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.
Do we know why the FDA is so broken? They slow-roll vaccines, massively overweight false positives relative to false negatives, are generally deeply bureaucratic -- and when they move quickly and of their own accord, it's to approve an Alzheimer's drug that doesn't work.
And yet somehow there's no political momentum to reform them. It's baffling. Makes you wonder whether the power they hold over drug companies keeps the companies from joining or funding a pro-reform coalition. After all, if the FDA doesn't like you, your drugs don't get approved and you're out of business.
"The European Medicines Agency (EMA) has authorised the use of the COVID-19 vaccine Comirnaty in children aged five years and older and Spikevax in children aged six years and older. Most EU/EEA countries are recommending vaccination of all children five years and older (28/30 countries, as of March 2022, with the other two countries recommending it only to children in risk groups)." — https://www.ecdc.europa.eu/en/covid-19/questions-answers/questions-and-answers-vaccines
Really I wonder if it's the other way around. The FDA has absolute power over pharma companies: if they don't like you, your drugs get rejected and you go out of business. Not a super safe business move to piss them off.
I wonder if this power inhibits pharma from joining or bankrolling coalitions to reform the FDA. I'm not that well-informed here, so maybe none of this makes sense, but I'd be curious to hear what those who know more think.
While some politics can play the role, most often FDA will not like the company if the data they submit are rubbish. Drugs get rejected because they are not effective or are barely effective over the existing ones.
If the drug for a common disease is effective, FDA will approve it. If the submitted data has some issues, the company will be asked to correct them, perform some additional studies etc. It can delay the registration and consequently reduce profits but it is not going to refuse the drug just because of some personal disagreement.
I can imagine that these delay can be crucial if the competitors manage to get approval for a similar drug. Then the first one to get approval is a winner. Has it really happened? I don't know but would be curious to hear such examples.
You people are ridiculous. The best way to stick it to big pharma would be to massively liberalize regulation and open up a startup ecosystem like exists in software. Instead clowns like you enable big pharma’s regulatory capture wherein bringing the most low-risk treatment to market costs $100m. Great job!
This is frustratingly common- people think that adding ever more regulations is the best way to hurt Big Pharma or whatever and not realizing that it’s the biggest companies that can handle complex regulatory schemes the best, and littler competitors get crushed by them.
Same story in housing- Big developers like Related and Tishman can handle absurd zoning laws or get easements just fine! It’s their smaller competition that gets screwed!
But how could a small company do large scale clinical trials that require thousands of patients and cost a lot?
I have some ideas but I doubt that those who suggest removing regulations have even thought about them. In fact, removing those regulations could easily work in the favour of big pharma, plus appearance of insufficiently tested drugs on market would not be in patients interests.
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.
They unblinded you so that they wouldn't see what happens a year later. They did the same thing with Pfizer and Moderna because they knew how the efficacy would drop negative months later...
They were omniscient enough to know that their vaccine would wear off in a year, and had the ability to go back in time to establish bioethics standards for unblinding in trials, but didn't use those powers to create a better vaccine faster. They would have gotten away with it too if it weren't you meddling kids...
A year? Even with clever accounting, six months, tops.
Also, you act like they knew nothing about mRNA products before now. They knew they had no durability, which is why they had to pretend like natural immunity durability was questionable.
Since there were more serious adverse events and deaths in the intervention arm of the trials, which bioethical standards would they be violating? There was a tiny difference in COVID-like infections. Seems they were more concerned with covering their ass and selling product than any bioethical standards.
At the risk of engaging an obvious troll, you do know that Novavax isn't a MRNA vaccine, right? There was over nine times as many COVID infections in the placebo arm. Of course there were more adverse effects in the treatment arm than the placebo arm. That's basically guaranteed since the treatment arm is actually receiving something for the body to react to. The biggest adverse effect was tenderness at the injection site, which is clearly worse than getting COVID. There weren't more deaths in the treatment group. So basically you nailed it and totally convinced me.
Are you referring to the fact that mRNA itself is broken down by the body in two weeks? That is irrelevant to the duration of immunity, which is unclear given that we’ve been getting new variants quicker than the vaccines can wane.
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.
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.
Those articles are good explainers for why intranasals / pan-sarbecovirus vaccines would be better. What those articles don't say is anything like "$10M and a coordinator could get us to trials a year earlier."
Predictions scare responsible professionals. But there's a huge policy difference between "$10 billion to accelerate a candidate just one month" and "$10 million to accelerate a candidate a full year."
That's four orders of magnitude difference in the dollar-time tradeoff. Yet I literally haven't seen a single expert be specific enough that I can cite them saying our tradeoffs are more like the second case than the first.
If our tradeoffs are more like the favorable end of that spectrum, it'd be great to have some reportage saying so!
Seems likely, yeah. But Topol and Iwasaki are so clear that _they_ see room for cost -effective acceleration, that I bet there's some degree of illustrative specifics available on what "low-hanging fruit" we're passing up right now, and how much speed that metaphorical fruit could get us.
The issue here is that everyone will try to advertise their product as potentially very impactful. The problem is that they don't really look at them critically and it is very hard to assess the real likelihood that the project will succeed.
And if the $10 million injection doesn't work, it may only cause $10 billion to be spend in vain. Just look at Alzheimer's research. It all has been in vain.
> 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.
It's difficult to respond to a vague comment. I do understand the thrust of your piece but there were some key issues that were not addressed. Vaccines are sterile products and manufacturing is carefully controlled Once a process has been validated it can be subsequently used if 'minor modifications' have been made. This is why the flu vaccine can be changed each year without having to do a full scale clinical development program. Similarly, my expectation is that new mRNA vaccine alterations (such as moving from alpha to omicron) can be made and approved in a much quicker time scale.
Do not underestimate the value of adjuvant-protein vaccines such as Novavax and Sanofi/GSK. Preparations such as these have already been proven to be extremely potent (GSK's shingles vaccine).
There were some multi-component Covid vaccines developed quite early on (one from the Walter Reed research group looked quite promising) but for some reason these have languished.
With respect to nasal vaccines, there has been a lot of effort put into nasal delivery of peptides and proteins (insulin, interferon,, several different types of vaccines). Clinically results have been all over the map.
My own bias is that we need a number of different vaccine platforms that can be quickly changed to accommodate new mutants as they arise. Protein based vaccines can be less complicated to manufacture than the mRNA ones.
I think that the article reflect naive opinion that it is only lack of financing that hampers faster development of nasal and other more effective vaccines. It ignores our previous experience that it is not that financing can always fix things. We have spent trillions on cancer research with very modest gains and a lot of money for Alzheimer's treatment with no gains.
Do you know anything about how and why Zika went away? I remember it was all over the news in 2016, and spreading quickly through the Americas. But then a few months later the media stopped mentioning it, and Wikipedia doesn’t clarify whether case counts dropped to zero or whether symptoms turned out not to be significant or what.
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.)
It's fine to be concerned about those who can't get vaccinated due to circumstances of their lives (E.g. Being in a country with poor access). But those willingly unvaxed can pound sand.
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.
Do we know why the FDA is so broken? They slow-roll vaccines, massively overweight false positives relative to false negatives, are generally deeply bureaucratic -- and when they move quickly and of their own accord, it's to approve an Alzheimer's drug that doesn't work.
And yet somehow there's no political momentum to reform them. It's baffling. Makes you wonder whether the power they hold over drug companies keeps the companies from joining or funding a pro-reform coalition. After all, if the FDA doesn't like you, your drugs don't get approved and you're out of business.
Bullshit.
"The European Medicines Agency (EMA) has authorised the use of the COVID-19 vaccine Comirnaty in children aged five years and older and Spikevax in children aged six years and older. Most EU/EEA countries are recommending vaccination of all children five years and older (28/30 countries, as of March 2022, with the other two countries recommending it only to children in risk groups)." — https://www.ecdc.europa.eu/en/covid-19/questions-answers/questions-and-answers-vaccines
>because big pharma owns our government and regulatory agencies
Yes, they own it so thoroughly that their preferences of having drug approval slow walked have been implemented.
Really I wonder if it's the other way around. The FDA has absolute power over pharma companies: if they don't like you, your drugs get rejected and you go out of business. Not a super safe business move to piss them off.
I wonder if this power inhibits pharma from joining or bankrolling coalitions to reform the FDA. I'm not that well-informed here, so maybe none of this makes sense, but I'd be curious to hear what those who know more think.
While some politics can play the role, most often FDA will not like the company if the data they submit are rubbish. Drugs get rejected because they are not effective or are barely effective over the existing ones.
If the drug for a common disease is effective, FDA will approve it. If the submitted data has some issues, the company will be asked to correct them, perform some additional studies etc. It can delay the registration and consequently reduce profits but it is not going to refuse the drug just because of some personal disagreement.
I can imagine that these delay can be crucial if the competitors manage to get approval for a similar drug. Then the first one to get approval is a winner. Has it really happened? I don't know but would be curious to hear such examples.
You people are ridiculous. The best way to stick it to big pharma would be to massively liberalize regulation and open up a startup ecosystem like exists in software. Instead clowns like you enable big pharma’s regulatory capture wherein bringing the most low-risk treatment to market costs $100m. Great job!
This is frustratingly common- people think that adding ever more regulations is the best way to hurt Big Pharma or whatever and not realizing that it’s the biggest companies that can handle complex regulatory schemes the best, and littler competitors get crushed by them.
Same story in housing- Big developers like Related and Tishman can handle absurd zoning laws or get easements just fine! It’s their smaller competition that gets screwed!
But how could a small company do large scale clinical trials that require thousands of patients and cost a lot?
I have some ideas but I doubt that those who suggest removing regulations have even thought about them. In fact, removing those regulations could easily work in the favour of big pharma, plus appearance of insufficiently tested drugs on market would not be in patients interests.
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.
They unblinded you so that they wouldn't see what happens a year later. They did the same thing with Pfizer and Moderna because they knew how the efficacy would drop negative months later...
They were omniscient enough to know that their vaccine would wear off in a year, and had the ability to go back in time to establish bioethics standards for unblinding in trials, but didn't use those powers to create a better vaccine faster. They would have gotten away with it too if it weren't you meddling kids...
A year? Even with clever accounting, six months, tops.
Also, you act like they knew nothing about mRNA products before now. They knew they had no durability, which is why they had to pretend like natural immunity durability was questionable.
Since there were more serious adverse events and deaths in the intervention arm of the trials, which bioethical standards would they be violating? There was a tiny difference in COVID-like infections. Seems they were more concerned with covering their ass and selling product than any bioethical standards.
At the risk of engaging an obvious troll, you do know that Novavax isn't a MRNA vaccine, right? There was over nine times as many COVID infections in the placebo arm. Of course there were more adverse effects in the treatment arm than the placebo arm. That's basically guaranteed since the treatment arm is actually receiving something for the body to react to. The biggest adverse effect was tenderness at the injection site, which is clearly worse than getting COVID. There weren't more deaths in the treatment group. So basically you nailed it and totally convinced me.
Are you referring to the fact that mRNA itself is broken down by the body in two weeks? That is irrelevant to the duration of immunity, which is unclear given that we’ve been getting new variants quicker than the vaccines can wane.
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 thought the Janssen (J&J) shot was not mRNA either ?
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.
Yes, but the links I sent from Iwasaki and Topol -- the two researchers I trust most -- have a lot of good info.
Those articles are good explainers for why intranasals / pan-sarbecovirus vaccines would be better. What those articles don't say is anything like "$10M and a coordinator could get us to trials a year earlier."
Predictions scare responsible professionals. But there's a huge policy difference between "$10 billion to accelerate a candidate just one month" and "$10 million to accelerate a candidate a full year."
That's four orders of magnitude difference in the dollar-time tradeoff. Yet I literally haven't seen a single expert be specific enough that I can cite them saying our tradeoffs are more like the second case than the first.
If our tradeoffs are more like the favorable end of that spectrum, it'd be great to have some reportage saying so!
Sure, that would be interesting. I think most of the actual time comes from the FDA phase 3 trials, though.
Seems likely, yeah. But Topol and Iwasaki are so clear that _they_ see room for cost -effective acceleration, that I bet there's some degree of illustrative specifics available on what "low-hanging fruit" we're passing up right now, and how much speed that metaphorical fruit could get us.
The issue here is that everyone will try to advertise their product as potentially very impactful. The problem is that they don't really look at them critically and it is very hard to assess the real likelihood that the project will succeed.
And if the $10 million injection doesn't work, it may only cause $10 billion to be spend in vain. Just look at Alzheimer's research. It all has been in vain.
> 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?
Copyrighted!
Sanchez did you dirty there.
Noah must be a Jets fan! ;-)
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.
I respect that opinion, but the top experts that I trust do disagree with you on this.
It's difficult to respond to a vague comment. I do understand the thrust of your piece but there were some key issues that were not addressed. Vaccines are sterile products and manufacturing is carefully controlled Once a process has been validated it can be subsequently used if 'minor modifications' have been made. This is why the flu vaccine can be changed each year without having to do a full scale clinical development program. Similarly, my expectation is that new mRNA vaccine alterations (such as moving from alpha to omicron) can be made and approved in a much quicker time scale.
Do not underestimate the value of adjuvant-protein vaccines such as Novavax and Sanofi/GSK. Preparations such as these have already been proven to be extremely potent (GSK's shingles vaccine).
There were some multi-component Covid vaccines developed quite early on (one from the Walter Reed research group looked quite promising) but for some reason these have languished.
With respect to nasal vaccines, there has been a lot of effort put into nasal delivery of peptides and proteins (insulin, interferon,, several different types of vaccines). Clinically results have been all over the map.
My own bias is that we need a number of different vaccine platforms that can be quickly changed to accommodate new mutants as they arise. Protein based vaccines can be less complicated to manufacture than the mRNA ones.
Thanks for your input.
I think that the article reflect naive opinion that it is only lack of financing that hampers faster development of nasal and other more effective vaccines. It ignores our previous experience that it is not that financing can always fix things. We have spent trillions on cancer research with very modest gains and a lot of money for Alzheimer's treatment with no gains.
Do you know anything about how and why Zika went away? I remember it was all over the news in 2016, and spreading quickly through the Americas. But then a few months later the media stopped mentioning it, and Wikipedia doesn’t clarify whether case counts dropped to zero or whether symptoms turned out not to be significant or what.
I don't know the answer. There is some discussion of this in a Mayo Clinic review of Zika Vaccine development. I don't know if Substack allows one to embed URL links so I will just provide you with the link itself: https://www.mayoclinicproceedings.org/article/S0025-6196(19)30483-5/fulltext#sec4
This is an interesting article as you can see there were mRNA and DNA vaccines being developed prior to the Covid pandemic outbreak.
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.)
It's fine to be concerned about those who can't get vaccinated due to circumstances of their lives (E.g. Being in a country with poor access). But those willingly unvaxed can pound sand.
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.