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Yeah, the fact that this doesn't even need a freezer is great news. The fact that we have three highly effective vaccines in such a short period is amazing and

Yeah, the fact that this doesn't even need a freezer is great news. The fact that we have three highly effective vaccines in such a short period is amazing and between them we might stand a chance of making and distributing them at the scale necessary to get things under some kind of control by August.

beagle3 6y ago
The safety concerns cannot be resolved yet. Effective - yes. Safe? We won’t know for a while. Pandemrix, a flu vaccine, caused a notable uptick in narcolepsy in Sweden, Finland and likely the UK. This was not (and could not) be seen in smaller trial populations. It is not a given that any of the covid vaccines is safe enough. Historically, two cases of rushed vaccines (cutter polio and Gullah barre) were worse than the disease - and these were for diseases worse than covid. Those were 50-60 years ago. Pandemrix was 10-20. I’m not sure we’re that much better on safety now to rush vaccines.
- acqq 6y ago
  2011: https://www.who.int/vaccine_safety/committee/topics/influenza/pandemic/h1n1_safety_assessing/narcolepsy_statement/en/ https://www.who.int/vaccine_safety/committee/topics/influenz... “Even at this stage, it does not appear that narcolepsy following vaccination against pandemic influenza is a general worldwide phenomenon, as no excess of narcolepsy has been reported from several other European states where Pandemrix was used, or from Canada where a pandemic vaccine similar to pandemrix was used. This complicates interpretation of the findings in Finland and Sweden. It seems likely that some as yet unidentified additional factor was operating in Sweden and Finland. The findings from the VAESCO project and further investigations in Finland and Sweden, may help clarify the determinants of any increased risk of narcolepsy, which currently appears to be restricted to the months following vaccination and by age group and country.” What’s certainly true that for some effects to be observable, millions have to be vaccinated first. 2013: https://www.reuters.com/article/us-narcolepsy-vaccine-pandemrix-idUSBRE90L07H20130122 https://www.reuters.com/article/us-narcolepsy-vaccine-pandem... “In total, the GSK shot was given to more than 30 million people in 47 countries during the 2009-2010 H1N1 swine flu pandemic.” “Independent teams of scientists have published peer-reviewed studies from Sweden, Finland and Ireland showing the risk of developing narcolepsy after the 2009-2010 immunization campaign was between seven and 13 times higher for children who had Pandemrix than for their unvaccinated peers.” “Europe’s drugs regulator has ruled Pandemrix should no longer be used in people aged under 20.”
- tialaramex 6y ago
  If the association between Pandemrix and narcolepsy is because it caused narcolepsy (as with Guillain-Barré it's also plausible the problem is that this is an auto-immune problem and so the vaccine wasn't actually the problem it just highlighted a problem you already had) then the incidence rate was estimated at like 18k patients per case. So if you give the entire US population a vaccine like that, less than twenty thousand of them develop narcolepsy. As a reminder a quarter million of them already died from COVID-19 and more are dying every day - not to mention the tens of thousands whose cause of death isn't listed as COVID-19 but would not be dead if not for an ongoing pandemic. Cutter screwed up. No amount of prior safety testing can fix that. Their Polio vaccine had Polio virus in it (to be clear: The traditional Oral Polio Vaccine is supposed to have a "live" virus in it, but the injected vaccine Cutter were selling is not). Obviously nobody is going to test "What happens if we inject children with the Polio virus" because the answer is "Some of them get Polio. Duh" and so no test could have prevented Cutter from screwing up. I have no idea what you meant by "Gullah barre" the Google results I get are all about Guillain-Barré syndrome, which I mentioned above. Guillain-Barré is not a vaccine, it's a weird auto-immune disorder, and arguably even where it's listed as very rare side effect of a vaccine, that's misleading because it's also a side effect from getting viral infection, so if you avoid vaccination but do get the virus you may get GBS as a result anyway. The human immune system is pretty inscrutable.
  - abacadaba 6y ago
    how about compared to the covid risk of a perfectly healthy young adult?
    - toyg 6y ago
      covid risk varies wildly depending on socioeconomic factors. Educated, WFH, small family, stable or low IRL social interaction: pretty low risk. Low-education, multiple in-person jobs, lots of casual social interaction, large family: very high risk. We've seen it very starkly in England. When entire communities are being ravaged by exponentially-growing transmission, it's hard to argue that a vaccine might be worse, because the chances are really minimal.
- i_cannot_hack 6y ago
  > Historically, two cases of rushed vaccines (cutter polio and Gullah barre) were worse than the disease - and these were for diseases worse than covid. This is just patently untrue. The Cutter Incidence gave patients Polio due to an improperly activated virus. While this is bad, it could not be worse than the disease itself - since it is the disease itself, no worse, no less. Regarding risk of Gullain-Barre syndrome due to vaccination, Wikipedia has this to say: "In fact, natural influenza infection is a stronger risk factor for the development of GBS than is influenza vaccination and getting the vaccination does reduce the risk of GBS overall by lowering the risk of catching influenza." So here I also find it hard to believe the vaccine would be worse than the disease, I'm also sceptical of the claim that Polio or the 1976 Swine Flu would unambiguously be worse than Covid19. 70% of Polio case have no symptoms, and less than 0.5% cause permanent injury, according to Wikipedia. The 1976 Swine Flu outbreak seems to have caused a few hundred cases and only one death.
  - roenxi 6y ago
    On the one hand I tend to agree, and all my expectations for this vaccine are positive. The medical industry tends to be paranoid to a level that exceeds rationality and even if they dropped their standards for this that should only get them down to "conservative and rather safe" levels of caution. On the other, a cursory search says the current record for fastest developed vaccine was mumps at 4 years. So this is a vaccine setting new milestones, and there is a risk that not all of them will be positive. I'd rather be a little late to be vaccinated than a little early, especially being in a lower risk demographic.
    - taejo 6y ago
      I'm not an expert by any means, but I do know that a lot of the speed comes from moving along the CHEAP-FAST side of the CHEAP-FAST-SAFE triangle, without necessarily changing anything on the FAST-SAFE axis. In particular, governments paid for the companies to start producing enough vaccines for phase 3 trials before phase 1 was complete, while normally drug companies would wait for phase 1 to be completed before preparing for phase 2 for economic reasons.
- snowwolf 6y ago
  I wonder if because the Oxford vaccine has taken an already tested and approved vaccine approach it has a higher chance of safety than the other 2 which use a new approach that has never been approved by regulators before.
  - Brakenshire 6y ago
    Is there precedent for the Oxford vaccine? I didn’t realise that.
    - DennisP 6y ago
      FTA: "The Oxford vaccine (ChAdOx1 nCoV-19) is made from a virus, which is a weakened version of a common cold virus (adenovirus), that has been genetically changed so that it is impossible for it to grow in humans. Adenovirus vaccines have been researched and used extensively for decades"
- 542354234235 6y ago
  > Pandemrix, a flu vaccine, caused a notable uptick in narcolepsy in Sweden, Finland and likely the UK. "The increased risk of narcolepsy due to vaccination was 1 in 18400 or 0.005%."[1] Considering the fatality and long term disability rate of Covid, and the way testing and safety protocols are done for vaccines, I don't really see how there could be an unknown and unseen risk that would outweigh the risk of contracting Covid. https://en.wikipedia.org/wiki/Pandemrix#Side_effects https://en.wikipedia.org/wiki/Pandemrix#Side_effects
  - beagle3 6y ago
    The risk of death in kids without underlying diseases is is approximately 0. It is not clear that giving (e.g. in the US) 30,000 of these kids narcolepsy is reasonable. It might be, but it’s not open and shut.
    - Exmoor 6y ago
      As far as I know, none of the COVID19 vaccines have been tested on children under 12 or are currently planned on being given to children. Additionally, it's not as if the average vaccine has a 0.005% chance of giving you narcolepsy. That figure was for the one vaccine in one country which appears to be the only example in most people's living memory of a vaccine possibly causing long-term side effects (it's not even proven the vaccine was the cause). There have been tens of billions of vaccines given during this time period and this is the only example where there may have been long term side effects.
      - beagle3 6y ago
        I've also mentioned the cutter polio vaccine and the 1976 swine flu vaccine which seems to have caused an uptick of GBS. > There have been tens of billions of vaccines given during this time period and this is the only example where there may have been long term side effects. No, there are other examples, the other two I just mentioned are from memory, I suspect if I go research I will find more (I don't have the time). You know what else is common to those other two cases? They were rushed (pandemrix wasn't AFAIK). SARS-Cov-2 vaccines were all rushed, and the safety protocols used to confidently ascertain those billions of vaccines were NOT followed - The standard is to wait 2-4 years to see that there's no ADE or other issues. I am pro-vaccination. I don't understand why it is hard to acknowledge and discuss the risk profile of vaccines - they re not risk free. Excuse me if I don't automatically think a rushed vaccine is perfectly safe.
jjeaff 6y ago
I think the cold storage issues are a bit overblown. Apparently the pfizer and Moderna vaccines will keep for 30 days at refrigerator temps after thawing out. You can ship in dry ice and then I can't imagine the vaccine sitting around in any doctors office or pharmacy for longer than 30 days.

beagle3 6y ago

The safety concerns cannot be resolved yet. Effective - yes. Safe? We won’t know for a while. Pandemrix, a flu vaccine, caused a notable uptick in narcolepsy in Sweden, Finland and likely the UK. This was not (and could not) be seen in smaller trial populations. It is not a given that any of the covid vaccines is safe enough. Historically, two cases of rushed vaccines (cutter polio and Gullah barre) were worse than the disease - and these were for diseases worse than covid. Those were 50-60 years ago. Pandemrix was 10-20. I’m not sure we’re that much better on safety now to rush vaccines.

acqq 6y ago
2011: https://www.who.int/vaccine_safety/committee/topics/influenza/pandemic/h1n1_safety_assessing/narcolepsy_statement/en/ https://www.who.int/vaccine_safety/committee/topics/influenz... “Even at this stage, it does not appear that narcolepsy following vaccination against pandemic influenza is a general worldwide phenomenon, as no excess of narcolepsy has been reported from several other European states where Pandemrix was used, or from Canada where a pandemic vaccine similar to pandemrix was used. This complicates interpretation of the findings in Finland and Sweden. It seems likely that some as yet unidentified additional factor was operating in Sweden and Finland. The findings from the VAESCO project and further investigations in Finland and Sweden, may help clarify the determinants of any increased risk of narcolepsy, which currently appears to be restricted to the months following vaccination and by age group and country.” What’s certainly true that for some effects to be observable, millions have to be vaccinated first. 2013: https://www.reuters.com/article/us-narcolepsy-vaccine-pandemrix-idUSBRE90L07H20130122 https://www.reuters.com/article/us-narcolepsy-vaccine-pandem... “In total, the GSK shot was given to more than 30 million people in 47 countries during the 2009-2010 H1N1 swine flu pandemic.” “Independent teams of scientists have published peer-reviewed studies from Sweden, Finland and Ireland showing the risk of developing narcolepsy after the 2009-2010 immunization campaign was between seven and 13 times higher for children who had Pandemrix than for their unvaccinated peers.” “Europe’s drugs regulator has ruled Pandemrix should no longer be used in people aged under 20.”
tialaramex 6y ago
If the association between Pandemrix and narcolepsy is because it caused narcolepsy (as with Guillain-Barré it's also plausible the problem is that this is an auto-immune problem and so the vaccine wasn't actually the problem it just highlighted a problem you already had) then the incidence rate was estimated at like 18k patients per case. So if you give the entire US population a vaccine like that, less than twenty thousand of them develop narcolepsy. As a reminder a quarter million of them already died from COVID-19 and more are dying every day - not to mention the tens of thousands whose cause of death isn't listed as COVID-19 but would not be dead if not for an ongoing pandemic. Cutter screwed up. No amount of prior safety testing can fix that. Their Polio vaccine had Polio virus in it (to be clear: The traditional Oral Polio Vaccine is supposed to have a "live" virus in it, but the injected vaccine Cutter were selling is not). Obviously nobody is going to test "What happens if we inject children with the Polio virus" because the answer is "Some of them get Polio. Duh" and so no test could have prevented Cutter from screwing up. I have no idea what you meant by "Gullah barre" the Google results I get are all about Guillain-Barré syndrome, which I mentioned above. Guillain-Barré is not a vaccine, it's a weird auto-immune disorder, and arguably even where it's listed as very rare side effect of a vaccine, that's misleading because it's also a side effect from getting viral infection, so if you avoid vaccination but do get the virus you may get GBS as a result anyway. The human immune system is pretty inscrutable.
- abacadaba 6y ago
  how about compared to the covid risk of a perfectly healthy young adult?
  - toyg 6y ago
    covid risk varies wildly depending on socioeconomic factors. Educated, WFH, small family, stable or low IRL social interaction: pretty low risk. Low-education, multiple in-person jobs, lots of casual social interaction, large family: very high risk. We've seen it very starkly in England. When entire communities are being ravaged by exponentially-growing transmission, it's hard to argue that a vaccine might be worse, because the chances are really minimal.
i_cannot_hack 6y ago
> Historically, two cases of rushed vaccines (cutter polio and Gullah barre) were worse than the disease - and these were for diseases worse than covid. This is just patently untrue. The Cutter Incidence gave patients Polio due to an improperly activated virus. While this is bad, it could not be worse than the disease itself - since it is the disease itself, no worse, no less. Regarding risk of Gullain-Barre syndrome due to vaccination, Wikipedia has this to say: "In fact, natural influenza infection is a stronger risk factor for the development of GBS than is influenza vaccination and getting the vaccination does reduce the risk of GBS overall by lowering the risk of catching influenza." So here I also find it hard to believe the vaccine would be worse than the disease, I'm also sceptical of the claim that Polio or the 1976 Swine Flu would unambiguously be worse than Covid19. 70% of Polio case have no symptoms, and less than 0.5% cause permanent injury, according to Wikipedia. The 1976 Swine Flu outbreak seems to have caused a few hundred cases and only one death.
- roenxi 6y ago
  On the one hand I tend to agree, and all my expectations for this vaccine are positive. The medical industry tends to be paranoid to a level that exceeds rationality and even if they dropped their standards for this that should only get them down to "conservative and rather safe" levels of caution. On the other, a cursory search says the current record for fastest developed vaccine was mumps at 4 years. So this is a vaccine setting new milestones, and there is a risk that not all of them will be positive. I'd rather be a little late to be vaccinated than a little early, especially being in a lower risk demographic.
  - taejo 6y ago
    I'm not an expert by any means, but I do know that a lot of the speed comes from moving along the CHEAP-FAST side of the CHEAP-FAST-SAFE triangle, without necessarily changing anything on the FAST-SAFE axis. In particular, governments paid for the companies to start producing enough vaccines for phase 3 trials before phase 1 was complete, while normally drug companies would wait for phase 1 to be completed before preparing for phase 2 for economic reasons.
snowwolf 6y ago
I wonder if because the Oxford vaccine has taken an already tested and approved vaccine approach it has a higher chance of safety than the other 2 which use a new approach that has never been approved by regulators before.
- Brakenshire 6y ago
  Is there precedent for the Oxford vaccine? I didn’t realise that.
  - DennisP 6y ago
    FTA: "The Oxford vaccine (ChAdOx1 nCoV-19) is made from a virus, which is a weakened version of a common cold virus (adenovirus), that has been genetically changed so that it is impossible for it to grow in humans. Adenovirus vaccines have been researched and used extensively for decades"
542354234235 6y ago
> Pandemrix, a flu vaccine, caused a notable uptick in narcolepsy in Sweden, Finland and likely the UK. "The increased risk of narcolepsy due to vaccination was 1 in 18400 or 0.005%."[1] Considering the fatality and long term disability rate of Covid, and the way testing and safety protocols are done for vaccines, I don't really see how there could be an unknown and unseen risk that would outweigh the risk of contracting Covid. https://en.wikipedia.org/wiki/Pandemrix#Side_effects https://en.wikipedia.org/wiki/Pandemrix#Side_effects
- beagle3 6y ago
  The risk of death in kids without underlying diseases is is approximately 0. It is not clear that giving (e.g. in the US) 30,000 of these kids narcolepsy is reasonable. It might be, but it’s not open and shut.
  - Exmoor 6y ago
    As far as I know, none of the COVID19 vaccines have been tested on children under 12 or are currently planned on being given to children. Additionally, it's not as if the average vaccine has a 0.005% chance of giving you narcolepsy. That figure was for the one vaccine in one country which appears to be the only example in most people's living memory of a vaccine possibly causing long-term side effects (it's not even proven the vaccine was the cause). There have been tens of billions of vaccines given during this time period and this is the only example where there may have been long term side effects.
    - beagle3 6y ago
      I've also mentioned the cutter polio vaccine and the 1976 swine flu vaccine which seems to have caused an uptick of GBS. > There have been tens of billions of vaccines given during this time period and this is the only example where there may have been long term side effects. No, there are other examples, the other two I just mentioned are from memory, I suspect if I go research I will find more (I don't have the time). You know what else is common to those other two cases? They were rushed (pandemrix wasn't AFAIK). SARS-Cov-2 vaccines were all rushed, and the safety protocols used to confidently ascertain those billions of vaccines were NOT followed - The standard is to wait 2-4 years to see that there's no ADE or other issues. I am pro-vaccination. I don't understand why it is hard to acknowledge and discuss the risk profile of vaccines - they re not risk free. Excuse me if I don't automatically think a rushed vaccine is perfectly safe.

jjeaff 6y ago

I think the cold storage issues are a bit overblown. Apparently the pfizer and Moderna vaccines will keep for 30 days at refrigerator temps after thawing out. You can ship in dry ice and then I can't imagine the vaccine sitting around in any doctors office or pharmacy for longer than 30 days.