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66% protection against getting moderate to severe Covid but 100% protection against death and hospitalization. I have no idea how the FDA can hold back these v

66% protection against getting moderate to severe Covid but 100% protection against death and hospitalization. I have no idea how the FDA can hold back these vaccines in good conscience while peoples are dying by the thousands on a daily basis.

gogopuppygogo 6y ago
Unpopular opinion: the FDA has to justify their existence. If vaccines can be developed safely and deployed quickly, inexpensively, and in large quantities all without FDA then people would realize how bloated our government really is.
- Traster 6y ago
  We saw this with Boeing - as the private company realised that the regulatory body wasn't going to hold it accountable, the private company started trading off profit versus safety with the result being lower short term costs and more dangerous planes.
- happytoexplain 6y ago
  >If vaccines can be developed safely ... without FDA You forgot a critical distinction: safely every time
  - Jtsummers 6y ago
    Doesn't need to be every time, it "just" needs to meet or beat the current FDA record. The FDA has approved treatments in the past that turned out to be harmful for substantial numbers of people. If the industry could reliably replicate the FDA's present track record (which is, overall, very good) then the FDA could be shown to be unnecessary. However, having worked in regulated industries I do not trust industry to do any better than the FDA. At least not in the long term.
- joncrane 6y ago
  I think this is a bit of a disingenuous approach. There's a slippery slope here. Just because "humanity, including giant healthcare conglomerates who stood to profit came together to fast track vaccines against a deadly global pandemic" it doesn't mean "regulation of the vaccine and drug industry is pointless." If the FDA were to relax its standards across the board due to this one success in the face of an anomaly, you'd better believe drug manufacturers would be fast tracking dangerous drugs. Heck even in the current regulatory environment dangerous products make it through. As evidenced by all the ads I see for litigation based on harm caused by various already-approved (in a non-fast track manner) drugs that have made it to the market in the last decade.
- FuckButtons 6y ago
  The reason this is unpopular is because of how obviously incorrect it is. The history of medicine is almost an allegory for why evolved evidence based systems like this to regulate what companies and doctors can do. Time and again, doctors and pharmaceutical companies have done unsafe, harmful and fraudulent things to patients who trusted them. The only reason we have medicine that works now is because we rigorously enforce the use of statistical proof that interventions work through bodies like the FDA.
  - cogman10 6y ago
    Yup. There's a lot of distrust in doctors and the medical community and some of that has been earned by past lapses in ethics or rigor. The only way to earn it back is by heightened scrutiny. That's the role the FDA finds itself in. It doesn't just approve things because approving something that later causes issues will ultimately result lost confidence. Getting people to take these vaccines will be a challenge in and of itself. Can you imagine how much harder it will be if we give antivaxxers more "they rushed this" ammunition?
  - abfan1127 6y ago
    I spent time at a large medical device company. I'm lightly familiar with the FDA submission process. I would not refer to it as rigorous. We were encouraged to keep the information light or the FDA would be easily confused and reject. Rejection had more to do with giving the FDA simple warm fuzzies rather than rigorous data analysis. The FDA process is more an exercise in paperwork, not in rigorous drug/device performance. As you say, doctors and pharma have done unsafe, harmful, and fraudulent things to patients. How much was the FDA complacent in this? All of these drugs were approved by the FDA's "process". https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls https://www.fda.gov/drugs/drug-safety-and-availability/drug-...
    - sterlind 6y ago
      Drugs are much more rigorously evaluated than medical devices. It's just a quirk of the FDA that medical devices aren't nearly as well regulated or tested.
- tootie 6y ago
  Safe, effective vaccines are being developed because they know if they don't they won't get past the FDA.
- raverbashing 6y ago
  The 737 Max would like a word
- malux85 6y ago
  There's always going to be work for the FDA, there's an unending stream of new diseases/conditions and cures. I very much doubt they are worried about running out of work
- klodolph 6y ago
  The FDA more than justified its existence when it prevented the entry of thalidomide into the US market without more evidence of its safety. https://en.wikipedia.org/wiki/Thalidomide https://en.wikipedia.org/wiki/Thalidomide
  - JamesBarney 6y ago
    How many people have died from drugs getting approved later or not being able to afford drugs due to the high price of drug testing? Or from drugs not being researched or approved because it's too expensive to do an fda trial?
- pfarnsworth 6y ago
  This is unfortunately an ignorant statement. During the Swine Flu epidemic, British health care workers were given an untested vaccine. It left many of them with lingering health problems like narcolepsy. This is what happens when things are unsafely and quickly distributed.
wtvanhest 6y ago
Personally, I’d rather take the J&J which uses old, proven tech. In 5 years we will know a lot more about nRNA vaccine long-term safety, and I’ll be much more comfortable taking an nRNA vaccine at that point. When I’m eligible, I still may take the nRNA, but my preference is on older tech at this point. I fully acknowledge that the nRNA is extremely likely to be safe, but it’s just my preference
- geuis 6y ago
  mRNA, not n. It’s short for messenger RNA.
- bawolff 6y ago
  Adenovirus vaccines are also a newish tech (not that anything wrong with that, that's why we have safety testing). Its not as bleeding edge as mRNA but its definitely not a traditional vaccine
  - zeku 6y ago
    Don't tell him that. He's willing to get any vaccine at all and the world desperately needs to be vaxxed. If people want to take adenovirus vaxs because they feel its safer I say just let them.
    - manwe150 6y ago
      I think what continues to surprise me (after talking about these for months now) is his underlying assumption that the third choice is a likely option. While the continued rate of spread seems to suggest to me that really we have a near binary option: 1. get injected with some vaccine soon, expose your body to a controlled amount of slightly noxious chemicals and hope your body learns how to eliminate them before they degrade on their own 2. contract COVID-19 soon, expose your body to those same noxious chemicals, plus a bunch of others that help it spread throughout your body and cause damage and linger, possibly for weeks or sometimes until you die (excluding extreme options, like living alone for the next 5 years far from other humans, or dying of a mundane cause sooner)
    - 6y ago
_Understated_ 6y ago
Sorry, but I take issue with that statement: 100% protection against death and hospitalization for a tiny minority that are susceptible. Your statement makes it sound like everyone that gets it will die when that is absolutely not true. In fact, the statistics show the exact opposite: here in the UK, for example, only around 400 people under the age of 70 (I think!) that have no underlying symptoms, have actually died from COVID. Edit: Oh here we go again... drive-by downvotes. Care to state your reasons?
- Grimm1 6y ago
  "Chest X-rays of asymptomatic patients – those infected but without symptoms – exhibited a severe chest X-ray 70%-80% of the time, but those with COVID-19 symptoms had one every time, she also added." https://www.usatoday.com/story/news/factcheck/2021/01/26/fact-check-covid-19-can-cause-worse-lung-damage-than-smoking/4237874001/ https://www.usatoday.com/story/news/factcheck/2021/01/26/fac... There are things that can make living quite uncomfortable. So while yes not everyone will be hospitalized and die, there is still a lot of reasons to get any decently effective vaccine. Edit: "Bankhead-Kendall, who has treated thousands of patients since the pandemic began last March, says patients who had COVID-19 symptoms show a severe chest X-ray every time, and those who were asymptomatic show a severe chest X-ray 80 percent of the time."
  - _Understated_ 6y ago
    > exhibited a severe chest X-ray 70%-80% of the time With a sample size of what? That's a nonsense statement that can't be scrutinised. Edit, found this: The finding is promising but will require further research given the small size of the study with only 82 patients, mostly male and average age over 50 82 people over the age of 50. It also doesn't mention how healthy these people were. This is typical of pretty much all media coverage: very little facts but also very little to throw back at them...
    - jfengel 6y ago
      The "70-80%" figure is based on thousands of the doctor's own patients. https://observer.com/2021/01/covid-long-term-health-impacts-lungs/ https://observer.com/2021/01/covid-long-term-health-impacts-... It's not a peer reviewed study, and it includes only the people whose situations were severe enough to be sent to a radiologist. But it's enough to conclude that it's more than just a dismissably small number of cases.
Moto7451 6y ago
Why do you believe that the FDA is holding them back? So far the process appears to be approval after the minimum of safety and effectiveness testing. This means that people won’t waste time or be harmed by a failed vaccine candidate. I don’t work in medicine and am just a bystander like most. Is there something I am missing?
- alexhutcheson 6y ago
  The AstraZeneca vaccine has been approved for use in the UK since December, but the FDA isn't currently scheduled to approve it in the US until April.
  - bluGill 6y ago
    The FDA isn't scheduled for anything. They told AZ long ago that their trail wouldn't meet FDA standards, and so AZ started a new trail that would. Everyone assumes the approval will happen in April, but that is just an educated guess.
    - alexhutcheson 6y ago
      That’s just semantics around the word “scheduled”. The FDA insisted on a course of action that makes it unlikely the AZ vaccine will receive an EUA before April. They did this despite the fact that pretty much no one with vaccine expertise doubts that it will meet the safety standards or the (relatively low) efficacy standards required to grant that EUA. No one disputes that AZ screwed up their trial, but it doesn’t make sense to prevent people from accessing a safe and reasonably effective vaccine just to make a point about that. That’s why the UK and EU have approved it and are moving forward with distribution, while the US waits months for absolutely perfect data before doing anything.
- JamesBarney 6y ago
  Because they care 6 orders of magnitude more about people who die from taking the vaccine than people who die from them witholding the vaccine.
5440 6y ago
I can give you a laundry list right now. For example, millions of vials are cracking around the rim, several of the filling rooms have mold issues, one of the vial hoppers is leaving metal particulates in the vials, weekly OOS for manufacturing impurities..I think the public would freak out if they knew what was happening in the supply chain.
- c0nsumer 6y ago
  Would you please provide citations for this? These are pretty extraordinary claims.
- gojomo 6y ago
  For which vaxes? How do you know this?
- arrayjumper 6y ago
  citation needed
- jdhn 6y ago
  If this is in any way true, you need to contact a journalist ASAP. Alex Berenson would love to hear from you. If this isn't true, then you should delete this immediately.
  - zug_zug 6y ago
    >> If this is in any way true, you need to contact a journalist ASAP. ??? It sounds like he's saying the supply chain is working out normal issues, and the FDA is rightly holding it back until they are resolved. I don't see anything newsworthy about that. Certainly could be misquoted/smudged for some great clickbait though.
    - jdhn 6y ago
      The way I'm interpreting the statement is that these issues are happening today during the production of Covid vaccines that have already been approved and are being sent out.
throwaway998866 6y ago
> I have no idea how the FDA can hold back these vaccines in good conscience… The UK versus FDA Thalidomide experience is at least one good reason.
- ggm 6y ago
  That's fifty years ago. If you think a fifty years ago story is why the FDA is delaying, I differ. They're delaying because of IPR chauvinism, and massive amounts of NIH and I'm not talking about nih.gov The FDA approved phen-fen, vioxx, des, the opiod disaster.. the hold up on AZ is not because they have magic time machine insight into why AZ should be delayed.
square_square 6y ago
The Novavax vaccine is way better than this one
- alexhutcheson 6y ago
  We're limited by supply, so the existence of (limited quantities of) better vaccines isn't a good reason to block people from choosing to get a safe vaccine that still provides a reasonable degree of protection. There are plenty of people in the lower-risk categories who would prefer to get a >60% effective vaccine now, rather than wait months for their turn in line for vaccines with the highest efficacy.
- eloff 6y ago
  I agree, but the old cliche "beggars can't be choosers" comes to mind. I'll take the first vaccine that becomes available to me, and I highly doubt they'd give me a choice at the clinic anyway.
beezle 6y ago
Not hospitalized does not mean no damage, short or long term. That is not to say this vaccine is a bust, but I for one was disappointed in the efficacy. The Novavax vaccine appears to be better and is also able to use existing supply chain technology.
gscott 6y ago
The yearly flue vaccines are also about 60%
- Scoundreller 6y ago
  Difference is that flu vaccines are mass-produced in advance of flu season based on a prediction of what the flu season will be. Here, we're targeting the actively-circulating virus. The match should be better, but getting enough into arms is the obvious problem.

gogopuppygogo 6y ago

Unpopular opinion: the FDA has to justify their existence. If vaccines can be developed safely and deployed quickly, inexpensively, and in large quantities all without FDA then people would realize how bloated our government really is.

Traster 6y ago
We saw this with Boeing - as the private company realised that the regulatory body wasn't going to hold it accountable, the private company started trading off profit versus safety with the result being lower short term costs and more dangerous planes.
happytoexplain 6y ago
>If vaccines can be developed safely ... without FDA You forgot a critical distinction: safely every time
- Jtsummers 6y ago
  Doesn't need to be every time, it "just" needs to meet or beat the current FDA record. The FDA has approved treatments in the past that turned out to be harmful for substantial numbers of people. If the industry could reliably replicate the FDA's present track record (which is, overall, very good) then the FDA could be shown to be unnecessary. However, having worked in regulated industries I do not trust industry to do any better than the FDA. At least not in the long term.
joncrane 6y ago
I think this is a bit of a disingenuous approach. There's a slippery slope here. Just because "humanity, including giant healthcare conglomerates who stood to profit came together to fast track vaccines against a deadly global pandemic" it doesn't mean "regulation of the vaccine and drug industry is pointless." If the FDA were to relax its standards across the board due to this one success in the face of an anomaly, you'd better believe drug manufacturers would be fast tracking dangerous drugs. Heck even in the current regulatory environment dangerous products make it through. As evidenced by all the ads I see for litigation based on harm caused by various already-approved (in a non-fast track manner) drugs that have made it to the market in the last decade.
FuckButtons 6y ago
The reason this is unpopular is because of how obviously incorrect it is. The history of medicine is almost an allegory for why evolved evidence based systems like this to regulate what companies and doctors can do. Time and again, doctors and pharmaceutical companies have done unsafe, harmful and fraudulent things to patients who trusted them. The only reason we have medicine that works now is because we rigorously enforce the use of statistical proof that interventions work through bodies like the FDA.
- cogman10 6y ago
  Yup. There's a lot of distrust in doctors and the medical community and some of that has been earned by past lapses in ethics or rigor. The only way to earn it back is by heightened scrutiny. That's the role the FDA finds itself in. It doesn't just approve things because approving something that later causes issues will ultimately result lost confidence. Getting people to take these vaccines will be a challenge in and of itself. Can you imagine how much harder it will be if we give antivaxxers more "they rushed this" ammunition?
- abfan1127 6y ago
  I spent time at a large medical device company. I'm lightly familiar with the FDA submission process. I would not refer to it as rigorous. We were encouraged to keep the information light or the FDA would be easily confused and reject. Rejection had more to do with giving the FDA simple warm fuzzies rather than rigorous data analysis. The FDA process is more an exercise in paperwork, not in rigorous drug/device performance. As you say, doctors and pharma have done unsafe, harmful, and fraudulent things to patients. How much was the FDA complacent in this? All of these drugs were approved by the FDA's "process". https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls https://www.fda.gov/drugs/drug-safety-and-availability/drug-...
  - sterlind 6y ago
    Drugs are much more rigorously evaluated than medical devices. It's just a quirk of the FDA that medical devices aren't nearly as well regulated or tested.
tootie 6y ago
Safe, effective vaccines are being developed because they know if they don't they won't get past the FDA.
raverbashing 6y ago
The 737 Max would like a word
malux85 6y ago
There's always going to be work for the FDA, there's an unending stream of new diseases/conditions and cures. I very much doubt they are worried about running out of work
klodolph 6y ago
The FDA more than justified its existence when it prevented the entry of thalidomide into the US market without more evidence of its safety. https://en.wikipedia.org/wiki/Thalidomide https://en.wikipedia.org/wiki/Thalidomide
- JamesBarney 6y ago
  How many people have died from drugs getting approved later or not being able to afford drugs due to the high price of drug testing? Or from drugs not being researched or approved because it's too expensive to do an fda trial?
pfarnsworth 6y ago
This is unfortunately an ignorant statement. During the Swine Flu epidemic, British health care workers were given an untested vaccine. It left many of them with lingering health problems like narcolepsy. This is what happens when things are unsafely and quickly distributed.

wtvanhest 6y ago

Personally, I’d rather take the J&J which uses old, proven tech. In 5 years we will know a lot more about nRNA vaccine long-term safety, and I’ll be much more comfortable taking an nRNA vaccine at that point. When I’m eligible, I still may take the nRNA, but my preference is on older tech at this point. I fully acknowledge that the nRNA is extremely likely to be safe, but it’s just my preference

geuis 6y ago
mRNA, not n. It’s short for messenger RNA.
bawolff 6y ago
Adenovirus vaccines are also a newish tech (not that anything wrong with that, that's why we have safety testing). Its not as bleeding edge as mRNA but its definitely not a traditional vaccine
- zeku 6y ago
  Don't tell him that. He's willing to get any vaccine at all and the world desperately needs to be vaxxed. If people want to take adenovirus vaxs because they feel its safer I say just let them.
  - manwe150 6y ago
    I think what continues to surprise me (after talking about these for months now) is his underlying assumption that the third choice is a likely option. While the continued rate of spread seems to suggest to me that really we have a near binary option: 1. get injected with some vaccine soon, expose your body to a controlled amount of slightly noxious chemicals and hope your body learns how to eliminate them before they degrade on their own 2. contract COVID-19 soon, expose your body to those same noxious chemicals, plus a bunch of others that help it spread throughout your body and cause damage and linger, possibly for weeks or sometimes until you die (excluding extreme options, like living alone for the next 5 years far from other humans, or dying of a mundane cause sooner)
  - 6y ago

_Understated_ 6y ago

Sorry, but I take issue with that statement: 100% protection against death and hospitalization for a tiny minority that are susceptible. Your statement makes it sound like everyone that gets it will die when that is absolutely not true. In fact, the statistics show the exact opposite: here in the UK, for example, only around 400 people under the age of 70 (I think!) that have no underlying symptoms, have actually died from COVID. Edit: Oh here we go again... drive-by downvotes. Care to state your reasons?

Grimm1 6y ago
"Chest X-rays of asymptomatic patients – those infected but without symptoms – exhibited a severe chest X-ray 70%-80% of the time, but those with COVID-19 symptoms had one every time, she also added." https://www.usatoday.com/story/news/factcheck/2021/01/26/fact-check-covid-19-can-cause-worse-lung-damage-than-smoking/4237874001/ https://www.usatoday.com/story/news/factcheck/2021/01/26/fac... There are things that can make living quite uncomfortable. So while yes not everyone will be hospitalized and die, there is still a lot of reasons to get any decently effective vaccine. Edit: "Bankhead-Kendall, who has treated thousands of patients since the pandemic began last March, says patients who had COVID-19 symptoms show a severe chest X-ray every time, and those who were asymptomatic show a severe chest X-ray 80 percent of the time."
- _Understated_ 6y ago
  > exhibited a severe chest X-ray 70%-80% of the time With a sample size of what? That's a nonsense statement that can't be scrutinised. Edit, found this: The finding is promising but will require further research given the small size of the study with only 82 patients, mostly male and average age over 50 82 people over the age of 50. It also doesn't mention how healthy these people were. This is typical of pretty much all media coverage: very little facts but also very little to throw back at them...
  - jfengel 6y ago
    The "70-80%" figure is based on thousands of the doctor's own patients. https://observer.com/2021/01/covid-long-term-health-impacts-lungs/ https://observer.com/2021/01/covid-long-term-health-impacts-... It's not a peer reviewed study, and it includes only the people whose situations were severe enough to be sent to a radiologist. But it's enough to conclude that it's more than just a dismissably small number of cases.

Moto7451 6y ago

Why do you believe that the FDA is holding them back? So far the process appears to be approval after the minimum of safety and effectiveness testing. This means that people won’t waste time or be harmed by a failed vaccine candidate. I don’t work in medicine and am just a bystander like most. Is there something I am missing?

alexhutcheson 6y ago
The AstraZeneca vaccine has been approved for use in the UK since December, but the FDA isn't currently scheduled to approve it in the US until April.
- bluGill 6y ago
  The FDA isn't scheduled for anything. They told AZ long ago that their trail wouldn't meet FDA standards, and so AZ started a new trail that would. Everyone assumes the approval will happen in April, but that is just an educated guess.
  - alexhutcheson 6y ago
    That’s just semantics around the word “scheduled”. The FDA insisted on a course of action that makes it unlikely the AZ vaccine will receive an EUA before April. They did this despite the fact that pretty much no one with vaccine expertise doubts that it will meet the safety standards or the (relatively low) efficacy standards required to grant that EUA. No one disputes that AZ screwed up their trial, but it doesn’t make sense to prevent people from accessing a safe and reasonably effective vaccine just to make a point about that. That’s why the UK and EU have approved it and are moving forward with distribution, while the US waits months for absolutely perfect data before doing anything.
JamesBarney 6y ago
Because they care 6 orders of magnitude more about people who die from taking the vaccine than people who die from them witholding the vaccine.

5440 6y ago

I can give you a laundry list right now. For example, millions of vials are cracking around the rim, several of the filling rooms have mold issues, one of the vial hoppers is leaving metal particulates in the vials, weekly OOS for manufacturing impurities..I think the public would freak out if they knew what was happening in the supply chain.

c0nsumer 6y ago
Would you please provide citations for this? These are pretty extraordinary claims.
gojomo 6y ago
For which vaxes? How do you know this?
arrayjumper 6y ago
citation needed
jdhn 6y ago
If this is in any way true, you need to contact a journalist ASAP. Alex Berenson would love to hear from you. If this isn't true, then you should delete this immediately.
- zug_zug 6y ago
  >> If this is in any way true, you need to contact a journalist ASAP. ??? It sounds like he's saying the supply chain is working out normal issues, and the FDA is rightly holding it back until they are resolved. I don't see anything newsworthy about that. Certainly could be misquoted/smudged for some great clickbait though.
  - jdhn 6y ago
    The way I'm interpreting the statement is that these issues are happening today during the production of Covid vaccines that have already been approved and are being sent out.

throwaway998866 6y ago

> I have no idea how the FDA can hold back these vaccines in good conscience… The UK versus FDA Thalidomide experience is at least one good reason.

ggm 6y ago
That's fifty years ago. If you think a fifty years ago story is why the FDA is delaying, I differ. They're delaying because of IPR chauvinism, and massive amounts of NIH and I'm not talking about nih.gov The FDA approved phen-fen, vioxx, des, the opiod disaster.. the hold up on AZ is not because they have magic time machine insight into why AZ should be delayed.

square_square 6y ago

The Novavax vaccine is way better than this one

alexhutcheson 6y ago
We're limited by supply, so the existence of (limited quantities of) better vaccines isn't a good reason to block people from choosing to get a safe vaccine that still provides a reasonable degree of protection. There are plenty of people in the lower-risk categories who would prefer to get a >60% effective vaccine now, rather than wait months for their turn in line for vaccines with the highest efficacy.
eloff 6y ago
I agree, but the old cliche "beggars can't be choosers" comes to mind. I'll take the first vaccine that becomes available to me, and I highly doubt they'd give me a choice at the clinic anyway.

beezle 6y ago

Not hospitalized does not mean no damage, short or long term. That is not to say this vaccine is a bust, but I for one was disappointed in the efficacy. The Novavax vaccine appears to be better and is also able to use existing supply chain technology.

gscott 6y ago

The yearly flue vaccines are also about 60%

Scoundreller 6y ago
Difference is that flu vaccines are mass-produced in advance of flu season based on a prediction of what the flu season will be. Here, we're targeting the actively-circulating virus. The match should be better, but getting enough into arms is the obvious problem.