Monday, November 22, 2021

Fauci urging mass covid boosters
despite poor data on effectiveness


From a Nov. 12 Yahoo News story by Kali Coleman
Matter in square braces is NEWS of the WORLD amplification, meant to put Fauci's reported comments in perspective. Italic type highlights the uncertainty in Fauci's assurances.

Anthony Fauci, MD, the White House covid adviser, is promoting covid vaccine booster shots even though he concedes the government's data on the boosters are weak.

Fauci told the New York Times that officials are now starting to see some waning immunity against both infection and hospitalization several months after initial vaccination. The infectious disease expert pointed toward incoming data from Israel, which he said tends to be about a month to a month-and-a-half ahead of America in terms of the outbreak.

[Actually, the shocking drop in immunity was detected in August. Please scroll down or control f 'Data clash' story below. Fauci here does not refer to this major U.S. study but focuses on what is happening overseas.]

"They are seeing a waning of immunity not only against infection but against hospitalization and to some extent death, which is starting to now involve all age groups. It isn't just the elderly," Fauci said on a Times podcast. "It's waning to the point that you're seeing more and more people getting breakthrough infections, and more and more of those people who are getting breakthrough infections [infection despite inoculation] are winding up in the hospital."

As a result of these findings, Fauci warned that vaccinated people should get a booster shot, as it might actually be more important than health officials first assumed. "If one looks back at this, one can say, do you know, it isn't as if a booster is a bonus, but a booster might actually be an essential part of the primary regimen that people should have," he told the Times.

[What grounds does he use for promoting boosters against fall-offs in vaccine potency? His vague, but firm assurances are reminiscent of what scientists often call "hand-waving" arguments. There is some question among epidemiologists of how useful such boosters are. As all vaccines have lost potency, any booster will have lower potency. So, according to one observer, a booster under these conditions is rather like a "Hail Mary" pass in football. But, is it really worth a shot?]

Fauci went on to say, "I think … that the boosting is gonna be an absolutely essential component of our response, not a bonus, not a luxury, but an absolute essential part of the program."

[Every year, a new vaccine is developed to counter the latest mutation of some flu virus. No one suggests we should be vaccinated with the old vaccine just in case it works or just in case some of the old flu strain is still around. Yet Biden and his advisers insist that nearly everyone must be inoculated with low potency vaccines.]

During the Times discussion, Fauci also touted the effectiveness and safety of the boosters. "We've shown that boosters are safe and effective in dramatically increasing the response not only immunologically, but also when you look at the clinical data from Israel, it's very clear that it reverses some of the waning effect that you see in people who have been vaccinated six months or more," he said.

[When did the "dramatic increases" occur. Had they occurred after the plunge in vaccine potency, one would think Fauci would have been eager to mention it. Also, how much of the waning effect is reversed? Is it statistically and medically meaningful?]

The need for boosters doesn't mean that the vaccines don't work, Fauci argued [though he doesn't deny that the vaccines don't work nearly as well as they initially did.] On the contrary, Fauci stressed the positive by saying that he does not think that "we've given the full rein to prove what it is that you need to make them work," like additional doses. According to the virus expert, researchers did not "have the time" to do extensive studies to determine whether two doses would be better than three, as there was a pressing need to get vaccines out to people sooner rather than later, which was "life-saving for millions of people," he said.

[In other words, Fauci and the federal government have insufficient data to justify vigorously promoting vaccination. Certainly the vaccine data are unclear enough that they cannot rationally justify vaccine mandates.]

Getting the unvaccinated vaccinated [with low-potency vaccines] and "aggressively" re-inoculating vaccinated people with boosters [whose efficacy is only vaguely known]  is likely to put the United States in a safer spot this winter than the country saw with previous surges, both over the past few months and during the winter of 2020, Fauci said. And as more time passes, health authorities will gather enough statistical data to see how long the boosters keep recipients protected from covid [and how many people it really helps].

"I think when all is said and done, as we get through boosting the overwhelming majority of the people who've been primarily vaccinated, we're gonna say, just like other vaccines that require multiple doses, like hepatitis B, like some of the childhood vaccinations, that it is likely" a booster is needed, he said [but at present the government doesn't know whether that belief is true]. "I'm making my own personal projection as an immunologist and infectious disease person. We don't have the proof yet—the proof of the pudding will be after you get people vaccinated and boosted, and we have a greater durability of protection that doesn't wane as easily."

[Fauci wants the U.S. population to serve as guinea pigs so as to gain information on whether the boosters give meaningful protection. By taking this stance, Fauci is giving a pseudo-scientific political justification for Biden's vaccine mandate decree, which has been severely undermined by the fact that a major study shows that the vaccines have plummeted in potency. (That decree is now tied up in the federal courts.) Though Fauci was apparently careful to ignore that study, he nevertheless tends to affirm its main finding: the vaccines are now working poorly.]

This report first appeared Oct. 26 on NEWS of the WORLD's predecessor site.

Data clash on vaccine's potency
as FDA clears its use for children

Conflicting data over the effectiveness of a covid vaccine emerged today during the controversy over immunization of children.

Pfizer-BioNtech's study, released today, shows that a low dose of its vaccine is 90.7 percent effective in children aged 5 to almost 12. Yet a separate massive study of veterans, released Oct. 14, shows that the formerly effective covid vaccines have all fallen off dramatically in potency, with Pfizer-BioNtech's plummeting from more than 90 percent effective in March to about 50 percent by August.

Neither study has been peer reviewed.

Pfizer-BioNTech presented data from a study of 1,518 children who received the 10-microgram vaccine — one-third the adult dose — and another 750 who received a placebo. The vaccinated volunteers were 90.7 percent less likely to develop symptomatic covid, and when they did become ill, their symptoms were less severe, the researchers said.

Earlier today an FDA advisory panel urged emergency use of the vaccine on children.

Pfizer-BioNtech scientists had argued that earlier this year covid was one of the top 10 killers of children in the 5- to 12-year age range. The FDA's advisers felt that those children who are at risk should be permitted to have the vaccine. The drug company's study also pointed out that schoolchildren, who may not get sick, can carry the disease home. But StatNews reported,
Several panelists expressed concern about whether the decision could lead to vaccine mandates — something Peter Marks, the head of the FDA’s Center for Biologics Evaluation and Research, assured them was unlikely. At the beginning of the day, Marks said that thoughts about vaccine mandates should not impact the panel’s decision.
The Pfizer-BioNtech study occurred sometime after July 16, when its study of teens and 12-year-olds ended. No specific start date for the child study is given, though a cutoff date of Oct. 8 is given. Hence the child immunizations occurred while the Pfizer vaccine's potency was on the decline among veterans.

It seems plausible that the aged and infirm were strongly represented among the veterans studied. Yet, during the early stage of the vaccination of veterans, effectiveness was reportedly high. Does this rule out immunological problems as a major factor in the drops in efficacy? Probably. Drops in efficacy are generally tied to virus mutations, such as the Delta variant, which, according to the  a July statement of the American Society for Microbiology, was by then responsible for more than 83 percent of U.S. cases.

StatNews said,
The panel weighed the benefits of preventing covid against the risks of the vaccine, in particular the risk of the heart conditions myocarditis and pericarditis, which, though hard to measure exactly, appear to occur once per every 10,000 or so in vaccinated older boys and young men. The cases seen after use of the vaccine appear to be milder than regular cases of the inflammatory condition, and last for a shorter time.
According to the study of veterans, which was carried out from Feb. 1 to Aug. 13, the effectiveness of full vaccination -- derailed by the rise of the Delta variant -- had plunged.

But the Pfizer study reports that its vaccine was successful in 90.7 percent of children who had not previously shown any covid-like symptoms. That caveat may be meaningful, as it strongly tends to select in favor of altogether healthy children -- even though a fair representation would include some children who are not in excellent health. (Ethical problems may have entered the picture here.)

Pfizer-BioNtech research paper
https://www.fda.gov/media/153409/download

Cohn et al on vaccine potency drop
https://www.medrxiv.org/content/10.1101/2021.10.13.21264966v1

Cohn and her colleagues wrote,
National data on COVID-19 vaccine breakthrough infections [infections after full vaccination] is inadequate but urgently needed to determine U.S. policy during the emergence of the Delta variant. We address this gap by comparing SARS CoV-2 infection by vaccination status from February 1, 2021 to August 13, 2021 in the Veterans Health Administration, covering 2.7% of the U.S. population. Vaccine protection declined by mid-August 2021, decreasing from 91.9% in March to 53.9% (p<0.01, n=619,755). Declines were greatest for the Janssen vaccine followed by Pfizer–BioNTech and Moderna. Patterns of breakthrough infection over time were consistent by age, despite rolling vaccine eligibility, implicating the Delta variant as the primary determinant of infection. Findings support continued efforts to increase vaccination and an immediate, national return to additional layers of protection against infection.

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