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> 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 sinc

by 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 ago
This is a Booster. I'm sure they could develop a primary vaccine that starts with this strain as the base.
- Izkata 4y ago
  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).
hasty 4y ago
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.
- itsthemmrvax 4y ago
  They've only tested it on mice....
lampshades 4y ago
- loceng 4y ago
Consultant32452 4y ago
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 4y ago
  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/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 ago
    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 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 ago
    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.
  - Imnimo 4y ago
    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?
- stainablesteel 4y ago
  - 4y ago
gfdsgfdsf 4y ago
- deleted 4y ago
  [deleted]
Symmetry 4y ago
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.

by xienze 4y ago

Spellman 4y ago

This is a Booster. I'm sure they could develop a primary vaccine that starts with this strain as the base.

Izkata 4y ago
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).

hasty 4y ago

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.

itsthemmrvax 4y ago
They've only tested it on mice....

lampshades 4y ago

loceng 4y ago

Consultant32452 4y ago

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 4y ago
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/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 ago
  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 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 ago
  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.
- Imnimo 4y ago
  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?
stainablesteel 4y ago
- 4y ago

gfdsgfdsf 4y ago

deleted 4y ago
[deleted]

Symmetry 4y ago

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.