11 ms·

Yes. The one in pole position. Until now.

by Marazan 6y ago

mrfusion 6y ago
Is that why the market was down today?
- marc__1 6y ago
  No, the AZN announcement was made after the market closed. Take for instance Moderna, who was -13% today, and is +3.7% after-hours
- codeisawesome 6y ago
  Not tracking the real world anymore
zerobits 6y ago
The Moderna mRNA vaccine was producing 103 degree fevers (and passing out) in a Phase 1 volunteer. [1] If that's the reaction in small sample with a healthy 29 year old (most volunteers had high fevers), I can't imagine old or unhealthy people will be unharmed. I was more concerned about the mRNA vaccines being at risk initially. Things aren't looking great... [1] https://www.statnews.com/2020/05/26/moderna-vaccine-candidate-trial-participant-severe-reaction/ https://www.statnews.com/2020/05/26/moderna-vaccine-candidat...
- pageandrew 6y ago
  Phase 1 trials are used to determine dosage. Different participants are given different doses of the vaccine so researchers can identify the proper dosage with maximal efficacy and minimal side effects. The 29 year volunteer who experienced the 103° fever received the highest dose of the vaccine given out during the Phase 1 trial. Such a adverse reaction is not unexpected during a Phase 1 trial, but the vaccine did move forward to Phase 2 and Phase 3 so it appears that the lower dosages do not trigger such a reaction.
  - ummonk 6y ago
    Even the "mild / moderate" reactions were pretty bad though. They sounded substantially worse than your average cold.
- djsumdog 6y ago
  The idea a vaccine can be safely made in less than a year is absolutely insanity. Many of these things shouldn't even be considered vaccines in the traditional sense. Are there any vaccines out on the market today that are not one of the two: 1) inactivated virus, 2) attenuated virus (run through another host/egg or a related virus found in an animation that's less harmful to humans)? Everything I've found indicates all our current viral vaccines are one of those two (excluding bacterial vaccines, which shouldn't be called vaccines either).
  - deleted 6y ago
    [deleted]
  - cblconfederate 6y ago
    The modeRNA vaccine is an mRNA vaccine, a completely new type of vaccine. While theoreticall less likely to have adverse effects, it did have adverse effects, and its efficacy remains a question. These are completely new types of vaccine, that presumably would need even more testing than the relatively well understood attenuated viruses.
    - linuxftw 6y ago
      > completely new type of vaccine Then is it a vaccine at all? Vaccines were traditionally live, dead, or attenuated virus/bacteria injections, some with adjutants, to stimulate an immune response. Technologically speaking, it's bicycle vs airplane. Similar underlying purpose, entirely different implementation.
      - LeoNatan25 6y ago
        Both a bicycle and an airplane are transportation vehicles. Likewise, anything that illicits imunity is a vaccine, regardless of how novel the approach is.
    - dehrmann 6y ago
      > modeRNA I can't believe I didn't notice that until now.
- _zlja 6y ago
  That was at the 250ug dose, current dose is 100ug. At that dose, even the elderly didn’t have bad side effects.
- thehappypm 6y ago
  It’s disingenuous to call it “the Moderna mRNA vaccine” when it was more accurately “one early Moderna mRNA vaccine candidate, which was ruled out for being far too high of a dose”.
  - zerobits 6y ago
    Thanks for the valid correction. I didn’t mean to be disingenuous. I forgot they rejected that dosage. Overall, the picture does look potentially concerning for the side effects of that vaccine and efficacy is still unclear.
    - thehappypm 6y ago
      What makes it concerning? Tylenol is concerning if you take 2.5x the safe dose. Of course the efficacy is unclear — it’s still in trials!
      - zerobits 6y ago
        There was a pretty high severe systemic adverse rate in the high dose group (20%). Severe local response rate was 5% in the middle dose. [1] I have no idea how this compares to other vaccines, and you can pessimistically extrapolate a bit from this tiny, healthy sample from the high dose (n=15 in middle dose group). I'd imagine some % of people when this scales to millions will have a bad response, and the high dose group might provide some model of the worst cases. [1] https://www.nejm.org/doi/full/10.1056/nejmoa2022483 https://www.nejm.org/doi/full/10.1056/nejmoa2022483
        DrAwdeOccarim 6y ago
        I think the comparison most are making is to Shingrix. Have a look at Table 2[1]. [1] https://www.nejm.org/doi/pdf/10.1056/NEJMoa1603800 https://www.nejm.org/doi/pdf/10.1056/NEJMoa1603800
- koheripbal 6y ago
  Fevers are very common in vaccines, normally. It is an indication that the immune system developing an immune response. It is not an indication of complication.
  - zerobits 6y ago
    Yes, but at some threshold wouldn’t this indicate a problem? 103F+ fevers are relatively rare from typical vaccines, and from my understanding a lot of the damage from COVID is immune response related. mRNA vaccines and our immune responses to these are uncharted territory, so I’m not sure how much we can reason by analogy from other vaccines vs. first principles.
    - koheripbal 6y ago
      High fevers are not uncommon in babies receiving their first vaccines. I'm not sure it indicates a problem. A fever is, itself, just an immune system response, not a "symptom" of disease. You are correct that there is a threshold beyond which a fever becomes unsafe, but it's above 103. But fevers of 103 in the test group do not indicate that fevers of say 105 will occur in some patients.
- BickNowstrom 6y ago
  mRNA would not have hit Phase III if found unsafe in earlier phases. If mRNA succeeds things will look really great, since it in principle it can protect against many other viruses and upcoming pandemics with slight modifications. The most reported side effect for mRNA is mild stiffness at application spot.
DebtDeflation 6y ago
Meanwhile, the CEOs of Pfizer and BioNTech have been talking up how their vaccine will be ready for approval in mid/late October the last few days. It's honestly a little disconcerting.
- refurb 6y ago
  Where are you seeing that? Pfizer's CEO's comments seems quite measured. "Last week, he said the company could have results from its late-stage coronavirus vaccine trial as early as October after enrolling 23,000 volunteers." https://www.cnbc.com/2020/09/08/coronavirus-vaccine-pfizer-ceo-says-people-who-dont-take-it-will-become-weak-link.html https://www.cnbc.com/2020/09/08/coronavirus-vaccine-pfizer-c...
  - DebtDeflation 6y ago
    The BioNTech CEO wasn't nearly as measured in his comments. https://www.cnn.com/2020/09/08/health/pfizer-biontech-vaccine-october-intl-grm/index.html https://www.cnn.com/2020/09/08/health/pfizer-biontech-vaccin...
    - refurb 6y ago
      "Pfizer and BioNTech are confident they can have a vaccine against the novel coronavirus ready for regulatory approval by the middle of October or early November." This doesn't seem extreme to me. "ready for regulatory approval" just means they've submitted a complete package to the FDA. However, this is a really stupid comment. "It has an excellent profile and I consider this vaccine ... near perfect, and which has a near perfect profile," And at least according to FDA regulations, that statement violates a number of rules around the promotion of unapproved products.
- vmurthy 6y ago
  If memory serves right, the CEOs were talking about it late August but from yesterday's announcement[0] : "Nine drug companies issued a joint pledge on Tuesday that they would “stand with science” and not put forward a vaccine until it had been thoroughly vetted for safety and efficacy" [0]https://www.nytimes.com/2020/09/08/world/covid-19-coronavirus.html?smtyp=cur&smid=tw-nytimes#link-313b443d https://www.nytimes.com/2020/09/08/world/covid-19-coronaviru...

Yes. The one in pole position. Until now.

mrfusion 6y ago

Is that why the market was down today?

marc__1 6y ago
No, the AZN announcement was made after the market closed. Take for instance Moderna, who was -13% today, and is +3.7% after-hours
codeisawesome 6y ago
Not tracking the real world anymore

zerobits 6y ago

The Moderna mRNA vaccine was producing 103 degree fevers (and passing out) in a Phase 1 volunteer. [1] If that's the reaction in small sample with a healthy 29 year old (most volunteers had high fevers), I can't imagine old or unhealthy people will be unharmed. I was more concerned about the mRNA vaccines being at risk initially. Things aren't looking great... [1] https://www.statnews.com/2020/05/26/moderna-vaccine-candidate-trial-participant-severe-reaction/ https://www.statnews.com/2020/05/26/moderna-vaccine-candidat...

pageandrew 6y ago
Phase 1 trials are used to determine dosage. Different participants are given different doses of the vaccine so researchers can identify the proper dosage with maximal efficacy and minimal side effects. The 29 year volunteer who experienced the 103° fever received the highest dose of the vaccine given out during the Phase 1 trial. Such a adverse reaction is not unexpected during a Phase 1 trial, but the vaccine did move forward to Phase 2 and Phase 3 so it appears that the lower dosages do not trigger such a reaction.
- ummonk 6y ago
  Even the "mild / moderate" reactions were pretty bad though. They sounded substantially worse than your average cold.
djsumdog 6y ago
The idea a vaccine can be safely made in less than a year is absolutely insanity. Many of these things shouldn't even be considered vaccines in the traditional sense. Are there any vaccines out on the market today that are not one of the two: 1) inactivated virus, 2) attenuated virus (run through another host/egg or a related virus found in an animation that's less harmful to humans)? Everything I've found indicates all our current viral vaccines are one of those two (excluding bacterial vaccines, which shouldn't be called vaccines either).
- deleted 6y ago
  [deleted]
- cblconfederate 6y ago
  The modeRNA vaccine is an mRNA vaccine, a completely new type of vaccine. While theoreticall less likely to have adverse effects, it did have adverse effects, and its efficacy remains a question. These are completely new types of vaccine, that presumably would need even more testing than the relatively well understood attenuated viruses.
  - linuxftw 6y ago
    > completely new type of vaccine Then is it a vaccine at all? Vaccines were traditionally live, dead, or attenuated virus/bacteria injections, some with adjutants, to stimulate an immune response. Technologically speaking, it's bicycle vs airplane. Similar underlying purpose, entirely different implementation.
    - LeoNatan25 6y ago
      Both a bicycle and an airplane are transportation vehicles. Likewise, anything that illicits imunity is a vaccine, regardless of how novel the approach is.
  - dehrmann 6y ago
    > modeRNA I can't believe I didn't notice that until now.
_zlja 6y ago
That was at the 250ug dose, current dose is 100ug. At that dose, even the elderly didn’t have bad side effects.
thehappypm 6y ago
It’s disingenuous to call it “the Moderna mRNA vaccine” when it was more accurately “one early Moderna mRNA vaccine candidate, which was ruled out for being far too high of a dose”.
- zerobits 6y ago
  Thanks for the valid correction. I didn’t mean to be disingenuous. I forgot they rejected that dosage. Overall, the picture does look potentially concerning for the side effects of that vaccine and efficacy is still unclear.
  - thehappypm 6y ago
    What makes it concerning? Tylenol is concerning if you take 2.5x the safe dose. Of course the efficacy is unclear — it’s still in trials!
    - zerobits 6y ago
      There was a pretty high severe systemic adverse rate in the high dose group (20%). Severe local response rate was 5% in the middle dose. [1] I have no idea how this compares to other vaccines, and you can pessimistically extrapolate a bit from this tiny, healthy sample from the high dose (n=15 in middle dose group). I'd imagine some % of people when this scales to millions will have a bad response, and the high dose group might provide some model of the worst cases. [1] https://www.nejm.org/doi/full/10.1056/nejmoa2022483 https://www.nejm.org/doi/full/10.1056/nejmoa2022483
      - DrAwdeOccarim 6y ago
        I think the comparison most are making is to Shingrix. Have a look at Table 2[1]. [1] https://www.nejm.org/doi/pdf/10.1056/NEJMoa1603800 https://www.nejm.org/doi/pdf/10.1056/NEJMoa1603800
koheripbal 6y ago
Fevers are very common in vaccines, normally. It is an indication that the immune system developing an immune response. It is not an indication of complication.
- zerobits 6y ago
  Yes, but at some threshold wouldn’t this indicate a problem? 103F+ fevers are relatively rare from typical vaccines, and from my understanding a lot of the damage from COVID is immune response related. mRNA vaccines and our immune responses to these are uncharted territory, so I’m not sure how much we can reason by analogy from other vaccines vs. first principles.
  - koheripbal 6y ago
    High fevers are not uncommon in babies receiving their first vaccines. I'm not sure it indicates a problem. A fever is, itself, just an immune system response, not a "symptom" of disease. You are correct that there is a threshold beyond which a fever becomes unsafe, but it's above 103. But fevers of 103 in the test group do not indicate that fevers of say 105 will occur in some patients.
BickNowstrom 6y ago
mRNA would not have hit Phase III if found unsafe in earlier phases. If mRNA succeeds things will look really great, since it in principle it can protect against many other viruses and upcoming pandemics with slight modifications. The most reported side effect for mRNA is mild stiffness at application spot.

DebtDeflation 6y ago

Meanwhile, the CEOs of Pfizer and BioNTech have been talking up how their vaccine will be ready for approval in mid/late October the last few days. It's honestly a little disconcerting.

refurb 6y ago
Where are you seeing that? Pfizer's CEO's comments seems quite measured. "Last week, he said the company could have results from its late-stage coronavirus vaccine trial as early as October after enrolling 23,000 volunteers." https://www.cnbc.com/2020/09/08/coronavirus-vaccine-pfizer-ceo-says-people-who-dont-take-it-will-become-weak-link.html https://www.cnbc.com/2020/09/08/coronavirus-vaccine-pfizer-c...
- DebtDeflation 6y ago
  The BioNTech CEO wasn't nearly as measured in his comments. https://www.cnn.com/2020/09/08/health/pfizer-biontech-vaccine-october-intl-grm/index.html https://www.cnn.com/2020/09/08/health/pfizer-biontech-vaccin...
  - refurb 6y ago
    "Pfizer and BioNTech are confident they can have a vaccine against the novel coronavirus ready for regulatory approval by the middle of October or early November." This doesn't seem extreme to me. "ready for regulatory approval" just means they've submitted a complete package to the FDA. However, this is a really stupid comment. "It has an excellent profile and I consider this vaccine ... near perfect, and which has a near perfect profile," And at least according to FDA regulations, that statement violates a number of rules around the promotion of unapproved products.
vmurthy 6y ago
If memory serves right, the CEOs were talking about it late August but from yesterday's announcement[0] : "Nine drug companies issued a joint pledge on Tuesday that they would “stand with science” and not put forward a vaccine until it had been thoroughly vetted for safety and efficacy" [0]https://www.nytimes.com/2020/09/08/world/covid-19-coronavirus.html?smtyp=cur&smid=tw-nytimes#link-313b443d https://www.nytimes.com/2020/09/08/world/covid-19-coronaviru...