I wish phase 1 included some older participants. I posted the Clinical Trial information yesterday. You can check what's expected next there.
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07-15-2020 11:50 AM
Quoted from the NEJM:
"BACKGROUND
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in late 2019 and spread globally, prompting an international effort to accelerate development of a vaccine. The candidate vaccine mRNA-1273 encodes the stabilized prefusion SARS-CoV-2 spike protein.
METHODS
We conducted a phase 1, dose-escalation, open-label trial including 45 healthy adults, 18 to 55 years of age, who received two vaccinations, 28 days apart, with mRNA-1273 in a dose of 25 μg, 100 μg, or 250 μg. There were 15 participants in each dose group.
RESULTS
After the first vaccination, antibody responses were higher with higher dose (day 29 enzyme-linked immunosorbent assay anti–S-2P antibody geometric mean titer [GMT], 40,227 in the 25-μg group, 109,209 in the 100-μg group, and 213,526 in the 250-μg group). After the second vaccination, the titers increased (day 57 GMT, 299,751, 782,719, and 1,192,154, respectively). After the second vaccination, serum-neutralizing activity was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum specimens. Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events.
CONCLUSIONS
The mRNA-1273 vaccine induced anti–SARS-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)."
Complete report:
I wish phase 1 included some older participants. I posted the Clinical Trial information yesterday. You can check what's expected next there.
07-15-2020 12:02 PM
This "warp speed" vaccine has me a little nervous. At this point I take all this talk with a grain of salt. These past few years have made me very distrustful. I take no joy in saying that.
07-15-2020 12:07 PM
we still will have no vaccine for well over another year OR MORE... then getting everyone vaccinated will take another year or more... so do not expect quick results... we are in this for the long haul... probably into 2023 or later...
07-15-2020 12:26 PM
I agree, @SeaMaiden . I certainly won't be first in line either.
07-15-2020 12:57 PM
@tends2dogs wrote:I agree, @SeaMaiden . I certainly won't be first in line either.
@tends2dogs I’m pretty sure I will never get in line for a vaccine for this virus. I highly doubt any will be worth taking. They don’t have any idea if any of them will work at all yet, just that side effects that everyone experiences aren’t deadly.
07-15-2020 01:06 PM - edited 07-15-2020 01:19 PM
@SeaMaiden wrote:we still will have no vaccine for well over another year OR MORE... then getting everyone vaccinated will take another year or more... so do not expect quick results... we are in this for the long haul... probably into 2023 or later...
Not true. Pfizer released results from the phase 1/2 studies of the vaccine they're developing with BioNTech on July 1st:
This was WIDELY, positively reported in the national news media, yet not a word was mentioned here.
Two of their 4 candidates are on fast track status with the FDA:
From various other, public sources, those vaccines are being made here in the US, in facilities that were part of the company that I spent the bulk of my career with prior to them being acquired by the big P. It's about 10 minutes from my house. The manufacturing facility has the capability to produce 100 million doses by the end of this year, and 1.2 billion by the end of next year, once FDA approval is received.
Yes, there are potential side effects, but they were similar to those of other vaccines. And no one will force you to receive one, just like you're not forced to receive other vaccines.
07-15-2020 01:06 PM
I want to know what the “severe” side effects were.
07-15-2020 01:16 PM
I'm taking a wait-and-see attitude. I am very much in favor of vaccines in general. It's going to quite some time as far as being widely available, and eve then, I would wait at least a couple months to see any unexpected problems.
07-15-2020 01:22 PM - edited 07-15-2020 01:27 PM
There is a case locally of a husband and wife whose 30 year old daughter defied the facemask order and social distancing order...she died from covid-19 and what's worse, she gave the disease to both of her parents who are fighting for their life in the ICU and it doesn't look good for either of them. These type of cases make me upset and I hope that others in the same set of circumstances get the advantage straight away of a vaccine which I'm sure they will not hesitate to take and be very grateful.
07-15-2020 01:39 PM
@willdob3 I'm not thinking never, but I am definitely not volunteering for early clinical trials. I'm also thinking that even if they find a vaccine apparently worth manufacturing in large amounts, those first amounts will go to those first responders who can't do their jobs without being exposed. That's not me - which gives me plenty of time to watch and learn.
The one thing I'm trying not to do is count on a miracle to give me back the normal life I had until a few months ago, but I am working day by day to chisel out a new and different life for myself.
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