Vaccine administration could occur as early as December 21.
https://apnews.com/article/technolog...886ded9052a85d
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Vaccine administration could occur as early as December 21.
https://apnews.com/article/technolog...886ded9052a85d
Attachment 9827
https://twitter.com/ashishkjha/statu...84647988965376
I'm just a layman, but 0 severe cases in the vaccine group strikes me as "Wow" news.
It's pretty impressive, so "Wow" seems appropriate. :)Quote:
Originally Posted by KSRBEvans
It is very much "wow" news.Quote:
Originally Posted by KSRBEvans
To put a slight damper on it, the number of placebo cases (n=30) is too low to say it is truly 100% effective at preventing severe cases. That being said, it could still be in the upper 90% (97-98%) range which is absolutely incredible. Comparatively, Pfizer had 9 severe cases in placebo and 1 in the vaccinated group. Due to the relatively low n-values for both trials and the similarities in the technology, it would not surprise me if those numbers approach each other when the vaccines are deployed in the general population.
I will put together my overall opinion on what data I can find in a bit!
Very much looking forward to reading it, Pedro. Really appreciate your thoughts and contributions in this area.Quote:
Originally Posted by PedroDaGr8
Very much agree. Thanks, Pedro!Quote:
Originally Posted by Darrell KSR
DittoQuote:
Originally Posted by Darrell KSR
Damn it, Chrome crashed and I lost everything I had written over the past two hours. I will try to rebuild the fully-detailed version, but here is an abbreviated version from memory for tonight:
By the numbers
The Moderna trial tested around 30,000 participants (15,000 vacinated and 15,000 placebo) The difference between this and the Pfizer trial number of 43,000 is mainly academic. Both showed similar numbers of infected in the placebo group. Both trials enrolled similar levels of diversity which should limit the amount of unanticipated adverse reactions.
Efficacy
The reported efficacy of 94.1% for the Moderna vaccine is basically identical to Pfizer's efficacy of 95.0%. These numbers are absolutely excellent! More importantly, both vaccines showed similar efficacy for patients over 65. This indicates an excellent protective effect for the most vulnerable.
As stated before, the number of placebo cases (n=30) is too low to say the Moderna vaccine is truly 100% effective at preventing severe cases. That being said, it could still be in the upper 90% (97-98%) range which is absolutely incredible. Comparatively, Pfizer had 9 severe cases in placebo and 1 in the vaccinated group. Due to the relatively low n-values for both trials and the similarities in the technology, it would not surprise me if those numbers approach each other when the vaccines are deployed in the general population.
Safety
Overall, the vaccine seems safe albeit potentially uncomfortable. That being said, I need to address an inaccuracy in the tweet. It is possible that the author intended to use severe colloquially, but this is a defined level of adverse effect (Grade 3). Truthfully, the press release intentionally does not mention them:
I'll be honest, this is a bit slimy. In my opinion, Moderna is not being fully truthful (something I have faulted them about before) by burying the lead. You have to go to the previous press release to find the actual safety information:Quote:
The safety profile of the Phase 3 study of mRNA-1273 was previously described on November 16. A continuous review of safety data is ongoing and no new serious safety concerns have been identified by the Company.
Compare this to Pfizer’s very clear press release:Quote:
The majority of adverse events were mild or moderate in severity. Grade 3 (severe) events greater than or equal to 2% in frequency after the first dose included injection site pain (2.7%), and after the second dose included fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%) and erythema/redness at the injection site (2.0%).
Cold-chainQuote:
The only Grade 3 (severe) solicited adverse events greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.8% and headache at 2.0% following dose 2.
In the near term, due to the supply constraints I doubt any vial lasts more than a day anytime in the near future. That being said, this is still one area where Moderna’s vaccine really shines. The Moderna vaccine requires regular freezer temperatures and has been validated for 30 days when stored thawed at refrigerator temperatures. While developed countries will have no issue with Pfizers requirements, these are storage conditions which will allow far more widespread adoption in under developed countries compared to the Pfizer vaccine.
Production
Moderna has indicated that they expect 20 million doses for the USA by the end of the year. Combine this with Pfizer’s estimated25 million doses and you have enough to fully vaccinate 22.5 million people by the end of the year! While that is less than 10% of the population, that is a huge chunk of the most vulnerable.
Overall
The vaccine has a slightly higher side-effect rate but nothing show stopping. It has excellent efficacy, just like Pfizer's. Keep in mind, we have not seen the fully detailed data (only Pfizer has promised to release this data for peer-review). Overall, at this point, I would take either vaccine. Honestly, this is just crazy, from the discovery of a new virus to a completed Phase III trial in essentially a year.
Agree. My one concern is that invariably with administration in the general population additional untoward effects are seen. Hopefully they will be minimal and not significant when they do occur.Quote:
Originally Posted by PedroDaGr8
It has been amazing and also fun to watch. I would also take either vaccine based on the data to date - no hesitation at all.Quote:
Originally Posted by PedroDaGr8
To be clear, my n-value statement was with respect to the prevention of severe cases. The overall n-value of the test from a safety perspective is very good. Furthermore, the diversity of the test subject pool is excellent. As such, I expect the adverse effects to be very few beyond what has been already discussed.Quote:
Originally Posted by KSRdallen
Indeed, the diversity has been superb. Yep, I took it for the severe cases. What I meant is that when we go from Phase 3 kinds of numbers to the population, we sometimes see things not observed before as you know that can't be anticipated. The profile thus far suggests they'll be minimal but it doesn't rule them out.Quote:
Originally Posted by PedroDaGr8
Edited to add: A Vioxx like situation is highly unlikely, though it has happened.
Fully agreed!Quote:
Originally Posted by KSRdallen
It took 40 years from the time we realized polio was an infectious disease to the time there was an effective vaccine. I point that out only to emphasize the wow factor.
That is amazing.Quote:
Originally Posted by MickintheHam
Thanks for that context! It really demonstrates how much things have changed.Quote:
Originally Posted by MickintheHam
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