Fauci: Children aged 4 and younger will likely need three-dose COVID vaccine regimen



White House chief medical adviser Dr. Anthony Fauci said Wednesday that children 4-years-old and younger will likely need three shots of a COVID-19 vaccine to complete their regimen once the government grants approval for toddlers to be vaccinated.

Fauci informed reporters at the daily White House press briefing that clinical trials for Pfizer-BioNTech's vaccine are currently underway in children from 6 months to 2 years old and from 2 to 4 years old. But so far, these vaccine doses have not been shown to meet the same standards for effectiveness that the shots approved for adults have met.

"With regard to the clinical trials that are being done in children from 6 months to 24 months and from 24 months through 4 years: As you probably know, the original data that was done was determine if the doses that were given to those children reached what we call 'non-inferiority' with a more adult or adolescent population," Fauci said.

He continued: "And in the original data that was put forth, it looked like the dose and the regimen for the children who were 6 months to 24 months worked well, but it turned out that the other dose — namely the other group, from 24 months to 4 years — did not yet reach the level of non-inferiority. So, the studies are continued."

"It looks like it will be a three-dose regimen," Fauci said. "I don’t think we can predict when we will see an [emergency use authorization] with that, because the company is still putting the data before the FDA."

Fauci did not want to speak for the Food and Drug Administration as to when the vaccines would be approved for children aged 4 and younger.

"I think we just need to be patient and know one thing for sure that that’s why the system works," Fauci said. "Because the FDA is very scrupulous in their ability and in their effort to make sure that before something gets approved for people at any age — including and especially children, because of the special vulnerability of the children — that when these vaccines become available for children at those ages, we can be certain that they will be safe and that they will be effective."

Reporters also asked Fauci when the U.S. would be able to lift coronavirus restrictions and treat COVID-19 as an endemic virus, rather than a pandemic, similar to what the United Kingdom and other European countries are doing.

"We are not there right now," Fauci said, citing the latest number of COVID-19 cases, deaths, and hospitalizations provided by the Centers for Disease Control and Prevention. "As [CDC Director] Dr. Walensky said, when you have over 2,000 deaths, 150,000 hospitalizations, and you have people who are now getting infected to the tune of somewhere around 700,000 a day, we’re not there yet."

The CDC reported Wednesday that the current seven-day daily average of cases is about 692,400 cases per day, a decrease of about 6% over the previous week. The seven-day average of hospital admissions for COVID-19 is about 19,800 per day, a decline of 8% over last week.

The seven-day average daily deaths reported was about 2,200 per day, which is an increase of 21% over the previous week.

Fauci said that before the U.S. could consider COVID-19 endemic, there would needto be "sufficient control" over infections, cases, and deaths. He clarified he does not mean COVID-19 needs to be eradicated like smallpox, which he said was "unreasonable," nor does it need to be eliminated like polio or measles, "but a level of control that does not disrupt us in society, does not dominate our lives, does not prevent us to do the things that we generally do under normal existence."

"That would be a level of infection, but more importantly, concentrating on the severity of disease, hospitalizations, and deaths that fall within the category of what we generally accept — we don’t like it, but we accept it — with other respiratory viruses: RSV, para flu, and even influenza," Fauci said.

To get to that point, Fauci said the community needs to be immunized "either through infection plus boosting, either vaccine plus boosting, or just vaccine alone."

"Those are the things that will hopefully get us to the point when we have antivirals to be able to treat people who are at high risk — that we no longer are in a situation of threat — threat to our equanimity, threat to our economy, the threat to allow us to live a normal life," he said.

"We believe we can get there because we have the tools with vaccines, with boosts, with masks, with tests, and with antivirals. That’s what we talk about when we get to the point where we can, quote, 'live with the virus.' But, as Dr. Walensky emphasized, that is not where we are at this point. So, we still have a way to go."

Horowitz: Who needs Biden? Trump shaming governors who don’t promote boosters



For those of you sick of the oligarchy of both political parties promoting COVID fascism and endless failed vaccines, you won’t find any relief with a Trump presidency. At a time when even the Europeans appear to be moving away from the failed boosters, Trump is doubling down on promoting them, even though he already has natural immunity from prior infection. Is his strategy to campaign against his base?

Perhaps Trump now subscribes to the view of Pfizer CEO Albert Bourla that two shots offer little if any protection, but he is now dumping on GOP governors who fail to disclose their booster status. That’s right: It’s not enough to declare their support for two shots; Trump would like each governor to declare whether they had a booster.

"I've had the booster. Many politicians—I watched a couple of politicians be interviewed and one of the questions was, 'Did you get the booster?' because they had the vaccine, and they're answering like—in other words, the answer is 'yes' but they don't want to say it because they're gutless," Trump told One America News Network. “You gotta say it—whether you had it or not. Say it. But the fact is that I think the vaccines saved tens of millions of people throughout the world. I've had absolutely no side effects," he added.

Well, after all, Trump is the only person in the universe, so if he did not experience side effects, then nobody else did. I mean, really, Mr. Trump? This sounds even more obnoxious than Mitch McConnell’s lecturing us about the polio vaccine or RINO Indiana Gov. Holcomb demanding that we get boosters. I guess RINO West Virginia Gov. Jim Justice, who is begging Biden for a supply of fourth shots, is the most “courageous” governor in Trump’s eyes.

It is bizarre that Trump is promoting boosters even for those with natural immunity at a time when even the NCAA has moved in the direction of recognizing immunity from prior infection. Trump also recognizes that younger people shouldn’t get the shots, a plain indication that he knows there are some clear risks to taking the shots. Even more tacky is the fact that Trump has been relatively quiet all year, then chose to speak up now, when the shots appear to be failing the most.

At a time when we need to rally against weak GOP governors who are promoting the shots too much and defeat all mandates against bodily autonomy, Trump is dumping on the few decent governors actually standing for his base?

Ironically, even the Europeans are waking up to the concerns of pumping endless boosters into people’s bodies. Just a month after suggesting boosters would be needed every three months, the European Medicines Agency is warning people that such a move is not cost-free. Aside from known and unknown risks of side effects, they are warning that boosters could weaken people’s immune systems in what is widely known as “original antigenic sin.” Has Trump ever studied this concern? Even the WHO stated this week that “avaccination strategy based on repeated booster doses of the original vaccine composition is unlikely to be appropriate or sustainable.”

Indeed, Trump has picked an inauspicious time to go “all in” on Pfizer. The shots clearly have no degree of efficacy against the new strain. Public Health Scotland is showing that for the last week in December, 85.8% of all cases were among the vaccinated. Although Scotland has a very high vaccination rates, most of the new cases (figure 2) are among children and younger adults who have lower vaccination rates. Case rates per 100,000 are about 2.5 times higher among the double-vaccinated than among the unvaccinated and about 1.4 times higher among the boosted (table 11).

Thus, from the get-go, even three shots produce negative efficacy, and given that other data show the boosters wane even quicker, why is there no concern that the more shots one gets, the more it will create rapidly accelerating negative efficacy (binding but not neutralizing antibodies) over time?

If anything, the numbers are even worse than this data suggests, because we know that the most vulnerable time is during the partially vaccinated period, where the T cells are depressed but before the antibodies ramp up. PHS counts those within 21 days of the first shot as completely “unvaccinated.”

As for hospitalizations, the double-vaccinated appeared to be more than twice as likely to be hospitalized with acute COVID and almost twice as likely to die of COVID than the unvaccinated.

While the death rates among the boosted were much lower, they are counting those within 14 days of their third shot among those with two shots, thereby making the double-vaxxed worse and triple-vaxxed appear better during the immune suppression period, just as they did between the unvaxxed and those with the first dose. The fact that the double-vaxxed go negative even against critical illness and death demonstrates that in the long run, the boosters are a dangerous game.

How could Trump in good conscience promote boosters?

Well, therein lies the problem. It’s not about the science for him, or even about the optics or the politics. I don’t think I’m speaking out of turn here by ascribing his motive to desiring to take credit for his legacy of Operation Warp Speed. It’s all personal. He doesn’t want to view what he believes to be his greatest legacy as an utter failure.

However, what the former president needs to understand is that nobody blames him for not seeing the scam of Big Pharma at the time and trying to make the shots available as soon as possible. However, to double down and triple down on failure after the safety signals have been breached and after the shots no longer work is unforgivable.

Top vaccine officials leave FDA amid infighting, political pressure — now there are warnings of a 'mutiny'



A pair of top vaccine regulators at the U.S. Food and Drug Administration resigned this week reportedly as a result of growing turmoil and disagreement within the agency as political pressures reportedly complicate the administration's scientific work.

What happened?

Dr. Marion Gruber, director of the FDA's Office of Vaccines Research and Review, and her deputy, Philip Krause, announced their intentions to leave the FDA with little fanfare on Tuesday. In a memo sent to news publishers, the FDA framed the decision as a simple retirement, thanking Gruber and Krause for their service but offering no reason for their forthcoming departure.

It seemed peculiar that two key vaccine officials would "retire" from the agency in the middle of a global pandemic and at a time when their expertise was most needed. Gruber, a veteran vaccine regulator, had been with the FDA for 32 years.

Sure enough, there was more bubbling under the surface.

In a report published Tuesday evening, Politico indicated the pair's departure was the result of increasing frustration over the Biden administration's top-down approach to managing the pandemic, specifically as it pertains to administering booster shots for adults:

FDA officials are scrambling to collect and analyze data that clearly demonstrate the boosters' benefits before the administration's Sept. 20 deadline for rolling them out to most adults ...

... On Tuesday, two top FDA vaccine regulators resigned — a decision that one former official said was rooted in anger over the agency's lack of autonomy in the booster planning so far. A current health official said the pair, Marion Gruber and Philip Krause, left over differences with FDA's top vaccine official Peter Marks. Now the agency is facing a potential mutiny among its staff and outside vaccine advisers, several of whom feel cut out of key decisions and who view the plan to offer boosters to all adults as premature and unnecessary.

POLITICO spoke to 11 current and former health officials and people familiar with the matter who described growing exasperation with the administration's disjointed process for implementing its booster plan. Those sources said there is little coordination between federal health agencies, even as two top FDA officials try to guide the rollout.

The news outlet characterized Gruber and Krause's exit as a symptom of a greater problem brewing within the FDA, even warning that a potential "mutiny" could be just around the corner.

What else?

Paul Offit, an infectious disease expert at the University of Pennsylvania who sits on FDA's vaccine advisory committee, shared a similar sentiment, claiming the administration has pushed ahead on boosters without allowing FDA scientists to meaningfully weigh in.

"[It was] the administration's booster plan; it wasn't the FDA's booster plan," Offit told Politico. "The administration has kind of backed themselves up against the wall a little bit here."

Moreover, disagreement over vaccine boosters may not be the only hot-button topic causing discord within the agency. The Hill reported on Monday that FDA regulators are facing "growing pressure to authorize vaccines for children under 12," something the agency has so far been reluctant to do.