CV-19 vaccine news...

KillerGopherFan

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Looks like Moderna has a potentially very effective, safe vaccine in development. I heard one source say that it could be available for emergency use by this Fall. 45 of 45 participants developed the antibodies after vaccination in early results.


Boy, maybe that ”happy talk” by Trump of a fast development of a vaccine wasn’t overly optimistic.

This is just more evidence that the free market and capitalism are the solution to problems, and not big government that can’t seem to get out of its own way. Those evil for-profit corporations that Bernie and lefties so hate.
 

bga1

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Looks like Moderna has a potentially very effective, safe vaccine in development. I heard one source say that it could be available for emergency use by this Fall. 45 of 45 participants developed the antibodies after vaccination in early results.


Boy, maybe that ”happy talk” by Trump of a fast development of a vaccine wasn’t overly optimistic.

This is just more evidence that the free market and capitalism are the solution to problems, and not big government that can’t seem to get out of its own way. Those evil for-profit corporations that Bernie hates so.
I have to say I am suspicious of this one. This one doesn't look so free market to me. It feels like Moderna might have gotten an early jump on this one.....

Bill Gates funded Moderna....http://www.ddn-news.com/index.php?newsarticle=10450

US Government got behind Moderna quickly...https://www.biopharmadive.com/news/coronavirus-moderna-barda-vaccine-manufacturing/576217/

Moderna worked with NIH (Fauci) early on this one: https://www.statnews.com/2020/02/11/major-drug-makers-havent-stepped-up-to-manufacture-coronavirus-vaccine-top-u-s-health-official-says/
 

TruthSeeker

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KGF stepped in it with his editorial. Let's just hope we get an effective vaccine as quickly as possible. Phase 1 trials don't mean anything. Even if we get one through a Phase 3 trial, we won't know long-term effects of the vaccine for years. Rushed medicinal therapies aren't always a good thing.
 

KillerGopherFan

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I have to say I am suspicious of this one. This one doesn't look so free market to me. It feels like Moderna might have gotten an early jump on this one.....

Bill Gates funded Moderna....http://www.ddn-news.com/index.php?newsarticle=10450

US Government got behind Moderna quickly...https://www.biopharmadive.com/news/coronavirus-moderna-barda-vaccine-manufacturing/576217/

Moderna worked with NIH (Fauci) early on this one: https://www.statnews.com/2020/02/11/major-drug-makers-havent-stepped-up-to-manufacture-coronavirus-vaccine-top-u-s-health-official-says/
Regardless of whether this or other vaccines are developed, I’ll bet on the free market to develop it over the government.

Larger pharma companies have more to risk. Smaller biotech and pharma companies are already risky ventures in and of themselves. They are working their tails off to find the big one with maybe more motivation than the big boys.
 

KillerGopherFan

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KGF stepped in it with his editorial. Let's just hope we get an effective vaccine as quickly as possible. Phase 1 trials don't mean anything. Even if we get one through a Phase 3 trial, we won't know long-term effects of the vaccine for years. Rushed medicinal therapies aren't always a good thing.
So what’s your point? We’re not going to “know long term effects...for years”. What does that even mean? It shouldn’t be used?

Potential CV-19 are on an expedited approval path. Is there risk in that? Yeah. There’s an obvious risk of not having a vaccine that is effective and safe as well, and it’s very well documented.

If studies total a 1000 patients, it may not show a side effect that occurs in 1 in 10K patients. If a side effect occurs a year or more after treatment, it won’t be discovered in less than that time.

Risks on both sides will be compared, including the possible risks of the unknown, but the known risks are the very most important to consider. The effectiveness and safety of any prospective vaccine will be thoroughly tested and known, b/c efficacy can be pretty well determined and most S/Es will occur in the short term and not show up 5 years from now.

If the Moderna vaccine continues to demonstrate efficacy and safety through Phase 2 and 3, it very well will be available in the Fall for emergency use. And, as it or others are used, that information will be continually evaluated.

But, there are no guarantees in science if that’s what you’re waiting for.
 

howeda7

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To speed up the testing, I think they should use MAGA rallies for phase I. 50,000 in the arena. 250,000 outside waiting to get in.

Of course if they're all chugging choloroquine, they'll be disqualified.
 

KillerGopherFan

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To speed up the testing, I think they should use MAGA rallies for phase I. 50,000 in the arena. 250,000 outside waiting to get in.

Of course if they're all chugging choloroquine, they'll be disqualified.
You shouldn’t be so publicly callous about your lack of concern for the health of Trump supporters. I mean, we know you wish they’d just die and stop interfering with your political wishes, but I didn’t think you’d admit it out loud.
 

howeda7

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You shouldn’t be so publicly callous about your lack of concern for the health of Trump supporters. I mean, we know you wish they’d just die and stop interfering with your political wishes, but I didn’t think you’d admit it out loud.
Who's saying they should die? Of course it would be voluntary, but I imagine many of them would volunteer for the Trump vaccine. It would take too many Biden rallies to get a decent sample size.
 

stocker08

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To speed up the testing, I think they should use MAGA rallies for phase I. 50,000 in the arena. 250,000 outside waiting to get in.

Of course if they're all chugging choloroquine, they'll be disqualified.
They'd already have been saved by that point.....by big beautiful choloroquine.
 

TruthSeeker

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So what’s your point? We’re not going to “know long term effects...for years”. What does that even mean? It shouldn’t be used?

Potential CV-19 are on an expedited approval path. Is there risk in that? Yeah. There’s an obvious risk of not having a vaccine that is effective and safe as well, and it’s very well documented.

If studies total a 1000 patients, it may not show a side effect that occurs in 1 in 10K patients. If a side effect occurs a year or more after treatment, it won’t be discovered in less than that time.

Risks on both sides will be compared, including the possible risks of the unknown, but the known risks are the very most important to consider. The effectiveness and safety of any prospective vaccine will be thoroughly tested and known, b/c efficacy can be pretty well determined and most S/Es will occur in the short term and not show up 5 years from now.

If the Moderna vaccine continues to demonstrate efficacy and safety through Phase 2 and 3, it very well will be available in the Fall for emergency use. And, as it or others are used, that information will be continually evaluated.

But, there are no guarantees in science if that’s what you’re waiting for.
I'll be in line to get a vaccine when it's available.

The companies creating vaccines and governments pressuring companies to get a vaccine created and expedited better not cut corners. A screw up on this vaccine will fuel the anti-vaxxers for decades.
 

KillerGopherFan

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Don's not really taking it. Jared's stock holdings just needed a boost.
Generic drug companies aren’t going to get a big boost from HQC sales. I don’t know that Jared is invested either, but neither do you.
 

jamiche

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I have to say I am suspicious of this one. This one doesn't look so free market to me. It feels like Moderna might have gotten an early jump on this one.....

Bill Gates funded Moderna....http://www.ddn-news.com/index.php?newsarticle=10450

US Government got behind Moderna quickly...https://www.biopharmadive.com/news/coronavirus-moderna-barda-vaccine-manufacturing/576217/

Moderna worked with NIH (Fauci) early on this one: https://www.statnews.com/2020/02/11/major-drug-makers-havent-stepped-up-to-manufacture-coronavirus-vaccine-top-u-s-health-official-says/
How many times do we have to tell you that Fauci never worked at NIH, beggar?
 

MplsGopher

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KGF stepped in it with his editorial. Let's just hope we get an effective vaccine as quickly as possible. Phase 1 trials don't mean anything. Even if we get one through a Phase 3 trial, we won't know long-term effects of the vaccine for years. Rushed medicinal therapies aren't always a good thing.
Bingo.

People need to perform the following Google search and educate themselves about this disaster: "Sanofi dengue vaccine".

Here is some help, to get started: https://www.reuters.com/article/us-sanofi-fr-philippines/philippines-to-charge-officials-of-sanofi-government-over-dengue-vaccine-idUSKCN1QI41L

"
Philippines to charge officials of Sanofi, government over dengue vaccine
The Philippine Department of Justice on Friday said it had found probable cause to indict officials from French drugmaker Sanofi and former and current Philippine health officials over 10 deaths it said were linked to use of a dengue vaccine.

...

Dengue is a mosquito-borne tropical disease that kills about 20,000 people a year and infects hundreds of millions.

Approved in late 2015 as the world’s first vaccine to treat the condition, Dengvaxia has rapidly become Sanofi’s most problematic program to date.

The company acknowledged two years ago its use could, in some cases, increase the risk of severe dengue in people who had not been previously exposed to the disease, limiting access to vaccine after deaths of children were reported in the Philippines.

...

“INEXCUSABLE”
The World Health Organization (WHO) advises the vaccine should only be used after testing individuals to assess whether they have ever been exposed to the disease.

Despite concerns around its use, the European Medicines Agency has approved Dengvaxia and the U.S. Food and Drug Administration has granted priority review with a decision expected in May.

However, the Philippines has permanently halted the sale, distribution and marketing of Dengvaxia, which was initially seen as a potential $1-billion-a-year-plus product.

"
 

KillerGopherFan

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The Coronavirus Vaccine Is on Track to Be the Fastest Ever Developed

In early April, as covid-19 cases and deaths in New York City were rising to horrifying numbers, Tal Zaks, the chief medical officer of Moderna, a Cambridge-based biotech company, was concerned about time. In just three months, his company had created an experimental vaccine to inoculate against covid-19, and begun to inject the vaccine into humans, under the guidance of the National Institute of Allergy and Infectious Diseases, in a Phase I clinical trial involving forty-five healthy men and women. This kind of speed in vaccine development was unprecedented, and largely derived from the revolutionary—and yet, on a large scale, untested—biomedical technology behind the Moderna vaccine. Still, if there was any chance of getting the vaccine federally licensed, and then manufactured into hundreds of millions of doses, in twelve to eighteen months—as Anthony Fauci, the director of the N.I.A.I.D., has said is the fastest possible timeline—Zaks knew that the company would have to be able to prove the vaccine’s potential, or an “expectation of benefit,” as he put it, by this summer.

To accomplish this, Moderna would have to demonstrate three things: first, that the vaccine causes no significant adverse side effects in the healthy people dosed; second, that the vaccine can prevent disease in other mammals, such as mice and monkeys; and, third, that the vaccine induces neutralizing antibodies in trial participants’ blood, which is tested by adding inoculated blood to a petri dish and seeing if the virus is prevented from infecting and killing cells in a tissue culture. “In virology,” Zaks told me, “generating neutralizing antibodies is a pretty good surrogate of your ability to eventually protect the human being from becoming sick.” Once you have these Phase I results, “it becomes a judgment call,” he said. “When does that expectation of benefit actually become strong enough to warrant exposing more and more people to an unknown risk?”
On May 15th, Zaks received his answer in his in-box—a hundred-and-forty-page report analyzing the initial results. As he read, his smile got bigger. “It was really, really reassuring,” he said. After two doses—a first shot and a booster shot—eight of the trial participants produced neutralizing antibodies at or exceeding the levels seen in the blood of people who have recovered from covid-19. (Moderna is still awaiting data on the other thirty-seven participants from N.I.A.I.D. and its academic partners, which are carrying out the dangerous experiments in Biosafety Level 3 labs.) Across the entire group of forty-five trial participants, all of whom were between the ages of eighteen and fifty-five, the vaccine was safe and tolerated, with almost no adverse side effects. Among the two lower-dosage groups, one person had some redness around the injection site, and, in the high-dosage group, three people experienced short-lived, mild flu-like symptoms. In mice, the vaccine provided full protection against viral replication in the lungs, which researchers tested by giving mice the vaccine and then deliberately infecting them with the virus. (Scientists place a small drop of virus-laced fluid over the mouse’s nostrils. Similar trials on rhesus macaques are about to start.)

With these results, Moderna and the N.I.A.I.D. could continue with their wildly ambitious plan to start Phase II trials almost immediately, in six hundred participants, with no limit on maximum age, and then, by July, to start Phase III efficacy trials, which will likely involve upward of ten thousand people. After finishing his review of the report, Zaks jumped on a call with other Moderna executives and scientists, and also investigators at N.I.A.I.D. “The sense of excitement was palpable,” he told me in a video call on Monday, still smiling, wearing a blood-red tie. “There was clapping.” But he emphasized that there was still a long way to go. Mice are not humans. “I have to say that the degree of excitement is the same as the degree, or sense, of responsibility,” Zaks said. “Now we’ve got to get this next bit right. It’s on us.”

Stéphane Bancel, the C.E.O. of Moderna, said last week that, pending the results of the Phase III efficacy trial this summer, the vaccine could be ready for approval and licensing as soon as the fall. In the Phase III trial, one group will get a placebo and another will get the vaccine. Everyone is given the same precautions to avoid infection. Then the investigators have to wait for people to stumble into the virus or get infected; once there are significantly more cases among the placebo group, to prove that the vaccine is working, an independent review board will analyze the data and decide whether the trial is done. “The biggest risk is how quickly we get enough people infected to have significant data,” Zaks said. “Designing the trial and picking the right place to run it is going to be key now.”

New York City, where there likely still will be some community circulation of the virus this summer, is one of the locations under consideration. Zaks could not confirm yet how many cases of infection would be needed to prove that the vaccine is effective. Often, in Phase III case-driven trials of this kind, investigators and regulators want to have between sixty and a hundred cases of infection with clinical symptoms (the kind that make a person go to the doctor) in the placebo group. Ideally, there would be zero cases of infection among the vaccinated group. “Fifty-to-zero would be great. Thirty-to-zero would be good,” Zaks said. “The higher the ratio, the sooner we’re likely to be able to show that, indeed, it is a statistically significant difference, and therefore we got it right.” But most vaccines are not a hundred-per-cent effective. “Even fifty-per-cent or seventy-per-cent efficacy would be helpful here,” Barney Graham, the deputy director of the Vaccine Research Center at the N.I.A.I.D., who has been deeply involved with the Moderna vaccine’s development and clinical trials, said.

Usually, vaccine development takes a decade or longer, and the statistical chance of failure, historically, is more than ninety per cent. But Moderna, which was founded a decade ago, has invested billions to create vaccines (and also therapeutic drugs) using messenger RNA, which is, essentially, the code—like the zeroes and ones that drive computing—that tells cells how to build new proteins (i.e., how to grow life). To make these vaccines, all that Moderna’s researchers need to know is the atomic-level genetic sequence—the messenger RNA—of the protein they want our bodies to create. Everything else about the vaccine—the upstream supply chain (the enzymes and nucleic acids, the lipids, the plastics) and the downstream processes (purification, tests for stability and integrity of the vaccine)—is the same as it would be for any of their other vaccines. That’s why they can move so quickly. With this coronavirus, the vaccine’s mRNA instructs our cells to make the now famous spike protein—the part of the virus that is particularly adept at binding to our cells—prompting our immune system to create antibodies that can disarm it. The company has some of its own manufacturing capacity, which allowed it to make the early doses. In April, the U.S. Biomedical Advanced Research and Development Authority (barda) awarded the company nearly five hundred million dollars to accelerate development, and, on May 1st, Moderna announced that it would be collaborating with Lonza, a Swiss multinational chemical and biotech company, to manufacture up to a billion doses of the coronavirus vaccine in 2021.

Still, this vaccine will be Moderna’s first to go into Phase III trials, a historic first for mRNA vaccines and therapeutics. Fauci, during Senate testimony on May 12th, said, “There is no guarantee the vaccine is going to be effective.” He also pointed out that there have been at least two vaccines in the past that have had adverse effects; the vaccines induced the wrong sort of antibodies, and people exposed to the virus got even sicker. That is unlikely in this case, Zaks said, thanks to years of research by Barney Graham and others at the Vaccine Research Center. But it is still a theoretical possibility. At this stage, almost anything could happen. For Moderna, there will be pressure from all sides—the crisis of the pandemic itself, the Trump Administration, a depressed economy—to quickly show that the vaccine works. Despite the first round of promising evidence, Zaks knows that the company must wait for proof. “There’s going to be a tension between our ability to generate data for safety and effectiveness and our wish to use the vaccine as we’re ramping up manufacturing,” he said. “We’re going to have a pile of vaccines ahead of having actual data that proves its safety profile and benefit.” For a desperate world, the wait will be painful.
 

KillerGopherFan

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AstraZeneca's COVID-19 vaccine enters phase 2/3 clinical trial

Researchers at the University of Oxford have begun enrolling subjects in a phase 2/3 clinical trial of AstraZeneca-partnered COVID-19 vaccine AZD1222. The next stage of the program, which follows a 1,000-subject phase 1, is set to enroll 10,260 people in the U.K. to generate results to support the first shipments to customers in September.

AZD1222, the recombinant adenovirus vaccine that originated in Oxford, entered the clinic shortly after Moderna’s candidate. The initiation of the phase 1 trial marked the start of a large, significantly truncated development program plotted out by researchers at the University of Oxford, who have talked up the prospect of making the vaccine available in September.

Work toward that goal is advancing apace on multiple fronts. On the R&D side, the University of Oxford said Friday that it has begun enrolling participants in the phase 2 portion of the program.

The phase 2 will relax the exclusion criteria used in the phase 1, notably by enrolling a small number of children aged 5 to 12 years and adults aged 56 years and older. One cohort will enroll adults aged over 70 years, a demographic that is particularly at risk from the coronavirus. By expanding the age range, the researchers aim to understand how immune response varies across demographics.

Once the vaccine moves into phase 3, the researchers will limit enrollment to people age 18 years and older. Adult participants in the phase 2 and 3 trials will be randomized to receive one or two doses of AZD1222 or a vaccine against meningococcal bacteria that will serve as the control.

The use of an active vaccine as a control is intended to ensure participants are unable to tell whether they received AZD1222 based on side effects such as soreness at the injection site. In the absence of such effects across both groups, participants could determine whether they had received the vaccine and make behavioral changes that skew the results of the study.

Investigators plan to administer the vaccines to participants in the next stage of the study across May and June. Subjects will then attend follow-up visits to provide blood samples that will show whether their immune system has responded to the virus. The researchers will also ask some participants to log any symptoms they feel in the week after vaccination.

Those measures will provide an early look at the safety and immunogenicity of the vaccine, but it will take longer to gauge whether the shot can prevent people from becoming infected with the coronavirus.

The researchers are trying to accelerate that process by enrolling healthcare workers and other people who are more likely to be exposed to the virus. Depending on the extent to which SARS-CoV-2 is present in the U.K., it is expected to take two to six months for enough infections to happen to show whether the vaccine is working.

Neither the university nor AstraZeneca are hanging around to see if that is the case before preparing for widespread use of the vaccine. The phase 2/3 trial is getting underway despite the university being yet to share phase 1 data, and AstraZeneca is already racing to equip itself to ship 1 billion doses.
 

MplsGopher

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I’ll let you all take these rushed vaccines first.

Don’t get me wrong, I will be taking one eventually. But doesn’t hurt to make sure they didn’t royally F it up in the name of speed and profit over science.
 

Ogee Oglethorpe

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Unfortunately, there's a segment of our population that would very much NOT like there to be an effective vaccine any time soon. This is where we are today it seems
 

MplsGopher

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Shocking. I hope Jared sold his too.
Go after them. Clawback every cent of the sale and put them in prison.

Very clearly dumping their shares knowing that either their candidate failed some tests and/or Astra/Oxford has been selected as the golden child.

Either way, disgusting. This is capitalism, ie fraud.
 

cncmin

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Looks like Moderna has a potentially very effective, safe vaccine in development. I heard one source say that it could be available for emergency use by this Fall. 45 of 45 participants developed the antibodies after vaccination in early results.


Boy, maybe that ”happy talk” by Trump of a fast development of a vaccine wasn’t overly optimistic.

This is just more evidence that the free market and capitalism are the solution to problems, and not big government that can’t seem to get out of its own way. Those evil for-profit corporations that Bernie and lefties so hate.
Dude, some of the news on the vaccine front is truly great, but you need to reconsider your information sources and thought process: governments, including ours, have been investing massive resources into vaccine development. It would be highly doubtful that any fast-scale vaccine development for Covid-19 would not include government funding/support.
 

cncmin

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Unfortunately, there's a segment of our population that would very much NOT like there to be an effective vaccine any time soon. This is where we are today it seems
Weird. Could you describe what "segment" to which you are referring? I personally know thousands and thousands of people (as do most folks my age), and not one of whom I am aware does not want to see a vaccine as soon as possible. Maybe the people you hang around with are just horrible people - something for you to consider about who you socialize with.
 

Pompous Elitist

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.In the Phase III trial, one group will get a placebo and another will get the vaccine. Everyone is given the same precautions to avoid infection. Then the investigators have to wait for people to stumble into the virus or get infected; once there are significantly more cases among the placebo group, to prove that the vaccine is working, an independent review board will analyze the data and decide whether the trial is done. “The biggest risk is how quickly we get enough people infected to have significant data,” Zaks said. “Designing the trial and picking the right place to run it is going to be key now.”
May we suggest MN nursing homes?
 

Pompous Elitist

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Yeah, that’s bad. What they did wasn’t illegal per se as they had pre-planned it and filed the necessary paperwork but by all appearances their recent press release touting early trial results - sans any actual data - was designed to stoke the stock price prior to their sale. They may yet produce a vaccine but it is new tech with a higher burden of safety proof IMO. This company stinks to high heaven. I’m getting on the Oxford University train.




Vaccine experts say Moderna didn’t produce data critical to assessing Covid-19 vaccine

Heavy hearts soared Monday with news that Moderna’s Covid-19 vaccine candidate — the frontrunner in the American market — seemed to be generating an immune response in Phase 1 trial subjects. The company’s stock valuation also surged, hitting $29 billion, an astonishing feat for a company that currently sells zero products.

But was there good reason for so much enthusiasm? Several vaccine experts asked by STAT concluded that, based on the information made available by the Cambridge, Mass.-based company, there’s really no way to know how impressive — or not — the vaccine may be.

While Moderna blitzed the media, it revealed very little information — and most of what it did disclose were words, not data. That’s important: If you ask scientists to read a journal article, they will scour data tables, not corporate statements. With science, numbers speak much louder than words.

 

cncmin

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Yeah, that’s bad. What they did wasn’t illegal per se as they had pre-planned it and filed the necessary paperwork but by all appearances their recent press release touting early trial results - sans any actual data - was designed to stoke the stock price prior to their sale. They may yet produce a vaccine but it is new tech with a higher burden of safety proof IMO. This company stinks to high heaven. I’m getting on the Oxford University train.




Vaccine experts say Moderna didn’t produce data critical to assessing Covid-19 vaccine

Heavy hearts soared Monday with news that Moderna’s Covid-19 vaccine candidate — the frontrunner in the American market — seemed to be generating an immune response in Phase 1 trial subjects. The company’s stock valuation also surged, hitting $29 billion, an astonishing feat for a company that currently sells zero products.

But was there good reason for so much enthusiasm? Several vaccine experts asked by STAT concluded that, based on the information made available by the Cambridge, Mass.-based company, there’s really no way to know how impressive — or not — the vaccine may be.

While Moderna blitzed the media, it revealed very little information — and most of what it did disclose were words, not data. That’s important: If you ask scientists to read a journal article, they will scour data tables, not corporate statements. With science, numbers speak much louder than words.

PE, I believe the Oxford University work is being heavily funded by...the US government. Don't quote me on that yet, but I've seen reports of such.

Edit: OK, yep, I heard correctly. The US is currently funding much of the Oxford work. Not that they don't deserve funding, but...
https://www.marketwatch.com/story/us-gives-astrazeneca-12-billion-to-fund-oxford-university-coronavirus-vaccine-securing-300-million-doses-for-country-from-october-2020-05-21

Of note, this goes through AstraZeneca. Of further note, AstraZeneca is not an American company. And of even further note, I believe that there are a lot of Republican Party funding ties to.....AstraZeneca. But don't quote me on the last one, and I don't plan to look that up right now. For all I know, these companies corrupt heavily across party lines.
 
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