Maybe our resident Doc(s) can chime in? Again, I’m thirsty for good news. This may be a big deal (I’m not a scientist), so here’s the whole thing:
WHOOP WHOOOP WHOOP ALERT ALERT ALERT
Actual vaccine study data
Not a press release, preprint
Data on BioNTech/Pfizer's vaccine candidate
-45 participants injected, 3 dosage arms
-neutralizing antibodies tested for and observed at levels greater than convalescent serum:
"Neutralization titers were measurable after a single vaccination at Day 21 for all dose levels. At Day 28 (7 days after Dose 2), substantial SARS-CoV-2 neutralization titers were observed. The virus neutralizing GMTs after the 10 μg and 30 μg Dose 2 were, respectively, 1.8-fold and 2.8-fold the GMT of the convalescent serum panel. Assuming that neutralization titers induced by natural infection provide protection from COVID-19 disease, comparing vaccine-induced SARS-CoV-2 neutralization titers to those from sera of convalescent humans quantifies the magnitude of the vaccine-elicited response and the vaccine’s potential to provide protection. "
-pain at injection site most common side effect but there were plenty of side effects, mostly mild and resolving (this is actually a sign of an effective vaccine, provided it's within tolerable bounds)
-highest dose cohort only 1 injection due to side effects
On to Phase III! "While our population of healthy adults 55 years of age and younger is appropriate for a Phase 1/2 study, it does not accurately reflect the population at highest risk for COVID-19. Adults 65 years of age and over have already been enrolled in this study and results will be reported as they become available. Later phases of this study will prioritize enrollment of more diverse populations, including those with chronic underlying health conditions and from racial/ethnic groups adversely affected by COVID-19"
Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: Interim Report
Mark J. Mulligan, Kirsten E. Lyke, Nicholas Kitchin, View ORCID ProfileJudith Absalon, Alejandra Gurtman, Stephen P. Lockhart, View ORCID ProfileKathleen Neuzil, View ORCID ProfileVanessa Raabe, Ruth Bailey, Kena A. Swanson, Ping Li, Kenneth Koury, Warren Kalina, David Cooper, Camila Fonter-Garfias, Pei-Yong Shi, Ozlem Tuereci, Kristin R. Tompkins, Edward E. Walsh, View ORCID ProfileRobert Frenck, View ORCID ProfileAnn R. Falsey, View ORCID ProfilePhilip R. Dormitzer, William C. Gruber, Ugur Sahin, Kathrin U. Jansen
We report the available safety, tolerability, and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose escalation study among healthy adults, 18-55 years of age, randomized to receive 2 doses, separated by 21 days, of 10 μg, 30 μg, or 100 μg of BNT162b1, a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD. Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers in sera increased with dose level and after a second dose. Geometric mean neutralizing titers reached 1.8- to 2.8-fold that of a panel of COVID-19 convalescent human sera. These results support further evaluation of this mRNA vaccine candidate.
......
These clinical findings for the BNT162b1 RNA-based vaccine candidate are encouraging and strongly support accelerated clinical development and at-risk manufacturing to maximize the opportunity for the rapid production of a SARS-CoV-2 vaccine to prevent COVID-19 disease.
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Pfizer has a track record of developing and getting vaccines approved, including on a short time line upon request of the FDA. Their vaccine development and manufacturing group is battle-tested and know what it takes - though this is gonna be big.
Results 2,361 to 2,370 of 7628
Thread: Covid-19
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07-04-2020, 03:01 PM #2361
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07-04-2020, 05:26 PM #2362
Yes very promising. It’ll be interesting when they get the 65 and over data. Seems like they’ll be able to find a good dose to be efficacious and prevent certain side effects.
Also, sounds like Moderna’s phase 3 trial was delayed because of protocol changes (not safety) but still has a goal of having data sometime in November. If I were a betting man, don’t think pharma companies will have any problem finding volunteers for their phase 3 trials.
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07-05-2020, 08:21 PM #2363
I'll let these two tweets from the city of Salem, Oregon speak for themselves...
https://twitter.com/MarkMelchi/statu...983554/photo/2
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07-06-2020, 06:48 AM #2364
And they wonder why people don’t trust government.
Sent from my iPhone using TapatalkGolf is a relatively simple game, played by reasonably intelligent people, stupidly.
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07-06-2020, 06:56 AM #2365
- Join Date
- Jan 2008
- Posts
- 2,984
One tweet is the Government regulating itself to be in line with the protocols it put in place while the other one is avoiding regulating free speech by its citizens. I think it is pretty easy to see the difference between the government trying to model the behavior it is promoting while at the same time continuing to respect the right of citizens to exercise their first amendment rights, which is likely exempt from the stay at home orders (just like they are here in Ohio).
Do I think the protest should be going on in a global pandemic? No. Do I think it will have negative consequences down the road especially if the protestors don't wear mask and attempt to socially distance? Yes. Would I participate in a protest right now if I agreed with the message? Hell no. However, no law openly suspending the first amendment would or should be upheld by a court, so all you can do is encourage proper behavior and provide a safe place to conduct the protest."If our season was based on A-10 awards, there’d be a lot of empty space up in the rafters of the Cintas Center." - Chris Mack
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07-06-2020, 07:58 AM #2366
- Join Date
- Jan 2012
- Posts
- 14,805
The government at multiple levels have been overstepping their jurisdiction for months, they can certainly do that again by telling people not to protest due to public health.
Btw I really dont care...if people want to protest, let them protest and encourage the "safe" way to do it. However, I also believe the same thing could be said for the fireworks.Last edited by Xville; 07-06-2020 at 08:15 AM.
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07-06-2020, 09:43 AM #2367
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07-06-2020, 01:44 PM #2368
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07-07-2020, 07:06 AM #2369
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07-07-2020, 08:04 AM #2370
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