[HN Gopher] FDA Authorizes Moderna, Pfizer-BioNTech Bivalent Cov... ___________________________________________________________________ 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. ___________________________________________________________________ (page generated 2022-08-31 23:00 UTC)