Coronavirus 2019-2020 thread (no unsubstantiated rumours!)

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OppositeDay

Senior Member
Registered Member
taxiya said:
What sense would that reference make? How does geography or national boundary have anything to do with medical trail anyway?

I quote from Lancet's publication of AZ phase III trail:

Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis.

Should AZ's trail be called supersized phase 2?
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Because the goals for the trials in China are to track neutralizing antibody level and monitor possible side-effects, which is basically what phase 2 trials are about.

Here's their filing at China Clinical Trials Registry:
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Their own description of the primary objectives of their trial in China
Primary Objectives:

Immunogenicity
To evaluate the seroconversion rates, geometric mean titers (GMTs) and geometric mean titer increase folds (GMIs) of S-RBD-specific IgG antibodies as well as neutralization antibodies as measured by pseudovirus and wild-type virus neutralization assays at 14 days following a 2-dose regimen of the SARS-CoV-2 mRNA vaccine at an interval of 28 days in population aged 18 years and above.

Safety
To evaluate the safety and reactogenicity of the SARS-CoV-2 mRNA vaccine to be administered in a 2-dose regimen at an interval of 28 days in population aged 18 years and above.
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Evaluating the efficacy should a primary objective for any real phase 3 trial, but it's the case here. Hence it's really a phase 2 trial.

I'm not denying that they are doing real phase 3 trials in other parts of the world (e.g. Mexico).
 
T

taxiya

Brigadier
Registered Member
OppositeDay said:
Because the goals for the trials in China are to track neutralizing antibody level and monitor possible side-effects, which is basically what phase 2 trials are about.

Here's their filing at China Clinical Trials Registry:
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Their own description of the primary objectives of their trial in China


Evaluating the efficacy should a primary objective for any real phase 3 trial, but it's the case here. Hence it's really a phase 2 trial.

I'm not denying that they are doing real phase 3 trials in other parts of the world (e.g. Mexico).
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From the same registration you provided, here is the full title

1626988154928.png

"A Global, Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase III Clinical Study to Evaluate the Protective Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine in Population Aged 18 Years and Older"

Is the efficacy being placed ahead of everything else?

Why are you keep overlooking? Firstly, in the SCMP article, "2000 being just a part" is right below the headline, and you skipped it. Now, in your own quotation, you even skipped the main title.
 
O

OppositeDay

Senior Member
Registered Member
taxiya said:
From the same registration you provided, here is the full title

View attachment 75003

"A Global, Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase III Clinical Study to Evaluate the Protective Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine in Population Aged 18 Years and Older"

Is the efficacy being placed ahead of everything else?

Why are you keep overlooking? Firstly, in the SCMP article, "2000 being just a part" is right below the headline, and you skipped it. Now, in your own quotation, you even skipped the main title.
Click to expand...

The global study has efficacy evaluation as a primary objective, but the China part doesn’t as one can clearly see from their filing. So the China part is not really phase 3. I don’t understand how this is controversial. We all know that doing phase 3 in China now is impossible because of the low number of cases.
 
T

taxiya

Brigadier
Registered Member
OppositeDay said:
The global study has efficacy evaluation as a primary objective, but the China part doesn’t as one can clearly see from their filing. So the China part is not really phase 3. I don’t understand how this is controversial. We all know that doing phase 3 in China now is impossible because of the low number of cases.
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There is no global study vs. a China part study. There is only one phase III trail with one study at the end.

I see it is controversial to make out a "China part" out of the phase III trail. The trail is a integral one with separate geographical samplings just like the AZ phase III trail in two geographical parts, yet that is not called "supersized phase II". It has nothing to do with whether China has enough cases to support the trail.

It is also strange to state "a part of phase III is not phase III" when that part serves the same purpose of the whole. It is not like that the outcome from "China part" is to be treated differently in final statistic.

It is controversial when twice skipping the important statements in the registration to support claim of "supersized phase II".
 
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supercat

supercat

Major

China calls for tracing COVID-19 origin in multiple countries, regions​

China hopes that the World Health Organization will genuinely treat the COVID-19 origin-tracing work as a scientific issue, get rid of political interference, and actively and prudently promote the tracing work to be carried out continuously in multiple countries and regions around the globe, said a senior official of the National Health Commission (NHC) on Thursday.

What has been carried out in the first stage of origin tracing, especially those that have reached a clear conclusion, should not be repeated, said Zeng Yixin, deputy head of the NHC, at a press conference on the COVID-19 origin-tracing work.
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Is China making an unreasonable demand that COVID-19 origin should be investigated in multiple countries? Not at all. Here is a recent paper argues for the possibility that the progenitors of SARS-CoV-2 might have been spreading worldwide months before the Wuhan outbreak.

An Evolutionary Portrait of the Progenitor SARS-CoV-2 and Its Dominant Offshoots in COVID-19 Pandemic​

...This progenitor genome differs from genomes of the first coronaviruses sampled in China by three variants, implying that none of the earliest patients represent the index case or gave rise to all the human infections. However, multiple coronavirus infections in China and the United States harbored the progenitor genetic fingerprint in January 2020 and later, suggesting that the progenitor was spreading worldwide months before and after the first reported cases of COVID-19 in China...
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O

OppositeDay

Senior Member
Registered Member
taxiya said:
There is no global study vs. a China part study. There is only one phase III trail with one study at the end.

I see it is controversial to make out a "China part" out of the phase III trail. The trail is a integral one with separate geographical samplings just like the AZ phase III trail in two geographical parts, yet that is not called "supersized phase II". It has nothing to do with whether China has enough cases to support the trail.

It is also strange to state "a part of phase III is not phase III" when that part serves the same purpose of the whole. It is not like that the outcome from "China part" is to be treated differently in final statistic.

It is controversial when twice skipping the important statements in the registration to support claim of "supersized phase II".
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When it's acknowledged from the very beginning that one of the 'geographical samplings' will not yield the piece of data that distinguishes phase 3 trials from phase 2 trials, then it makes sense to differentiate that sample from other samples that will yield the data.
 
K

KYli

Brigadier
If it is true that after 6 months the effectiveness dropped to 16%, then it is impossible to administer a booster shot every six months or so.
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Minutes before Bennett’s speech, the Health Ministry released new data showing that the Pfizer coronavirus vaccine remains 91% effective against developing serious cases of the disease. However, its effectiveness at stopping infection declined from 90%-95% to 39%.

The vaccine was found to be 40% effective against symptomatic COVID-19 and 88% effective against hospitalization.

This is specifically with regard to the new Delta variant, which is responsible for more than 90% of cases in the country and has been found to be significantly more contagious.

For people vaccinated more than six months ago, the effectiveness of the vaccine at stopping coronavirus dropped as low as 16%.
 
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