Moderna says first-stage study of coronavirus vaccine produced antibodies in subjects

[brooklynite]

Source: Boston Globe

Moderna said Monday that the vaccine the Cambridge biotech helped develop for COVID-19 produced antibodies in the blood of eight volunteers comparable to those seen in people who recovered from the disease.

The company’s chief medical officer, Dr. Tal Zaks, said the initial results from the first phase of a clinical trial suggest that the vaccine “has the potential to prevent COVID-19 disease.”

Scientists suspect that antibodies found in the blood of people who recover from the new coronavirus may make them immune to reinfection, but that has not been proven yet.

A few dozen volunteers participated in the first stage of the study, but Moderna said data were available for only a small portion of them.

Read more: https://www.bostonglobe.com/2020/05/18/nation/moderna-says-first-stage-study-coronavirus-vaccine-shows-its-potential/?event=event12

[Steelrolled]

1. Great news!

And this is one of the companies that is already gearing up for manufacturing.

[DrToast]

2. Very good news

Could be available by end of year.

[bucolic_frolic]

3. Way out over their skis

Why so few volunteer results reported?

What did I read? Recall no vaccine for previous corona viruses ever developed. I just think they're going to find corona to be readily mutating in small ways, and its effect on individual subjects to depend on a large, large variety of co-factors such as genetics, diet, immunity, perhaps even other symbiotic organisms (virus, pathogens, yeast, allergens, toxins, minerals, metals) present. From a vaccine standpoint, they haven't really cracked HIV after 30 years' research.

[DrToast]

5. "Why so few volunteer results reported?"

It's Phase 1 study.

[bucolic_frolic]

6. Is that the way Phase 1's are normally reported?

They report the good news patients and the rest are studied more or dismissed so as to focus on the positive outcomes?

[DrToast]

8. I misunderstood your question

I thought you were asking why so few patients, but you were asking why only partial results were reported.

I'm not sure. I do know the study was being conducted at different locations. It could be that the vaccine wasn't administered on the same timeline to all the patients.

[Steelrolled]

11. From what little I know, that would be true.

Within phase 1 you start with a single person getting the actual drug, followed by a safety period of observation, and then continuing on. And there will be different groups getting different dose levels. So from the first person to the last person within phase 1, it will be some time.

[modrepub]

9. Hard to Do A Statistical Significance Test

with that few a number of people IMO. But I'm not a doctor, nor did I stay at a Holiday Inn Express last night...

[spinbaby]

4. Hopeful

Even a small chance is hopeful.

[Politicub]

7. It's news -- it could be good, great or bad.

These Pharma companies use little bits of positive news to bolster their share prices. They don't make a lot of noise about negatives, though.

As someone who came of age through the 80s and lost a friend to AIDS, I have seen so many hopeful pieces of news that turned out to be worth nothing. If you go back and search news archives (like the Times Machine for the New York Times), there are hundreds of stories about supposed promising vaccines for HIV that never panned out.

So, I'm remaining skeptical until a broad study is conducted and efficacy is proven.

[bronxiteforever]

10. Established in 2010, Moderna has never brought a product to market or

gotten any of its nine or so vaccine candidates approved for use by the FDA. It has also never brought a product to the third and final phase of a clinical trial.

https://www.cnn.com/2020/05/01/us/coronavirus-moderna-vaccine-invs/index.html

Skeptical until substantial scientific proof is available.

[Steelrolled]

12. Here is the trial information

https://clinicaltrials.gov/ct2/show/NCT04283461

This is a phase I, open-label, dose ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273 manufactured by ModernaTX, Inc. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2. Enrollment will occur at up to 3 domestic clinical research sites. One hundred and five subjects will be enrolled into one of nine cohorts (25 micrograms [mcg], 100 mcg, and 250 mcg). Subjects will receive an intramuscular (IM) injection (0.5 milliliter [mL]) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post second vaccination (Day 394). Follow-up visits will occur 1, 2, and 4 weeks post each vaccination (Days 8, 15, 29, 36, 43, and 57), as well as 3, 6, and 12 months post second vaccination (Days 119, 209, and 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 3 dosages in healthy adults. The secondary objective is to evaluate the immunogenicity as measured by Immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) to the SARS-CoV-2 S (spike) protein following a 2-dose vaccination schedule of mRNA-1273 at Day 57.

[NotHardly]

13. Sure a lot of these same "vaccines coming" articles across the web... what is really going on...

Planned advertisements of 'feel good' so everyone rushes out to hug each other. Period.

[Steelrolled]

15. The other thing is that a lot of companies working on it.

And there is a lot of money, pride, and potential fame, riding on it. For someone working in vaccines, this is probably the biggest event in their lifetime.

The Moderna trial pipeline is now full, so I expect periodic reports as the volunteers reach the testing date. As long as the results are like this one, I'll keep feeling good.

[greenjar_01]

14. Early trials were very promising. - Dr. Charles Nichols

[Baclava]

16. Great news. great 1st step, getting antibodies that bind, but confirming vaccination equals immunity

Thats the holy grail