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FDA approves Moderna and J&J COVID Vaccine Booster Shots

FDA approves Moderna and J&J COVID Vaccine Booster Shots

MIX and MATCH: Agency also approves of mixing vaccine types used in booster shots!

Officials at the Food and Drug Administration have approved extending COVID-19 boosters to Americans who got the Moderna or Johnson & Johnson vaccine.  Additionally, the agency also gave the thumbs up to allow anyone eligible for an extra dose to get a brand different from the one they initially received.

The Food and Drug Administration’s decisions mark a big step toward expanding the U.S. booster campaign, which began with extra doses of the Pfizer vaccine last month. But before more people roll up their sleeves, the Centers for Disease Control and Prevention will consult an expert panel Thursday before finalizing official recommendations for who should get boosters and when.

The latest moves would expand by tens of millions the number of Americans eligible for boosters and formally allow “mixing and matching” of shots — making it simpler to get another dose, especially for people who had a side effect from one brand but still want the proven protection of vaccination.

Specifically, the FDA authorized a third Moderna shot for seniors and others at high risk from COVID-19 because of their health problems, jobs or living conditions — six months after their last shot. One big change: Moderna’s booster will be half the dose that’s used for the first two shots, based on company data showing that was plenty to rev up immunity again.

For J&J’s single-shot vaccine, the FDA said all U.S. recipients, no matter their age, could get a second dose at least two months following their initial vaccination.

The ruling will now go to the Centers for Disease Control and Prevention (CDC) and its vaccine advisory committee for formal review and policy development.

If the committee issues a recommendation, and CDC Director Dr. Rochelle Walensky signs off, additional shots for those vaccines could be distributed immediately to eligible people.

The authorization would open up booster doses to the more than 15 million people who have been inoculated with J&J’s shots and the more than 69 million people who have been fully immunized with Moderna’s vaccine.

Eligible Americans will also be able to “mix and match” vaccines. A highly anticipated National Institutes of Health study published last week showed all the combinations of boosters increased antibody levels, though Pfizer’s and Moderna’s boosters appeared to work best.

However, there are a few caveats to the vaccine-joy that the press is spreading. FDA officials indicate an increased risk of rare inflammatory heart conditions, myocarditis, and pericarditis, following vaccination with the Moderna vaccine, particularly following the second dose.

The risk of mRNA Covid booster shots causing heart inflammation in young adults continues to worry top scientists weighing whether to approve third doses for anyone over 12, Dr. Ofer Levy, a voting member of the Food and Drug Administration’s advisory panel, said Friday.

Levy, the director of the Precision Vaccines Program at Boston Children’s Hospital, spoke just hours after the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously recommended giving second shots to all recipients of Johnson & Johnson’s single-dose Covid vaccine over 18 years old.

The panel previously recommended the FDA approve boosters from Moderna and Pfizer for all seniors and other high-risk groups. But some committee members have voiced concern about authorizing third mRNA doses for people 12 and up due to the risk of two rare heart inflammation conditions, myocarditis and pericarditis.

“As we go into younger and younger age groups, they’re less and less at personal risk of severe Covid, and on the other hand, somewhat more at risk of this inflammatory heart condition with the mRNA vaccine,” Levy told CNBC’s “Closing Bell.” “So it’s a risk benefit analysis, and that’s why you’re seeing that deliberation.”

Meanwhile, the US is now experiencing cases of the “Delta Plus” variant.

A new sub-lineage of the highly contagious Delta variant that is spreading throughout the UK has been detected in the United States, health officials said Wednesday.

AY.4.2 is being closely monitored in the UK after British health officials revealed that the new variant — reported to be 10 to 15 percent more transmissible that Delta — had been linked to a growing number of COVID-19 infections there.

Of course, officials are assuring everyone the vaccine booster will totally work on this variant. Color me skeptical.

Fourteen Israelis have been diagnosed with COVID-19 despite having been inoculated with a third COVID-19 vaccine dose, according to Health Ministry data reported by Channel 12 news on Sunday.

According to the network, two of those infected after receiving the booster shot have been hospitalized.

Here’s hoping public health officials start focusing on safe, effective, and inexpensive treatments sooner rather than later.

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Comments

After both initially being rejected. My faith isn’t increasing.

TY Leslie,,, Hard to follow the FDA,,,, seems like they would rubber stamp anything… I personally know 6 people in Florida with breakthrough cases, within 2 weeks of getting JJ… One dmn near died, his recovery is very, very slow.
To each their own.. Troubling times.

    gonzotx in reply to amwick. | October 22, 2021 at 11:59 am

    I know FOUR and 3 died fully vaccinated!

    MattMusson in reply to amwick. | October 22, 2021 at 2:12 pm

    I had two shots. After the 2nd I got fever and chills. It triggered arthritis in my hip and I began seeing skin slough out in patches the size of quarters. Now, 6 months later, the dermatitis has subsided and mostly clear.

    What this means is – mRNA vaccines can cause your immune system to go haywire. In my case it was attacking me.

    Now, 3 women in my Sunday School class have suddenly been diagnosed with breast and skin cancer. From medical studies I have read, there is a possibility that the vaccine can restrict immune system’s anti-cancer fighting ability.

    Ironclaw in reply to amwick. | October 22, 2021 at 7:29 pm

    The FDA is, at least in part, funded by the same companies they regulate. Of course they’re going to rubber-stamp what those companies want.

these half-assed “vaccines” are driving the mutations. furthermore, they are now seeing that if you get the jab, then come down with the ChiCom Crud, your body doesn’t produce anywhere near as many N-antibodies that an unjabed person does, so they are interfering with the strength of natural immunity by inhibiting the natural immune system response.

i’ll stick with keeping my levels of Vit C & D plus zinc high, along with a daily antihistamine and lots of iron in my diet.

besides, i don’t qualify for a shot anyway: guinea pigs have 4 feet, and i only have two. 😎

Switching vaccines for a booster doesn’t really bother me…in fact, that might lessen the chance of a bad reaction, even if ever so slightly.

On the other hand, I’m not taking a booster without first getting a titer quantified.

    Actually I down voted that, there is no real data the side effects will be less

      healthguyfsu in reply to gonzotx. | October 22, 2021 at 3:07 pm

      Of course, there aren’t (data is plural BTW)

      That’s why the words “might”, “chance”, and “slightly” were used….reading comprehension is key.

        healthguyfsu in reply to healthguyfsu. | October 22, 2021 at 3:17 pm

        The point of the matter for the less dense is that there are no data to indicate that switching vaccines for a booster will increase the chance of a bad reaction.

        My logic (not data) was that there’s a possibility it’d be better to switch since the antigens each vaccine was raised against is slightly different. In fact, if I were forced to take a booster without the aforementioned titer data indicating safety then I would probably insist on switching unless I see data to the contrary.

    The Friendly Grizzly in reply to healthguyfsu. | October 22, 2021 at 12:34 pm

    I have seen the term titer. what does it mean?

      Brave Sir Robbin in reply to The Friendly Grizzly. | October 22, 2021 at 2:23 pm

      It refers to your posterior anatomy. Not everyone’s. Just yours. If I am wrong, Milhouse will correct me.

        healthguyfsu in reply to Brave Sir Robbin. | October 22, 2021 at 3:13 pm

        Snark on full blast today I guess? The minstrels not doing a good job? Just sack them I say.

        Grizz,
        It is the antibody count from your blood that responds to a particular antigen. So in this case, you would expose a sample of your blood to COVID-19 antigen and quantify the agglutination reaction….the quantified value is your antibody titer against COVID-19.

        The reaction is similar to how you would do blood typing but kind of in reverse. In blood typing, you expose blood of unknown type to known antibodies against A, B, or (Rh)+. If you get no clumping, then you are negative for that type.

        In the COVID 19 antibody test, you are exposing blood to a known antigen, looking for the reaction to see how much you would react to exposure. It should give you a pretty good idea of whether your immunity (natural or acquired) is still working and if it is working too well, you could easily have a bad reaction to the booster. It’s similar to how people who already had COVID 19 infection, responded worse to the vaccine than people who had not had COVID 19.

          Brave Sir Robbin in reply to healthguyfsu. | October 22, 2021 at 3:29 pm

          My minstrels left me long ago. After a particularly vigorous episode of bravely running away, I turned to look back, after making a safe distance from danger of course, and they were simply gone. With the current labor shortages and such, its impossible to find replacement minstrels at any price.

          I hear there is a boat load of them waiting off the coast of LA, however, so I hold out hope, though I am competing with Joe Biden for their employment, and Janet Yellen and Jerome Powell have his back regarding these particular negotiations.

Over/under on how long before they will be mandatory?

I’m giving it before Thanksgiving, myself.

    CommoChief in reply to Voyager. | October 22, 2021 at 12:49 pm

    How soon will their be a policy of mandatory booster? Soon. The real question is how long before the fully approved vaccine is available for distribution. Currently there is only one vaccine that is fully approved. All vaccines available for distribution in the US are still under emergency use authorization and not fully FDA approved.

    The DoD policy follies are about to demonstrate this. The policy implementation letter from SECDEF specifically states that the mandatory jab relates to fully FDA approved vaccine not any vax offered under emergency use authorization. The lawsuits from service members are going to point out this issue; that the DoD mandate is toothless in the absence of a fully authorized vaccine.

Of cour$e they approved the clot $hot$. Why not? Make$ $en$e.

Let’s see, the VAERS system of adverse reactions (including DEATH) from this vaccine are astronomical, far surpassing all other adverse vaccine reactions – COMBINED.

It’s well-proven the vaccinated equally catch, and spread the virus. In other words, it’s not a vaccine in the legacy sense. It’s merely a theraputic, and a poor one, with fast fading efficacy that requires continuous boosters mere months after the first jab. In other words, your immune system is now a subscription service for BIG PHARMA.

Speaking of therapeutics, the oral and IV therapeutics prescribed in the (flccc.net) protocol have demonstrably proved successful for millions of people in the early treatment of COVID-19. Yet, these protocols are marginalized, demonized, and even banned by the so-call medical experts. Natural immunity is not ever part of any of these covid survival discussions – only GET. the. JAB.

Data from around the world confirms there are more covid cases, hospitalizations, and deaths THIS YEAR than last year. And there was no vaccine last year! The 1st rule of holes is STOP DIGGING, yet we persist in vaccinating our world into a pandemic.

These are crimes against humanity, and many ‘experts’ must be brought to justice.

https://www.americanthinker.com/articles/2021/10/the_unvaccinated_are_looking_smarter_every_week.html

caseoftheblues | October 22, 2021 at 12:53 pm

…”the proven protection of the vaccine”
🤣🤣🤣🤡

And by ‘approve’ they mean ‘let businesses demand you get it but continue to shield them from all liability’.

Apparently, it’s news that people with compromised immune systems have compromised immune systems. Somehow, this shows that vaccines don’t work. Instead it shows that some people’s immune systems don’t protect them, and don’t create the immune response that would be hoped for from either exposure or a vaccine.

Colin Powell didn’t die despite being vaccinated. Powell’s body was seriously immune-compromised and his body was incapable of responding properly to the vaccine. He likely had a limited or no immune response to shot. Lots of cancer patients and people with other issues had the same lack of response. As we age, our immune system also weakens, so older people have some degree of immune difficiency.

This shouldn’t be an argument that vaccines don’t work, but that people need to consider our brothers and sisters with weak immune systems when we think about getting vaccinated.

    Or, alternatively, it has been suggested that the jabs are CAUSING the immune deficiency by focusing the immune system specifically at the alpha version and inhibiting/destroying the immune system’s ability to recognize other variants and viruses. Nasty things can happen when you inject an experimental substance that has the ability to alter your DNA and affect your body in unknown and unexpected ways.

The Feds approve another round of assisted suicide, with the provision that if the first poison you tried didn’t work, you can switch to another.

Lucifer Morningstar | October 22, 2021 at 1:25 pm

.

FDA approves Moderna and J&J COVID Vaccine Booster Shots

Correct me if I’m wrong but how do you approve the Moderna and J&J vaccines for booster shots when those two vaccines have never actually been approved for primary use as vaccines in the first place. (At least I’ve never seen FDA approval for the use of those two vaccines. Just EUAs.)

MIX and MATCH: Agency also approves of mixing vaccine types used in booster shots!

And if you’re given a different vaccine than the one you received originally that isn’t a “booster shot”. You are being vaccinated all over again.

    You are almost certainly correct. The only thing that’s been done is that their EUAs were revised or new EUAs were issued to cover the new usage. The FDA and CDC are very slippery on these points, because they’re trying to encourage vaccination by calling the current vaccines “approved”, when in fact they’re still under EUAs.

    If the story doesn’t also include “administration of the Pfizer vaccine will be halted”, they are talking about revised EUAs (or new) to cover uses other than those uses already “approved.” Because if “approval” actually means what they want the public to think, then no vaccine operating under an EUA could remain on the market – the Pfizer vaccine is definitely still being administered under an EUA. (According to Pfizer, Comirnaty won’t be “generally available” in the US market until “2022 or 2023.”)

    See a good explanation of this bait-and-switch here:
    https://cdn.locals.com/documents/47656/47656_ww3goeprr5s2dj6.pdf
    Or search for Navy SEAL 1 et al v. Joe Biden
    Case 8:21-cv-02429 US Dist Court, Middle District of Florida
    Starting at paragraph 116

All they’re really doing is just amending the Emergency Use Authorizations, right?

There can’t possibly be reliable safety studies on the interactions between these pseudo vaccines. Or is it like the others: They issue or amend the EUAs and the effects on the general population form the basis of the safety studies.

    Brave Sir Robbin in reply to Idonttweet. | October 22, 2021 at 2:42 pm

    This is correct. Any “vaccine” that requires a “booster” after two months, or four, or six, could be considered to not be efficacious. They clearly have very limited benefit. There is no reason to give a drug that lacks benefit to a patient, especially ones with known poor short term and unknown long-tern safety profiles.

    If they did not constantly lie to me, I might be inclined to believe them. Clearly, these therapeutics are not vaccines. Clearly they are not 95% effective. Clearly they do not hinder infection or contagion. Clearly they have adverse short-term safety profiles that have never before been tolerated. Clearly they are not thoroughly tested for safety of efficacy. Clearly they are derived from a technology that has a very poor history when tested on animal populations. And clearly the US was funding gain of function experimentation on bat coronaviruses in Wuhan to enhance their ability to infect humans to make them ill, and clearly the virus did not develop naturally via zoonotic sources and processes and emerge in a “wet market” some hundreds of meters from a lab this research was being conducted in, a lab, by the way, well-known for its sloppy safety protocols.

    Now you know why you can’t say its from Wuhan or China. It’s part of the Fauci coverup.

      “Clearly they have adverse short-term safety profiles”

      Despite how much they down play it, pericarditis and myocarditis are not short-term safety issues, they’re very much long-term safety issues. 2/3 of people with those conditions die in 5 years or less. They are almost certainly lying about the incidence of these conditions in the middle aged and elderly. And we are still waiting for the other shoe to drop, antibody-dependent enhancement and autoimmune diseases. We are seeing negative effectiveness from the vaccines (they are worse than placebo), which is evidence that we’re seeing ADE.

        Brave Sir Robbin in reply to randian. | October 22, 2021 at 11:41 pm

        Please allow me to clarify. By short-term, I do not necessarily refer to the duration of the negative effects, but rather the timing of onset. What we do not know are what negative consequences occur months and years and after “vaccine” uptake. But given the short-term safety profiles, I would wager the long-term safety profiles will be as bad or worse.

        At my age, there is no long-term risk. But this drug should not be given to healthy young people who very rarely suffer a serious incidence of disease from COVID. There is no benefit but substantial risk.

2smartforlibs | October 22, 2021 at 2:44 pm

Seems the UK (UK government publishing service) is one of the few places that’s questioning this. Out today not months ago. Covid vaccines will keep you from acquiring full immunity EVEN IF YOU ARE INFECTED AND RECOVER.

I got my Moderna booster today.

I think this is still an emergency use authorization, with a bunch of legal ramifications. The article should probably clarify that. Anyone wanting to describe the ramifications?

    CommoChief in reply to A Thinker. | October 22, 2021 at 5:42 pm

    The whole line of ‘OSHA made us’ arguments that corporations will invoke are unlikely to succeed as:

    1. There is no final OSHA rule or guidance
    2. Any OSHA ‘mandate’ is purely speculative
    3. No vaccine currently available in the US is not operating under emergency use authorization
    4. All the current vaccines are legally speaking; experimental
    5. No one can be forced or coerced into taking an experimental vaccine. See DoD and anthrax vax.

    How’s that?

BREAKING:

From the British government, via Alex Berenson:

“N antibody levels appear to be lower in people who acquire infection following two doses of vaccination.” (Page 23: see attached document)

What the British are saying is they are now finding the vaccine interferes with your body’s innate ability after infection to produce antibodies against not just the spike protein but other pieces of the virus. Specifically, vaccinated people don’t seem to be producing antibodies to the nucleocapsid protein, the shell of the virus, which are a crucial part of the response in unvaccinated people.

This means vaccinated people will be far more vulnerable to mutations in the spike protein EVEN AFTER THEY HAVE BEEN INFECTED AND RECOVERED ONCE (or more than once, probably).
It also means the virus is likely to select for mutations that go in exactly that direction, because those will essentially give it an enormous vulnerable population to infect. And it probably is still more evidence the vaccines may interfere with the development of robust long-term immunity post-infection.

Source (attached)
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1027511/Vaccine-surveillance-report-week-42.pdf

https://alexberenson.substack.com/p/urgent-covid-vaccines-will-keep-you/comments

    Brave Sir Robbin in reply to TheFineReport.com. | October 23, 2021 at 12:05 am

    An astonishing report in many respects. In particular, what caught my eye is Table 2. COVID-19 cases by vaccination status between week 38 and week 41 2021 on page 13. Please see the two rightmost columns. This indicate that for EVERY age group, age 30 and above, infection “case” rates are higher in the vaccinated than the unvaccinated, indeed, about twice as high per 100,000 people for people age 40 to 79. .

    However, the rate of hospitalization per 100,000 is very much less for the vaccinated than the unvaccinated. (See able 3. COVID-19 cases presenting to emergency care (within 28 days of a positive specimen) resulting in an overnight inpatient admission by vaccination status between week 38 and week 41 2021 on page 14.)

    Death rates are also very much lower amongst the vaccinated.

    Still, oddly, why the higher infection rates in the vaccinated? And what are the long-term implications?

Re: Here’s hoping public health officials start focusing on safe, effective, and inexpensive treatments sooner rather than later.

It appears Nebraska has. Worth reading, covers all the studies. Page 47 – Conclusion – Per Nebraska State Attorney General, doctors can now prescribe either Ivermectin or HCQ with informed consent, October 14, 2021.
https://ago.nebraska.gov/sites/ago.nebraska.gov/files/docs/opinions/21-017_0.pdf

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