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FDA and CDC Assert Covid Booster is Safe after ‘Safety Signal” Flagged and Reviewed

FDA and CDC Assert Covid Booster is Safe after ‘Safety Signal” Flagged and Reviewed

Meanwhile, studies suggest bivalent covid boosters offer no extra protection.

The Centers for Disease Control and Prevention (CDC) recently noted that when a preliminary covid vaccine “safety signal” was identified it began investigating whether the bivalent booster from Pfizer-BioNTech created an increased risk of stroke in people 65 and older.

In the Friday statement, the CDC said that the preliminary signal hasn’t been identified with the Bivalent Moderna COVID-19 vaccine.

“Following the availability and use of the updated (bivalent) COVID-19 vaccines, CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent,” the CDC said.

“Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination.”

However, the agency now asserts that a detailed review of the databases failed to confirm the preliminary information. Therefore, federal health officials have concluded the risk is extremely low.

The CDC and FDA described the early signal in a statement updating their websites Friday afternoon. The signal set off a debate among officials about whether and how to release the information. CDC officials argued for releasing it, while some other officials, including at the FDA, were concerned that putting out unconfirmed data would fuel anti-vaccine sentiment and scare older Americans into avoiding the boosters. Ultimately, the agencies decided to release the information in the hopes that transparency “will build confidence,” said a CDC official.

The signal was detected in the Vaccine Safety Datalink, a collaboration involving the CDC and about a dozen health-care organizations with electronic health records on 12 million people. As part of routine monitoring for possible adverse events, officials noticed late last year that they were picking up indications of higher-than-expected stroke risk, officials said.

Among about 550,000 people 65 and older who had already been vaccinated and received a booster dose of the Pfizer bivalent vaccine, 130 people had strokes in the first three weeks after getting the shot. No deaths have been reported. That finding raised a question because it suggested that people who received the bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with Days 22 through 44 following vaccination.

Despite the rapid reversal, new studies show that the bivalent boosters, which were intended to defend people against emerging Omicron variants, don’t appear to provide any better protection than the original shot does.

The new mRNA bivalent boosters produced by Moderna and Pfizer only attack the COVID-19 virus about as well as the companies’ first-wave vaccines, according to a blood testing study led by renowned virologist Dr. David Ho, a professor of microbiology and immunology at Columbia University, in New York City.

The bivalent shots also failed to promote higher antibody levels or a better immune response than the original COVID-19 vaccines, according to another study led by Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, in Boston. Both studies were published online Jan. 11 in the New England Journal of Medicine.

As a reminder the U.S. has purchased 171 million doses of the bivalent booster at a cost of $4.9 billion.


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UnCivilServant | January 14, 2023 at 10:16 am

“We can’t admit we were wrong or we might have a chance to salvage some shred of the false respectability we’d tried to cultivate.”

Shut down your worthless agencies and get lost.

We have gone from 10 years to 6 months to develop and test a new vaccine. That is sufficient reason to reject it unless the disease targeted is both highly contagious and has an infection mortality rate approaching that of rabies. This is the only information needed to make a decision about taking the vaccine. All else is noise. Operation Warp Speed is as fanciful as Warp Drive rocket engines.

    That was always my take. There is no indication what long-term consequences of taking this thing are. There aren’t even good indications of what short-term consequences are, other than myocarditis and blood clots. The one long-term effect you don’t get is the one we want, immunity to the virus.

    Which is why I never took the experimental gene therapy. I’ve been vaccinated more than most with military overseas and civilian overseas “travel” but I refused this one because it’s not been tested correctly and the efficacy is questionable.

Yes, we can generate a new vaccine in a few months, and properly do efficacy and primary safety testing within a year.

The virus, of course, mutates faster than that. That’s what RNA viruses do.

We’ll need a new breakthrough in our understanding of RNA viruses to defeat that problem. In the meantime, we may fairly expect each new vaccine to be “modestly effective”.

    E Howard Hunt in reply to stevewhitemd. | January 14, 2023 at 12:36 pm

    I agree with you, but primary safety testing is an unacceptably low standard. The punishingly safe vaccine introduction process has been thrown out the window for the sake of greed.

      The real truth is the Democrats needed the Chinese Death Kooties to complete their treasonous mission to remove Trump. All the deaths that occurred over the period that coincided with Democrats manufactured pandemic was acceptable collateral damage.

    Then it would seem that all of these “vaccines” are a waste of time. Naturally acquired immunity actually works and costs, essentially, nothing.

Is there any evidence that the first set offered any protection?

    Ironclaw in reply to MajorWood. | January 14, 2023 at 12:42 pm

    No, there isn’t. In fact, a Pfizer executive had to admit before the EU parliament that they never even tested to see if it protected against spread.

    Otto Kringelein in reply to MajorWood. | January 14, 2023 at 1:25 pm

    Is there any evidence that the first set offered any protection?

    None whatsoever. The original mRNA gene therapy serum formulation neither prevented infection nor did it prevent transmission of the infection to others. But Pfizer & the FDA always knew that. But nonetheless they gave it an EUA and later final approval.

    gonzotx in reply to MajorWood. | January 14, 2023 at 2:00 pm


Is this the same bivalient booster that was tested on 8 mice and zero humans?

    Otto Kringelein in reply to Ironclaw. | January 14, 2023 at 1:37 pm

    Yes, it is. The “bivalent booster” mRNA serum should have been regarded as a completely new drug product and have to undergo safety and efficacy evaluation like any other new drug that is proposed to be released in the United States. But it wasn’t. Eight mice. The test failed and yet the FDA approved and released the bivalent booster for use.

    Bivalent Booster’s “8-Mice Trial” Actually FAILED

October 2020, at a hotel bar in Cape May NJ, I get into a conversation with a fellow visitor, a white guy about my age [then 68], and he proceeds to loudly call Covid the “Trump virus”, etc.
Democrats did a superb job of politicizing everything about the virus and the vaccines, in a successful effort to unseat a President, and then wonder why nobody trusts anything said by government about the virus or the vaccine.

These totalitarian bastards and narcissists in our federal government possess zero credibility on any health issue as far as I’m concerned, given their manifestly duplicitous, contradictory, political and dishonest behavior since the Wuhan virus was unleashed by the Chinese communist regime.

The FDA and the CDC said it? Oh well, then, tHe sYinCe iS seTTlEd!

Babylon Bee today: “Experts Say They Don’t Know What Thing Is Causing Everyone To Suddenly Collapse, But It’s Definitely Not That One Thing.”

retiredcantbefired | January 14, 2023 at 6:02 pm

Having spent $4.9 bil, our government knows what to do with serious evidence of harm from the booster:

Conceal it or destroy it.

The government asserts COVID booster is safe. They say abortion is safe too, but it kills the baby.

Australia tried that booster. From the over-view I read, it didn’t seem to do anything. The virus, like all high-mutation viruses, changes too much, too often for modern vaccination technology to keep up.

We have the same problem with HIV. It’s not that we don’t know how to kill the virus and make a vaccine, it’s just by the time we do, it’s changed and the vaccine is ineffective.

There is strong evidence that the theory of vaccinating large swaths of the population with a vaccine of questionable efficacy to be generous actually has made the virus mutate far faster than it would naturally and the vaccinated are more vulnerable than the unvaccinated who may have natural immunity..

I am one of the victims of this untested vaccine. I had an ischemic stroke within the 44-day limit after my booster shot. I was in the best health I had been in for many years. I will never take another Covid related shot again. When it becomes personal all of the odds become meaningless. I do not believe one word from the CDC or anyone in this administration. Like all other professions and federal agencies, including the medical pros, I no longer trust any of them. They are all ruled by politics or greed. I asked while I was in the hospital if the vaccine could have caused my stroke and was almost laughed out of my bed. Every person Nurses, PAs, and MDs all said a resounding no.