And you didn't even mention that they only approved vaccines for younger kids one week ago. They sat on the data: Moderna submitted almost 2 months ago, they cancelled the meeting Vaccines and Related Biological Products Advisory Committee scheduled for shortly afterwards and didn't request any further data. Just sat, doing nothing while it swept through preschools and lots of kids got sick. Sure, not many in that age group will die, but why have them get sick/have long-term effects for absolutely zero reason.
The administration needed to fire Dr. Marks long ago.
I'm in the Novavax trial and it's been astounding to me how much it's been slow walked. It's been well over a year since the vaccine was deemed effective enough that everyone in the trial was given the vaccine because it would have been considered unethical to withhold from those that got the placebo. If you would have told me then that it still wouldn't have FDA approval now and that my infant would have an approved vaccine first, I'd have thought you were insane. The supposed manufacturing concerns get more nonsensical as more and more countries are using it without any indication of problems. If it had been the first vaccine to report its data there is no doubt it in my mind, it would have been approved long ago.
Jun 26, 2022·edited Jun 26, 2022Liked by Noah Smith
There are quite a few people who can't take the mRNA vaccines. I am one of them. The reaction from the first jab was so severe that I knew I was risking serious damage with a second jab. The VAERS reports on fatality and damaging side effects are through the roof. I really don't CARE that the data isn't completely accurate. When you see the trajectory of the data and the similarity of symptoms, YOU PAY ATTENTION and tease out the problems so people don't die or suffer permanent health issues while trying to do the right thing.
I'm a virtual prisoner of this pandemic - stuck at home as a high-risk person. I've been waiting and waiting and waiting and waiting and waiting for Novavax and I am beyond furious that we don't have it yet when most developed countries do.
Further, you need to vaccinate the 3rd world or we will keep getting variants, some virulent, some not-so-much. Right now BA5 appears to have achieved immune escape. BOTH sides have botched this and have tuned their debates for political gain. As someone with pre-existing conditions, I understood in January with Dr. Walensky's horrific press conference, that the government I pay taxes to considers me to be completely disposable.
Here is that quote:
“The overwhelming number of deaths — over 75 percent — occurred in people who had at least four comorbidities, so really these are people who were unwell to begin with — and, yes, really encouraging news in the context of Omicron.”
I take a more cynical view, that a more effective vaccine with way fewer side effects (like death and permanent disability) would put a spotlight on the flaws of the vaccines they were MANDATING for people to return to work while CEO's were clamoring for the end of working from home.
And btw, in case you are wondering, I'm a life-long democrat with a Ph.D. in a related field.
I don’t always agree with you but on this one, bravo. It’s a national tragedy. My sense is the congress is saying, use all that money that the states haven’t spent. The states are saying, we are just about to spend it and the administration is just blowing in the wind.
Jun 26, 2022·edited Jun 26, 2022Liked by Noah Smith
Yes, please. Noah, could you do a follow-up, with some actual researchers' opinions on how much faster we could make them, and what specific support would enable their speedup?
"Give us more support, everywhere" is the core answer, but it's so generic it's hard to lobby with. Where's the concrete unmet ask? What's the credible payoff?
Specifics have power. "If my lab had an extra $10M and an FDA coordinator, we could aim for human trials a year sooner" is specific enough we can lobby with it - and get results.
I'd love if you did a follow-up like that, built on researchers' specifics of "support X could accelerate our project by Y months." I know half of these researchers seem to be on Twitter already, and I bet they'd give you the emails of the other half.
Of course, if the actual researchers are scared to give any specifics to you, even though they desperately want more support, that would be fascinating news for a very different reason.
(I notice Eric Topol has been vague rather than specific about the tradeoffs, in his own "do more" posts. I've assumed it's because he's not doing this work in his own lab and doesn't want to speak for others. But there _could_ be a more interesting reason.)
But if you could figure out more specific examples of what we're not doing, and what the researchers themselves reckon it costs us in delay, that would be a great tool to make this change happen.
> So the real problem here might be that our leadership, like some segments of the American populace, have simply decided that they’re “done with Covid”, even if the virus isn’t done with America. This is unacceptable.
I'm inclined to put it more strongly. The attitude seems to me to be more like "back into the Covid mines, proles!" — and I have some confidence in that interpretation since it fits America's global Covid policy as well as America's domestic Covid policy. See the approach to the TRIPS waiver proposed by India and South Africa, as summarized by Sarah Lazare: https://inthesetimes.com/article/failure-wto-trips-waiver-covid-vaccines-tests-treatments-pharmaceutical-industry.
I'm sorry to say that this post is really wrong in a lot of ways. I spent almost my entire working career in the biopharma industry working on regulatory affairs and drug safety. The Novavax development was stalled by manufacturing problems during clinical development which is well documented. It's now on the road forward as is the Sanofi/GSK Covid vaccine which is quite similar and has demonstrated effectiveness against the omicron strains (it is expected to be available later this year).. During the first year of the pandemic, I wrote a daily newsletter for industry friends that covered scientific developments in the vaccine area. There were a large number of potential vaccine approaches that had some early development and we don't know why many of them fell by the wayside. I think the Canada developed vaccine grown in tobacco plants is pretty far along (approved in Canada but the WHO doesn't like it because some of the funding came from Phillip Morris - more wokeness I guess).
Nasal vaccine delivery is not new at all. There was a nasal influenza vaccine FluMist that was sold in the US for a while but it was not as good as the traditional vaccine and is now off the market.
The bigger issue for me is that all of the preliminary work that was done on a Zika vaccine six or so years ago was tossed away once the disease went a way. They could have done some safety and immunogenicity trials on the various vaccines that would have helped standardize the manufacturing processes and made the development of a Covid vaccine easier (vaccines for the most part can be changed once the manufacturing process is licensed which is why we are able to have a new flu vaccine every year without having to do lengthy studies).
I could go on but it's hard to describe the nuances of vaccine development and regulation in a short space.
We've been searching for cancer drugs or vaccines for decades, with only incremental successes, its easy to blame Biden, in fact, "if it bleeds it leads" dominates media, I have no idea whether new vaccines are months or years away, and, your thoughts are speculative. Food for the anti-vaxxers and anti=governmental folks. ....
Even Moderna's improved booster formulation, which has been shown in trials to be 78% (IIRC) effective against Omicron, is being slow-rolled by the FDA. (To the point that they may ultimately not approve it at all, by requiring a different formulation.)
An inability to multitask has plagued the Biden administration since Day 1. It really harms what I found to be one of his chief electoral advantages: that he and his team had been in the White House before and could hit the ground running.
Not just vaccines. Across the board, with the possible exception of Ukraine, this admin has been frustrating. You can complain all day about the filibuster or Joe Manchin, but it seemed like Trump was trotting out a new executive order every week. Come on, get some balls
I think the “won’t someone think of the global unvaccinated” was itself a red herring. The real reason that boosters were delayed by the FDA is that the anti-vaxxers at the FDA didn’t like authorizing boosters on the back of the data that was offered. (In real life that data is and should be more than sufficient but you get the point.)
And you didn't even mention that they only approved vaccines for younger kids one week ago. They sat on the data: Moderna submitted almost 2 months ago, they cancelled the meeting Vaccines and Related Biological Products Advisory Committee scheduled for shortly afterwards and didn't request any further data. Just sat, doing nothing while it swept through preschools and lots of kids got sick. Sure, not many in that age group will die, but why have them get sick/have long-term effects for absolutely zero reason.
The administration needed to fire Dr. Marks long ago.
I'm in the Novavax trial and it's been astounding to me how much it's been slow walked. It's been well over a year since the vaccine was deemed effective enough that everyone in the trial was given the vaccine because it would have been considered unethical to withhold from those that got the placebo. If you would have told me then that it still wouldn't have FDA approval now and that my infant would have an approved vaccine first, I'd have thought you were insane. The supposed manufacturing concerns get more nonsensical as more and more countries are using it without any indication of problems. If it had been the first vaccine to report its data there is no doubt it in my mind, it would have been approved long ago.
There are quite a few people who can't take the mRNA vaccines. I am one of them. The reaction from the first jab was so severe that I knew I was risking serious damage with a second jab. The VAERS reports on fatality and damaging side effects are through the roof. I really don't CARE that the data isn't completely accurate. When you see the trajectory of the data and the similarity of symptoms, YOU PAY ATTENTION and tease out the problems so people don't die or suffer permanent health issues while trying to do the right thing.
I'm a virtual prisoner of this pandemic - stuck at home as a high-risk person. I've been waiting and waiting and waiting and waiting and waiting for Novavax and I am beyond furious that we don't have it yet when most developed countries do.
Further, you need to vaccinate the 3rd world or we will keep getting variants, some virulent, some not-so-much. Right now BA5 appears to have achieved immune escape. BOTH sides have botched this and have tuned their debates for political gain. As someone with pre-existing conditions, I understood in January with Dr. Walensky's horrific press conference, that the government I pay taxes to considers me to be completely disposable.
Here is that quote:
“The overwhelming number of deaths — over 75 percent — occurred in people who had at least four comorbidities, so really these are people who were unwell to begin with — and, yes, really encouraging news in the context of Omicron.”
I take a more cynical view, that a more effective vaccine with way fewer side effects (like death and permanent disability) would put a spotlight on the flaws of the vaccines they were MANDATING for people to return to work while CEO's were clamoring for the end of working from home.
And btw, in case you are wondering, I'm a life-long democrat with a Ph.D. in a related field.
Yep
I don’t always agree with you but on this one, bravo. It’s a national tragedy. My sense is the congress is saying, use all that money that the states haven’t spent. The states are saying, we are just about to spend it and the administration is just blowing in the wind.
Yes, please. Noah, could you do a follow-up, with some actual researchers' opinions on how much faster we could make them, and what specific support would enable their speedup?
"Give us more support, everywhere" is the core answer, but it's so generic it's hard to lobby with. Where's the concrete unmet ask? What's the credible payoff?
Specifics have power. "If my lab had an extra $10M and an FDA coordinator, we could aim for human trials a year sooner" is specific enough we can lobby with it - and get results.
I'd love if you did a follow-up like that, built on researchers' specifics of "support X could accelerate our project by Y months." I know half of these researchers seem to be on Twitter already, and I bet they'd give you the emails of the other half.
Of course, if the actual researchers are scared to give any specifics to you, even though they desperately want more support, that would be fascinating news for a very different reason.
(I notice Eric Topol has been vague rather than specific about the tradeoffs, in his own "do more" posts. I've assumed it's because he's not doing this work in his own lab and doesn't want to speak for others. But there _could_ be a more interesting reason.)
But if you could figure out more specific examples of what we're not doing, and what the researchers themselves reckon it costs us in delay, that would be a great tool to make this change happen.
> So the real problem here might be that our leadership, like some segments of the American populace, have simply decided that they’re “done with Covid”, even if the virus isn’t done with America. This is unacceptable.
I'm inclined to put it more strongly. The attitude seems to me to be more like "back into the Covid mines, proles!" — and I have some confidence in that interpretation since it fits America's global Covid policy as well as America's domestic Covid policy. See the approach to the TRIPS waiver proposed by India and South Africa, as summarized by Sarah Lazare: https://inthesetimes.com/article/failure-wto-trips-waiver-covid-vaccines-tests-treatments-pharmaceutical-industry.
By Joe Biden's own Trump-era standard, his administration's Covid response has been a failure (https://splained.substack.com/p/a-year-here-a-year-there).
I wish I disagreed.
What, you couldn’t use a pic of The Butt Fumble?
I'm sorry to say that this post is really wrong in a lot of ways. I spent almost my entire working career in the biopharma industry working on regulatory affairs and drug safety. The Novavax development was stalled by manufacturing problems during clinical development which is well documented. It's now on the road forward as is the Sanofi/GSK Covid vaccine which is quite similar and has demonstrated effectiveness against the omicron strains (it is expected to be available later this year).. During the first year of the pandemic, I wrote a daily newsletter for industry friends that covered scientific developments in the vaccine area. There were a large number of potential vaccine approaches that had some early development and we don't know why many of them fell by the wayside. I think the Canada developed vaccine grown in tobacco plants is pretty far along (approved in Canada but the WHO doesn't like it because some of the funding came from Phillip Morris - more wokeness I guess).
Nasal vaccine delivery is not new at all. There was a nasal influenza vaccine FluMist that was sold in the US for a while but it was not as good as the traditional vaccine and is now off the market.
The bigger issue for me is that all of the preliminary work that was done on a Zika vaccine six or so years ago was tossed away once the disease went a way. They could have done some safety and immunogenicity trials on the various vaccines that would have helped standardize the manufacturing processes and made the development of a Covid vaccine easier (vaccines for the most part can be changed once the manufacturing process is licensed which is why we are able to have a new flu vaccine every year without having to do lengthy studies).
I could go on but it's hard to describe the nuances of vaccine development and regulation in a short space.
We've been searching for cancer drugs or vaccines for decades, with only incremental successes, its easy to blame Biden, in fact, "if it bleeds it leads" dominates media, I have no idea whether new vaccines are months or years away, and, your thoughts are speculative. Food for the anti-vaxxers and anti=governmental folks. ....
Even Moderna's improved booster formulation, which has been shown in trials to be 78% (IIRC) effective against Omicron, is being slow-rolled by the FDA. (To the point that they may ultimately not approve it at all, by requiring a different formulation.)
An inability to multitask has plagued the Biden administration since Day 1. It really harms what I found to be one of his chief electoral advantages: that he and his team had been in the White House before and could hit the ground running.
Not just vaccines. Across the board, with the possible exception of Ukraine, this admin has been frustrating. You can complain all day about the filibuster or Joe Manchin, but it seemed like Trump was trotting out a new executive order every week. Come on, get some balls
I think the “won’t someone think of the global unvaccinated” was itself a red herring. The real reason that boosters were delayed by the FDA is that the anti-vaxxers at the FDA didn’t like authorizing boosters on the back of the data that was offered. (In real life that data is and should be more than sufficient but you get the point.)
you suggest that these vaccines are within our reach: isnt that a guess at best?
I rather think CEPI should get the credit for Operation Warp Speed, rather than Trump's administration.