Coronavirus SARS-Cov2 (COVID-19)

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jaydeep
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Re: Coronavirus SARS-Cov2 (COVID-19)

Post by jaydeep »

jayakris wrote: Tue Jan 05, 2021 7:10 am But the crazy thing in this whole affair, is that Bharat Biotech is also pretty confused about what approval they actually got! ICMR and the health ministry have some explaining to do. If it is indeed some sort of trial regime that is to be done along with the vaccination drive, then a lot of details need to be set in place. Pure technical details on sampling, as well as things like legal issues, dealing with those who get vaccinated. But nothing seems to be clear even to B.Biotech.

Instead, as is their tendency, the BJP government will probably go after those who question things, calling them "anti-Modi" or "anti-national"... Well, some of them, or most of them probably are anti-Modi, but almost none would be anti-national. May be nation-skeptic, at best. But that is all irrelevant, when we have a pandemic to deal with. The Government should realize that info needs to be released. Whatever info and data that B.Biotech has given to ICMR and DCGI need to be publicly released in some form. Even in general terms. Trust in Government institutions is very important. To take it to political twitter fights and back-and-forth will serve no purpose, from the public's standpoint right now.
Agree with your points Jay, but those were unnecessary comment from Adar Poonawalla for other vaccine manufactures.


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Re: Coronavirus SARS-Cov2 (COVID-19)

Post by jayakris »

jaydeep wrote: Tue Jan 05, 2021 1:44 pmAgree with your points Jay, but those were unnecessary comment from Adar Poonawalla for other vaccine manufactures.
Yeah, that was unusually brash of him. More than others' criticism, that may be what drove Krishna Ella mad. Anyway, it looks like these two realized that it is no use for either of them to be in a pi**ing match, and they sent out a joint statement today that everybody is united in the fight.

Meanwhile, here is the ICMR powerpoint explaining the status of vaccines and some info on what data they have -
https://www.thehindubusinessline.com/re ... 0draft.pdf


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Re: Coronavirus SARS-Cov2 (COVID-19)

Post by jayakris »



That means people who consent to take B.Biotech's Covaxin will simply be counted to be part of phase-III trials (but there will be no new control/comparison group of placebo-takers, except for those already drafted into the trial). That clarifies things a little bit better. Looks like my guess above is what they are doing. Simply counting those who take the vaccine to be part of the trial. That would imply that they have data (hopefully) that give them confidence that there is no safety concern and that only efficacy is being tested, to speed up the phase-III. Pretty much what I guessed. They should've explained these things first. Not sure what ethical concerns I may be missing in my thinking...

So, it will be the vaccine-takers who will basically make it the backup vaccine. No reason for them to take Covaxin and join the trial if Serum Institute's Covishield is available at their location... Right? [It is a little unfair, because Astra-Zeneca data behind Covishield is patchy too, though better than what we have from B.Biotech]

Here is the ANI wire article on the details Dr. Bhargava gave. Emergency use of vaccine is based on safety, immunogenicity data, says ICMR chief
"Remarkable efficacy in phase I/II" is being used as a surrogate, and apparently it is allowed as per our drug control protocol (I think others question this; but I guess it is a judgment call?).


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Re: Coronavirus SARS-Cov2 (COVID-19)

Post by jayakris »

Only +17.9K today, which is about 2600 less than on last Tuesday. From 1020K tests @ 1.76%... The death total was 265... The 7-day average of case additions dropped by 376 more, and we are at +18.3K per day now.

Unbelievable rises in case numbers in UK (up to 60K per day now... Wow)... Also big percentage growth in Ireland, Japan, Thailand, etc. What a weird virus, this is. People think they have it all under control, and then, boom, it just starts spreading uncontrollably. More than how it spreads fast, what is weird is how it stays low in some countries for so long, if it is able to spread and add case numbers so fast once it gets going. How did Thailand stay out of trouble so long? The more I look at it, the more it looks like luck - provided one is doing testing at a high level (like Thailand and Korea); but that by itself does not keep you out of trouble. It still gets going at some point.

Meanwhile, Argentina, the only other country that earlier seemed to be getting only a single peak like India, is also on to a second wave. They went up to 15K daily average at the peak and was steadily dropping like India till early December to 5K... But they have now had rises the last 3-4 weeks, going back up. There isn't even the cold indoors issue there and it started well before Christmas. I wonder how anybody can explain these infection waves.

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ICMR Update: 177,463,405 total tests... Tuesday tests: 931,408... Lab count: 2305


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Re: Coronavirus SARS-Cov2 (COVID-19)

Post by usaindia »

US has vaccinated 4.8 million people with 17 million distribution.
Logistics seems to be problems
https://covid.cdc.gov/covid-data-tracker/#vaccinations


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Re: Coronavirus SARS-Cov2 (COVID-19)

Post by jayakris »

Kerala and Maharashtra each showed about 1000 cases more than we wanted, and today's total was not that low, at +20.5K... From about 1074K tests at 1.91%... It is still about 1500 less than last week's Wednesday peak and the positivity is also a tad bit lower than the 1.95% last Wednesday... The 7-day average dropped about 211 to 18.1K and today's deaths were only 221... But we need to keep an eye out for a week, to see if anything starts rising after the Christmas and year-end activities.

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ICMR Update: 178,400,995 total tests... Wednesday tests: 937,590... Lab count: 2308


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Re: Coronavirus SARS-Cov2 (COVID-19)

Post by Kumar »

usaindia wrote: Wed Jan 06, 2021 12:53 pm US has vaccinated 4.8 million people with 17 million distribution.
Logistics seems to be problems
https://covid.cdc.gov/covid-data-tracker/#vaccinations

They are doing health care workers and it is not easy especially when they need to make sure they are not all vaccinated at same tim! Also,I heard they can’t even open the vials until they have the people present for vaccination!

I


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Re: Coronavirus SARS-Cov2 (COVID-19)

Post by kujo »

jayakris wrote: Tue Jan 05, 2021 3:48 pm That would imply that they have data (hopefully) that give them confidence that there is no safety concern and that only efficacy is being tested, to speed up the Phase-III. Pretty much what I guessed. They should've explained these things first. Not sure what ethical concerns I may be missing in my thinking...
The point of Phase 1, Phase II and phase III trials for any new drug is to exactly discover those aspects: Safety, efficacy, long term effects, etc. To say we will approve a drug, even before phase III is done - defeats that purpose. And to somehow claim, there is no safety concerns so far, hence we are moving forward - no no, not right!

By the way, I looked at the data / presentation on Covaxin. A curosry look will show you immediately that we should be concerned on safety until proven otherwise. To quote: "Very low Adeverse events" for Phase I and phase II 375 and 380 participants.

What is an adverse event? https://www.fda.gov/safety/reporting-se ... erse-event

There is no exact number on these adverse events for CoVaxin. Should "low' mean 1 event?- naaah Then they would have said exactly that! My guess is 5 to 6 events for "very low". Which means, approximately 1% of the study participants had an adverse event.

Remember, an entire Phase 3 trial was put on hold for another vaccine candidate - because of 1 serious adverse event?

So, in all reality, we are not sure of the safety profile of CoVaxin. Until that is established, approving it as a vaccine drug is simply wrong!


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Re: Coronavirus SARS-Cov2 (COVID-19)

Post by jayakris »

^^^ Agree. If they did not have safety data, the drug approval must absolutely not have happened. I assume they did. Because they keep saying they did. They should release that data, of course. But I am usually NOT an India-skeptic in these things, whichever party is in power. We still have a lot of honest people with integrity among our scientists and even politicians. I just do not think they would let this happen, unless they saw very very few cases of clearly adverse side-effects.


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Re: Coronavirus SARS-Cov2 (COVID-19)

Post by jayakris »

+18.1K cases today, from 1072K cases at our best-ever positivity of 1.69% .... About 1900 less than last Thursday, which dropped our 7-day average of cases by 269 to 17.8K... The deaths were 233. No problematic trends seen anywhere. Kerala's test positivity improved a tad bit to 8.3% (hope it keeps dropping, and quickly!)... That's it.

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ICMR uodate: 179,336,364 total tests... Thursday tests: 935,369... Lab count: 2308


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Re: Covid-19 Daily Number Updates (June 12 onward)

Post by suresh »

Safety/Efficiency data will be available in March for Bharat Biotech's vaccine.


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Re: Coronavirus SARS-Cov2 (COVID-19)

Post by jayakris »

The blasted anti-national newspaper is at it again. Helping an anti-vacciune nut group to form in India. Irresponsible journalism.
I would not take the vaccine without efficacy data: Gagandeep Kang (The Hindu)

See the ending of the article. She was not saying that she expects any problem with the vaccine. Said she will have no problem taking the vaccine as a volunteer in a trial. She won't take the vaccine if it is given under terms of "restricted use" because "it doesn't make sense" to her. That is a perfectly reasonable stand. But the newspaper made a headline that makes people feel that there could be something wrong with the vaccine.

Efficacy data has nothing to do with safety. But it "makes no sense" to have a vaccine that has no efficacy, of course. Especially when a vaccine with proven 50+ efficacy is available! ... The distinction is not being made clear by Indian newspapers and commentators with an agenda, and they are doing damage to our vaccine plans.

Anyway, Dr. Kang should shut the hell up. She just speaks her mind like an academic, and people make use of her to push their anti-Modi agenda. But Modiji and ICMR asked for it this time too.


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Re: Coronavirus SARS-Cov2 (COVID-19)

Post by jayakris »

+18.5K today, from 1071K tests at 1.72%... A few hundred cases less than on last Friday. The 7-day average fell by 110, to 17.7K, so we are actually flattening a bit in the dropping case totals. It was 400+ average drop per day for a few weeks, but it may be down to 100 to 250 or so per day now.

Kerala's positivity has shown a little improvement this week, without the test counts going down. So hopefully KER will also start dropping, after a holding pattern at around 5000 cases (7 day average) for almost 2 months now. They've been "chopping the peak" as I call it. That happens when states refuse to raise their testing in proportion to case numbers. Ultimately the case numbers do drop, but that would be after unnecessarily having a lot more infections happen than there should have been; if people were caught before they infected others through more contact tracing.

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ICMR Update: 180,253,315 total tests... Friday tests: 916,951... Lab count: 2316


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Re: Coronavirus SARS-Cov2 (COVID-19)

Post by Kumar »

I agree that double bind placebo trials at this point are extremely difficult especially when approved efficient vaccine is available! It is probably unethical as well!! For those getting the vaccine on experimental basis, are we going to do follow ups to understand the safety/efficacy of the vaccine! What is the limit on who’s many doses will be given? Are we talking 1 million participants!

I think these are questions that must be absolutely answered!


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Re: Coronavirus SARS-Cov2 (COVID-19)

Post by jayakris »

Kumar wrote: Sat Jan 09, 2021 2:37 pmFor those getting the vaccine on experimental basis, are we going to do follow ups to understand the safety/efficacy of the vaccine!
Absolutely. That was clearly in ICMR's statements. They will be under observation/follow-up. But no details on how. Do they even have the data and software utilities ready for all this? Who knows.
What is the limit on who’s many doses will be given? Are we talking 1 million participants!
I think this will depend on how many people will volunteer to take Covaxin. If Covishield is available, I don't think anybody will take Covaxin now. When they run out of Covishield at any vaccination location, some people may decide that takiong a shot is better than not taking one, and may just volunteer (with B.Biotech and the Government will take legal responsibility like in the phase-III trial; not as in regular vaccination).

So, basically this looks like nothing but a way to sign up people for the trial, saying it is voluntary. Data collection using the vast healthcare/vaccination machinery, at probably 100 times the number of locations than they can do in a clinical trial study like what B.Biotech is now doing.

Just my guess. Say, when the people register for vaccination, I assume they will be asked "if Covidshield is not available, are you willing to take Covaxin that has ICMR's preliminary safety approval, and be part of its phase-III trial on its efficacy?".. Would people say yes? Only very very few, but some just might, and those numbers can add up. Now, assume they offer something like "if you agree, you can recommend another person not in the priority group to get vaccinated too".... Then some more people might take a shot at getting the vaccination, as their wife or son or somebody else can also get vaccinated early. Maybe... [But offering money would be unethical, of course]

I can only guess such possibilities, and I have no clue if any of that is practical. But if they can get a few thousands to volunteer from all around India (and can set up the follow-up system properly), it is probably worth it... to speed up the phase-III trial. Even one or two months of speed-up is worth it.

But, without some scheme like above (volunteers recommending non-priority people also), I don't understand how the sampling can be done without bias. Vaccination at first will only be for the priority groups. So, if only they volunteer to be part of the Covaxin trial, it would be a very biased sample. I think this is the part that makes the experts totally suspicious of things. They have never seen an attempt to do it this way, because it can't work due to sampling issues!

I am talking about a topic on which I have no clue at all, so I may be totally wrong in my guesses.

The Government and ICMR have been terrible in telling people what the hell they are doing. They deserve the criticism. I think they are not saying much because they are basically working out the details on how they can do this, or IF they can do this. Then they should've announced the approval after figuring out the details. Even B.Biotech seems to have been caught off-guard, as they didn't seem to expect an approval and were asking what exactly is the approval they got!