Monday, February 27, 2023

There's NOT enough data to support multiple annual Covid vaccines, CDC advisers say

A leading Centers for Disease Control and Prevention (CDC) expert panel says people with weakened immune systems do not need more than one annual Covid booster.

The Advisory Committee For Immunization Practices (ACIP) said Friday that there is no reason for the elderly or immunocompromised to receive multiple shots in one year.

This goes against current CDC guidance, which recommends people most vulnerable to the virus to receive shots more often than once a year.

They did recommend the group who are most at risk from the virus receive a dose each fall, just before the winter season where the virus generally surges.

It is yet another setback for America's leading public health agencies, whose trust from the public has fallen dramatically during the Covid pandemic.

In the spring of 2022, the CDC recommended immunocompromised and people over age 50 receive an additional shot if they had received their first booster at least four months earlier.

The CDC advisers did not vote on new recommendations for how the COVID-19 shots should be administered on Friday.

But ACIP advised showing flexibility in recommendations for those with compromised or weakened immune systems to allow more frequent doses for those most vulnerable to severe COVID.

Both the CDC and the Food and Drug Administration (FDA) are working on how to best update COVID vaccines to target circulating variants annually, similar to flu vaccine campaigns.

About 53.3million people in the United States - around 16 percent of the US population - have received a Covid booster shot since updated versions of the vaccines were authorized in September.

That compares with 230million people, around 70 percent of the population, that received an initial two-dose series of the Covid vaccines.

The CDC's guidance being shunned by its own panel of experts is another setback for the beleaguered agency.

A report in January led by Julie Gerberding, who served as the CDC's director from 2002 to 2009, said the agency needed a reset and was not fit for purpose.

'The big picture here is, we all see the need for a reset of the agency,' Julie Gerberding, who served at the CDC's director from 2002 to 2009 and now a CSIS member, told CNN.

'Some of the reset has to be structural, some of it needs to be activity that only Congress can really manage and that has to do with how the budget is structured, the size and scope of the budget and the flexibilities or lack thereof.'

Report: CDC is not fit for purpose, has lost public's trust and needs a complete overhaul

The embattled agency has faced a rocky few years marred by repeated troubles during the Covid pandemic.

Another hindrance the agency faces, according to the report is that it is based in Atlanta, more than 500 miles from the Nation's Capital.

While communication is simplified in the digital age, experts fear the proximity of CDC from the federal government hub adds unnecessary barriers.

An NBC poll last year found that only 44 percent of Americans, and just one-in-five Republicans - trusted the agency on Covid.

Many lost trust in the agency because of its support for school closures, letting mask orders on public transportation last too long, and for its slow reaction to changes in the pandemic landscape.

This is the second major call for an overhaul of America's leading public health agency.

In August, Dr Rochelle Walensky, director of the agency, internally told her staff the agency must focus more on public health issues and less on the publishing of research.

She had taken her post in early 2021, mid-way through the pandemic.

Experts said the CDC was slow to recognize how much virus was entering the US from Europe, to recommend people wear masks, to say the virus can spread through the air, and to ramp up systematic testing for new variants.

The decision resulted from a review Walensky ordered in April after the CDC faced heavy criticism for its mixed messaging on the Covid pandemic.

The agency gave muddled and confusing recommendations on masking and other mitigation efforts.

The guidance during the pandemic has been 'confusing and overwhelming,' according to the CDC briefing document provided by the agency to the New York Times.

The review also found that the CDC often takes too long to publish data people needed to make decisions and that the agency should be more transparent about what it does and doesn't know, a CDC official told the Wall Street Journal.

There were staff shortages too with those tasked with leading the CDC's covid team rotating out after a few months.


Xylitol Nasal Spray Prevents SARS-CoV-2 Infection

Peter A. McCullough, MD, MPH

The sophisticated American consumer has grown accustomed to the gold-standard for drug and health products—the prospective randomized, double-blind, placebo-controlled trial (RCT).

Operation Warp Speed (OWS) was supposed to be a churning mill of large RCT’s to help the nation understand what conclusively is effective in the prevention and treatment of COVID-19.

Unfortunately, after three years, has delivered failed products (remdesivir, baricitinib, molnupiravir, COVID-19 vaccines) and small inconclusive trials of products that doctors have found effective in practice including off-target generic antivirals and anticoagulants.

OWS did not test simple, affordable, available prevention strategies. Fortunately such RCTs where done outside of the US and have brought us important findings.

Balmforth et al, conducted a prospective double-blind, placebo-controlled trial of a xylitol based nasal spray in the prevention of SARS-CoV-2 infection in exposed healthcare workers in two hospitals in Uttar Pradesh, India.

Xylitol is known to have anti-infective and anti-inflammatory properties and is used in XLEAR nasal spray and anti-infective chewing gum to prevent dental caries.

Balmforth found that SARS-CoV-2 infection confirmed by serology was 71 percent lower with xylitol compared to placebo [36 cases (13.1 percent) Vs 97 cases (34.5 percent); odds ratio [OR] 0.29 (95 percent CI; 0.18–0.45), p < 0.0001].

Fewer clinical symptoms were also seen in the test group [57 cases (17.6 percent) vs 112 cases (34.6 percent); OR 0.40, (95 percent CI; 0.27–0.59), p < 0.0001]. No harmful effects were associated with xylitol.

A smaller study of xylitol nasal spray in mild COVID-19 cases demonstrated that persistent loss of smell may be eliminated with xylitol nasal spray during the acute congestion phase.

I have been impressed with the RCTs of topical nasal sprays and gargles in COVID-19 far more than those with oral or intravenous drugs.

Xylitol available as XLEAR in US pharmacies is one of several choices for local nasopharyngeal protection and treatment of COVID-19.


Republicans React to Energy Department’s Reported Finding That COVID ‘Likely’ Leaked From Wuhan Lab

Republican lawmakers responded to a news report saying that the U.S. Energy Department had concluded the lab leak theory was “likely,” saying that the finding supports what many have long suspected.

A Wall Street Journal article on Feb. 26 reported that a classified intelligence report by the Energy Department said that the virus likely leaked from the Wuhan Institute of Virology.

“So the government caught up to what Real America knew all along,” Rep. Jim Jordan (R-Ohio) wrote in a Twitter post on Sunday.

The responses came as GOP lawmakers ramp up investigations into the origin of COVID-19 and allegations of government-big tech censorship of the debate.

The Energy Department was previously undecided on the issue but now joins the FBI in corroborating the lab leak hypothesis, according to the report. Several people who have read the report said the Department’s judgment was made with “low confidence,” the Journal reported.

Responding to the report on Sunday, White House national security advisor Jake Sullivan told CNN that the intelligence community does not have a “definitive answer” on the matter at this point.

Republican lawmakers have been vocal about the theory that the virus leaked from the Wuhan laboratory soon after the onset of the pandemic in 2020. Initially, some health professionals and legacy media outlets dismissed the theory, labeling the theory’s proponents as racist and conspiracy theorists.


Some lawmakers also accused Anthony Fauci, former head of the National Institutes of Allergy and Infectious Diseases (NIAID), of colluding with big tech companies, such as Facebook and Twitter, and censoring stories about the lab leak theory via what these companies describe as a crackdown on “misinformation.”

“Fauci knew this immediately but dismissed it because of funding for the Wuhan lab,” Sen. Eric Schmitt (R-Mo.) wrote in another post. “We know what happened next — when Fauci spoke Big Tech censored. I exposed this collusion as AG and I’ll work to ensure this type of censorship never happens again.”

“Americans knew this from Day One,” Rep. Andy Biggs (R-Ariz.) wrote on Twitter on Sunday. “Unfortunately, Big Tech and Big Government silenced them.”

Republicans and critics of Fauci have raised concerns about the NIAID’s funding of the Wuhan Institute of Virology via the non-governmental organization EcoHealth Alliance, including for research described by experts as gain-of-function. The NIAID issued about 3.4 million in grants to EcoHealth.

Gain-of-function research makes the virus more deadly by enhancing its pathogenicity, its ability to cause disease and harm the host, or transmissibility, how easily it spreads.

The NIH has denied that the grants were for gain-of-function research, while Fauci has defended the decision to issue the grants to EcoHealth.

“More evidence continues to mount that COVID came from the Wuhan lab. We’ve uncovered emails showing Dr. Fauci was warned that the virus looked man-made & came from a lab, but he may have acted to cover it up. Why? We need answers & accountability,” wrote the official Twitter account of the House Oversight Republican Committee.

Republicans on the committee previously disclosed internal NIH emails that showed Fauci was informed by senior scientists early in the pandemic that the theory that COVID-19 had a natural origin was “highly unlikely,” even while Fauci was publicly promoting the natural origin theory.




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