Moderna Phase 1 Results NEJM
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Last: 5 yr ago by BiochemAg97
Quote:
CONCLUSIONS
The mRNA-1273 vaccine induced antiSARS-CoV-2 immune responses in all participants, and no trial-limiting safety concerns were identified. These findings support further development of this vaccine. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 ClinicalTrials.gov number, NCT04283461. opens in new tab).
Is this the best news we've had since this started? Well, other than death rates being lower than initially thought.
Here is the Vaccine Safety section of the report. Dropping one of the low dose group from a set of 15 for developing hives after the first dose might be a red flag to some.
https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true
No serious adverse events were noted, and no prespecified trial halting rules were met. As noted above, one participant in the 25-g group was withdrawn because of an unsolicited adverse event, transient urticaria, judged to be related to the first vaccination.
After the first vaccination, solicited systemic adverse events were reported by 5 participants (33%) in the 25-g group, 10 (67%) in the 100-g group, and 8 (53%) in the 250-g group; all were mild or moderate in severity (Fig. 1 and Table S2). Solicited systemic adverse events were more common after the second vaccination and occurred in 7 of 13 participants (54%) in the 25-g group, all 15 in the 100-g group, and all 14 in the 250-g group, with 3 of those participants (21%) report- ing one or more severe events.
None of the participants had fever after the first vaccination. After the second vaccination, no participants in the 25-g group, 6 (40%) in the 100-g group, and 8 (57%) in the 250-g group reported fever; one of the events (maximum tem- perature, 39.6C) in the 250-g group was graded severe. (Additional details regarding adverse events for that participant are provided in the Supplementary Appendix.)
Local adverse events, when present, were nearly all mild or moderate, and pain at the injection site was common. Across both vaccinations, so- licited systemic and local adverse events that occurred in more than half the participants in- cluded fatigue, chills, headache, myalgia, and pain at the injection site. Evaluation of safety clinical laboratory values of grade 2 or higher and unso- licited adverse events revealed no patterns of con- cern (Supplementary Appendix and Table S3).
https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true
No serious adverse events were noted, and no prespecified trial halting rules were met. As noted above, one participant in the 25-g group was withdrawn because of an unsolicited adverse event, transient urticaria, judged to be related to the first vaccination.
After the first vaccination, solicited systemic adverse events were reported by 5 participants (33%) in the 25-g group, 10 (67%) in the 100-g group, and 8 (53%) in the 250-g group; all were mild or moderate in severity (Fig. 1 and Table S2). Solicited systemic adverse events were more common after the second vaccination and occurred in 7 of 13 participants (54%) in the 25-g group, all 15 in the 100-g group, and all 14 in the 250-g group, with 3 of those participants (21%) report- ing one or more severe events.
None of the participants had fever after the first vaccination. After the second vaccination, no participants in the 25-g group, 6 (40%) in the 100-g group, and 8 (57%) in the 250-g group reported fever; one of the events (maximum tem- perature, 39.6C) in the 250-g group was graded severe. (Additional details regarding adverse events for that participant are provided in the Supplementary Appendix.)
Local adverse events, when present, were nearly all mild or moderate, and pain at the injection site was common. Across both vaccinations, so- licited systemic and local adverse events that occurred in more than half the participants in- cluded fatigue, chills, headache, myalgia, and pain at the injection site. Evaluation of safety clinical laboratory values of grade 2 or higher and unso- licited adverse events revealed no patterns of con- cern (Supplementary Appendix and Table S3).
One person had a "severe" fever of 103. That doesn't sound too good.
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I think I read something that they didn't test for anti-bodies or for Covid in subjects prior to administering the vaccine?
I hope that's not the case.... that could poison the results if there were people with a base line of antibodies from a prior exposure already who were entered into the study.
I hope that's not the case.... that could poison the results if there were people with a base line of antibodies from a prior exposure already who were entered into the study.
Have you heard all of the side effects for every medicine advertised on TV?OldArmy71 said:
One person had a "severe" fever of 103. That doesn't sound too good.
Diarrhea, nausea, fever, cramps, chills, bloating, constipation, drowsiness, headaches, ANAL LEAKAGE!
AggieAuditor said:Have you heard all of the side effects for every medicine advertised on TV?OldArmy71 said:
One person had a "severe" fever of 103. That doesn't sound too good.
Diarrhea, nausea, fever, cramps, chills, bloating, constipation, drowsiness, headaches, ANAL LEAKAGE!
Check out Claridryl. Scary stuff
Yea I pretty much hit mute when the drug commercials come on, I am thinking how desperate to live would I have to be to think "anal leakage, sign me up Doc!"
Easy come, Easy go
OldArmy71 said:
One person had a "severe" fever of 103. That doesn't sound too good.
OldArmy71 said:
One person had a "severe" fever of 103. That doesn't sound too good.
One only one and it was during 2nd injection
That person was given the highest dose (250)
Even the flu vaccine causes a fever
At least it does in me
mode RNA
Not really. Phase 1 is about safety. It is worth checking antibodies at that phase because if it doesn't at least produce antibodies, it is a waste of time to go further. But since it was effective in stimulating antibody production in all the subjects, even if some were previously exposed, it still worked on those who weren't. Also keep in mind this study was done months ago when the likelihood of someone having already had it being much lower.Player To Be Named Later said:
I think I read something that they didn't test for anti-bodies or for Covid in subjects prior to administering the vaccine?
I hope that's not the case.... that could poison the results if there were people with a base line of antibodies from a prior exposure already who were entered into the study.
The phase 3 trial (30,000 subjects) about to start will compare infection rates between test and control groups.
I had the yellow fever vaccine a few years back and basically had all the symptoms for a few days and my arm swelled up...even the approved vaccines can give you side effects
Yes please
It clearly states in the paper that nobody had neutralizing antibodies prior to vaccine.Player To Be Named Later said:
I think I read something that they didn't test for anti-bodies or for Covid in subjects prior to administering the vaccine?
I hope that's not the case.... that could poison the results if there were people with a base line of antibodies from a prior exposure already who were entered into the study.
No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. See full Medical Disclaimer.
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I don't know why the face..... I"m very glad to hear that's not the case.
Sorry, I couldn't work my way through that kind of a paper in college to read every detail, sure can't now at 47.
Sorry, I couldn't work my way through that kind of a paper in college to read every detail, sure can't now at 47.
How soon could this be rolled out for the public? Still trying to hit up Vegas for Labor Day. Need this to happen!
Yeah **** bothering to do any research before throwing out your opinion on the matter.
They are expecting the Phase 3 trial to be completed in late October. I have not seen an estimate of when they'll be able to make it available on a wide-scale basis, if that trial looks good.
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Where did I give my opinion?terradactylexpress said:
Yeah **** bothering to do any research before throwing out your opinion on the matter.
Christ, people are so agitated around here that they jump on things just because it's the thing to do now.
I said I had heard something...... that is not giving my opinion. That is asking for clarification.
Player To Be Named Later said:
I think I read something that they didn't test for anti-bodies or for Covid in subjects prior to administering the vaccine?
I hope that's not the case.... that could poison the results if there were people with a base line of antibodies from a prior exposure already who were entered into the study.
CompEvoBio94 said:
They are expecting the Phase 3 trial to be completed in late October. I have not seen an estimate of when they'll be able to make it available on a wide-scale basis, if that trial looks good.
Thanks! Vegas over New Years celebrating everyone's regained mobility freedom wouldn't be a bad alternative. Nor would March madness 2021!
God bless these scientists, we are all rooting for you.
Symptoms of an illness should be expected with vaccination.
The whole point of a vaccine is to create an immune response to develop immunity to the actual disease.
With a systemic immune response you're going to get all the typical viral illness feelings: malaise, fatigue, mild fever, body aches.
The whole point of a vaccine is to create an immune response to develop immunity to the actual disease.
With a systemic immune response you're going to get all the typical viral illness feelings: malaise, fatigue, mild fever, body aches.
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Husband of an Aggie, Class of 1999;
Father to future Class of 2029 and 2031
No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. See full Medical Disclaimer.
Should mRNA vaccine mitigate the range of symptoms as opposed to attenuated/inactivated vaccination?
I doubt it. You are still stimulating the immune system and the immune system response is what gives most viral syndromes the symptoms we experience.lazuras_dc said:
Should mRNA vaccine mitigate the range of symptoms as opposed to attenuated/inactivated vaccination?
No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. See full Medical Disclaimer.
boy is this the pot calling the kettle black
Your also asking the body to take the genetic code injected (in this case messenger RNA) and produce a protein that is similar to what the virus has and the body encounters upon infection. Sounds simple, but there could be issues with how the protein is folded and then recognized by the immune system to start antibody production. You are also only producing one select protein instead of the others encoded and produced by the complete viral genome. It seems to be ok in this case as the spike protein being produced has been shown to lead to neutralizing antibodies as seen in other studies.
Two things I'm concerned about -- lack of T-cell response seen in supplemental data and then the fact you need two injections. Going to be a mess trying to get people to go back twice a month apart for both infections for adequate protection.
Two things I'm concerned about -- lack of T-cell response seen in supplemental data and then the fact you need two injections. Going to be a mess trying to get people to go back twice a month apart for both infections for adequate protection.
The mRNA vaccines will get to market first, but the big boys (GSK) will follow with standard vaccines as well. If the mRNA ones aren't great you'll probably end up with a more standard one as a booster next fall.
My wife is at AZ so that's probably good for the stick options, but not great for the US as we won't be first in line to get those vials as they roll off the production line
Haha, no joke. That guy has been all over this board attacking people, and suddenly he's upset someone attacks him back?cone said:
boy is this the pot calling the kettle black
Thanks for sharing, been following that one since first announced. We'll know relatively soon!texaggie90 said:
https://www.bloomberg.com/news/features/2020-07-15/oxford-s-covid-19-vaccine-is-the-coronavirus-front-runner?utm_source=url_link
Still need phase 3 trail starting later this month to show at least 50% efficacy (half as many people vaccinated get covid compared to control group that gets placebo). Then you need manufacturing to ramp up. The hope is around Dec/Jan, but I'm guessing that initially it will be limited and prioritized. Healthcare workers, high risk individuals, etc.SUag said:
How soon could this be rolled out for the public? Still trying to hit up Vegas for Labor Day. Need this to happen!
I'd think you wouldn't get some of the more severe COVID symptoms, like loss of taste/smell, respiratory issues, etc.KidDoc said:I doubt it. You are still stimulating the immune system and the immune system response is what gives most viral syndromes the symptoms we experience.lazuras_dc said:
Should mRNA vaccine mitigate the range of symptoms as opposed to attenuated/inactivated vaccination?
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