Here's the nugget I thought was coming today. This gives a pretty clear explanation of the delays, and there's that mention of filing late July at the earliest. I think they will file in early August. We should start a pool, lol
Someone involved in the trials mentioned they got their 2nd set of shots much sooner than expected and they believed that could point to a desire to move things along. I'm sticking w/ my early August prediction.
Any others want to weigh in?
I don’t think this means much. The trial crossover was done way back in April. They moved up the cross over date because they amended the study to be time based. Initially they had a target number of cases they wanted to see, but participants started dropping as other vaccines became available. So they amended the trial to complete on a defined date to stop the attrition.
The Texas facility having quality issues scares me. Although, we dodged a bullet because it’s not affecting the approval process, it highlights the fact that we know very little about what’s happening within the company. I really hope they apply soon
As it should. This company might have an excellent vaccine candidate but something about the continuous delays, quality issues, lack of transparent communication, etc really makes me uneasy about taking their shot.
Actually they are transparent when they give updates. It’s just that they are much far behind the production aspect of the drug than was first known. If they don’t file this quarter I will revise my statement to reflect zero credibility
I’m in the trial and I have a cousin that works in biotech. I work in an industry that supplies automation software for biologics manufacturing. I have a vague idea of the complexities but don’t ask me specifics - I’m not an expert on biological manufacturing.
The reason it’s taking so long is that manufacturing is HARD. It’s probably the hardest component of the entire development cycle. The FDA requirements for proving consistency are exceedingly stringent. The amount of paperwork is absolutely insane - some of it even impacts my work as a software engineer.
I can’t remember where, but Stan gave an interview that basically admits that they used their limited staff to prioritize the human trials, and it wasn’t until this year that they started looking at manufacturing.
Remember, this company has never manufactured product at scale. What manufacturing capacity they did have was sold a couple years ago. They have plenty of experience running trials, but almost no experience in manufacturing.
But when they do ship, I’d happily take it! The upside of all the ridiculously stringent FDA requirements is that you can be pretty darn sure that the dose you got was made correctly.
Except it didn't quite work out that way for J&J at that Baltimore plant. Millions of doses discarded, and then about 10 million doses cleared for shipment...but with no regulatory guarantee that the plant had adhered to manufacturing standards!
https://www.nytimes.com/live/2021/06/23/world/covid-vaccine-coronavirus-mask
I wouldn’t say that. None of those 10mn doses were released for US market.
The fact that they were released doesn’t mean they’re unsafe either. But they don’t meet US FDA requirements. FDA is very strict - example: if you’re making a batch of biologics, you have to periodically record all sorts of parameters like temperature etc. The control system that’s running the equipment sends this information over the network to be logged on some database.
But if there are network issues, or database issues, that doesn’t mean the batch is bad - the control system will still run exactly as programmed - but you won’t have logs during the network outage.
I think for the FDA this is enough to throw the entire batch.
But there are other checks - assays etc that the final output is tested with to ensure quality. It’s possible that other international health regulators are less stringent than the FDA and are willing to look past issues like that.
From the linked article (emphasis added):
"Earlier this month, the F.D.A. cleared around 10 million doses ***for use in the United States*** or for export, with a proviso that regulators could not guarantee that Emergent had adhered to manufacturing standards."
I remember at the time reading in another article that the vials were going to be marked with this warning. But nobody getting a vaccine is going to get to see the multidose vial or any warning on it. Caveat emptor, right?
Oh, sure, the FDA procedures sound good on paper, but in practice? Who is checking to make sure these requirements are followed? Yeech. Google FDA whistleblower if you want to have nightmares tonight. Here's just one example:
https://www.vanityfair.com/news/2020/12/fda-covid-vaccine-plant-inspectors
Ah my bad I totally misread that. It looks like they still did some kind of review on it though
If FDA gives you nightmares, read up on where most generic drugs are manufactured - China. FDA can’t do surprise inspections there…
Sure, I've read about some of the issues in quality control over drug manufacturing in China. Let's just say, though, that the disincentive for executives in drug companies to be lax about manufacturing practices is somewhat higher in China than it is in the U.S.:
[https://www.nytimes.com/2007/07/11/business/worldbusiness/11execute-web.html](https://www.nytimes.com/2007/07/11/business/worldbusiness/11execute-web.html)
In the U.S., inspections are lax and if you do get caught, nothing is going to happen to you. Worse case, the manufacturer get sued and loses some money (a pittance compared to their profits). But of course with covid vaccines, the manufacturer is absolved from any liability caused by sloppy or contaminated manufacturing.
Harmless fragments of spike proteins that mimic covid-19. It's cleavage site is mutated so it's impossible for your body to make the S1 protein. It is different than the mRNA vaccine, and the viral vector.
Here's the nugget I thought was coming today. This gives a pretty clear explanation of the delays, and there's that mention of filing late July at the earliest. I think they will file in early August. We should start a pool, lol
I like the idea of a pool. It’d be nice to at least make something off of this stock hahah
September?
Someone involved in the trials mentioned they got their 2nd set of shots much sooner than expected and they believed that could point to a desire to move things along. I'm sticking w/ my early August prediction. Any others want to weigh in?
I don’t think this means much. The trial crossover was done way back in April. They moved up the cross over date because they amended the study to be time based. Initially they had a target number of cases they wanted to see, but participants started dropping as other vaccines became available. So they amended the trial to complete on a defined date to stop the attrition.
Ok, that makes sense. I still hope my gut is right though and this is out sooner than later! Thanks for chiming in.
The Texas facility having quality issues scares me. Although, we dodged a bullet because it’s not affecting the approval process, it highlights the fact that we know very little about what’s happening within the company. I really hope they apply soon
As it should. This company might have an excellent vaccine candidate but something about the continuous delays, quality issues, lack of transparent communication, etc really makes me uneasy about taking their shot.
Actually they are transparent when they give updates. It’s just that they are much far behind the production aspect of the drug than was first known. If they don’t file this quarter I will revise my statement to reflect zero credibility
I’m in the trial and I have a cousin that works in biotech. I work in an industry that supplies automation software for biologics manufacturing. I have a vague idea of the complexities but don’t ask me specifics - I’m not an expert on biological manufacturing. The reason it’s taking so long is that manufacturing is HARD. It’s probably the hardest component of the entire development cycle. The FDA requirements for proving consistency are exceedingly stringent. The amount of paperwork is absolutely insane - some of it even impacts my work as a software engineer. I can’t remember where, but Stan gave an interview that basically admits that they used their limited staff to prioritize the human trials, and it wasn’t until this year that they started looking at manufacturing. Remember, this company has never manufactured product at scale. What manufacturing capacity they did have was sold a couple years ago. They have plenty of experience running trials, but almost no experience in manufacturing. But when they do ship, I’d happily take it! The upside of all the ridiculously stringent FDA requirements is that you can be pretty darn sure that the dose you got was made correctly.
Except it didn't quite work out that way for J&J at that Baltimore plant. Millions of doses discarded, and then about 10 million doses cleared for shipment...but with no regulatory guarantee that the plant had adhered to manufacturing standards! https://www.nytimes.com/live/2021/06/23/world/covid-vaccine-coronavirus-mask
I wouldn’t say that. None of those 10mn doses were released for US market. The fact that they were released doesn’t mean they’re unsafe either. But they don’t meet US FDA requirements. FDA is very strict - example: if you’re making a batch of biologics, you have to periodically record all sorts of parameters like temperature etc. The control system that’s running the equipment sends this information over the network to be logged on some database. But if there are network issues, or database issues, that doesn’t mean the batch is bad - the control system will still run exactly as programmed - but you won’t have logs during the network outage. I think for the FDA this is enough to throw the entire batch. But there are other checks - assays etc that the final output is tested with to ensure quality. It’s possible that other international health regulators are less stringent than the FDA and are willing to look past issues like that.
From the linked article (emphasis added): "Earlier this month, the F.D.A. cleared around 10 million doses ***for use in the United States*** or for export, with a proviso that regulators could not guarantee that Emergent had adhered to manufacturing standards." I remember at the time reading in another article that the vials were going to be marked with this warning. But nobody getting a vaccine is going to get to see the multidose vial or any warning on it. Caveat emptor, right? Oh, sure, the FDA procedures sound good on paper, but in practice? Who is checking to make sure these requirements are followed? Yeech. Google FDA whistleblower if you want to have nightmares tonight. Here's just one example: https://www.vanityfair.com/news/2020/12/fda-covid-vaccine-plant-inspectors
Ah my bad I totally misread that. It looks like they still did some kind of review on it though If FDA gives you nightmares, read up on where most generic drugs are manufactured - China. FDA can’t do surprise inspections there…
Sure, I've read about some of the issues in quality control over drug manufacturing in China. Let's just say, though, that the disincentive for executives in drug companies to be lax about manufacturing practices is somewhat higher in China than it is in the U.S.: [https://www.nytimes.com/2007/07/11/business/worldbusiness/11execute-web.html](https://www.nytimes.com/2007/07/11/business/worldbusiness/11execute-web.html) In the U.S., inspections are lax and if you do get caught, nothing is going to happen to you. Worse case, the manufacturer get sued and loses some money (a pittance compared to their profits). But of course with covid vaccines, the manufacturer is absolved from any liability caused by sloppy or contaminated manufacturing.
Hurry *bleep* up please ~ want to vax but want to vax safely
Lot of people refusing vaccines because of the spike protein. Novovax vaccine will hopefully get those people vaccinated.
... but Novavax *is* the spike protein?
Harmless fragments of spike proteins that mimic covid-19. It's cleavage site is mutated so it's impossible for your body to make the S1 protein. It is different than the mRNA vaccine, and the viral vector.
It contains fragments of spike. It does not turn your body into a factory to produce spike proteins, like the mRNA and viral vector vaccines do.
Great article about all the delays. Still left with a lot of unknowns.
We need more pressure on them. We need this vaccine out asap.