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Thu Jun 11, 2020, 10:39 PM

Moderna Will Start Testing Its Covid-19 Vaccine on 30,000 People in July

Source: Barrons

The biotech startup Moderna says it will begin the pivotal trial of its candidate vaccine against Covid-19 in July. In a Thursday morning announcement, it said it hopes to enroll 30,000 volunteers—randomizing them to receive either a placebo or the vaccine, and a second booster shot one month later. Researchers will then watch to see how many in each group contract Covid as they go about their lives over the subsequent year.



Read more: https://www.barrons.com/articles/moderna-will-start-testing-its-covid-19-vaccine-in-july-51591878151

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Reply Moderna Will Start Testing Its Covid-19 Vaccine on 30,000 People in July (Original post)
Steelrolled Jun 2020 OP
LudwigPastorius Jun 2020 #1
still_one Jun 2020 #3
Initech Jun 2020 #8
Blue_playwright Jun 2020 #9
still_one Jun 2020 #2
flibbitygiblets Jun 2020 #4
still_one Jun 2020 #5
Miguelito Loveless Jun 2020 #12
still_one Jun 2020 #14
Miguelito Loveless Jun 2020 #17
Steelrolled Jun 2020 #6
relayerbob Jun 2020 #7
Ford_Prefect Jun 2020 #10
LiberalFighter Jun 2020 #11
Steelrolled Jun 2020 #13
NNadir Jun 2020 #15
Steelrolled Jun 2020 #16
NNadir Jun 2020 #18
NNadir Jun 2020 #19

Response to Steelrolled (Original post)

Thu Jun 11, 2020, 10:42 PM

1. 2020 has been so shitty thus far...

I'm kind of afraid, because this looks like that beginning point in all those zombie movies when things start to go terribly wrong.

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Response to LudwigPastorius (Reply #1)

Thu Jun 11, 2020, 10:46 PM

3. It will be a double blind study, and peered reviewed. It should be pretty conclusive

the percent that are turned to zombies

All kidding aside, with 30000 volunteers, if a significant number of them have serious side-effects, there is going to be a lot of blow back on the process that allowed it to get into a phase three study






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Response to LudwigPastorius (Reply #1)

Fri Jun 12, 2020, 12:07 AM

8. Better start learning what's new in composting.

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Response to LudwigPastorius (Reply #1)

Fri Jun 12, 2020, 12:28 AM

9. I Am Legend comes to mind. Nt

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Response to Steelrolled (Original post)

Thu Jun 11, 2020, 10:43 PM

2. Hoping it is effective and is safe

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Response to Steelrolled (Original post)

Thu Jun 11, 2020, 10:47 PM

4. Does anyone know how one would become a volunteer?

It doesn't sound like they intentionally give volunteers the virus, so how can they tell if the vaccine is effective or not, given that different people would behave differently (staying home, avoid crowds, wear PPE etc.--or not)?

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Response to flibbitygiblets (Reply #4)

Thu Jun 11, 2020, 10:57 PM

5. Since it is a double blind study, if there is no difference between those that were

given the vaccine verses those that were given the placebo, then it will be an indicator that the vaccine isn't effective. However, if there is a noticeable difference between the two groups, and those given the vaccine show significantly less infection, that will be a pretty good indicator on its effectiveness.

30000 is a pretty good number of test subjects.

They will also be checking for neutralizing antibodies

My understanding is that if this phase shows a definite advantage with the vaccine, it will be given first to health care workers on the front line.

No vaccine are 100% effective:

"This is another argument frequently found in anti-vaccine literature, the implication being that this proves that vaccines are not effective. In fact it is true that in an outbreak those who have been vaccinated often outnumber those who have not — even with vaccines such as measles, which we know to be about 98% effective when used as recommended.

This apparent paradox is explained by two factors. First, no vaccine is 100% effective. To make vaccines safer than the disease, the bacteria or virus is killed or weakened (attenuated). For reasons related to the individual, not all vaccinated persons develop immunity. Most routine childhood vaccines are effective for 85% to 95% of recipients. Second, in a country such as the United States the people who have been vaccinated vastly outnumber those who have not.

How these two factors work together to result in outbreaks in which the majority of cases have been vaccinated can be more easily understood by looking at a hypothetical example:

"in a high school of 1,000 students, none has ever had measles. All but five of the students have had two doses of measles vaccine, and so are fully immunized. The entire student body is exposed to measles, and every susceptible student becomes infected. The five unvaccinated students will be infected, of course. But of the 995 who have been vaccinated, we would expect several not to respond to the vaccine. The efficacy rate for two doses of measles vaccine can be as high as >99%. In this class, seven students do not respond, and they, too, become infected. Therefore seven of 12, or about 58%, of the cases occur in students who have been fully vaccinated."

As you can see, this doesn't prove the vaccine didn't work — only that most of the children in the class had been vaccinated, so those who were vaccinated and did not respond outnumbered those who had not been vaccinated. Looking at it another way, 100% of the children who had not been vaccinated got measles, compared with less than 1% of those who had been vaccinated. Measles vaccine protected most of the class; if nobody in the class had been vaccinated, there would probably have been 1,000 cases of measles.

WHO gratefully acknowledges the permission of CDC Atlanta, to present an edited version of "Six common misconceptions about immunization".

https://www.who.int/vaccine_safety/initiative/detection/immunization_misconceptions/en/index2.html

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Response to still_one (Reply #5)

Fri Jun 12, 2020, 09:32 AM

12. Will they be testing anyone other than

young, male, white, college students?

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Response to Miguelito Loveless (Reply #12)

Fri Jun 12, 2020, 09:41 AM

14. From my understanding the majority will be between 18 to 55 people regardless of gender, but

will also include some older Americans 65 years or older

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Response to still_one (Reply #14)

Fri Jun 12, 2020, 12:33 PM

17. Good. To many drug trials

exclude older people, POCs, and women.

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Response to flibbitygiblets (Reply #4)

Thu Jun 11, 2020, 11:02 PM

6. You ask a very good question.

My understanding is they tell volunteers to live their lives as they otherwise would, including taking precautions against infection. Of course, they "need" to see infections in the control group (and few or none in the test group) to prove the efficacy of the vaccine. If no one from either group gets infected, they won't have any good data.

There were reports from the UK that they worry about the infection rate dropping so quickly it will be hard to test the vaccine.

I have heard stories of volunteers who say they would be willing to be intentionally exposed (after getting the real vaccine) to speed up the trial, but I doubt these volunteers would be taken up on their offer.

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Response to flibbitygiblets (Reply #4)

Thu Jun 11, 2020, 11:26 PM

7. This is also in large part a study of side effects and reactions

As well as to be able to correlate for the personal behavior variance.

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Response to Steelrolled (Original post)

Fri Jun 12, 2020, 06:35 AM

10. While I expect this to be a responsible study I cannot help feeling that we better prepare for the

Zombies. They will be the ones who refused to mask or distance but now demand the drug from anyone whom they imagine could provide it. Swarming in packs from clinic to hospital to city hall and back again while howling at the cameras as they wave their 2nd amendment artifacts and MAGA hats to show they are entitled.

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Response to Steelrolled (Original post)

Fri Jun 12, 2020, 08:19 AM

11. A startup?

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Response to LiberalFighter (Reply #11)

Fri Jun 12, 2020, 09:34 AM

13. Yes, and Moderna has a lot riding on this

As I understand, they are using new technology, and of course we are all expecting the vast amounts of biomedical and genetic research to lead to new technologies like this.

I believe Moderna had a "head start" in that they were working on a vaccine for a similar virus. What is incredible is that they developed this vaccine based only on published genetic information and not actual viruses (as I understand).

If this is successful, it could be a revolution in vaccine development.

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Response to Steelrolled (Original post)

Fri Jun 12, 2020, 11:23 AM

15. I've been reading "Bad Blood" about Elizabeth Holmes and Theranos.

She had great press, generated tons of hype, but had no real product.

Moderna does produce a lot of patents, but I'm not entirely sure they will ever produce a drug. They have wonderful press.

I hope I'm wrong, but I feel uneasy about that company.

For a company allegedly worth billions of dollars, they have a very unimpressive set of clinical trials under way.

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Response to NNadir (Reply #15)

Fri Jun 12, 2020, 11:50 AM

16. I'm with you

I really have no idea how they will do. But if the covid-19 vaccine is a big success, based on new technology, and after a string of failures, their story will be one of legends. On the other hand, it might tank them. I can't wait to see.

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Response to Steelrolled (Reply #16)

Fri Jun 12, 2020, 12:37 PM

18. I visited their offices when they were just a few people and again when they got to...

...the cubicle stage.

I don't even bother to read their patents any more.

Synthetic mRNA is certainly no slam dunk. Now, when I was a kid, I was wrong about protein drugs, so I never say never.

I'm familiar with their claim about how their vaccine might work, but it seems to rely on intracellular delivery. I'm not sure I'd buy it.

My son, still an undergraduate, is working on microfluidics, and he gave me the copy of "Bad blood" I'm reading. After the first several pages, I said to myself that anyone who heard these claims and actually knew something about clinical bioanalysis and for that matter, microfluids, should have understood readily that the whole Theranos thing was nonsense.

In the RNA world, they have a delicious word for RNA based drugs - to be fair, a few have actually been approved - and that word is "anti-sense." It took two decades from start to finish to get the first anti-sense drug approved. Several companies collapsed trying.

They seem to be saying at Moderna, from a very brief look at their latest science (or sci-fi) press release that their vaccine will rely on messenger RNA to create antigens. Another way to shortcut this process would simply to generate the antigens ex vivo and use them as a vaccine.

It's telling that they seem to have gone from being a therapeutics company to being a vaccine company. That often is a warning sign from God.

The issue with Covid certainly involves glycosylation - fortunately the glycan shield of this virus is nothing as tough as the glycan shield of HIV - and I'm not sure that they will generate the correct antigens. To my knowledge - and admittedly I'm not an expert - RNA to glycan synthesis is ill defined.

We'll see. Hopefully I'm just too stupid to get it, or maybe I'm wary because I happen to be reading "Bad Blood," but I'm thinking that their are other vaccine programs that make better sense and are neither nonsense or anti-sense.

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Response to Steelrolled (Reply #16)

Fri Jun 12, 2020, 01:06 PM

19. Here, by the way, is the scary news report on them from Nature.

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