Moderna COVID-19 vaccine enters final-stage trial this month

[dukkha]

The U.S. biotech firm Moderna said Tuesday it would enter the final stage of human trials for its COVID-19 vaccine on July 27, after promising early results were published in an influential journal.

The Phase 3 trial will recruit 30,000 participants in the U.S., with half to receive the vaccine at 100 microgram dose levels, and the other half to receive a placebo.

It is designed to show whether the vaccine is safe and can prevent infection by the SARS-CoV-2 virus, or — if people still get infected — whether it can prevent the infection progressing toward symptoms.

If they do get symptoms, the vaccine can still be considered a success if it stops severe cases of COVID-19.

The study should run until Oct. 27, according to its page on clinicaltrials.gov.
https://www.japantimes.co.jp/news/20.../#.Xw9XIed7mM8

[dukkha]

"operation Warp speed" the Trump name for the money and support from the feds
has accelerated vaccine development to....well,,warp speed.

Plans are to manufacture it as soon as trials look good -so by the time of final approval
it will be manufactured and dispersed for immediate uses

Yes "Trump did it"

[dukkha]

Coronavirus Vaccine Tracker
https://www.nytimes.com/interactive/...e-tracker.html

[dukkha]

PHASE 3 Scientists give the vaccine to thousands of people and wait to see how many become infected, compared with volunteers who received a placebo. These trials can determine if the vaccine protects against the coronavirus.

APPROVAL: Regulators in each country review the trial results and decide whether to approve the vaccine or not. During a pandemic, a vaccine may receive emergency use authorization before getting formal approval.

WARP SPEED: The U.S. government’s Operation Warp Speed program is expected to name five or more vaccine projects to receive billions of dollars in federal funding before there’s proof that the vaccines work. We will update the tracker and label the Warp Speed projects when there is an official announcement.

COMBINED PHASES: Another way to accelerate vaccine development is to combine phases. Some coronavirus vaccines are now in Phase I/II trials, for example, in which they are tested for the first time on hundreds of people. (Note that our tracker would count a combined Phase I/II trial as both Phase I and Phase II.)

[dukkha]

According to the paper, 45 participants were split into three groups to test doses of 25 micrograms, 100 micrograms and 250 micrograms.

They were given a second dose of the same amount 28 days later.

After the first round, antibody levels were found to be higher with higher doses.

Following the second round, participants had higher levels of antibodies than most patients who have had Covid-19 and gone on to generate their own antibodies.

More than half the participants experienced mild or moderate side effects, which is considered normal.

The side effects included fatigue, chills, headache, body ache and pain at the injection site.

Three participants did not receive their second dose.

They included one who developed a skin rash on both legs, and two who missed their window because they had COVID-19 symptoms, but their tests later returned negative.

Amesh Adalja, an infectious diseases specialist at Johns Hopkins University, said it was encouraging that the participants developed high levels of an advanced class of antibodies.

He added, however: "You have to be very limited in how much you can extrapolate from a phase one clinical trial, because you want to see how this works when a person is exposed to the actual virus."

The Moderna vaccine belongs to a new class of vaccine that uses genetic material – in the form of RNA – to encode the information needed to grow the virus's spike protein inside the human body, in order to trigger an immune response.

The spike protein is a part of the virus that it uses to invade human cells, but by itself the protein is relatively harmless.

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The advantage of this technology is that it bypasses the need to manufacture viral proteins in the lab, helping to ramp up mass production.

No vaccines based on this platform have previously received regulatory approval.

Early work using this technology backfired by making hosts more, not less, susceptible to infection, David Lo, a professor of biomedical sciences at University of California Riverside told AFP.

"One of the things we certainly want to look out for is whether there is a long term effect where the immune response... potentially develops an immunologic tolerance which would actually be detrimental to protection," he said.
https://www.france24.com/en/20200715...al-stage-trial

[Darth Omar]

"operation Warp speed" the Trump name for the money and support from the feds
has accelerated vaccine development to....well,,warp speed.

Plans are to manufacture it as soon as trials look good -so by the time of final approval
it will be manufactured and dispersed for immediate uses

Yes "Trump did it"

Good luck with that lol.

[dukkha]

Good luck with that lol.

why the pessimism?

[Geeko Sportivo]

"operation Warp speed" the Trump name for the money and support from the feds
has accelerated vaccine development to....well,,warp speed.

Plans are to manufacture it as soon as trials look good -so by the time of final approval
it will be manufactured and dispersed for immediate uses

Yes "Trump did it"

Let me tell you what Trump is not doing.

He has no Task force Or even assigned a federal agency in place to govern how an American Vaccine will be dispersed to the America public. Just like he has no task force in place to insure Americans are getting tested for the virus. Naturally not, because Trump will use the Vaccine politically by providing it to Red States first and maybe not al all to what he calls his Shit hole states and cities. NEVER LEAVE SOMETHING LIKE THIS TO AN EVIL CORRUPT PRESIDENT LIKE TRUMP.

And he has nothing in place to insure it will be available world-wide. HERE IS THE DEAL. If we do not help other countries deal with the virus, it will only fester out of control, and WILL NEVER GO AWAY AS IT WILL JUST CHURN AWAY IN THE REST OF THE WORLD. America's economic success will always depend upon the economic success of many other countries around the world.

So unless we have policies already in place- WE ARE NOT READY FOR A VACCINE EVEN IF IT WERE AVAILABLE TODAY!

THIS IS JUST ANOTHER FAILURE OF THIS ADMINISTRATION!

[Micawber]

My biotech stocks are up 25-40 percent this month... place you bets

[Concart]

My biotech stocks are up 25-40 percent this month... place you bets

I bought some preferred in down sectors. Still paying dividends, and they'll recover eventually. But I like the biotech strategy. Just no need for me to grow my massive holdings

[Concart]

A vaccine was always the way to end this. But the plan for dealing with it in the interim was a disaster. And it continues to be. We're still looking at six months, and Trump can and will do a massive amount of damage in that time, aided by his cult followers and his sycophants in the Senate. Now he's got Navarro bashing Fauci because he's too chickenshit to do his own work. Always has been a coward.

[Micawber]

I bought some preferred in down sectors. Still paying dividends, and they'll recover eventually. But I like the biotech strategy. Just no need for me to grow my massive holdings

Yep, mine aren't massive, but I have mad money about 50k, (now worth 75 today 80 yesterday) in volatile biotechs.
It makes the day interesting to try and time the ins and outs in case the posting here sux raw.
If SRNE goes back to $2 and VIR goes to 20, I still won't miss a meal. But I'm not rich like you.
Just having fun with it. Livin the dream. The 401 K is in stock fund and 40% short term bonds. IRA, I don't even remember
but safe stuff. I figure better to play with stocks than invest in art, wine and parlay cards. If everything goes Russian well I still have
social security!!!

[dukkha]

A vaccine was always the way to end this. But the plan for dealing with it in the interim was a disaster. And it continues to be. We're still looking at six months, and Trump can and will do a massive amount of damage in that time, aided by his cult followers and his sycophants in the Senate. Now he's got Navarro bashing Fauci because he's too chickenshit to do his own work. Always has been a coward.

rant Trump doesn't "deal with it in the interim" the states do that.
The states have run the show from the beginning after Trump agreed to the shutdown.

I realize all you GAF about is partisan politics -but at least direct your fire towards the decision makers.

Same with the schools.
Trump can jawbone kids (which is needed) back in school,
but he can't withhold funds and he cant control locals decision

[Darth Omar]

why the pessimism?

Trump isn’t allowed to be credited with anything lol.

[dukkha]

Let me tell you what Trump is not doing.

He has no Task force Or even assigned a federal agency in place to govern how an American Vaccine will be dispersed to the America public. Just like he has no task force in place to insure Americans are getting tested for the virus. Naturally not, because Trump will use the Vaccine politically by providing it to Red States first and maybe not al all to what he calls his Shit hole states and cities. NEVER LEAVE SOMETHING LIKE THIS TO AN EVIL CORRUPT PRESIDENT LIKE TRUMP.

And he has nothing in place to insure it will be available world-wide. HERE IS THE DEAL. If we do not help other countries deal with the virus, it will only fester out of control, and WILL NEVER GO AWAY AS IT WILL JUST CHURN AWAY IN THE REST OF THE WORLD. America's economic success will always depend upon the economic success of many other countries around the world.

So unless we have policies already in place- WE ARE NOT READY FOR A VACCINE EVEN IF IT WERE AVAILABLE TODAY!

federal agencies dont manufacture or disperse. manufactures do that.
the feds can back up critical supplies - but primary distribution is done by the players.

What Trump has done is direct "Operation Warp Speed" (i even just wrote this ) that uses government finances
to go ahead and get the vaccine out during the pending approval process.
And they've removed a lot of red tape there as well to speed it all up ASAP.

If it keeps going this wayy we;ll have a vaccine by years end -as Trump has made that the goal