[BostonCard]

Three weeks ago, that would have been considered a very solid result, but with the mRNA vaccines showing 95% efficacy, I think we were all hoping for more.  It will be interesting to see how this evolves.  My understanding is that this vaccine scales better and it doesn’t require freezing temperatures, but given a choice, who is going to pick a 70% effective vaccine over a 95% effective vaccine.  It probably makes most sense to offer the vaccine to lower risk patients.  There is also potentially a dosing regimen (half dose followed by a full dose) that appears to offer better (90%) protection, but I’d have to see details.

https://www.bloomberg.com/news/articles/...=applenews


BC

[BostonCard]

Three weeks ago, that would have been considered a very solid result, but with the mRNA vaccines showing 95% efficacy, I think we were all hoping for more.  It will be interesting to see how this evolves.  My understanding is that this vaccine scales better and it doesn’t require freezing temperatures, but given a choice, who is going to pick a 70% effective vaccine over a 95% effective vaccine.  It probably makes most sense to offer the vaccine to lower risk patients.  There is also potentially a dosing regimen (half dose followed by a full dose) that appears to offer better (90%) protection, but I’d have to see details.

https://www.bloomberg.com/news/articles/...=applenews


BC

[Snorlax94]

My recollection is that one of the major strengths of the Oxford vaccine is that we anticipated getting a lot more of it, sooner.

If it works at 70% that is still great news.

Because I’m lower risk, if I has to choose between getting a 70% vaccine very soon or waiting 6-9 months for an mRNA vaccine,  I might take the Oxford one now.

A CNN articlec said: “ The company said in a news release that its vaccine was "highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine."

If it protects from serious disease or death, that sounds really good to me.

In terms of prioritization, I think essential workers with many contacts (healthcare workers, police, grocery clerks) should get the more effective vaccine. Also, does the Oxford vaccine do a good job preventing transmission (protect upper and lower respiratory?) this could also be a factor in determining who gets which.

I haven’t read the details but having another option and even more supply sooner with easier distribution sounds like great news to me.

[Snorlax94]

My recollection is that one of the major strengths of the Oxford vaccine is that we anticipated getting a lot more of it, sooner.

If it works at 70% that is still great news.

Because I’m lower risk, if I has to choose between getting a 70% vaccine very soon or waiting 6-9 months for an mRNA vaccine,  I might take the Oxford one now.

A CNN articlec said: “ The company said in a news release that its vaccine was "highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine."

If it protects from serious disease or death, that sounds really good to me.

In terms of prioritization, I think essential workers with many contacts (healthcare workers, police, grocery clerks) should get the more effective vaccine. Also, does the Oxford vaccine do a good job preventing transmission (protect upper and lower respiratory?) this could also be a factor in determining who gets which.

I haven’t read the details but having another option and even more supply sooner with easier distribution sounds like great news to me.

[Farm93]

The dose stepping approach that potentially gets to 90% is very important, for global efforts.
The AZ vaccine offers far easier logistics for distribution.

[Farm93]

The dose stepping approach that potentially gets to 90% is very important, for global efforts.
The AZ vaccine offers far easier logistics for distribution.

[DocSavage87]

I'd focus less on the 70% effective and more on the better dosing regimen, the half then full dose, which is 90% effective.  One can only assume they have sufficient numbers for that approach to hold, and they aren't just throwing that in to help out stock price.  I believe the Oxford profs, who know the data, wouldn't attach their name to such a release, so I think that'll be the true Oxford/AZ offering.  Importantly, even if infected in either dosing regimen, there were no hospitalized or severe cases out of the 131 cases reported.  There is some indication that it could reduce virus transmission.  It's also going to be a lot cheaper, which is important for global efforts, particularly with the reduced dosage requirement.

https://www.ox.ac.uk/news/2020-11-23-oxf...19-vaccine

[DocSavage87]

I'd focus less on the 70% effective and more on the better dosing regimen, the half then full dose, which is 90% effective.  One can only assume they have sufficient numbers for that approach to hold, and they aren't just throwing that in to help out stock price.  I believe the Oxford profs, who know the data, wouldn't attach their name to such a release, so I think that'll be the true Oxford/AZ offering.  Importantly, even if infected in either dosing regimen, there were no hospitalized or severe cases out of the 131 cases reported.  There is some indication that it could reduce virus transmission.  It's also going to be a lot cheaper, which is important for global efforts, particularly with the reduced dosage requirement.

https://www.ox.ac.uk/news/2020-11-23-oxf...19-vaccine

[OutsiderFan]

This is one of the key reason the transition must start post-haste. Everyone talks about need to figure out vaccine distribution, but the other reality is someone in the government must decide which vaccines to choose for what people, when, and where.  I am 100% certain the current government would do it as corruptly as possible. If there was grift to be found, it would be pursued at the expense of sound science and epidemiology. If there was political favoritism - like say Florida and Texas getting the vaccine before CA and NY - to be pursued it would be. So getting on with the transition planning is really important.

[tweet]https://twitter.com/Laurie_Garrett/status/1330896391787470853[/tweet]

[OutsiderFan]

This is one of the key reason the transition must start post-haste. Everyone talks about need to figure out vaccine distribution, but the other reality is someone in the government must decide which vaccines to choose for what people, when, and where.  I am 100% certain the current government would do it as corruptly as possible. If there was grift to be found, it would be pursued at the expense of sound science and epidemiology. If there was political favoritism - like say Florida and Texas getting the vaccine before CA and NY - to be pursued it would be. So getting on with the transition planning is really important.

[tweet]https://twitter.com/Laurie_Garrett/status/1330896391787470853[/tweet]

[lex24]

This is one of the key reason the transition must start post-haste. Everyone talks about need to figure out vaccine distribution, but the other reality is someone in the government must decide which vaccines to choose for what people, when, and where.  I am 100% certain the current government would do it as corruptly as possible. If there was grift to be found, it would be pursued at the expense of sound science and epidemiology. If there was political favoritism - like say Florida and Texas getting the vaccine before CA and NY - to be pursued it would be. So getting on with the transition planning is really important.

[tweet]https://twitter.com/Laurie_Garrett/status/1330896391787470853[/tweet]

The only things I’m 100% certain on is that the sun will rise in the east set in the west, death and taxes. But I do agree with you that the transition should happen as quickly as possible. As to the 70% - my question is simple: side effects. If it’s 70% effective  with a low risk of any significant side effects than to me that’s another option.

[lex24]

This is one of the key reason the transition must start post-haste. Everyone talks about need to figure out vaccine distribution, but the other reality is someone in the government must decide which vaccines to choose for what people, when, and where.  I am 100% certain the current government would do it as corruptly as possible. If there was grift to be found, it would be pursued at the expense of sound science and epidemiology. If there was political favoritism - like say Florida and Texas getting the vaccine before CA and NY - to be pursued it would be. So getting on with the transition planning is really important.

[tweet]https://twitter.com/Laurie_Garrett/status/1330896391787470853[/tweet]

The only things I’m 100% certain on is that the sun will rise in the east set in the west, death and taxes. But I do agree with you that the transition should happen as quickly as possible. As to the 70% - my question is simple: side effects. If it’s 70% effective  with a low risk of any significant side effects than to me that’s another option.

[OutsiderFan]

This is one of the key reason the transition must start post-haste. Everyone talks about need to figure out vaccine distribution, but the other reality is someone in the government must decide which vaccines to choose for what people, when, and where.  I am 100% certain the current government would do it as corruptly as possible. If there was grift to be found, it would be pursued at the expense of sound science and epidemiology. If there was political favoritism - like say Florida and Texas getting the vaccine before CA and NY - to be pursued it would be. So getting on with the transition planning is really important.

The only things I’m 100% certain on is that the sun will rise in the east set in the west, death and taxes. But I do agree with you that the transition should happen as quickly as possible. As to the 70% - my question is simple: side effects. If it’s 70% effective  with a low risk of any significant side effects than to me that’s another option.

You seem to have missed the part about 90% effective at lower dose rates.  Here's a reporter explaining it:

[tweet]https://twitter.com/jchatterleyCNN/status/1330878291264278529[/tweet]

[OutsiderFan]

This is one of the key reason the transition must start post-haste. Everyone talks about need to figure out vaccine distribution, but the other reality is someone in the government must decide which vaccines to choose for what people, when, and where.  I am 100% certain the current government would do it as corruptly as possible. If there was grift to be found, it would be pursued at the expense of sound science and epidemiology. If there was political favoritism - like say Florida and Texas getting the vaccine before CA and NY - to be pursued it would be. So getting on with the transition planning is really important.

The only things I’m 100% certain on is that the sun will rise in the east set in the west, death and taxes. But I do agree with you that the transition should happen as quickly as possible. As to the 70% - my question is simple: side effects. If it’s 70% effective  with a low risk of any significant side effects than to me that’s another option.

You seem to have missed the part about 90% effective at lower dose rates.  Here's a reporter explaining it:

[tweet]https://twitter.com/jchatterleyCNN/status/1330878291264278529[/tweet]

[BostonCard]

One other thing about the vaccine trial is that the trial screened for asymptomatic infections, not just symptomatic infections as the Moderna and Pfizer/BioNTech trials did, so the comparisons are a bit apples-to-oranges:

https://www.ox.ac.uk/news/2020-11-23-oxf...19-vaccine

This will be interesting to follow.  If the Oxford/AZ vaccine protects against asymptomatic infections, at a 70% rate it is still possible that protection against symptomatic infections will be better. We actually don't know if the Moderna and Pfizer/BioNTech vaccines reduce asymptomatic transmission at all (though it is assumed they do).

BC

[BostonCard]

One other thing about the vaccine trial is that the trial screened for asymptomatic infections, not just symptomatic infections as the Moderna and Pfizer/BioNTech trials did, so the comparisons are a bit apples-to-oranges:

https://www.ox.ac.uk/news/2020-11-23-oxf...19-vaccine

This will be interesting to follow.  If the Oxford/AZ vaccine protects against asymptomatic infections, at a 70% rate it is still possible that protection against symptomatic infections will be better. We actually don't know if the Moderna and Pfizer/BioNTech vaccines reduce asymptomatic transmission at all (though it is assumed they do).

BC

[BostonCard]

In the meantime, this thread is worth reading on the Chinese version of the vaccine:

[tweet]https://twitter.com/Kate_OKeeffe/status/1330897591693938690?s=20[/tweet]

I think the data that is out there suggests the vaccine is less immunogenic (produces less of a antibody response).

BC

[BostonCard]

In the meantime, this thread is worth reading on the Chinese version of the vaccine:

[tweet]https://twitter.com/Kate_OKeeffe/status/1330897591693938690?s=20[/tweet]

I think the data that is out there suggests the vaccine is less immunogenic (produces less of a antibody response).

BC

[dabigv13]

Russia and China both use similar tech, an adenovirus vector, to the Oxford/AZ vaccines.

Personally, even though mRNA vaccines are completely novel, I'd prefer one of those even if efficacy were similar. Open question when or if FDA will approve this. They are submitting based on international data, with less numbers than the mRNA studies, after already having a long safety pause.

[dabigv13]

Russia and China both use similar tech, an adenovirus vector, to the Oxford/AZ vaccines.

Personally, even though mRNA vaccines are completely novel, I'd prefer one of those even if efficacy were similar. Open question when or if FDA will approve this. They are submitting based on international data, with less numbers than the mRNA studies, after already having a long safety pause.

[BostonCard]

Minor detail on the Oxford/AZ vaccine, which is that it is based on a replication incompetent chimpanzee adenovirus, whereas the Russian and Chinese vaccines use an attenuated human adenovirus.

https://www.nature.com/articles/s41586-020-2798-3

Several replication-incompetent vector vaccine candidates against SARS-CoV-2 have progressed far in clinical development: results from NHP trials and/or clinical trials in humans have been reported for ChAdOx1 nCoV-19 (based on a chimpanzee AdV)47, by Janssen (using an AdV26-based vector)41 and by CanSino (AdV5)45,46; in addition, a candidate from the Gamaleya Research Institute (Ad5/Ad26)50 is in phase III clinical trials and another from ReiThera (gorilla AdV) is in phase I trials32 (Fig. 4, Tables 1, 2).

(CanSino is the Chinese vaccine, the Gamaleya Research Institute is the Russian one).


BC

[BostonCard]

Minor detail on the Oxford/AZ vaccine, which is that it is based on a replication incompetent chimpanzee adenovirus, whereas the Russian and Chinese vaccines use an attenuated human adenovirus.

https://www.nature.com/articles/s41586-020-2798-3

Several replication-incompetent vector vaccine candidates against SARS-CoV-2 have progressed far in clinical development: results from NHP trials and/or clinical trials in humans have been reported for ChAdOx1 nCoV-19 (based on a chimpanzee AdV)47, by Janssen (using an AdV26-based vector)41 and by CanSino (AdV5)45,46; in addition, a candidate from the Gamaleya Research Institute (Ad5/Ad26)50 is in phase III clinical trials and another from ReiThera (gorilla AdV) is in phase I trials32 (Fig. 4, Tables 1, 2).

(CanSino is the Chinese vaccine, the Gamaleya Research Institute is the Russian one).


BC

[Farm93]

Russia and China both use similar tech, an adenovirus vector, to the Oxford/AZ vaccines.

Personally, even though mRNA vaccines are completely novel, I'd prefer one of those even if efficacy were similar. Open question when or if FDA will approve this. They are submitting based on international data, with less numbers than the mRNA studies, after already having a long safety pause.

I am with you on that one.

The USA has loads of very empty convention centers around major cities.   I would definitely be ready and willing to be assigned an appointment time at a convention center that was <200 miles from my home.    After the NFL football season, there would also be a large number of doom stadiums that could be utilized too.

I mention driving to a non-hospital location because I suspect the equipment to keep the vaccines cool will be limited AND it will not be possible or practical to go to large urban hospitals or medical centers in Q1 2021.

I am confident the first batches will go to government officials (at least those yet to get COVID), the military and health care workers.   Those groups should exhaust the supplies likely to be available pre-Jan 20, so no need to worry too much about what POTUS45 might or might not recommend.

[Farm93]

Russia and China both use similar tech, an adenovirus vector, to the Oxford/AZ vaccines.

Personally, even though mRNA vaccines are completely novel, I'd prefer one of those even if efficacy were similar. Open question when or if FDA will approve this. They are submitting based on international data, with less numbers than the mRNA studies, after already having a long safety pause.

I am with you on that one.

The USA has loads of very empty convention centers around major cities.   I would definitely be ready and willing to be assigned an appointment time at a convention center that was <200 miles from my home.    After the NFL football season, there would also be a large number of doom stadiums that could be utilized too.

I mention driving to a non-hospital location because I suspect the equipment to keep the vaccines cool will be limited AND it will not be possible or practical to go to large urban hospitals or medical centers in Q1 2021.

I am confident the first batches will go to government officials (at least those yet to get COVID), the military and health care workers.   Those groups should exhaust the supplies likely to be available pre-Jan 20, so no need to worry too much about what POTUS45 might or might not recommend.

[CompSci87]

doom stadiums

Paging CI...

[CompSci87]

doom stadiums

Paging CI...

[akiddoc]

Russia and China both use similar tech, an adenovirus vector, to the Oxford/AZ vaccines.

Personally, even though mRNA vaccines are completely novel, I'd prefer one of those even if efficacy were similar. Open question when or if FDA will approve this. They are submitting based on international data, with less numbers than the mRNA studies, after already having a long safety pause.

I am with you on that one.

The USA has loads of very empty convention centers around major cities.   I would definitely be ready and willing to be assigned an appointment time at a convention center that was <200 miles from my home.    After the NFL football season, there would also be a large number of doom stadiums that could be utilized too.

I mention driving to a non-hospital location because I suspect the equipment to keep the vaccines cool will be limited AND it will not be possible or practical to go to large urban hospitals or medical centers in Q1 2021.

I am confident the first batches will go to government officials (at least those yet to get COVID), the military and health care workers.   Those groups should exhaust the supplies likely to be available pre-Jan 20, so no need to worry too much about what POTUS45 might or might not recommend.

Practically every clinic and physician office in the USA is used to dealing with vaccines that need freezer storage. Even pharmacies can frequently handle these vaccines. So the Moderna vaccine could be doled out in a multitude of locations. The Pfizer vaccine not so much.

Personally, I think that everyone who gets the vaccine needs to get some kind of documentation. Vaccination may be required for school, college or work in the coming year. We can handle this for children pretty easily. Most states have state-wide data bases for all children to track vaccines. California has that, for example. Although Kaiser refuses to participate for unknown reasons. If your child is vaccinated in Modesto, and you move to Eureka, your new physician should be able to find your child's vaccines in the state data base.

[akiddoc]

Russia and China both use similar tech, an adenovirus vector, to the Oxford/AZ vaccines.

Personally, even though mRNA vaccines are completely novel, I'd prefer one of those even if efficacy were similar. Open question when or if FDA will approve this. They are submitting based on international data, with less numbers than the mRNA studies, after already having a long safety pause.

I am with you on that one.

The USA has loads of very empty convention centers around major cities.   I would definitely be ready and willing to be assigned an appointment time at a convention center that was <200 miles from my home.    After the NFL football season, there would also be a large number of doom stadiums that could be utilized too.

I mention driving to a non-hospital location because I suspect the equipment to keep the vaccines cool will be limited AND it will not be possible or practical to go to large urban hospitals or medical centers in Q1 2021.

I am confident the first batches will go to government officials (at least those yet to get COVID), the military and health care workers.   Those groups should exhaust the supplies likely to be available pre-Jan 20, so no need to worry too much about what POTUS45 might or might not recommend.

Practically every clinic and physician office in the USA is used to dealing with vaccines that need freezer storage. Even pharmacies can frequently handle these vaccines. So the Moderna vaccine could be doled out in a multitude of locations. The Pfizer vaccine not so much.

Personally, I think that everyone who gets the vaccine needs to get some kind of documentation. Vaccination may be required for school, college or work in the coming year. We can handle this for children pretty easily. Most states have state-wide data bases for all children to track vaccines. California has that, for example. Although Kaiser refuses to participate for unknown reasons. If your child is vaccinated in Modesto, and you move to Eureka, your new physician should be able to find your child's vaccines in the state data base.

[Goose]

Personally, I think that everyone who gets the vaccine needs to get some kind of documentation. Vaccination may be required for school, college or work in the coming year. We can handle this for children pretty easily. Most states have state-wide data bases for all children to track vaccines. California has that, for example. Although Kaiser refuses to participate for unknown reasons. If your child is vaccinated in Modesto, and you move to Eureka, your new physician should be able to find your child's vaccines in the state data base.

Very true. The WHO "yellow card" serves this function as well. It would be useful if your immunization record was included electronically in your passport, as I am pretty certain a COVID-19 vaccination will be required to enter many countries, at least for a while. This entire system needs to be updated, as it is inevitable nations will seek to control disease this way in the future. In the US, HHS distributes this card. Back in the 1970s you needed this card to go pretty much anywhere in Asia, and you needed to have the required vaccinations or you didn't get in. I stopped carrying mine as a matter of routine in the late 80s.

[Goose]

Personally, I think that everyone who gets the vaccine needs to get some kind of documentation. Vaccination may be required for school, college or work in the coming year. We can handle this for children pretty easily. Most states have state-wide data bases for all children to track vaccines. California has that, for example. Although Kaiser refuses to participate for unknown reasons. If your child is vaccinated in Modesto, and you move to Eureka, your new physician should be able to find your child's vaccines in the state data base.

Very true. The WHO "yellow card" serves this function as well. It would be useful if your immunization record was included electronically in your passport, as I am pretty certain a COVID-19 vaccination will be required to enter many countries, at least for a while. This entire system needs to be updated, as it is inevitable nations will seek to control disease this way in the future. In the US, HHS distributes this card. Back in the 1970s you needed this card to go pretty much anywhere in Asia, and you needed to have the required vaccinations or you didn't get in. I stopped carrying mine as a matter of routine in the late 80s.

[BostonCard]

Note that the Pfizer vaccine can be outside of -80 for up to 5 days.  You could probably imagine a vaccine distribution system that keeps the vaccine at -80 in depot and doles out a week's worth of the vaccine to pharmacies and physician offices on Monday mornings.

Initially demand >> supply so there is little risk that there will be left over vaccine by the end of the week.

It's an unbelievable logistics problem, but it's one that can be worked out.

BC

[BostonCard]

Note that the Pfizer vaccine can be outside of -80 for up to 5 days.  You could probably imagine a vaccine distribution system that keeps the vaccine at -80 in depot and doles out a week's worth of the vaccine to pharmacies and physician offices on Monday mornings.

Initially demand >> supply so there is little risk that there will be left over vaccine by the end of the week.

It's an unbelievable logistics problem, but it's one that can be worked out.

BC

[cctop]

One other thing about the vaccine trial is that the trial screened for asymptomatic infections, not just symptomatic infections as the Moderna and Pfizer/BioNTech trials did, so the comparisons are a bit apples-to-oranges:

https://www.ox.ac.uk/news/2020-11-23-oxf...19-vaccine

Per that link, 70% efficacy for the Oxford/AZ vaccine is an average of it being 90% effective giving a half-dose first and 62% effective giving a full dose first.

Somewhere there's an AstraZenaca marketing exec pulling out his hair that the headlines say 70% effective rather than 90% effective if administered in a certain way.

I was curious why a first half-dose would be more effective than a full dose, so I found this article:

https://www.nature.com/articles/d41586-020-03326-w

The theories are:
1)  small sample size.  With a larger sample size the actual number might be as low as 66%.
2)  a half first dose does a better job stimulating production of the "memory" T-cells.  It's possible that more time between a full first dose and second dose would do the same thing.
3)  the Oxford/AZ vaccine is based on a modified chimpanzee virus.  A full dose might be prompting the immune system to fight the chimp virus as well.

[cctop]

One other thing about the vaccine trial is that the trial screened for asymptomatic infections, not just symptomatic infections as the Moderna and Pfizer/BioNTech trials did, so the comparisons are a bit apples-to-oranges:

https://www.ox.ac.uk/news/2020-11-23-oxf...19-vaccine

Per that link, 70% efficacy for the Oxford/AZ vaccine is an average of it being 90% effective giving a half-dose first and 62% effective giving a full dose first.

Somewhere there's an AstraZenaca marketing exec pulling out his hair that the headlines say 70% effective rather than 90% effective if administered in a certain way.

I was curious why a first half-dose would be more effective than a full dose, so I found this article:

https://www.nature.com/articles/d41586-020-03326-w

The theories are:
1)  small sample size.  With a larger sample size the actual number might be as low as 66%.
2)  a half first dose does a better job stimulating production of the "memory" T-cells.  It's possible that more time between a full first dose and second dose would do the same thing.
3)  the Oxford/AZ vaccine is based on a modified chimpanzee virus.  A full dose might be prompting the immune system to fight the chimp virus as well.

[BostonCard]

One other thing about the "half dose" theory... it was an accident.  As in, the company didn't mean to have an arm with a half-dose initial dose.

https://www.fiercebiotech.com/biotech/as...e-efficacy

Pangalos said the mistake became apparent when researchers noticed the side effects seen in some participants were milder than expected. An attempt to explain the mild side effects revealed “they had underpredicted the dose of the vaccine by half,” Pangalos said. The participants went on to take a full booster shot.

Because this was not a pre-specified analysis, it is correct for the company to lump in the 90% with the 62% efficacy of the full-dose.  In normal times, the FDA would ask the company to run a new trial with the half-dose first dose before it could make any claims about the 90% efficacy of a half-dose initial dose, because, as you mention it, because the 90% efficacy could have arisen by chance.  These are not normal times, though, and it is possible that they will allow the regimen with some post-marketing commitments to report on its efficacy.

BC

[BostonCard]

One other thing about the "half dose" theory... it was an accident.  As in, the company didn't mean to have an arm with a half-dose initial dose.

https://www.fiercebiotech.com/biotech/as...e-efficacy

Pangalos said the mistake became apparent when researchers noticed the side effects seen in some participants were milder than expected. An attempt to explain the mild side effects revealed “they had underpredicted the dose of the vaccine by half,” Pangalos said. The participants went on to take a full booster shot.

Because this was not a pre-specified analysis, it is correct for the company to lump in the 90% with the 62% efficacy of the full-dose.  In normal times, the FDA would ask the company to run a new trial with the half-dose first dose before it could make any claims about the 90% efficacy of a half-dose initial dose, because, as you mention it, because the 90% efficacy could have arisen by chance.  These are not normal times, though, and it is possible that they will allow the regimen with some post-marketing commitments to report on its efficacy.

BC

[newguy]

One other thing about the "half dose" theory... it was an accident.  As in, the company didn't mean to have an arm with a half-dose initial dose.

https://www.fiercebiotech.com/biotech/as...e-efficacy

Pangalos said the mistake became apparent when researchers noticed the side effects seen in some participants were milder than expected. An attempt to explain the mild side effects revealed “they had underpredicted the dose of the vaccine by half,” Pangalos said. The participants went on to take a full booster shot.

Because this was not a pre-specified analysis, it is correct for the company to lump in the 90% with the 62% efficacy of the full-dose.  In normal times, the FDA would ask the company to run a new trial with the half-dose first dose before it could make any claims about the 90% efficacy of a half-dose initial dose, because, as you mention it, because the 90% efficacy could have arisen by chance.  These are not normal times, though, and it is possible that they will allow the regimen with some post-marketing commitments to report on its efficacy.

BC

as former Texas governor Rick Perry once said:  "Oops."
but i suppose these things happen.
and congrats on 20,000 posts.

[newguy]

One other thing about the "half dose" theory... it was an accident.  As in, the company didn't mean to have an arm with a half-dose initial dose.

https://www.fiercebiotech.com/biotech/as...e-efficacy

Pangalos said the mistake became apparent when researchers noticed the side effects seen in some participants were milder than expected. An attempt to explain the mild side effects revealed “they had underpredicted the dose of the vaccine by half,” Pangalos said. The participants went on to take a full booster shot.

Because this was not a pre-specified analysis, it is correct for the company to lump in the 90% with the 62% efficacy of the full-dose.  In normal times, the FDA would ask the company to run a new trial with the half-dose first dose before it could make any claims about the 90% efficacy of a half-dose initial dose, because, as you mention it, because the 90% efficacy could have arisen by chance.  These are not normal times, though, and it is possible that they will allow the regimen with some post-marketing commitments to report on its efficacy.

BC

as former Texas governor Rick Perry once said:  "Oops."
but i suppose these things happen.
and congrats on 20,000 posts.

[magnus]

One other thing about the "half dose" theory... it was an accident.  As in, the company didn't mean to have an arm with a half-dose initial dose.

https://www.fiercebiotech.com/biotech/as...e-efficacy

Pangalos said the mistake became apparent when researchers noticed the side effects seen in some participants were milder than expected. An attempt to explain the mild side effects revealed “they had underpredicted the dose of the vaccine by half,” Pangalos said. The participants went on to take a full booster shot.

Because this was not a pre-specified analysis, it is correct for the company to lump in the 90% with the 62% efficacy of the full-dose.  In normal times, the FDA would ask the company to run a new trial with the half-dose first dose before it could make any claims about the 90% efficacy of a half-dose initial dose, because, as you mention it, because the 90% efficacy could have arisen by chance.  These are not normal times, though, and it is possible that they will allow the regimen with some post-marketing commitments to report on its efficacy.

BC

One of the more vocal scientific voices during this pandemic, Natalie Dean, is worried about the transparency and rigor of the AstroZen trials.  

[tweet] https://twitter.com/nataliexdean/status/...70400?s=20[/tweet]

She goes on to say that the protocols for this study seem to vary per country that the study is conducted in and she worries that the sample size is indeed too small to commit on.  She's not coming down against the vaccine. Just the methods with which this vaccine is being advanced.

[magnus]

One other thing about the "half dose" theory... it was an accident.  As in, the company didn't mean to have an arm with a half-dose initial dose.

https://www.fiercebiotech.com/biotech/as...e-efficacy

Pangalos said the mistake became apparent when researchers noticed the side effects seen in some participants were milder than expected. An attempt to explain the mild side effects revealed “they had underpredicted the dose of the vaccine by half,” Pangalos said. The participants went on to take a full booster shot.

Because this was not a pre-specified analysis, it is correct for the company to lump in the 90% with the 62% efficacy of the full-dose.  In normal times, the FDA would ask the company to run a new trial with the half-dose first dose before it could make any claims about the 90% efficacy of a half-dose initial dose, because, as you mention it, because the 90% efficacy could have arisen by chance.  These are not normal times, though, and it is possible that they will allow the regimen with some post-marketing commitments to report on its efficacy.

BC

One of the more vocal scientific voices during this pandemic, Natalie Dean, is worried about the transparency and rigor of the AstroZen trials.  

[tweet] https://twitter.com/nataliexdean/status/...70400?s=20[/tweet]

She goes on to say that the protocols for this study seem to vary per country that the study is conducted in and she worries that the sample size is indeed too small to commit on.  She's not coming down against the vaccine. Just the methods with which this vaccine is being advanced.