[HN Gopher] FDA Authorizes Moderna, Pfizer-BioNTech Bivalent Cov...
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FDA Authorizes Moderna, Pfizer-BioNTech Bivalent Covid-19 Vaccines
Booster Dose
Author : Trouble_007
Score : 62 points
Date : 2022-08-31 20:10 UTC (2 hours ago)
(HTM) web link (www.fda.gov)
(TXT) w3m dump (www.fda.gov)
| imapeopleperson wrote:
| https://www.wsj.com/articles/latest-covid-boosters-are-set-t...
| greenyoda wrote:
| Or, without paywall: https://archive.ph/gInAt
| walterbell wrote:
| 12 August 2022, https://brownstone.org/articles/cdc-quietly-ends-
| differentia...
|
| _> 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.
|
| > CDC's COVID-19 prevention recommendations no longer
| differentiate based on a person's vaccination status because
| breakthrough infections occur, though they are generally mild,
| and persons who have had COVID-19 but are not vaccinated have
| some degree of protection against severe illness from their
| previous infection._
| danans wrote:
| > 12 August 2022, https://brownstone.org/articles/cdc-quietly-
| ends-differentia...
|
| > 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 us 1M dead people in the US to get there, and the
| death rate for the unvaccinated was many multiples that of the
| unvaccinated [1].
|
| 1. https://ourworldindata.org/covid-deaths-by-vaccination
| konfusinomicon wrote:
| awful lot of downvoted comments making good points here. why is
| that?
| swatcoder wrote:
| I'm going to assume this is an earnest question.
|
| 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.
| version_five wrote:
| Covid (not the infection, the social phenomenon) short
| circuited many people's ability to have a rational discussion.
| See the example from this thread, someone asks an apparently
| earnest question and gets a ridiculously disproportionate
| response.
|
| 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...
| [deleted]
| [deleted]
| yieldcrv wrote:
| oh nice, I always mentioned I would _consider_ an Omicron
| /variant specific booster. As in, completely ignore anybody
| talking about boosters for something 3 years ago, and not
| _completely ignore_ one for the seasonal covid.
|
| So, glad they're finally successfully catering to that sentiment.
| I'll look into it.
| tunesmith wrote:
| It sounds like you are under the impression that booster that
| exists now gives _no_ additional protection compared to the
| two-shot vaccine, beyond the very temporary antibody boost. I
| don 't have a source right now, but I believe that impression
| is incorrect, isn't it? Yes, the booster does give a temporary
| antibody boost, but it also gives a lower level of increased
| long-term efficacy, even against Omicron.
| Izkata wrote:
| From the post, they're only available to people who are already
| "up-to-date":
|
| > 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.
| tablespoon wrote:
| >> oh nice, I always mentioned I would consider an
| Omicron/variant specific booster. As in, completely ignore
| anybody talking about boosters for something 3 years ago, and
| not completely ignore one for the seasonal covid.
|
| > 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.
| ZanyProgrammer wrote:
| _or_ not gotten. You can have the primary series and no
| booster and get the updated shot, as long as it 's more
| than two months since.
| konfusinomicon wrote:
| is this round free too?? if so, at what point do the governments
| of the world stop subsidizing covid shots? will a new booster
| come out ever few months until then?
| robertlagrant wrote:
| Vaccine manufacturers would be crazy to stop making boosters
| until that point.
| ZanyProgrammer wrote:
| The previous booster shot wasn't even a new variant, and most
| people have only received one since fall 2021. So no, not every
| few months as you scaremonger.
| wmf wrote:
| _at what point do the governments of the world stop subsidizing
| covid shots?_
|
| Considering the costs of infection to the economy, probably
| never. This has been called the world's easiest cost/benefit
| calculation.
| 2OEH8eoCRo0 wrote:
| Awesome news. I'll get one with my yearly influenza vaccine and
| get on with my life.
| jamisteven wrote:
| Am I the only one that doesnt read these articles anymore? Its
| like they are continually trying to force covid down your throats
| in effort for it to still be a topic of relevance, and for what?
| Has the world not moved on?
| morvita wrote:
| Given that the EU and US are both seeing around 100,000 new
| cases daily, no, I don't think the world has moved on.
|
| 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.
| standardUser wrote:
| My elderly grandfather has never had COVID and is excited to
| get a new, updated shot. If he does get COVID, he has a pretty
| good chance of suffering a pretty severe illness. Maybe
| occasionally think about other people, and their varying life
| experiences, which may be radically unlike your own? It's a
| really great habit.
| gfdsgfdsf wrote:
| shadowtree wrote:
| xienze wrote:
| > 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.
|
| 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?
| lampshades wrote:
| loceng wrote:
| Consultant32452 wrote:
| My random guess which should be taken with a grain of salt is
| there is some kind of workaround based on the fact that the
| original vaccine and this are both under the EUA.
|
| 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.
| ok_dad wrote:
| Both Pfizer[0] and Moderna[1] vaccines are full-approved, so
| your "context info" is absolutely false.
|
| [0] - https://www.fda.gov/emergency-preparedness-and-
| response/coro...
|
| [1] - https://www.fda.gov/emergency-preparedness-and-
| response/coro...
| Consultant32452 wrote:
| The approved versions of the vaccine are not actually being
| distributed, at least as of a few months ago. Your own FDA
| article differentiates them.
|
| >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.
| wrl wrote:
| > The Pfizer-BioNTech version is different than the
| Comirnaty version.
|
| How do they differ? Aren't they both tozinameran?
| Consultant32452 wrote:
| As I stated in my comment, the difference may only be the
| label. But the FDA article clearly differentiates them
| and explicitly discusses how the approvals vs EUA are
| different for each.
| jltsiren wrote:
| At least in the EU, the vaccine that was approved in
| December 2020 was already called Comirnaty.
| Consultant32452 wrote:
| I'm less familiar with EU liability laws. In the US the
| FDA differentiates an EUA version and the regular FDA
| approved version. The difference may only be the label,
| but Pfizer would be foolish to distribute a version with
| liability attached when they could distribute a version
| without liability attached.
|
| 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.
| bb88 wrote:
| > The Pfizer-BioNTech version is different than the
| Comirnaty version.
|
| You haven't proved this to be the case. It seems like
| fearmongering to me.
|
| It's "marketed" differently, not "formulated"
| differently.
| loceng wrote:
| Spellman wrote:
| This is a Booster.
|
| I'm sure they could develop a primary vaccine that starts with
| this strain as the base.
| Izkata wrote:
| In case you weren't aware, the primary shots and boosters (up
| until these two) were all the same shot. These also work the
| same as those.
|
| The only reason it's not being treated as a primary shot is
| it wasn't tested as such (and probably also marketing
| purposes).
| ok_dad wrote:
| stainablesteel wrote:
| yeah if you ask any questions ever just shut up
|
| seriously, who actually thinks acting like this offers any
| benefit to public health
|
| everyone should be scared into silence and forced to follow
| whatever an authority figure says
| bb88 wrote:
| I read it as this:
|
| "I don't have an advanced scientific medical degree in
| epidemiology, but don't you guys also see this as sketchy?"
| ok_dad wrote:
| Questions and FUD are different:
| https://en.wikipedia.org/wiki/Fear,_uncertainty,_and_doubt
|
| Your comment is an example of FUD: you're trying to level
| the field between "people asking questions" and FUD, which
| have different goals. The goal of a "question" is to learn
| something you don't know. The goal of FUD is to do
| something that makes it harder and more complex to
| determine the facts. Your comment effectively states that
| any question anyone is asking should be answered, whereas
| some people will ask FUD questions that are simply a
| massive time sink for those who have to deal with them. A
| lie can run around the world before the truth puts on
| shoes.
| robertlagrant wrote:
| The goal of calling things FUD is not some automatically
| pure thing, though. A question is easy to identify.
| Calling a question FUD is a subjective judgment by
| someone whose motives we also don't know.
| butUhmErm wrote:
| gfdsgfdsf wrote:
| robertlagrant wrote:
| > Also, you could just be spreading FUD, in which case: shut
| up.
|
| This seems pretty flaggable.
| xienze wrote:
| > Most people in the USA have gotten the first two shots, so
| it's probably best to speed the release of the booster by
| doing a shorter study of just booster use
|
| I understand that, but I think you're missing the bigger
| issue. Let's say five years from now they're on the fifth new
| booster (optimistically, since this one took longer than a
| year to come out), will you have had to complete all 6+
| earlier boosters in sequence before you can get the latest
| one? Surely at some point it's not a reasonable assumption to
| think that everyone has diligently gotten the latest shots,
| like clockwork. Eventually the shots have to be able to work
| independently, right? Again, we seem to be able to pull off a
| new flu shot every single year...
| Imnimo wrote:
| But this one requires only the primary course - why would
| you assume that you would need "all 6+ earlier boosters in
| sequence" when this one doesn't even require any previous
| booster?
| ok_dad wrote:
| Agree, those are questions we need to understand the
| answers to, and I would guess that's the next focus area:
| how to improve the initial series of vaccinations using
| this bivalent vaccine, or maybe a later a more-multi-valent
| vaccine. My guess is that right now, it's a matter of doing
| what needs to be done now to cover the majority of people,
| since we can't do it all at once.
| hasty wrote:
| They only approve that which they've tested for; in this case,
| they've only tested using this dosage as a booster. If, later,
| there's more testing on people who have not had any vaccine,
| they may expand the authorization. It's not a conspiracy.
| gfdsgfdsf wrote:
| [deleted]
| Symmetry wrote:
| With most things there's the right way to do something, the
| wrong way to do it, and the bureaucratic way. Honestly I'm
| happily surprised that they're going with the Flu system for
| Covid because the rules for the yearly Flu vaccine are
| grandfathered in from a time when the vaccine approval process
| was very different. There were a lot variances in the ways that
| vaccines can be administered, like "first doses first", that
| would have made a huge positive difference in our overall
| response and that other countries like the UK employed
| successfully but that didn't match existing procedures. Well,
| except that given years of work the procedures were changed and
| now we're doing that with Monkeypox vaccination. So yeah, it's
| stupid but it isn't sinister, it's just a big bureaucracy being
| a big bureaucracy.
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