[BostonCard]

Interesting, the FDA is poised to announce a new EUA standard for vaccines.

https://www.washingtonpost.com/health/20...-standard/

And it is more stringent than many people expected.  Three key aspects:

* Under it, the FDA would ask manufacturers seeking an emergency authorization — a far quicker process than a formal approval — to follow participants in late-stage clinical trials for a median of at least two months, starting after they receive a second vaccine shot...

* As a sign the vaccine works, the agency also is likely to look for at least five severe cases of covid-19, the disease caused by the coronavirus, in the placebo group for each trial...

* as well as some cases of the disease in older people.

BC

[BostonCard]

Interesting, the FDA is poised to announce a new EUA standard for vaccines.

https://www.washingtonpost.com/health/20...-standard/

And it is more stringent than many people expected.  Three key aspects:

* Under it, the FDA would ask manufacturers seeking an emergency authorization — a far quicker process than a formal approval — to follow participants in late-stage clinical trials for a median of at least two months, starting after they receive a second vaccine shot...

* As a sign the vaccine works, the agency also is likely to look for at least five severe cases of covid-19, the disease caused by the coronavirus, in the placebo group for each trial...

* as well as some cases of the disease in older people.

BC

[Leftcoast]

FYI .... For those in the South Bay, Kaiser began giving the normal flu vaccinations 2 weekends ago.  They are not available in walk-in clinics but instead are available as drive-up, in-car vaccinations given at Mission College near Great America.  

Wait times vary.  I was in line with three other from my family for about 5 minutes but friends have reported up to a 90 minute wait.

I have no idea which variant they are giving.   

I get the flu about 50% of the flu seasons when I don't get the vaccine so I'm usually first in line - 4 kids and my wife works in a pre-school so lots of possible vectors for exposure.

[Leftcoast]

FYI .... For those in the South Bay, Kaiser began giving the normal flu vaccinations 2 weekends ago.  They are not available in walk-in clinics but instead are available as drive-up, in-car vaccinations given at Mission College near Great America.  

Wait times vary.  I was in line with three other from my family for about 5 minutes but friends have reported up to a 90 minute wait.

I have no idea which variant they are giving.   

I get the flu about 50% of the flu seasons when I don't get the vaccine so I'm usually first in line - 4 kids and my wife works in a pre-school so lots of possible vectors for exposure.

[OutsiderFan]

We don't have a true flu vaccine, which I guess is why we have a "flu shot."

What is the likelihood we won't have a true "SARS-CoV-2" vaccine that stops the virus like a Measles or Polio vaccine, and instead we'll have the equivalent of the flu shot for it, something that might lessen the chances someone gets Covid-19, but if they do, makes the impact less severe than it would be otherwise in most but not all cases?

[OutsiderFan]

We don't have a true flu vaccine, which I guess is why we have a "flu shot."

What is the likelihood we won't have a true "SARS-CoV-2" vaccine that stops the virus like a Measles or Polio vaccine, and instead we'll have the equivalent of the flu shot for it, something that might lessen the chances someone gets Covid-19, but if they do, makes the impact less severe than it would be otherwise in most but not all cases?

[Mick]

J&J entering Phase III:

https://www.cnbc.com/2020/09/23/coronavi...rial-.html

[Mick]

J&J entering Phase III:

https://www.cnbc.com/2020/09/23/coronavi...rial-.html

[BostonCard]

We don't have a true flu vaccine, which I guess is why we have a "flu shot."

What is the likelihood we won't have a true "SARS-CoV-2" vaccine that stops the virus like a Measles or Polio vaccine, and instead we'll have the equivalent of the flu shot for it, something that might lessen the chances someone gets Covid-19, but if they do, makes the impact less severe than it would be otherwise in most but not all cases?

What do you mean, we don't have a true flu vaccine?  There are aspects of influenza that make it different from measles or polio, but that makes it no less of a vaccination.

BC

[BostonCard]

We don't have a true flu vaccine, which I guess is why we have a "flu shot."

What is the likelihood we won't have a true "SARS-CoV-2" vaccine that stops the virus like a Measles or Polio vaccine, and instead we'll have the equivalent of the flu shot for it, something that might lessen the chances someone gets Covid-19, but if they do, makes the impact less severe than it would be otherwise in most but not all cases?

What do you mean, we don't have a true flu vaccine?  There are aspects of influenza that make it different from measles or polio, but that makes it no less of a vaccination.

BC

[OutsiderFan]

We don't have a true flu vaccine, which I guess is why we have a "flu shot."

What is the likelihood we won't have a true "SARS-CoV-2" vaccine that stops the virus like a Measles or Polio vaccine, and instead we'll have the equivalent of the flu shot for it, something that might lessen the chances someone gets Covid-19, but if they do, makes the impact less severe than it would be otherwise in most but not all cases?

What do you mean, we don't have a true flu vaccine?  There are aspects of influenza that make it different from measles or polio, but that makes it no less of a vaccination.

BC

When I think of "vaccine" I think of something that works 100% effective or close enough that it creates herd immunity for diseases like measles and polio.  I've never heard of a flu vaccine. Everyone always calls it a flu shot.  Maybe it is in fact a vaccine, but that's not what it's commonly called, ostensibly because it isn't full proof. Plenty of people get the flu who had flu shots/vaccine.

Therefore, my question is based on concern the SARS-CoV-2 vaccine will have similar efficacy to a flu shot, which is to say not all that much. I can't justify getting a flu shot.  I've never had one and only had any bad flu one time in my life.

[OutsiderFan]

We don't have a true flu vaccine, which I guess is why we have a "flu shot."

What is the likelihood we won't have a true "SARS-CoV-2" vaccine that stops the virus like a Measles or Polio vaccine, and instead we'll have the equivalent of the flu shot for it, something that might lessen the chances someone gets Covid-19, but if they do, makes the impact less severe than it would be otherwise in most but not all cases?

What do you mean, we don't have a true flu vaccine?  There are aspects of influenza that make it different from measles or polio, but that makes it no less of a vaccination.

BC

When I think of "vaccine" I think of something that works 100% effective or close enough that it creates herd immunity for diseases like measles and polio.  I've never heard of a flu vaccine. Everyone always calls it a flu shot.  Maybe it is in fact a vaccine, but that's not what it's commonly called, ostensibly because it isn't full proof. Plenty of people get the flu who had flu shots/vaccine.

Therefore, my question is based on concern the SARS-CoV-2 vaccine will have similar efficacy to a flu shot, which is to say not all that much. I can't justify getting a flu shot.  I've never had one and only had any bad flu one time in my life.

[JeffInCorvallis]

A vaccine is a biological agent that stimulates the immune system to identify an infectious disease and generate an immune response. You are correct that influenza vaccines are not 100% efficacious. Neither are vaccines for Polio, Measles, or any other disease, and effectiveness can vary widely. Two doses of MMR are 97% effective against Measles.

I've never understood the argument of "well, it's not 100% effective so I'm not going to get it". You have something that reduces your chance of becoming sick by 50, 60, 70% or more, and your risk of becoming seriously ill by more than that, all for a vanishingly small risk of serious side effects assuming the vaccine has been tested properly. Humans are generally bad at assessing risk. As for the "I've never had the flu" argument, you have been riding on the level of herd immunity, such as it is, or been very lucky, or had good hand sanitation practices. Or some combination thereof.

[JeffInCorvallis]

A vaccine is a biological agent that stimulates the immune system to identify an infectious disease and generate an immune response. You are correct that influenza vaccines are not 100% efficacious. Neither are vaccines for Polio, Measles, or any other disease, and effectiveness can vary widely. Two doses of MMR are 97% effective against Measles.

I've never understood the argument of "well, it's not 100% effective so I'm not going to get it". You have something that reduces your chance of becoming sick by 50, 60, 70% or more, and your risk of becoming seriously ill by more than that, all for a vanishingly small risk of serious side effects assuming the vaccine has been tested properly. Humans are generally bad at assessing risk. As for the "I've never had the flu" argument, you have been riding on the level of herd immunity, such as it is, or been very lucky, or had good hand sanitation practices. Or some combination thereof.

[Mick]

A vaccine is a biological agent that stimulates the immune system to identify an infectious disease and generate an immune response. You are correct that influenza vaccines are not 100% efficacious. Neither are vaccines for Polio, Measles, or any other disease, and effectiveness can vary widely. Two doses of MMR are 97% effective against Measles.

I've never understood the argument of "well, it's not 100% effective so I'm not going to get it". You have something that reduces your chance of becoming sick by 50, 60, 70% or more, and your risk of becoming seriously ill by more than that, all for a vanishingly small risk of serious side effects assuming the vaccine has been tested properly. Humans are generally bad at assessing risk. As for the "I've never had the flu" argument, you have been riding on the level of herd immunity, such as it is, or been very lucky, or had good hand sanitation practices. Or some combination thereof.

I caught the flu bigtime in 1991.  I was in bed for two weeks, really knocked me for a loop.  I've had a flu shot every year since then, and I've never caught the flu since.

I have an anti-vaxx acquaintance who tells me that it's just 29 years' worth of coincidences.

Oh.

[Mick]

A vaccine is a biological agent that stimulates the immune system to identify an infectious disease and generate an immune response. You are correct that influenza vaccines are not 100% efficacious. Neither are vaccines for Polio, Measles, or any other disease, and effectiveness can vary widely. Two doses of MMR are 97% effective against Measles.

I've never understood the argument of "well, it's not 100% effective so I'm not going to get it". You have something that reduces your chance of becoming sick by 50, 60, 70% or more, and your risk of becoming seriously ill by more than that, all for a vanishingly small risk of serious side effects assuming the vaccine has been tested properly. Humans are generally bad at assessing risk. As for the "I've never had the flu" argument, you have been riding on the level of herd immunity, such as it is, or been very lucky, or had good hand sanitation practices. Or some combination thereof.

I caught the flu bigtime in 1991.  I was in bed for two weeks, really knocked me for a loop.  I've had a flu shot every year since then, and I've never caught the flu since.

I have an anti-vaxx acquaintance who tells me that it's just 29 years' worth of coincidences.

Oh.

[Hurlburt88]

I got flu vaccines from 85 to 89, and then lapsed.   IN 1991 I also got a nasty case of influenza--while traveling which really made it no fun.   Took a good 6 weeks to get my lungs back to normal function.   and I also now have gotten a vaccine every year, including just a couple of weeks ago.

[Hurlburt88]

I got flu vaccines from 85 to 89, and then lapsed.   IN 1991 I also got a nasty case of influenza--while traveling which really made it no fun.   Took a good 6 weeks to get my lungs back to normal function.   and I also now have gotten a vaccine every year, including just a couple of weeks ago.

[CompSci87]

FYI .... For those in the South Bay, Kaiser began giving the normal flu vaccinations 2 weekends ago.  They are not available in walk-in clinics but instead are available as drive-up, in-car vaccinations given at Mission College near Great America.  

Wait times vary.  I was in line with three other from my family for about 5 minutes but friends have reported up to a 90 minute wait.

I have no idea which variant they are giving.   

Kaiser Redwood City is giving the flu vaccine indoors at a walk in clinic. It's in the usual place (a room near the main pharmacy), but they modified the traffic pattern so that the waiting line is outdoors.

[CompSci87]

FYI .... For those in the South Bay, Kaiser began giving the normal flu vaccinations 2 weekends ago.  They are not available in walk-in clinics but instead are available as drive-up, in-car vaccinations given at Mission College near Great America.  

Wait times vary.  I was in line with three other from my family for about 5 minutes but friends have reported up to a 90 minute wait.

I have no idea which variant they are giving.   

Kaiser Redwood City is giving the flu vaccine indoors at a walk in clinic. It's in the usual place (a room near the main pharmacy), but they modified the traffic pattern so that the waiting line is outdoors.

[Goose]

I caught the flu bigtime in 1991.  I was in bed for two weeks, really knocked me for a loop.  I've had a flu shot every year since then, and I've never caught the flu since.

I have an anti-vaxx acquaintance who tells me that it's just 29 years' worth of coincidences.

Oh.

I had a really bad case of the flu in the late 80s. In bed for 4 days, which for me is unheard of. I never received a flu shot from then on until 2019. I have not had the flu once in the interim. So yeah, 30+ years of "good luck" or maybe my immune system figured something out that research hasn't yet detected. YMMV.

[Goose]

I caught the flu bigtime in 1991.  I was in bed for two weeks, really knocked me for a loop.  I've had a flu shot every year since then, and I've never caught the flu since.

I have an anti-vaxx acquaintance who tells me that it's just 29 years' worth of coincidences.

Oh.

I had a really bad case of the flu in the late 80s. In bed for 4 days, which for me is unheard of. I never received a flu shot from then on until 2019. I have not had the flu once in the interim. So yeah, 30+ years of "good luck" or maybe my immune system figured something out that research hasn't yet detected. YMMV.

[lex24]

A vaccine is a biological agent that stimulates the immune system to identify an infectious disease and generate an immune response. You are correct that influenza vaccines are not 100% efficacious. Neither are vaccines for Polio, Measles, or any other disease, and effectiveness can vary widely. Two doses of MMR are 97% effective against Measles.

I've never understood the argument of "well, it's not 100% effective so I'm not going to get it". You have something that reduces your chance of becoming sick by 50, 60, 70% or more, and your risk of becoming seriously ill by more than that, all for a vanishingly small risk of serious side effects assuming the vaccine has been tested properly. Humans are generally bad at assessing risk. As for the "I've never had the flu" argument, you have been riding on the level of herd immunity, such as it is, or been very lucky, or had good hand sanitation practices. Or some combination thereof.

+1

[lex24]

A vaccine is a biological agent that stimulates the immune system to identify an infectious disease and generate an immune response. You are correct that influenza vaccines are not 100% efficacious. Neither are vaccines for Polio, Measles, or any other disease, and effectiveness can vary widely. Two doses of MMR are 97% effective against Measles.

I've never understood the argument of "well, it's not 100% effective so I'm not going to get it". You have something that reduces your chance of becoming sick by 50, 60, 70% or more, and your risk of becoming seriously ill by more than that, all for a vanishingly small risk of serious side effects assuming the vaccine has been tested properly. Humans are generally bad at assessing risk. As for the "I've never had the flu" argument, you have been riding on the level of herd immunity, such as it is, or been very lucky, or had good hand sanitation practices. Or some combination thereof.

+1

[BostonCard]

Influenza affects between 9 million and 45 million Americans a year, so even in a heavy flu year, only about 1 in 7 of Americans will get the flu.  On an average year, your chance is probably one in 10, so going 30 years without the flu does imply good luck.  Your chances of doing so without a vaccine are about 4%; vaccinating every year with a 50% effective vaccine improves your chances to about 20%.

BC

[BostonCard]

Influenza affects between 9 million and 45 million Americans a year, so even in a heavy flu year, only about 1 in 7 of Americans will get the flu.  On an average year, your chance is probably one in 10, so going 30 years without the flu does imply good luck.  Your chances of doing so without a vaccine are about 4%; vaccinating every year with a 50% effective vaccine improves your chances to about 20%.

BC

[oldalum]

vaccinating every year with a 50% effective vaccine improves your chances to about 20%.

And if the vaccine is 70% effective, your chances are doubled to about 40% of going 30 years without getting the flu. Not bad.

[oldalum]

vaccinating every year with a 50% effective vaccine improves your chances to about 20%.

And if the vaccine is 70% effective, your chances are doubled to about 40% of going 30 years without getting the flu. Not bad.

[Goose]

Influenza affects between 9 million and 45 million Americans a year, so even in a heavy flu year, only about 1 in 7 of Americans will get the flu.  On an average year, your chance is probably one in 10, so going 30 years without the flu does imply good luck.  Your chances of doing so without a vaccine are about 4%; vaccinating every year with a 50% effective vaccine improves your chances to about 20%.

BC

I believe the numbers cited are based on a random person, assuming all people have the same probability of catching the flu. True in bulk, not true for each individual. Some people don't get sick much. I am one of them. I have not had a cold in probably 20 years. I travel a lot for my job, sometimes to places where the general standard of immunization isn't great. Since I spend time in airports, one would think I am exposed to all kinds of things. My wife has had the flu several times and I didn't get it. FWIW, I have received immunizations against somewhat less common diseases. Maybe somehow that is a factor. No way to know. Yes, it could just be luck, but...

[Goose]

Influenza affects between 9 million and 45 million Americans a year, so even in a heavy flu year, only about 1 in 7 of Americans will get the flu.  On an average year, your chance is probably one in 10, so going 30 years without the flu does imply good luck.  Your chances of doing so without a vaccine are about 4%; vaccinating every year with a 50% effective vaccine improves your chances to about 20%.

BC

I believe the numbers cited are based on a random person, assuming all people have the same probability of catching the flu. True in bulk, not true for each individual. Some people don't get sick much. I am one of them. I have not had a cold in probably 20 years. I travel a lot for my job, sometimes to places where the general standard of immunization isn't great. Since I spend time in airports, one would think I am exposed to all kinds of things. My wife has had the flu several times and I didn't get it. FWIW, I have received immunizations against somewhat less common diseases. Maybe somehow that is a factor. No way to know. Yes, it could just be luck, but...

[Mick]

I've never understood the argument of "well, it's not 100% effective so I'm not going to get it". You have something that reduces your chance of becoming sick by 50, 60, 70% or more, and your risk of becoming seriously ill by more than that, all for a vanishingly small risk of serious side effects assuming the vaccine has been tested properly. Humans are generally bad at assessing risk. As for the "I've never had the flu" argument, you have been riding on the level of herd immunity, such as it is, or been very lucky, or had good hand sanitation practices. Or some combination thereof.

That reminds me, I once taught an undergrad marketing class in which the class split up into groups to poll a test audience regarding the desireability of a proposed product.  One of the groups decided that the product was not market-viable because "only" 93% of the test subjects claimed they would purchase the product.  Since there wasn't 100% purchasing support -- merely 93% -- the kid decided that the product wasn't saleable.  

Undergrads.  Gotta love 'em.

[Mick]

I've never understood the argument of "well, it's not 100% effective so I'm not going to get it". You have something that reduces your chance of becoming sick by 50, 60, 70% or more, and your risk of becoming seriously ill by more than that, all for a vanishingly small risk of serious side effects assuming the vaccine has been tested properly. Humans are generally bad at assessing risk. As for the "I've never had the flu" argument, you have been riding on the level of herd immunity, such as it is, or been very lucky, or had good hand sanitation practices. Or some combination thereof.

That reminds me, I once taught an undergrad marketing class in which the class split up into groups to poll a test audience regarding the desireability of a proposed product.  One of the groups decided that the product was not market-viable because "only" 93% of the test subjects claimed they would purchase the product.  Since there wasn't 100% purchasing support -- merely 93% -- the kid decided that the product wasn't saleable.  

Undergrads.  Gotta love 'em.

[BostonCard]

https://www.nytimes.com/2020/10/16/healt...74f24220a2

Pfizer, which is the company closest to having results, could have results to enable an EUA for the vaccine by mid-November.  That is probably disappointing to some people who had hoped for a vaccine before the election, but nonetheless would be a truly remarkable achievement.  Whether it is before or after November 3, it is truly a heroic feat to even be in the position to evaluate a vaccine that quickly.

BC

[BostonCard]

https://www.nytimes.com/2020/10/16/healt...74f24220a2

Pfizer, which is the company closest to having results, could have results to enable an EUA for the vaccine by mid-November.  That is probably disappointing to some people who had hoped for a vaccine before the election, but nonetheless would be a truly remarkable achievement.  Whether it is before or after November 3, it is truly a heroic feat to even be in the position to evaluate a vaccine that quickly.

BC

[DocSavage87]

https://www.nytimes.com/2020/10/16/healt...74f24220a2

Pfizer, which is the company closest to having results, could have results to enable an EUA for the vaccine by mid-November.  That is probably disappointing to some people who had hoped for a vaccine before the election, but nonetheless would be a truly remarkable achievement.  Whether it is before or after November 3, it is truly a heroic feat to even be in the position to evaluate a vaccine that quickly.

BC

There are some bright spots about how the world has responded in the midst of all the dark spots.  The rapid vaccine developments, the extraordinary funding by governments and major foundations, but also stuff like this:

Gates said he was encouraged to see that pharmaceutical companies will offer their factories for the production of their rivals’ Covid-19 vaccines, if needed. On Thursday, the GAVI alliance is announcing a program that commits to buying Covid vaccines when they become available, as an incentive for manufacturers such as AstraZeneca (AZN) to invest in production capacity.

https://www.barrons.com/articles/gates-f...1591284623

[DocSavage87]

https://www.nytimes.com/2020/10/16/healt...74f24220a2

Pfizer, which is the company closest to having results, could have results to enable an EUA for the vaccine by mid-November.  That is probably disappointing to some people who had hoped for a vaccine before the election, but nonetheless would be a truly remarkable achievement.  Whether it is before or after November 3, it is truly a heroic feat to even be in the position to evaluate a vaccine that quickly.

BC

There are some bright spots about how the world has responded in the midst of all the dark spots.  The rapid vaccine developments, the extraordinary funding by governments and major foundations, but also stuff like this:

Gates said he was encouraged to see that pharmaceutical companies will offer their factories for the production of their rivals’ Covid-19 vaccines, if needed. On Thursday, the GAVI alliance is announcing a program that commits to buying Covid vaccines when they become available, as an incentive for manufacturers such as AstraZeneca (AZN) to invest in production capacity.

https://www.barrons.com/articles/gates-f...1591284623

[82lsju]

Brazilian newspaper O Globo reported that the volunteer had been given a placebo and not the trial vaccine, citing unnamed sources.

https://uk.reuters.com/article/uk-health...762OT?il=0

Brazilian health authority Anvisa said on Wednesday that a volunteer in a clinical trial of the COVID-19 vaccine developed by AstraZeneca and Oxford University has died, stating it had received data from an investigation into the matter.

The Federal University of Sao Paulo, which is helping coordinate phase 3 clinical trials in Brazil, separately said that the volunteer was Brazilian.

https://www.usnews.com/news/world/articl...ority-says

In a statement, a spokesperson from the University of Oxford, which is developing the vaccine with AstraZeneca, said “there have been no concerns about safety of the clinical trial” after an assessment of the case in Brazil.

“The independent review in addition to the Brazilian regulator have recommended that the trial should continue,” Oxford spokesperson Alexander Buxton said.

https://www.cnbc.com/2020/10/21/astrazen...-dies.html

[82lsju]

Brazilian newspaper O Globo reported that the volunteer had been given a placebo and not the trial vaccine, citing unnamed sources.

https://uk.reuters.com/article/uk-health...762OT?il=0

Brazilian health authority Anvisa said on Wednesday that a volunteer in a clinical trial of the COVID-19 vaccine developed by AstraZeneca and Oxford University has died, stating it had received data from an investigation into the matter.

The Federal University of Sao Paulo, which is helping coordinate phase 3 clinical trials in Brazil, separately said that the volunteer was Brazilian.

https://www.usnews.com/news/world/articl...ority-says

In a statement, a spokesperson from the University of Oxford, which is developing the vaccine with AstraZeneca, said “there have been no concerns about safety of the clinical trial” after an assessment of the case in Brazil.

“The independent review in addition to the Brazilian regulator have recommended that the trial should continue,” Oxford spokesperson Alexander Buxton said.

https://www.cnbc.com/2020/10/21/astrazen...-dies.html

[BostonCard]

https://www.politico.com/news/2020/10/21...ial-430788

Perhaps relatedly, AZ may be close to restarting its COVID-19 vaccine trial in the US.

BC

[BostonCard]

https://www.politico.com/news/2020/10/21...ial-430788

Perhaps relatedly, AZ may be close to restarting its COVID-19 vaccine trial in the US.

BC