the flagging effectiveness, and have since authorized and recommended additional shots.

In the spring of 2023, regulators had authorized, without clinical trial data, newly formulated versions of the vaccines aimed at Omicron subvariants. Federal officials had said that people should get a booster if more than two months had elapsed since their most recent shot. The U.S. Centers for Disease Control and Prevention (CDC) said most people should only receive one additional shot, but that certain groups could receive more.

In another statement promoting vaccination, Vice President Kamala Harris claimed that a single shot would protect people from COVID-19 for an entire year. There's no evidence supporting that claim.

Mr. Becerra said the day after the initial post: “An updated COVID vaccine can help protect you from the worst outcomes of COVID. If it’s been over 2 months since your last dose, make a plan to get one now.”

He later wrote: "Time to get your updated COVID vaccine if 1) You haven’t gotten the updated vaccine yet & had the primary series or original booster 2+ months ago 2) It’s been 3+ months since you’ve had COVID If you have a big event in 2+ weeks, it’s a good time to go."

FGI said the differing messages were causing confusion and made it appear as if Mr. Becerra was, at least at one point, recommending up to six shots in a year.

HHS has declined to comment on the suit.

"The clear message from across the Administration is: Don’t wait," an HHS spokesperson previously told The Epoch Times, after being asked about Mr. Becerra's statements. "Get your free COVID-19 vaccine. It’s safe and effective. People can go to vaccines.gov to find free and easily available vaccines in their community."

New Vaccines Coming

The updated slate of vaccines isn't working well, prompting plans to implement new formulations that, for the first time, won't include components of the Wuhan virus strain.

The updated shots are expected to be rolled out in the fall.

The CDC's new director, Dr. Mandy Cohen, said recently that the agency is poised to recommend annual shots.

"We anticipate that COVID will become similar to flu shots, where it is going to be you get your annual flu shot and you get your annual COVID shot," Dr. Cohen said.

The CDC didn't respond to a request for comment.

Rep. Brad Wenstrup (R-Ohio), chairman of the U.S. Select Subcommittee on the Coronavirus Pandemic, and other members asked the CDC (pdf) for information on the planned recommendation, noting that it would "mark a significant change in federal policy and guidance regarding COVID-19 vaccines and the way in which they are utilized."

https://www.zerohedge.com/political/biden-admin-concedes-no-evidence-behind-recommendation-6-annual-covid-booster-shots

Eagle Pharma cut to Underweight from Neutral by Piper

 Target to $17 from $26

https://finviz.com/quote.ashx?t=EGRX&ty=c&ta=1&p=d

SPAC MedTech Acquisition shareholders approve TriSalus merger (MTAC)

 MedTech Acquisition Corp. (MTAC) shareholders have voted in favor of the SPAC's planned merger with oncology products developer TriSalus.

https://seekingalpha.com/news/4000224-spac-medtech-acquisition-shareholders-approve-trisalus-merger?source=feed_sector_healthcare

Rand Paul Slaps Fauci With DC Criminal Referral Over Perjury Allegations

 Sen. Rand Paul (R-KY) has filed a criminal referral against Dr. Anthony Fauci for allegedly lying under oath about the origins of Covid-19.

In a Tuesday letter to DC US Attorney Matthew Graves, Paul demanded an investigation into Fauci for allegedly perjuring himself during a 2021 congressional hearing in which he said COVID-19 couldn't have come from a Chinese lab he was funding

"Dr. Fauci testified that 'the NIH has not ever and does not now fund gain-of function research in the Wuhan Institute of Virology.' In a subsequent hearing, I warned Dr. Fauci of the criminal implications of lying to Congress and offered him an opportunity to recant his previous statements," Paul wrote in the letter obtained by the Daily Mail.

"In response, Dr. Fauci stated that he had 'never lied before the Congress' and 'd[id] not retract that statement,'" adding "Dr. Fauci's testimony is inconsistent with facts that have since come to light."

The move comes weeks after Paul submitted an 'official criminal referral' to the Justice Department, which a Paul aid told the Mail, never responded.

"Since AG Garland doesn’t appear to want to do his job, I’ve today sent evidence for a criminal referral for Anthony Fauci to the US Attorney in DC," Paul said in another tweet.

"Before Congress, Dr. Fauci denied funding gain-of-function research, to the press he claims to have a dispassionate view on the lab leak hypothesis, and in private he acknowledges gain-of-function research at WIV to his colleagues  His own colleagues have acknowledged Dr. Fauci's inconsistency," the letter to Graves continues. "A congressional hearing, however, is not the place for a public servant to play political games – especially when the health and well-being of American citizens is on the line."

Paul previously wrote to Attorney General Merrick Garland on July 14 and July 23 calling for an investigation into whether Fauci lied under oath over his knowledge of dangerous virus research that was taking place at the Wuhan lab, in China.

In July 2021, Dr Fauci testified how his former department 'has not ever and does not now fund gain-of-function research in the Wuhan Institute of Virology.'

Gain-of-function research refers to a type of scientific investigation conducted on  viruses, with the purpose of enhancing their transmissibility or virulence.

The aim is to understand how viruses evolve and potentially predict and prepare for future disease outbreaks, but also raises concerns regarding biosafety and biosecurity. -Daily Mail

Earlier this month, Paul said he had Fauci 'dead to rights' over lying during testimony

Meanwhile, journalist Hans Mahncke has an interesting thought for Rand... send the referral to AGs in red states.

As Summit News notes, Earlier this week, Paul shared a link to an article in the Free Press, outlining how Fauci is "guilty as charged."

Terns Pharmaceuticals (NASDAQ:TERN) Price Target Cut to $8.00

 HC Wainwright lowered their price objective on Terns Pharmaceuticals from $11.00 to $8.00 in a research note on Wednesday

https://www.marketbeat.com/instant-alerts/nasdaq-tern-a-buy-or-sell-right-now-2023-08-09/

Virios to Advance Fibromyalgia Candidate IMC-1 to Phase 3

  Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases such as fibromyalgia (“FM”) and Long-COVID, today announced that the Food & Drug Administration (“FDA”) communicated that, following their initial review of the Company’s chronic toxicology program, the program’s studies appear adequate to support the safety of IMC-1 at the dose proposed by the Company for chronic use. With this critical feedback in hand, the Company plans to initiate its proposed pharmacokinetic and food effect study (“pK”) this year, while concurrently resubmitting a final Phase 3 program outline and study protocols for FDA review. Following completion of the pK study, the goal will be to begin enrollment in the first fibromyalgia Phase 3 safety and efficacy study in mid-2024.

Key Highlights and Upcoming Milestones

  • The Company plans to execute the pK study in males and females as a precursor to the FM studies with an updated IMC-1 dose and formulation, which is intended to enable the Company to take advantage of all of the efficiencies afforded with utilization of the 505(b)(2) regulatory pathway.
  • Consistent with the previously proposed Phase 3 plan, the Company will concurrently submit its final Phase 3 program outline and associated study protocols to FDA, to progress the following:
    • Two adequate and well-controlled clinical studies; and
    • A long-term extension trial to support chronic administration of IMC-1.
  • Based on the results from its recently completed FORTRESS Phase 2b trial, the Company has designed a Phase 3 development program targeting community-based FM patients who have not participated in prior FM trials.

“We look forward to initiating our pK study with the updated formulation of IMC-1 while finalizing the protocols and procedures required for Phase 3 development of IMC-1 as a treatment for FM. The safety and efficacy results from the FORTRESS trial, along with the chronic toxicology program results, have enabled us to define a clinical trial program as well as a formulation and dose of IMC-1 to enhance our chances for success,” said R. Michael Gendreau, Chief Medical Officer of Virios Therapeutics.

The Company will share more information about its FM Phase 3 program during its earnings update on Thursday, August 10, 2023 at 8:30 a.m. ET.

https://www.biospace.com/article/releases/virios-therapeutics-announces-plans-to-advance-lead-candidate-imc-1-to-phase-3-development-as-a-new-treatment-option-for-fibromyalgia/

Takeda, Denali Scrap Phase I Alzheimer’s Drug Showing ‘Narrow Therapeutic Window’

 Takeda and Denali Therapeutics have jointly ended an investigation into the effectiveness of an experimental Alzheimer’s therapy after early Phase I data suggested a “narrow therapeutic window” for the treatment.

The two companies first partnered back in 2018 to investigate three different targets for neurodegenerative disorders. Later, in late 2021, they agreed to go forward with a drug collaboration using an antibody transport vehicle (ATV) called DNL919, to activate the TREM2 receptor.

However, it quickly ran into headwinds after the FDA put a clinical hold on drug development before it could enter human trials, though it got the go-ahead and entered clinics in July 2022. Denali has previously said that function loss in that receptor is associated with increased Alzheimer’s risk, and the hope was that the ATV could increase microglial function—and, early Phase I data appeared to back that up.

In its second-quarter financial results reported Tuesday, Denali said the data showed “robust target engagement and effects on microglial biomarkers” as well as the drug being “clinically well tolerated at doses with demonstrated changes” while “there were no serious adverse events or severe treatment emergent adverse events.”

Still, those data also showed “safety signals of moderate, reversible hematolic effects were observed at the highest dose tested, suggesting a narrow therapeutic window for the Alzheimer’s disease patient population,” Denali said. The companies agreed to drop drug development on that basis, citing the “rapidly evolving treatment landscape for Alzheimer's disease whereby an understanding of drug combinations with newly approved therapies will be important.”

Denali, however, also noted that these safety findings are “believed to be specific to properties of DNL919 and TREM2 biology,” leaving the window open for other treatments. The companies “will focus research efforts on back-up molecules in preclinical development, including exploration of potential combination therapy given recent new drug approvals in Alzheimer's disease.”

With DNL919 scrapped, the companies may switch their focus to amyloid-targeting therapies. Not only do they have these therapies in the pipeline, but they’ve already demonstrated success: Biogen and Eisai already have a monoclonal amyloid antibody treatment, Leqembi, approved, and Eli Lilly’s donanemab is undergoing Phase III clinical trials.

Denali has its own separate partnership with Biogen and noted in its financial report that “Biogen exercised their option to our ATV-amyloid-beta program for Alzheimer’s disease.” With Biogen, the company “made revisions to the BIIB122 (LRRK2 inhibitor) clinical development plan intended to increase efficiency by focusing on one study in Parkinson’s disease.”

https://www.biospace.com/article/takeda-denali-scrap-phase-i-alzheimer-s-candidate-data-shows-narrow-therapeutic-window-/