University of Pittsburgh saves the world

[gaussian]

I disagree. I bet by September we will have a vaccine. It will be super fast tracked. Hell, they can even just post online the how to do it, if they don't care about the money. Then other countries immediately can make their own.

The point is though, that we can see the end of the tunnel, because so far the government hasn't told us any kind of longer term plan.

These things cannot really be fast tracked too fast.

Even if they speed things up there are various phases that are necessary. They need to first insure it works. If it works, then they need to give it to people of varying genetic make up (different races, conditions, genders, etc). If it still works, it needs to be blinded and tested again. Moreover, they need to confirm the side effects are not bad and that it doesnt make things worse.

I had read an article a while back from an epidemiologist that said even fast tracked each phase will likely take 3-4 months. The data has to roll back in and then be analyzed which is sometimes the slowest part.

The world is high on hopium when they read these things not recognizing that a "fast track" is still almost a year out at best.

Here's an article:

https://www.cnbc.com/2020/01/31/coronavirus-why-it-takes-at-least-a-year-to-make-a-vaccine.html

Here's a related paper:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1083939/

Another piece of good news is that the FDA is likely to approve the ‘Animal Rule’ in the next few weeks to months, said Sandra Qweder, Acting Director of the Office of Review Management at the FDA’s Center for Drug Evaluation and Review (CDER). ‘This rule, proposed in 1999, would allow drugs and vaccines to be reviewed and approved without human data because testing them by challenging patients with diseases such as inhalation anthrax, bubonic plague, and smallpox “is not feasible and cannot be ethically conducted”,’ Qweder said.

For most other drugs that do not fall under this rule, the agency was able to reduce the average time required for drug review from 30 to 15 months after the Prescription Drug User Fee Act (PDUFA) was passed in the USA in 1992. The FDA added nearly 700 employees to CDER and CBER (biologics) and in so doing, increased its capability of reviewing more drugs in less time. ‘Fast-Track designation, initiated by the FDA Modernization Act (FDMA) of 1997 […] is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs,’ according to the CDER. ‘Actually, Fast-Track designation means that companies can apply at any stage of development to expedite their drugs,’ Qweder explained. Between 1998 and March 31, 2001 the FDA approved 10 fast-track designated products with a median response time of 55 days, according to CDER. Of these, eight are for HIV-AIDS and two for cancer.

One example of this may be the anti-diabetic compound Rezulin, which was approved after a 6-month fast-track review. The drug was withdrawn following the FDA attribution of 63 liver-failure deaths to it. Yet the drug remained on the US market for more than 2 years after the UK had withdrawn it for the same reason.

There are significant risks to fast tracking drugs. Moreover, these "fast tracked" vaccines will only be given to the most vulnerable populations where the risk of potentially fatal side effects does not outweigh the certain fatality from the virus. It won't be general issue for YEARS. It's not worth it to get excited over these prospects if you are remotely healthy. You won't be chosen for the vaccine trials and you won't be rushed into a clinic to get it. Nor would you want to be...in my opinion.

 

[Pekelo]

Death toll figure will peak within 3-4 weeks as long as social distancing works and R-0 value drops to zero.

This doesn't contradict my 10-20K worldwide daily death guess.(I am lowballing here) Hell, the USA alone will have 2K by Sunday and could be 4K by next Sunday.
And no, people don't keep social distancing, see the churches in Florida and the shelter in place "lite" version in Phoenix. Bunch of states still haven't enacted shit, those are full of walking deads, they just don't know it. There wave is coming in 3-4 weeks.

Anyhow here is the video of the news:

 

[Pekelo]

These things cannot really be fast tracked too fast.

Sure they can be. Don't look at it from the USA pov. Let's say in Brazil they reach 4-5K death /day because the president is a moron there too. He is going to be so desperate he will greenlight any human experience and you can bet there will be thousands willing to sign up.

Mind you Brazil was the country who simply copied the AIDS cocktail not worrying about copyrights and patents because it was declared a national emergency.

Now if the US wants to go slow and take its sweet time, fine. But the whole world doesn't have to follow US FDA guidelines and rules.

I bet Italy would sign up for a free trial tomorrow....

 

[Amun Ra]

I had a feeling somebody will come up with a solution sooner than expected. I just didn't know it was going to be the local boys:

https://triblive.com/local/pittsbur...uld-be-fast-tracked-after-key-animal-testing/

"A potential vaccine against the novel coronavirus causing the covid-19 outbreak has been created in a University of Pittsburgh lab.

Researchers say the first phase of human clinical trials — which would include healthy volunteers in the Pittsburgh area — could start in the coming months.

Scientists at the University of Pittsburgh School of Medicine announced Thursday that the vaccine, when tested in mice, produces antibodies specific to the coronavirus SARS-CoV-2 that could be enough to fight off the virus. Testing the vaccine in mice doesn’t guarantee efficacy in humans."

For the history buffs:

", Falo invoked Pitt’s own Jonas Salk — the medical pioneer whose team developed the world’s first effective polio vaccine in 1955."

Even if this thing doesn't work out:

"At least 50 other potential vaccine candidates are in development worldwide, and two candidates — one developed by researchers in Beijing, the other by the Cambridge, Massachusetts-based biotechnology company Moderna and the U.S. National Institutes of Health — have proceeded to clinical trials, according to a tally kept by the World Health Organization."

Those boys are late to the party. A woman has already had a vaccine injected into her 2 weeks ago.

 

[Pekelo]

Those boys are late to the party. A woman has already had a vaccine injected into her 2 weeks ago.

I am glad to hear that the world doesn't need to depend on 1 lab. By the way this new invention is not a shot, and I think this makes it way more cheap, accessible and affordable.

Long version of the press release:

 

[HeSaidSheSaid]

Keep in mind there are multiple phases to a proper vaccine trial. This is great news but we are still 8-18 months from viability under the assumption it passes each phase flawlessly.

when comes to the worst case scenario (choosing between life, death, and drug reaction), I wouldn't be surprised people would choose drug reaction... who knows one might gain a pair of boobs to play with.

 

[Nobert]

Vaccine is the ONLY solution to this mess.

...

It's equal to saying :

,,Money solves all of the problems''


One can site on a pile of greens, all day long, but that paper ain't gonna do pushups for you.
Neither the vaccine is directed, to raise up people wisdom and intellect.
(those are two different things, one can be of average intellect and still wise enough to make good/benefiting decisions)

 

[Pekelo]

Actually, vaccine isn't the only solution. If we could alter the human response such way that the lung doesn't fill up with fluid we could avoid using the ventilators and cut down the death rate drastically. Then it would be just another flu strain.

 

[wrbtrader]

I had a feeling somebody will come up with a solution sooner than expected. I just didn't know it was going to be the local boys:

https://triblive.com/local/pittsbur...uld-be-fast-tracked-after-key-animal-testing/

"A potential vaccine against the novel coronavirus causing the covid-19 outbreak has been created in a University of Pittsburgh lab.

Researchers say the first phase of human clinical trials — which would include healthy volunteers in the Pittsburgh area — could start in the coming months.

Scientists at the University of Pittsburgh School of Medicine announced Thursday that the vaccine, when tested in mice, produces antibodies specific to the coronavirus SARS-CoV-2 that could be enough to fight off the virus. Testing the vaccine in mice doesn’t guarantee efficacy in humans."

For the history buffs:

", Falo invoked Pitt’s own Jonas Salk — the medical pioneer whose team developed the world’s first effective polio vaccine in 1955."

Even if this thing doesn't work out:

"At least 50 other potential vaccine candidates are in development worldwide, and two candidates — one developed by researchers in Beijing, the other by the Cambridge, Massachusetts-based biotechnology company Moderna and the U.S. National Institutes of Health — have proceeded to clinical trials, according to a tally kept by the World Health Organization."

They need to get in the long line of the growing list of potential vaccine against the novel coronavirus causing the covid-19 outbreak has been created.

There's a few on that list of potential vaccine associated with public traded companies too.

Not sure whom is the front runner to get to human trials although there has been a few testing a potential vaccine on themselves.

To contrast the vaccine, others are concentrating on developing a effective treatment to minimize the potential of death...something that you either have a minor illness even if you have a weak immune system.

wrbtrader

 

[toc]

Vaccine can help only against this version of Covid. What happens when another strain hits? same cycle of "allround mess" again ?

The real challenge is to find ways to quickly identify the strain and develop it's cure like nanotech based medicines that go inside and hunt for the virus with specific RNA/DNA and destroy them. Such cures will be the real victory against the viruses and their mutations.

In US labs, RNA code was deciphered within few hours of receiving the strain from China but exact "killer antibodies" based medicine has not been formulated even after 2 months.

Medicine/Cure found can be fast tracked into system in few months rather than vaccine taking upto 2 years.

Both US and Italy messed things up by reacting too late while S. Korea and Taiwan acted fast and got over it rapidly.