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FDA Authorizes Moderna, Pfizer-BioNTech Bivalent Covid-19 Vaccines Booster Dose
- xienze 4y ago> 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?
- Spellman 4y agoThis is a Booster. I'm sure they could develop a primary vaccine that starts with this strain as the base.
- Izkata 4y agoIn 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).
- hasty 4y agoThey 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.
- itsthemmrvax 4y agoThey've only tested it on mice....
- lampshades 4y ago
- loceng 4y ago
- Consultant32452 4y agoMy 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 4y agoBoth 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/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccines https://www.fda.gov/emergency-preparedness-and-response/coro... [1] - https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccines https://www.fda.gov/emergency-preparedness-and-response/coro...
- Consultant32452 4y agoThe 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 4y ago> The Pfizer-BioNTech version is different than the Comirnaty version. How do they differ? Aren't they both tozinameran?
- loceng 4y ago
- ok_dad 4y ago
- gfdsgfdsf 4y ago
- xienze 4y ago> 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...
- ok_dad 4y agoAgree, 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.
- Imnimo 4y agoBut 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?
- stainablesteel 4y ago
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- Symmetry 4y agoWith 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.
- imapeopleperson 4y agohttps://www.wsj.com/articles/latest-covid-boosters-are-set-to-roll-out-before-human-testing-is-completed-11661679003 https://www.wsj.com/articles/latest-covid-boosters-are-set-t...
- greenyoda 4y agoOr, without paywall: https://archive.ph/gInAt https://archive.ph/gInAt
- yieldcrv 4y agooh 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.
- Izkata 4y agoFrom 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 4y ago>> 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 4y agoor 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.
- yieldcrv 4y agoWas there something about my post that suggested I wouldn’t be up to date to that standard? Are you/others conflating my ambivalence towards alpha boosters as a negative statement on primary vaccination?
- shadowtree 4y ago
- walterbell 4y ago12 August 2022, https://brownstone.org/articles/cdc-quietly-ends-differentiation-on-covid-vaccination-status/ 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 4y ago> 12 August 2022, https://brownstone.org/articles/cdc-quietly-ends-differentia 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 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 https://ourworldindata.org/covid-deaths-by-vaccination
- itsthemmrvax 4y ago
- walterbell 4y agoPerhaps someone has the patience to review the track record of the last two years on attribution accuracy for classification of death causes, including the CDC's (re)statements on this topic.
- danans 4y agoExcess mortality due to COVID has been analyzed and found to be greater than even the official COVID death toll: https://www.thelancet.com/article/S0140-6736(21)02796-3/fulltext https://www.thelancet.com/article/S0140-6736(21)02796-3/full... https://www.economist.com/briefing/2021/05/15/there-have-been-7m-13m-excess-deaths-worldwide-during-the-pandemic 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.
- konfusinomicon 4y agoawful lot of downvoted comments making good points here. why is that?
- swatcoder 4y agoI'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.
- konfusinomicon 4y agoyour assumption was correct..genuinely curious and it's interesting to see how polarizing the topic is in every sphere, especially one such as this which is more than full of critical thinkers
- version_five 4y agoCovid (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 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...
- redeeman 4y agoit has been a multi-pronged assault on people. 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.
- konfusinomicon 4y agois 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 4y agoVaccine manufacturers would be crazy to stop making boosters until that point.
- konfusinomicon 4y agothe capitalist in me understands. the tax payer is a little more uncertain
- robertlagrant 4y agoI'm with you.
- ZanyProgrammer 4y ago
- wmf 4y agoat 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.
- version_five 4y ago> costs of infection to the economy 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)
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- jamisteven 4y agoAm 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?
- standardUser 4y agoMy 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 4y ago
- wellthatsawrap1 4y agoHe wants your Grandpa to have the vaccine. What he does not want is to have to wear diapers because someone else might be incontinent.
- throwaway13909 4y agoThe problem are the people who think they are continent but are overwhelming our health care system which is already past or at least at its limits.
- standardUser 4y agoNo one wears a diaper to prevent the spread of COVID. You sound profoundly confused.
- morvita 4y agoGiven 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.
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- 2OEH8eoCRo0 4y agoAwesome news. I'll get one with my yearly influenza vaccine and get on with my life.
- incrudible 4y agoSure, why not inject a pharmaceutical with indeterminate benefit and a minor risk of heart injury of unknown etiology, on an annual basis. Scrutinizing the methodology and motivations of the people responsible is totally uncalled for.
- jrockway 4y agoWhat do you think their motivations were?
- incrudible 4y agoMoney, as well as the prospects of further money down the line.
- nikolay 4y agoI'm sure Pfizer will be happy treating ED later on - both those who got COVID-19 and those who didn't but get vaccinated and get injured.
- jrockway 4y agoYour claim is that the COVID-19 vaccine causes ED? What's the mechanism?
- nikolay 4y agoYes, both the disease and the vaccine cause vasculitis, which is linked to ED. Of course, not all vaccinated get vasculitis, because not all the vaccine ends up in the blood stream of the vacinated, but for a good portion of them it does and it's a well-documented fact already. That's why in Germany and Austria they recommend giving the vaccine shot using the classical appraoch with aspiration. Many European dotors have been sounding the alarm for well over a year now!
- nikolay 4y agoA bit too late! I'm sure there's a hidden wave of BA.2.75 as nobody gets tested officially due to the omnipresence of at-home antigen tests. Pretty much everybody I know got hit relatively hard, but I don't see a rastic raise in the cases in California. The sore throat is terrible and another common symptom I hear from people is dizziness. My wife and daughter got it, my son and I didn't thanks to a science-based respiratory hygiene at home, but they needed benzocaine throat spray to even just breathe - our friends also had to get it as one got severely dehydrated due to fever and not being able to even swallow his own saliva from pain and even less so - drink water. And days after negative antigen tests, my family members are starting the third week with still positive PCR tests!
- t0bia_s 4y agoGreat. But it's not working. Hopefully majority realize that it is just agenda for sell many unused doses.
- dudeDDRrulez 4y agoOh that’s for sure. You know that this is the case when the Omicron Ba4/Ba5 booster alone had higher antibody response (on mice, not humans. Humans weren’t even tested) than the EUA authorized bivalent booster which combines old and new formulas.
- t0bia_s 4y agoI don't care. Covid is not threat for healthy people. Vaccines could be.