FDA Authorizes Moderna, Pfizer-BioNTech Bivalent Covid-19 Vaccines Booster Dose
fda.gov
fda.gov
> US Centers for Disease Control and Prevention (CDC) quietly ended its policy of differentiating within COVID-19 prevention guidance between those who have received Covid vaccines and those who have not:
Unvaccinated people now have the same guidance as vaccinated people.
> Unvaccinated people now have the same guidance as vaccinated people
> Someone might want to tell the millions of workers who lost their jobs
It only took 1M dead people in the US to get there, and the death rate for the unvaccinated was many multiples that of the unvaccinated [1].
https://www.thelancet.com/article/S0140-6736(21)02796-3/full...
https://www.economist.com/briefing/2021/05/15/there-have-bee...
If you have another explanation backed by something other than a conspiracy theory - like another massively correlated global cause of excess death that everyone else missed - then please share, because you will have uncovered the greatest internationally coordinated cover-up or cognitive lapse in human history.
International consensus isn't required. Scientific consensus is the best we can do, and per Occam's razor, COVID is the best explanation we have for the excess deaths.
The articles I linked make that falsifiable claims.
You are making unfalsifiable speculative statements and asking vague unrelated rhetorical questions about process.
Please make a specific claim about what you think the cause of the excess deaths is, like "influenza" or "car accidents", "natural die off of a previous population bubble", or some combination thereof, and provide citations to studies and data to back it up, as people would be interested in learning about that.
> The present study estimates the burden of COVID-19 on mortality. The state-of-the-art method of actuarial science is used to estimate the expected number of all-cause deaths in 2020 to 2022, if there had been no pandemic. Then the number of observed all-cause deaths is compared with this expected number of all-cause deaths, yielding the excess mortality in Germany for the pandemic years 2020 to 2022.
> In 2020, the observed number of deaths was close to the expected number with respect to the empirical standard deviation. By contrast, in 2021, the observed number of deaths was two empirical standard deviations above the expected number. The high excess mortality in 2021 was almost entirely due to an increase in deaths in the age groups between 15 and 79 and started to accumulate only from April 2021 onwards. A similar mortality pattern was observed for stillbirths with an increase of about 11 percent in the second quarter of the year 2021.
> Something must have happened in April 2021 that led to a sudden and sustained increase in mortality in the age groups below 80 years, although no such effects on mortality had been observed during the COVID-19 pandemic so far.
Say what the heck you mean, Mr Bright, because you’re dancing around it like you’re on American idol or something.
Therefore it's not surprising that the pandemic's excess mortality signature isn't as clear there.
How about an increase in deaths from other causes due to the lockdowns? Because that happened in the US, where covid-19 only accounts for about 60-70% of the excess deaths: https://jamanetwork.com/journals/jama/fullarticle/2778234
I don't buy that. It upsets me how people skirt around what should be a straightforward, reasonable question to answer. "Did people die with covid or from covid". Without knowing that, all you can do is look at shadows. What age bracket did these deaths come from? Does it line up with what we know about who is most at risk from covid?
... And even then, the demographics most at risk of covid are the same that are at risk for many, many other things too. And when we scared the living fuck out of people such that they stopped getting routine care a lot of deaths could start to occur.
I've yet to hear any "expert" actually assert that the "official death count" is composed of only people who died as a direct result of covid. All I ever hear is people dancing around the issue. Which really ought to make one wonder about the statistics presented. After all Occam's Razor would suggest that the simplest course of action for these "experts" would be to assert that all deaths were "from covid"--they'd love to assert that. Yet they dont. Why is that? Hmmmmmm........
This is false. You're assuming no deaths caused by vaccines, which isn't a valid assumption. When people compare all cause deaths they find little difference; this was also observed in the Pfizer trial where in fact the vaccinated arm had more deaths overall than the unvaccinated arm. Simply trading one cause of death for another is a bad move especially because "COVID deaths" were overwhelmingly in the elderly, very sick or both, but vaccine deaths tend to affect the young more than the old for some reason.
This obviously doesn't include all the non-fatal injuries, of which there have been a staggering amount.
Finally, the USA did not have 1 million COVID deaths. It had 1 million deaths labelled as COVID which is not the same thing given the financial incentives to over-label and minimal/zero checking of attribution accuracy. That's how you got the New York Times publishing a list of 1000 names of "COVID deaths" on the front page where literally the sixth name on the list was someone who was shot to death. Nobody was doing even the most basic sanity checks and as a consequence the data is garbage quality.
So if you haven’t had the primary course of shots you can’t take this one? Why not? I’m pretty sure I can take the flu shot even if I didn’t take it last year, or in the last ten years for that matter. So what gives? I thought this was supposed to be a “vaccine” just like any other?
Context info: FDA approved one of the original vaccines (Pfizer I think?) but the approved version has never hit the market because the approved version comes with liability. Literally no one has access to the approved vaccine, only the EUA one. If the EUA version harms/kills you then you can't sue anyone.
[0] - https://www.fda.gov/emergency-preparedness-and-response/coro...
[1] - https://www.fda.gov/emergency-preparedness-and-response/coro...
>The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and the approved vaccine is marketed as Comirnaty, for the prevention of COVID-19 in individuals 12 years of age and older.
The Pfizer-BioNTech version is different than the Comirnaty version. Even if the difference is just the label, we have no way of knowing. The difference is likely the difference between name brand and generic. There's no reason, as far as I know, to believe there's any difference in efficacy or safety. However, the one that is being distributed is still the Pfizer-BioNTech version because that one carries liability immunity for Pfizer due to the EUA. They would be foolish to produce and distribute the approved version. I believe the prevailing narrative that the vaccines are safe enough and effective enough to use.
How do they differ? Aren't they both tozinameran?
The products are legally distinct with certain differences that do not impact safety or effectiveness
I for one do care about legal distinctions. So, what are these differences?
"The two formulations of the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) differ with respect to certain inactive ingredients only and have been shown to be analytically comparable.35
35 Analytical comparability assessments use laboratory testing to demonstrate that a change in product formulation does not impact a product's safety or effectiveness. For the Pfizer-BioNTech COVID-19 Vaccine, multiple different release parameters were evaluated to assess the comparability of the modified formulation (the formulation with the Tris buffer) to the originally-authorized formulation (the formulation with the PBS buffer). These release parameters ranged from product appearance to size of the lipid-nanoparticle to the integrity of the modRNA in the product. Release and characterization tests include tests for purity, composition, and critical attributes of mRNA associated with the activity of the vaccine. The combination of release testing and characterization testing demonstrated that the modified formulation is analytically comparable to the original formulation."
Changing one buffer to another (to keep the vaccine at a similar pH to the body) isn't likely to have any active effect.
So, what are the legal distinctions? Is this legally distinct product actually available and what are the distinctions, for instance, regarding liabilities?
Are you familiar enough with EU drug liability laws to speak to whether Pfizer has any liability?
I hate having these autistic fine detail discussions in this context because people assume I'm anti-vax. I will state here again I believe the vaccines are safe enough and effective enough to justify use.
You haven't proved this to be the case. It seems like fearmongering to me.
It's "marketed" differently, not "formulated" differently.
I already stated the difference may just be the label. Or perhaps like the difference between name brand and generic. I explicitly stated there's no reason to believe there's any difference in safety or efficacy.
My commentary is about skirting liability laws, not efficacy or safety.
“The two formulations of the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) differ with respect to certain inactive ingredients only and have been shown to be analytically comparable.”
They go on to explain that the modified formulation uses a different buffer. He is correct at least regarding a formulation difference.
Again, no proof of this. Just speculation and fearmongering.
Further they have to show that have potential legal exposure from a fully approved vaccine over an EUA.
From my understanding of the PREP [1] act, Alex Azar declared a public health emergency in 2020. The PREP act gives immunity for all medical companies working on Covid 19 treatments until 2024.
[1] https://crsreports.congress.gov/product/pdf/LSB/LSB10443
I have no idea about the liability issue. The more interesting one to me was the government vaccine mandates last year (medical vs legal interchangeability, eua vs approved).
Interestingly, according to Pfizer the 08/23/2021 originally approved Comirnaty formulation (PBS buffer) was never available: “… These NDCs will not be manufactured. Only NDCs for the subsequently BLA approved tris-sucrose formulation will be produced” (https://www.cdc.gov/vaccines/programs/iis/COVID-19-related-c...).
The updated Tris buffer Comirnaty formulation was FDA approved on 10/29/2021 (https://www.fda.gov/media/150386/download, Page 8).
As for if its available, I guess you would have to go check a few pharmacies and ask if the Pfizer vaccine they have is labeled ‘Comirnaty.’ Some articles from the end of last year say they couldn’t find it, but who knows now. I have not looked into this at all, and to be honest I’ve already spent too much time searching this stuff up today so I’ll leave that for another person.
In fact both the eua and fully approved version have the same protection due to the PREP act.
OP please stop spreading false rumors that originated on Steve bannons war room. Now that you know the rumors you posted are false it would be appreciated if you go back to wherever you’ve posted the wrong info and post updates indicating the mistake.
Original post: Please provide a citation for saying the fda approved version is not being distributed because it seems highly illogical that the full approval wouldn’t supersede the eua, with all the legal entailing implications, and the eua would cease to be valid. The fda has done some odd things in the past but a citation is needed on that claim that the approved version is not distributed and that both approvals coexist rather then the eua is superceded.
There are subtleties around the precise vaccine series, in that the FDA approved, and COMIRNATY marketed thing is precisely a two dose series for people 12 and up, and there are a bunch of places where only the EUA applies (a three dose, non-booster series for immunocompromised folks, anything for kids 4-12 years old, etc.).
Your claim about the EUA appears to be wholly unfounded, as I don't think there are significant liability differences between an EUA and full FDA approval anyway (you get limited liability with FDA approval normally, the National Vaccine Injury Compensation Program existed pre Covid-19). And there's tons of resources that trivially confirm that the vaccines are identical and that you can even get half COMIRNATY and half not, which makes the whole liability argument even less legitimate looking.
They actually said in the approval document that they're not the same, there were changes to inactive ingredients (to improve shelf life IIRC).
I'm sure they could develop a primary vaccine that starts with this strain as the base.
The only reason it's not being treated as a primary shot is it wasn't tested as such (and probably also marketing purposes).
https://www.ft.com/content/af8da7d4-43ea-41d6-90ee-f959b3675...
"Two top scientists who recently announced their retirements from the US drug watchdog have criticised the policy of giving most people Covid-19 booster vaccinations, just days before the Biden administration plans to start doing so.
Philip Krause and Marion Gruber, who resigned from the Food and Drug Administration two weeks ago, are among the authors of a scathing critique of widespread booster shots, which was published in The Lancet on Monday.
The article, which argues that the scientific evidence does not yet justify giving most people third shots of messenger RNA vaccines, offers an insight into the internal tensions in the Biden administration that were ignited by the White House’s sudden decision to back the booster plan."
FDA approval no longer means anything. Did they even do a trial at all this time? For Omicron boosters they accepted trials with tiny sample sizes, in which "not getting sick" wasn't actually the outcome they tested for (because the vaccines would have failed). Instead they only looked for antibody generation. Judging from the press release the answer is no: the authorization cites the "totality of available evidence" including evidence from other vaccines that aren't the one they authorized. They also talk about the "extensive safety data" which is all far worse than would have been tolerated for any vaccine in the pre-COVID era.
But sure, if you want to go on trusting the Experts™ then go right ahead. Please for the love of god don't try to inflict your naivety on everyone else though!
https://ourworldindata.org/grapher/united-states-rates-of-co...
Looks like more like a rodeo to me. Younger age groups aren't even tracked.
All jokes aside, the only benefit of this booster was seen in wildly inconsistent antibody levels of 8 mice. It has never been tested on humans.
In the US and Canada (can't speak to other countries), we've collectively agreed to pretend that COVID has just disappeared and return to normalcy because we're tired of dealing with it, but in spite of pretending it's gone away people are still getting sick and dying from this disease every day.
I caught COVID for the first time in July and my "mild" case knocked me out for five days. It was the sickest I've been in ten years and I'm a fit, healthy thirty-something.
If we take your more charitable interpretation, I still think it is fair to ask whether we are ok just accepting 100,000 new infections/day of a serious respiratory illness as a normal thing in the summer months, a time that we usually see lower infection rates for this type of illness. For every endemic disease, there is a number of infections that are considered acceptable and public health measures are taken to keep the real infection rates at or below that. I, for one, do not think 100,000 daily is an acceptable number of infections in the US and we should be speaking out to say so. We can collectively do more to bring that rate down, but we don't want to because we're tired of wearing masks on the bus and for some reason have tied protecting yourself personally to a political ideology. We can do better as a society and should be demanding as much from our leaders, not encouraging them to do less.
This is so incredibly rude and dismissive. It's straight up bullying. It requires a serious amount of privilege to think people should hunker down in some kind of "new normal" like the die-hard zero covid people suggest.
Perhaps the vast majority of people are well aware of the actual risks of covid and have decided that there are thousands of problems in their life that have to to take priority over one single respiratory illness with a vaccine. To expect the entire world to live this kind of myopic covid-centric lifestyle for years on end with zero defined end-state is complete and utter nonsense. It is scary to me how long society managed to get fooled into playing along.
This might come as a shock to some of the more hard-core covid people but there exists millions of other problems in the world besides just COVID.
> a time that we usually see lower infection rates for this type of illness.
We're still mass-testing, which is drastically inflating the numbers compared to all other viruses, which we don't mass-test for. Nowhere near that many people are actually getting sick.
The recent “5 times higher deaths for the unvaccinated!!!” headline was a study the CDC cited that used predictive models to make the claim that you’re more likely to die being unvaccinated. They put a number on it of 5 times but it’s just estimates of what could happen, not what did happen.
There are no numbers that exist to back up your claim. Or post away with a source if you think it’s real.
I enjoy constructive discussion on HN, but the downvoted/dead/flagged posts I see all seem to be short, unsubstantive comments that repeat familiar tropes and beg others to proceed with similarly trite responses. It would seem to fall short of this guideline:
> Comments should get more thoughtful and substantive, not less, as a topic gets more divisive.
And of course people also downvote to disagree. The winds blow certain ways here.
https://news.ycombinator.com/item?id=32668716
In all serious I feel like a group has been "radicalized" from all the government propaganda, and never got talked back down, and now we're living through the consequences, in online discussion particularly, for some reason...
they have appealed to people who love to have any authority over others, because now they have a personal "moral high ground" to impose restrictions and their will on others.
they have appealed to what is probably mostly those that are intellectuals (or percieve themselves to be) with the whole "trust the science" crowd. At the same time we conveniently forget all the evidence of how science has been deeply corrupted, and "well the science changed".
but it has also, very frighteningly so, exposed that people have almost no memory, and way too high trust in authorities. looking back at all the directly insane things governments have done and pushed their citizens to endure, it has also often come with "trust the science" or whatever equivelant thing used back then. Would you line up for the DDT spraying in the streets now? and lead was surely safe in the gasoline. but now of course things are different! the government couldnt possibly be wrong now? and if you think they might be? SCIENCE DENIER YOU ARE KILLING GRANDMA!!!!
people have reverted to tribal mentality, and there was enough tribes that several people could find a spot they identified with.
Public health is firstly of prime importance, and secondly something that only collective action can really secure. 'Personal responsibility' won't cut it. This must be a nasty shock to those who were told it was ok to be selfish. Of course, not many people are likely to own up to selfishness, even to themselves, so they dress it up with 'science is wrong' 'don't trust the government' 'they are trying to control us' etc etc.
I note in passing that life expectancy continues to fall in the US, while recovering in peer nations.
It's this kind of dismissive attitude that really grinds peoples gears. There is a lot of reasons to be pissed about what society did besides "getting a haircut". For example, we absolutely completely fucked over the younger people when they weren't even an at-risk population.
> not many people are likely to own up to selfishness
I assert the most selfish people were those who expected all of society to shut down because they expected everybody to be as fearful as they were. It is very selfish to make that ask.
And plus, these public health "experts" are unelected and unaccountable. They have absolutely no right to impose any of what they did for more than two years. Especially given none of them could assert any of their mandates even worked in a way that was worth the huge costs.
Dismissing skeptics like myself in the way you did in your comment is incredibly condesending and sanctimonious. It's downright terrifying that voices like yours were allowed to dominate the discussions over the last two years. It's bullying and abusive.
yeah, nations like Sweden that was very very very light on these lockdowns.. perhaps you'd entertain the idea that it is not related? :)
At this point which group you are talking about could be anybody.
All I can personally say is I’m still incredibly pissed off at being told to shut the fuck up and obey some “authority”. I’ve been yelled at, followed by nutjobs with cameras for the crime of taking my mask off while leaving a building, I’ve had people accuse me of being some alt-right kook.
I’m especially pissed because the people who told me that (many in real life) were people I used to consider rational, intelligent people. I’ll never trust those people again.
So yeah, a lot of “skeptics”, most of which are just normal fucking people, are pretty god damn pissed off at how we were gaslit, dismissed and abused. A lot of people owe us a huge apology for being such absolute assholes.
Steven Pinker had some comments about this -- I recommend his new book.
We essentially experienced two pandemics, one of which was unreason.
Some examples:
* Permitting Public Assembly (for BLM), but then damning public assembly for other reasons (such as religion).
* Characterizing the lab leak covid origin theory as racism.
Aerosols don't accumulate outdoors.
Considering the costs of infection to the economy, probably never. This has been called the world's easiest cost/benefit calculation.
I think we've seen it's the costs of the political reaction, not the infection itself. Which is ironic because as I understand the way covid becomes dangerous is when the immune system overreacts to it (I don't know if that interpretation is still current)
Cost per ICU case 100k USD
ICU Case per infection: 1%
Cost per infection thus 1000 USD
Cost per vaccine: x times 20 USD (x=2,3,4)
At some point the sensationalism about COVID-19 will fade away and we will we back to normal, with lots of other illnesses (many of them a lot worse than COVID-19), and viruses, and all of that. Outside the Western world, unvaccinated people just go on with their lives and guess what, bodies are not piled up on the streets. Maybe the new variants are milder, maybe there was just a lot of fear when the first wave happened and COVID-19 countermeasures caused many of the deaths. We will probably never know.
So, glad they're finally successfully catering to that sentiment. I'll look into it.
> Who is eligible to receive a single booster dose and when:
> Individuals 18 years of age and older are eligible for a single booster dose of the Moderna COVID-19 Vaccine, Bivalent if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.
> Individuals 12 years of age and older are eligible for a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.
> From the post, they're only available to people who are already "up-to-date":
> ...
I don't think so. I read that to mean, to be eligible for the bivalent booster, you must have gotten a primary vaccination and not gotten a COVID vaccine (primary or booster) in the last two months.
Are you/others conflating my ambivalence towards alpha boosters as a negative statement on primary vaccination?
I’m hoping that an omicron/variant specific one would give more utility