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FDA Proposing a Yearly COVID Vaccine But Some Might Need Two Shots

FDA Proposing a Yearly COVID Vaccine But Some Might Need Two Shots

FDA proposing it treat the COVID vaccine like the flu shot.

The FDA is proposing people receive a COVID vaccine once a year, similar to the flu shot since the virus continues to evolve. From the FDA briefing:

In addition, SARS-CoV-2 continues to evolve and spread in an unpredictable manner, including examples of regional dominance of virus variants that do not lead to worldwide prevalence (e.g., XBB1.5). Currently, it remains impossible to predict which virus VOC [varint of concern] will gain dominance in any particular region of the world and how long a VOC will remain dominant. As such, whether or when the epidemiology of SARS-CoV-2 will adopt a pattern that makes a regular cadence of globally coordinated recommendations for updating COVID 19 vaccine composition obvious or needed remains to be seen. Neither is it clear whether or when most areas of the world will have similar levels of pre-existing immunity (be it from vaccination or infection), susceptibility to clinically significant COVID-19, nor access to the same types and quantities of COVID-19 vaccines. With these uncertainties taken together, the FDA and VRBPAC may need to consider a change in COVID-19 strain composition for U.S. vaccines without a prior WHO strain recommendation.

Officials will operate the vaccine the same as they do the flu shot. They will choose the COVID strain in the spring for consumption in September.

The briefing recommends one shot for healthy people, mainly those with “‘sufficient preexisting immunity,’ through prior infection, vaccination, or combination thereof.”

Older people and those with compromised immune systems might need two shots. The FDA described these people as having “insufficient preexisting immunity.”

A few people told The New York Times the proposal surprised them, especially since they don’t have much “research to support the suggested plan”:

“I’m choosing to believe that they are open to advice, and that they haven’t already made up their minds as to exactly what they’re going to do,” Dr. Paul Offit, one of the advisers and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said of F.D.A. officials.

“I’d like to see some data on the effect of dosing interval, at least observational data,” said Dr. Eric Rubin, one of the advisers and editor in chief of the New England Journal of Medicine. “And going forward, I’d like to see data collected to try to tell if we’re doing the right thing.”

Still, Dr. Rubin added, “I’d definitely be in favor of something simpler, as it would make it more likely that people might take it.”

Dr. Offit offered a few important questions: “How old are they? What are their comorbidities? When was the last dose of vaccine they got? Did they take antiviral medicines?”

He dismissed the “present national strategy” because it’s like “‘OK, well, let’s just dose everybody all the time.’ And that’s just not a good reason.”

Infectious disease physician Dr. Céline Gounder thinks the majority of “people are ‘well protected against severe Covid disease with a primary series and without yearly boosters.'”

The advisers hope Thursday’s meeting will answer some of these questions.

Dr. Gounder is not optimistic because the actual “voting questions ‘are framed in such a way as to force a certain outcome.'”

Ouch.

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Comments

The Gentle Grizzly | January 24, 2023 at 11:03 am

I think I will treat their “proposal” like one to wed. The answer is, “no”.

Interesting how it went from “the sky is falling” to will it’s just the seasonal crap you have been getting a jab for decades for.

This seems utterly divorced from reality.

Uptake of the vaccine has been incredibly low since the first booster dose (and not high even then). The entire government has had its fingers in its ears regarding safety signals, but even for them the evidence for significant adverse effects is becoming difficult to ignore. Providers are skeptical, and CDC/FDA happy singing doesn’t seem to be convincing anyone.

Worse, the virus is just not frightening any more. When they pushed pediatric vaccination despite a complete absence of risk/benefit analysis (and what evidence we have suggests that there is actually no benefit, even if you disregard the risk), they gave up all their credibility.

If they want to actually get providers and health systems to push this, they’re going to have to put up real numbers for COVID risk and vaccine side effects. But if they do that, it’s going to completely undercut the case for routine vaccination going out years.

To quote a famous movie: It’s over. Go home.

Once in my life I got the flu shot…I still got the flu that year. I think I’ll pass.

    The Gentle Grizzly in reply to NotCoach. | January 24, 2023 at 12:00 pm

    That’s why they are called flu shots.

    DEEBEE in reply to NotCoach. | January 25, 2023 at 8:37 pm

    I have had the same experience multiple times. Re-trying, thinking it was my superstition. Then I made the mistake, of what I thought was light-hearted, to repeat that to my ex-doctor. His serious faced answer was “Flu vaccine does not cause flu.”. Hmm!

The level of coercion and the fear porn ginned up got the vax numbers up in the first six months following the availability of the vax. After that it was ones and twos for folks who had avoided it but due to travel or whatever were forced into it. Booster numbers never got going. People have unanswered questions, even many who allowed themselves to be coerced into taking the initial vax. Until those questions are answered in a transparent manner they won’t get acceptance, particularly not for an exclusively mRNA version.

There is no more direct way to put my thoughts from pen to paper.

You’re an IDIOT if you’re still getting the jab especially if you believe the FDA and CDC or an apparent fear porn campaign to sell jabs.

simple answer.
f*ck off

Never have gotten a flu shot.

Never got the clot shot.

Never got “covid,” despite attending more than one “superspreader” event.

Not gonna start getting poked now.

retiredcantbefired | January 24, 2023 at 11:59 am

The proposal is complete garbage. Certain companies will like it, though.

The ultimate historical take on this… “The cure was worse than the disease”. The greatest medfical/political catastrophe in the history of the world.

So… now I’m even less likely to get even the flu shot.

I’ll treat this like I treat offers root canal. PASS.

So, they want you to take one shot, but if that doesn’t kill you, they want to give you a second one.

None of my fellow “Conspiracy Theorists” will be getting any annual COVID vaccine. In fact, those who I know who have gotten the jab have also said to me, “no more”. So who is left to comply?

“FDA Proposing a Yearly COVID Vaccine But Some Might Need Two Shots”

Clearly, some at the FDA will require two shots to the body, and one to the head.

I wish for once that the public health professionals familiarize themselves with data, such as this French report https://www.medrxiv.org/content/10.1101/2023.01.11.23284137v1.full.pdf, that suggests successive booster shots are progressively less effective and for progressively shorter durations and furthermore might actually leave the recipient more vulnerable than before.

There needs to be a national outside-of-government-service non-advocate review from top to bottom of the FDA, CDC, NIAID policies and supporting data. There should be an immediate release of all publicly financed data related to the COVID-19 pandemic.

Let not wing it any more.

    healthguyfsu in reply to Arnoldn. | January 24, 2023 at 2:00 pm

    That doesn’t quite say what you think it does.

    It doesn’t say that the vaccinated are more vulnerable. It says that if you did get infected, then you have a higher chance of avoiding reinfection against the newer strains. That makes sense, of course, because the vaccine dev strains are always behind the latest spreading strains (unless you are dealing with a virus that mutates very slowly…COVID mutates relatively quickly)

    It’s basically saying that if you want boosters to be more effective then you have to update their components faster raised against latest sub-variants.

      henrybowman in reply to healthguyfsu. | January 24, 2023 at 2:25 pm

      Other studies say it, though.

      Extended SARS-CoV-2 RBD booster vaccination induces humoral and cellular immune tolerance in mice

      Highlights
      • Extended immunizations impaired the serum neutralization activity
      • Extended immunizations suppressed the formation of germinal center
      • Extended immunizations inhibited the activation of CD8+T cells

        healthguyfsu in reply to henrybowman. | January 24, 2023 at 6:02 pm

        Really wish they would fix the indexing glitch.

        The study you just linked is from a lab in China that uses a lab-grown version of the Chinese vaccine known as Sinovac. It’s also not an mRNA vaccine, and it’s only 60% effective compared to the 90+ numbers for US vaccines.

        Take that one with a mountain of salt.

          Only if you believe those numbers for US vaccines. They lied about preventing spread, why should I believe effectiveness numbers?

          healthguyfsu in reply to healthguyfsu. | January 25, 2023 at 7:48 pm

          Would you rather believe China?

          They didn’t really lie about preventing spread. While an individual’s titer was high, it did help prevent them from spreading because their symptomatic period was non-existent or shorter and the viral load given off without symptoms is very, very low. After 6 months, though, it didn’t do much. Because everyone’s vaccine timeline was different (or perhaps non-existent in your case), that spread prevention message was still true for some people. 6 months is also a good amount of time to slow spread….it did have an effect.

          ‘Would you rather believe China?”
          That was asinine

The problem is if you get COVID then get a vax, you are going to feel it and it won’t be fun.

I’ll pass. Maybe one every other year at most.

Hard pass.

BierceAmbrose | January 24, 2023 at 3:40 pm

The FDA’s mandate to assess treatments as “safe and effective” or not, now includes prescribing treatment protocols? Everybody wants to be a regulatory body, it seems, telling people what they must, and may not do. For the privilege of being a live human, I suppose.

I mean, the Center for Disease Control’s ‘rona diktats have been all about people control. I get it. Telling people what to do has some teeth. The Virus will just run around chortling “Make me.”

No wonder the FDA wants in on the act.

They’re also looking to prohibit going “off label”, with an obscure clause buried in the … the one after the “infrastructure” bill, as I recall. Promote a use outside the official protocols, they can go after yr license, federally for UN-professional behavior.

Everything not compulsory is forbidden!

    ThePrimordialOrderedPair in reply to BierceAmbrose. | January 25, 2023 at 7:14 am

    You mean the CDC “eviction moratorium” wasn’t within their purview?

    My understanding was that everything in the world affects health – everything is a ‘disease” – so the CDC has control over everything.

    BierceAmbrose in reply to BierceAmbrose. | January 25, 2023 at 5:06 pm

    Correction — That particular FDA “no off-label uses” power grab is a current proposed law. The fact that I can’t trivially keep track of what encroachment is Trojan-horseing in where is its own problem.

BierceAmbrose | January 24, 2023 at 4:14 pm

Seems like our Authoritah now get off on inflicting stupid inconvenience for nothing. Their thing used to be head count and budget, didn’t it? These days, Never have so many, been so burdened, by so few, for so little.

Of course Spartacus demanded the CSPC ban gas stoves. “Look at what we made them do! “For nothing, and on the D-L.” “Wooooooo!”

You’d think they’d promote their wins. Why’d the FDA bury their “We get to fire wrongthink doctors.” in some appropriation nobody’s read? “Doing so much good, we have to hide it from everybody.”

The study you just linked is from a lab in China that uses a lab-grown version of the Chinese vaccine known as Sinovac. It’s also not an mRNA vaccine, and it’s only 60% effective compared to the 90+ numbers for US vaccines.

Take that one with a mountain of salt.

The Serenity Prayer as given to me by my Dad.

“God, grant me the serenity to accept the things I cannot change, courage to change the things I can, and wisdom to know the difference.”

With a few years of life under the belt, I now know the prayer was simply guidance to submission. So, I changed it a bit:

“God grant me the wisdom to recognize falsehoods and the courage and strength to change those things I know you would not ask me to accept,”

Listen to Scott Adam’s comments.

https://youtu.be/C41GCgyG4mI

The proposed new “vaccine” for kids – FDA says they won’t know the results for several years after they are given. These folks have become monsters that believe that experimenting on kids is just okay.

Seems that about 80 plus years ago many people died to put this type of living nightmare to an end.

If all they’re offering is more experimental mRNA shots, I will forever pass on it. They’re not worth the risk. I will wait until there is a true vaccine that has been properly gold-standard vetted, where the manufacturer can be sued for adverse reactions. And then I will only consider it, with a lot of skepticism.

BierceAmbrose | January 26, 2023 at 4:28 pm

Latest Micro-Bill interview making the rounds, he declares that these ‘rona and MRNA jabs don’t work so well. Says out loud several things The Biome Gnome still tries to weasel around.

Apparently moving disease resistance to a subscription model (like they did with software.)