Vaccine Maker Novavax Enters Final Large-Scale Testing of Its Covid-19 Vaccine (deccanherald.com) 57
The New York Times reports:
Vaccine maker Novavax said Thursday that it would begin the final stages of testing its coronavirus vaccine in the United Kingdom and that another large trial was scheduled to begin next month in the United States. It is the fifth late-stage trial from a company supported by Operation Warp Speed, the federal effort to speed a coronavirus vaccine to market, and one of 11 worldwide to reach this pivotal stage.
Novavax, a Maryland company that has never brought a vaccine to market, reached a $1.6 billion deal with the federal government in July to develop and manufacture its experimental vaccine, which has shown robust results in early clinical trials. The new study, known as a Phase 3 trial, is expected to enroll up to 10,000 people in the United Kingdom. Half of the volunteers will receive two doses of the experimental vaccine, 21 days apart, and the others will receive a placebo.
Although Novavax is months behind the front-runners in the vaccine race, independent experts are excited about its vaccine because its early studies delivered particularly promising results. Monkeys that were vaccinated got strong protection against the coronavirus. And in early safety trials, published early this month in The New England Journal of Medicine, volunteers produced strikingly high levels of antibodies against the virus. It is not possible to make a precise comparison between early clinical studies of different vaccines, but John Moore, a virologist at Weill Cornell Medicine, said that the antibodies from Novavax were markedly higher than any other vaccine with published results. "You just can't explain that away," he said. The Phase 3 trials will determine if Novavax can live up to that promise.
Novavax, a Maryland company that has never brought a vaccine to market, reached a $1.6 billion deal with the federal government in July to develop and manufacture its experimental vaccine, which has shown robust results in early clinical trials. The new study, known as a Phase 3 trial, is expected to enroll up to 10,000 people in the United Kingdom. Half of the volunteers will receive two doses of the experimental vaccine, 21 days apart, and the others will receive a placebo.
Although Novavax is months behind the front-runners in the vaccine race, independent experts are excited about its vaccine because its early studies delivered particularly promising results. Monkeys that were vaccinated got strong protection against the coronavirus. And in early safety trials, published early this month in The New England Journal of Medicine, volunteers produced strikingly high levels of antibodies against the virus. It is not possible to make a precise comparison between early clinical studies of different vaccines, but John Moore, a virologist at Weill Cornell Medicine, said that the antibodies from Novavax were markedly higher than any other vaccine with published results. "You just can't explain that away," he said. The Phase 3 trials will determine if Novavax can live up to that promise.
Somebody has to say it...we're all thinking it (Score:1, Funny)
"Monkeys that were vaccinated got strong protection against the coronavirus..."
Leading to great rejoicing in the community of Trump supporters, no doubt. Chimps and baboons also are delighted.
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Re:Somebody has to say it...we're all thinking it (Score:4, Interesting)
How is he "racist" for poking fun at Trump supporters? Are Trump supporters all one race, or something?
Re: Somebody has to say it...we're all thinking it (Score:1)
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We will under the condition Monkey Boy goes to prison for tax evasion in NYS.
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I would never humiliate a monkey by comparing it directly to a Trump supporter. Even an animal that spends a substantial part of its life in a cage whacking off in front of children deserves some dignity.
You have yourself a lovely day, now.
Re: Somebody has to say it...we're all thinking i (Score:2)
How is he "racist" for poking fun at Trump supporters? Are Trump supporters all one race, or something?
Comparing a group of people to Monkeys is a racist dog whistle.
Racist and offensive to monkeys, unless Trump supporters are a race, is that what you meant?
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Awww. Poor little snowflake. Did um get um's feewings hurt?
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This year? (Score:4, Insightful)
I still think it's unlikely that a vaccine will be widely available this year. If they even manage to get approval this year it will be a miracle.
At least we have several contenders in the final stages. The Chinese will probably have the first. I'm discounting the Russian one until it's properly tested.
I forget where I read it (Score:5, Insightful)
If we do it right it'll be 3 or 4th quarter 2021 or early 2022 before it's universally available.
But it's also possible it'll just be put out there for political reasons. You'll have a few thousand die, but we've already had 200,000, so what's a few thousand more, right?
I remembered why it takes so long (Score:2)
They way it works is they give it to a few very healthy volunteers. Then they have to wait several weeks. Then they give it to some more very healthy volunteers. Then more waiting. Then they can start giving it to less than perfect volunteers, and more waiting. And on and on until they've got a large sample size of every possible health demographic who might take the vaccine.
Because you have to constantly pause and wait and see if some
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We have precedence for how bad it can be [seattletimes.com]. The article says "fiasco". Over 1000 people paralyzed for life is not what I'd call a "fiasco".
What happened in 1976 bears absolutely no resemblance to what is happening now. Believe it or not, we actually know quite a bit more about vaccine development than we did 44 years ago.
BTW, your article says 94 paralysis victims, not 1000. 94 out of some 45,000,000 vaccinations. But don't let that stop your continuous virus fear-mongering with your made-up numbers.
44 years isn't all that long (Score:2)
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44 years isn't all that long even in science terms.
LOL, In the last 44 years there have been so many advances in genetics, immunology, and other related fields that many scientists have said there's been a revolution [nih.gov] in vaccine R&D. But sure man, whatever you say.
Yes, we've got a lot of new tech, but that hasn't done away with the need for lengthy clinical trials. Vaccines still average 2 years to make.
Two years to develop and complete trials for the "average" vaccine under pre-COVID protocols? Wow. Yet another example of your uncanny ability to pull numbers straight out of your ass.
We started work on a vaccine around March. If you try to compress 24 months of work into 6 or 7 months you're rolling dice.
Gee, I guess it's a good thing nobody's doing that then.
What I don't understand is your compulsion to con
It's not compulsion (Score:2)
Meanwhile I'm an American (most of
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Everything I read about the virus scares the pants off me.
That's no excuse for posting wildly exaggerated, made up numbers all over Slashdot. That's no excuse for posting "sources" that don't say what you claim they say all over Slashdot.
"We're" plenty worried about COVID. But I can assure you "we" don't want outright false information shoved in our faces by some idiot who's constantly spewing bullshit like "Over 1000 people paralyzed for life". A completely made up number pulled from the darkest reaches of your ass.
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Its 400 ppl according to the now-deleted CDC article https://www.discovermagazine.c... [discovermagazine.com]
(that's 0.0008%)
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Deleted article? How did you access it?
In any event, your article says 450 people came down with Guillain-Barré syndrome, not that they were all paralyzed. GBS doesn't paralyze everybody who catches it. According to the National Organization for Rare Disorders, [rarediseases.org] "fewer than 15 percent have substantial long-term disability severe enough to need a cane, walker or wheelchair."
Any way you slice it, it's a far far cry from "Over 1000 people paralyzed". That number was completely made up.
De linked to another web page (Score:2)
The number is heavily in dispute and always will be because the company that made the vaccine will dispute it (and spend money making sure you do). 1000 or so people were paralyzed around that time and took the vaccine. There's debate and discussion whether something else caused their particular case of paralysis.
I find the timing too good to be coincidence. Hence I use the 1000 figure. Again, this just means I don't want to skip the proper trials. I am NOT anti vaxxer (I
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the CDC deleted the article.
The number is heavily in dispute and always will be because the company that made the vaccine will dispute it (and spend money making sure you do).
So there's a 44 year long conspiracy between the CDC and "the company that made the vaccine" (there were actually 4 companies) with the goal of suppressing the "true" number of people paralyzed by a swine flu vaccine given in 1976. Additionally, you somehow "know" the CDC recently deleted an article because it was (supposedly) harmful to the aims of the conspiracy.
And am I reading that right? You're saying I'm being paid by the conspirators to keep this all under wraps? Simply by pointing out your so
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I'd take it right now if there was some major benefit like being able to travel internationally. But domestically until a majority of people have it then it won't make a lot of difference I think.
In fact it'll probably never go back to how it was. Some people will have to keep shielding, and hopefully 5 days a week in the office is over.
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but it's not happening this year.
Fake news. Trump promised one before November
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but it's not happening this year.
Fake news. Trump promised one before November
Trump says a lot of stupid shit...
February 26: "The 15 (cases in the US) within a couple of days is going to be down to close to zero."
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No that's also fake news what he actually meant by that was ... errr ... Nah the CDC is wrong, I saw the RNC, Trump is the greatest man in the world and everyone praised him for saving America and taking a tough stance on COVID. There's no way he actually said that! More Fake News. All the videos of him saying something stupid are just AI Deep Fakes from Hillary's campaign.
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All the videos of him saying something stupid are just AI Deep Fakes from Hillary's campaign.
Yes those Chinese rascals.
I want to know how they get the hair so realistic. But also, why don't they make the hands full sized?
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200,000 have died in 8 months. 3Q or 4Q 2021 (about 10-12 months from now) the death toll would be 450,000-500,000. Early 2022 (about 18 months from now) would be 650,000 deaths. Probably more since the virus was not widespread in part
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The risk is not just that a few people might die directly as a result of an unsafe vaccine. If there is a rash of deaths or even serious side effects as the vaccine program starts, many people will refuse to vaccinate even when a properly tested and safe vaccine comes out some months later. If the government says a vaccine is safe and it then kills or maims people, why should anyone have confidence in them when they same the same thing again? The cost of rushing an unsafe vaccine to the market is a continue
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Just a guess, the alleged administration continues in office, no one will trust them to field a vaccine. The right wing loonies will figure it is a government plot. The alleged administration has no credibility from the left.
If we get a new administration, the right wing loonies will figure it is government plot. The new administration will have no credibility from the right.
Either way, we have a lot of right wing loonies out infecting people. It is almost as if the alleged president IS the virus.
False dichotomy (Score:2)
But to do that requires a coordinated response from the government. And doing *that* would show people that gov't can be helpful and effective. The powers that be do not want that, because they want you thinking government is the problem, not the solution. That way you'll refuse to participate in gov't, a
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. Not unless we ignore all safety protocols and just say "let 'er rip".
Trump is quite willing to do just that if he can say "I got a vaccine done" to get votes een if it ends up hurting or killing millions. He doesn't care because all he cares about is himself and getting elected again.
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I still think it's unlikely that a vaccine will be widely available this year.
Pretty much impossible.
If they even manage to get approval this year it will be a miracle.
No, the first approvals will probably be around the end of the year. Could be the last couple weeks of December, could be the first couple weeks of January. Certainly isn't guaranteed that approvals will come before January 1, but it would hardly be a miracle if approvals are announced on December 31. It's possible that the trials that started around August 1 will have enough data by about November 1. They might be able to announce a preliminary result then, but it will still be a lit
Nov or Dec for approval & 10 million, March-Ap (Score:3)
Just based on some simple math using averages of other vaccines, there is about a 92% chance of approval in November or December. That's just figuring that these vaccines follow a similar pattern to other vaccines for other diseases that have undergone stage 3 trials.
Eleven vaccines are in stage 3. Once you're in stage 3, each one has a good shot and there are several in stage 3, so it's very likely that *at least one* of them will be ready for approval in the expected time frame. (Ten vaccines of the eleve
Novavax vaccine is much safer (Score:5, Informative)
Hmm ... (Score:5, Interesting)
Novavax, a Maryland company that has never brought a vaccine to market, reached a $1.6 billion deal with the federal government in July to develop and manufacture its experimental vaccine, which has shown robust results in early clinical trials.
And in early safety trials, published early this month in The New England Journal of Medicine, volunteers produced strikingly high levels of antibodies against the virus. ... a virologist at Weill Cornell Medicine, said that the antibodies from Novavax were markedly higher than any other vaccine with published results.
Never done it before and now has the best results in just a few months?
Seems fishy. Anyone peer-review the study and results yet?
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Novavax, a Maryland company that has never brought a vaccine to market, reached a $1.6 billion deal with the federal government in July to develop and manufacture its experimental vaccine, which has shown robust results in early clinical trials.
And in early safety trials, published early this month in The New England Journal of Medicine, volunteers produced strikingly high levels of antibodies against the virus. ... a virologist at Weill Cornell Medicine, said that the antibodies from Novavax were markedly higher than any other vaccine with published results.
Never done it before and now has the best results in just a few months?
Seems fishy. Anyone peer-review the study and results yet?
The New England Journal of Medicine [nejm.org] doesn't publish a manuscript until it has been reviewed by at least two outside reviewers.
Re:Hmm ... (Score:4, Informative)
Never done it before and now has the best results in just a few months?
Seems fishy. Anyone peer-review the study and results yet?
Wikipedia has a good entry on them: https://en.wikipedia.org/wiki/... [wikipedia.org]
They aren't new the game, they have been around since 1987 and have about 375 employees globally. It also shows they have done a lot of development work in the recent past. I don't doubt their work but peer-review is a must for anyone putting out a vaccine.
There are many possible reasons for coming up with a better vaccine. It could be that they took the safer long-term path while others took the "results sooner" path. They aren't the first to stage III but they have the best candidate for distribution. Then again, maybe they simply didn't want to work on the same solution everyone else seems to be using in case it didn't pan out. Then of course their is the x-factor in which someone inadvertently stumbles upon a superior solution to a problem. The x-factor is completely unpredictable and happens all the time throughout the history of science. To know for sure then you would have to talk to the researchers at Novavax.
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Peer reviewed or it didn't happen. Peer review doesn't happen via press releases. This sounds like they are stroking the alleged administration for more money.
Questions (Score:4, Insightful)
Since the outbreak started, covid-19 has slightly mutated so there are now two different strains. In this regard it is similar to the flu which mutates each year. Does this vaccine, or any of the other vaccines undergoing testing, protect against covid-19 as a whole, or a specific strain of the virus? Is this a once-and-done vaccine, similar to smallpox, or will we have to get booster shots every so often? How long does protection last? Does being vaccinated prevent you from transmitting the virus to others, or does it only protect you from contracting the virus?
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Does this vaccine, or any of the other vaccines undergoing testing, protect against covid-19 as a whole, or a specific strain of the virus?
We don't know. But since people who have recovered from one strain of Covid, do not appear to be infected by other strains, the vaccine will most like protect against all strains.
Is this a once-and-done vaccine, similar to smallpox, or will we have to get booster shots every so often?
We don't know. But Covid re-infections are very rare. So it may be once-and-done.
How long does protection last?
We don't know.
Does being vaccinated prevent you from transmitting the virus to others, or does it only protect you from contracting the virus?
If you don't contract the virus in the first place, then you can't transmit it to others. Duh.
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Since the outbreak started, covid-19 has slightly mutated so there are now two different strains.
There have been lots of insignificant mutations, The new report, however, did not find that these mutations have made the virus deadlier or changed clinical outcomes. All viruses accumulate genetic mutations, and most are insignificant, scientists say. [washingtonpost.com]
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Does this vaccine, or any of the other vaccines undergoing testing, protect against covid-19 as a whole, or a specific strain of the virus?
Mutations are funny things, they can completely change a virus in many ways. They can make it immune from vaccines, they can make them more or less contagious, they can make them more or less deadly. Currently there are two mutations in the wild, the European mutation spreads more easily but is milder than the Asian original. From what I've read experts pretty universally think both of the currently rampant mutations would be covered by a vaccine targeting either one.
What does 50% effective mean? (Score:1)
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Is this a once-and-done vaccine, similar to smallpox, or will we have to get booster shots every so often?
How long does protection last?
Does being vaccinated prevent you from transmitting the virus to others, or does it only protect you from contracting the virus?
For all of your questions, we don't fully know the answers at this stage.
Quite probably we will have t
Re: Nice (Score:2)
I know a guy who would do that (Score:2)
Never brought a vaccine to market... (Score:2)
Never brought a vaccine to market... announces spectacular, robust result. Sure sure. Touches a match to the gasoline all around the house, response is also spectacular, robust. Actually, just throw the virus in the fire, it will die. Done.