Anybody want a Corona?

[spike]

Latest Covid Boosters Are Set to Roll Out Before Human Testing Is Completed

The Food and Drug Administration is expected to authorize new Covid-19 booster shots this week without a staple of its normal decision-making process: data from a study showing whether the shots were safe and worked in humans.

Based.

Sounds like it’s essentially the same recipe, just slightly altered. They do this with flu shots already.

[JuanHamm]

Latest Covid Boosters Are Set to Roll Out Before Human Testing Is Completed

The Food and Drug Administration is expected to authorize new Covid-19 booster shots this week without a staple of its normal decision-making process: data from a study showing whether the shots were safe and worked in humans.

Based.

Sounds like it’s essentially the same recipe, just slightly altered. They do this with flu shots already.

Why do you want us all to die?

[Bi_3]

It's not exactly the same: https://www.npr.org/sections/health-sho ... d-boosters

The U.S. Food and Drug Administration is using a controversial strategy to evaluate the next generation of COVID-19 boosters.

The approach is stirring debate as the agency works to make new, hopefully improved, boosters available in September to help prevent severe disease and save lives in the fall and winter.

For the first time, the FDA is planning to base its decision about whether to authorize new boosters on studies involving mice instead of humans.

"For the FDA to rely on mouse data is just bizarre, in my opinion," says John Moore, an immunologist at Weill Cornell Medicine in New York. "Mouse data are not going to be predictive in any way of what you would see in humans."

But others defend the approach, arguing that the country has had enough experience with the vaccines at this point to be confident the shots are safe and that there's not enough time to wait for data from human studies.

"We have 500 people a day dying of coronavirus right now. Those numbers sadly might very well rise in the fall and the winter. The question is: 'Can we do something better?'" says Dr. Ofer Levy, a pediatrics and infectious disease researcher at Harvard Medical School who also advises the FDA. "And I think the answer is: 'We can, by implementing this approach.'"

The U.K. just approved a new booster

The United Kingdom just approved a new booster that targets both the original strain of the virus and the original omicron variant, called BA.1 — a so-called bivalent vaccine.

But the FDA rejected BA.1 bivalent boosters last spring. Instead, the FDA told the vaccine companies that make the mRNA vaccines, Moderna and Pfizer and BioNTech, to develop bivalent vaccines that target the dominant omicron subvariants — BA.4 and BA.5 — in the hopes they will offer stronger, longer-lasting protection.

That's why the FDA decided to use a new, streamlined strategy for testing the new boosters. The agency is asking the companies to initially submit only the results of tests on mice. Regulators will rely on those results, along with the human neutralizing antibody data from the BA.1 bivalent booster studies, to decide whether to authorize the boosters.

The companies will continue to gather more data from human studies; those results probably won't be available until late October or early November.

But the big concern is the boosters may not work as well as the mouse data might suggest. Mouse experiments are notoriously unreliable.

And with the government telling people not to get the old boosters now and rejecting the first bivalent vaccines, the FDA really needs good evidence that the BA.4/5 boosters are in fact better, critics say.

"We need to make sure that we have solid immunogenicity data in people to show that you have a dramatically greater neutralizing antibody response against BA.4, BA.5," says Dr. Paul Offit of the University of Pennsylvania, who also advises the FDA. "I think anything short of that is not acceptable."

Some also worry that the approach may further erode the long-faltering efforts to persuade people to get boosted.

"I think it would be good to have neutralizing antibody data in a small group of humans," says Dr. Monica Gandhi, an infectious disease researcher at the University of California, San Francisco. "Otherwise, extrapolation may be considered too great."

But others agree the time constraints mean the country can't wait for more evidence. The billions of people who have gotten Moderna and Pfizer-BioNTech mRNA vaccines show how safe they are, those experts say.

The new booster will be identical to the original vaccines except it will contain genetic coding for two versions of the protein the virus uses to infect cells — the protein from the original vaccine and proteins from the BA.4 and BA.5 omicron subvariants.

And some scientists say health officials know enough about how vaccines work to start handling the COVID-19 vaccines like the flu vaccines, which are changed every year to try to match whatever strains are likely to be circulating but aren't routinely tested again every year.

"We're going to use all of these data that we've learned through not only from this vaccine but decades of viral immunology to say: 'The way to be nimble is that we're going to do those animal studies," says Deepta Bhattacharya, an immunobiologist at the University of Arizona College of Medicine in Tucson. "We're really not going out too far on a limb here."

The companies are expected to submit their data to the FDA by the end of the month and the administration hopes to make millions of doses of the new boosters available starting in September..

You've got to think about the perception here. The pandemic response is over even if the pandemic itself isn't. That's how the overwhelming majority of the population sees it and they act accordingly. Isolation from exposure, contact tracing, a two week vacation from work even when asymptomatic... all over. And a lot of reckoning is happening right now about the effects of the pandemic response on schools in particular. This is gonna be a campaign issue in soon as well and the trust factor here is very low. Putting out a new booster when critics and antivaxxers can claim it's risky because it wasn't test on humans, regardless of the validity of that claim, can push the needle in the wrong direction (pun intended). It's a big gamble to give them that ammunition. It's big gamble to allow the MAGAts in the midterms to spout things like "The Biden Admin is mandating an untested vaccine for your kids to make you scared so you vote for them". Or "they know it's dangerous and they want deniability".

I think everyone (here at least) understands this is an endemic disease now and yearly boosters are probably going to be a thing we will need to keep ourselves safe. I am not debating that. I'm suggesting the FDA isn't doing itself or the rest of us any favors here by not requiring even small human trials to rebuild trust... and maybe not toss the antivaxxers softballs.





edit showing how nutjob twitter is already spinning this:

[spike]

The politicalization of the vaccine continues to be unfortunate. I don’t think the FDA will or should respond to political pressure on this.

[B]

Yeah, and growing flu strains is different than building RNA. This needs SOME sort of human trial.

[B]

OK, this is weird. They pulled the monvalent booster from the EUA in expectation of the bivalent booster being approved.

For the rest of the week, no one in the US 12 and over can get a booster dose of COVID.

[Bi_3]

I guess all that "more people die of flu" talk backfired:

[spike]

Tyranny!!!!!!!!!!!!!!!

[blueviper]

My wife informed me her dad got his ivermectin prescription from Walgreens the other day.

[simple schoolboy]

My medical insurer just sent out a listicle on why you should get a flu vaccine. Maybe they always did this, but it's kind of weird they are parroting COVID vaccine language about protecting others.

I assume general vaccine hesitancy is up and they are pushing back in their dumb, ineffectual manner.

I'll take a flu vaccine if my medical professional family member grabs one for me, otherwise I'm not scheduling an appointment for it. Who doesn't know that they commonly vaccinate for the strain(s) that don't end up being the ones in circulation?

[Norah]

so dumb to explain why vaccines aren't just about you

[B]

Or that it's been a decade and a half since a major mismatch caused a bump in disease.

[spike]

Sounds like science, guys.

[Stickman]

Even mild COVID-19 can cause your brain to shrink

[BurtReynolds]

Would explain both why it was created and the degrading quality of RM posting lately.

[Bammer]

Coronavirus pandemic thread September 2022

[simple schoolboy]

Norris and Spike pop up, but if it saves one life! (The friend is with 95% confidence not wearing an N95 or equivalent)

[simple schoolboy]

Or that it's been a decade and a half since a major mismatch caused a bump in disease.

So I hear there's a mismatch between the previous COVID vaccine and the extant disease. How confident are you with the match up with the new vaccine (trials not complete) and the extant disease?

Flu vaccine was never mandated partially due to low morbidity but also (separately) it went through the normal approval process.

[B]

Or that it's been a decade and a half since a major mismatch caused a bump in disease.

So I hear there's a mismatch between the previous COVID vaccine and the extant disease. How confident are you with the match up with the new vaccine (trials not complete) and the extant disease?

Flu vaccine was never mandated partially due to low morbidity but also (separately) it went through the normal approval process.

COVID mutation is currently way more rapid than flu, but given it's a much worse disease, I take what I can get and hope for the best

[simple schoolboy]

Or that it's been a decade and a half since a major mismatch caused a bump in disease.

So I hear there's a mismatch between the previous COVID vaccine and the extant disease. How confident are you with the match up with the new vaccine (trials not complete) and the extant disease?

Flu vaccine was never mandated partially due to low morbidity but also (separately) it went through the normal approval process.

COVID mutation is currently way more rapid than flu, but given it's a much worse disease, I take what I can get and hope for the best

Good to have that choice.

Really curious if COVID has outcompeted the flu and that's not so much a thing anymore, any data on that?