Naked Science Forum
General Discussion & Feedback => Just Chat! => Topic started by: Jolly2 on 06/02/2021 04:26:20
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India wanted a trial of the Pfizer vaccine before they would allow it to be used, so Pfizer dropped the application? Why?
https://www.reuters.com/article/health-coronavirus-india-pfizer/pfizer-drops-india-vaccine-application-after-regulator-seeks-local-trial-idUSKBN2A50GE
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Trials cost money.
The vaccine is established as being safe (in the sense that it's a hell of a lot better than the virus)
So the Indian government insisting on further trials is not anything to do with actually getting more information. They are just for some reason- presumably a political reason- being uncooperative.
Pfizer knows it has a good product and that India has a huge demand for it.
They know that they just have to wait for India's government to recognise that, by their stubbornness, they are putting their people at risk for no good reason.
Presumably Pfizer figures the short term loss of sales is less of a cost than the trial.
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There is already a contract for the manufacture of OAZ vaccine in India, signed very early on in the Oxford trial. Assuming that the Indian government is no less corrupt than any other, we can guess that some brown envelopes were exchanged to delay the competition.
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There is already a contract for the manufacture of OAZ vaccine in India, signed very early on in the Oxford trial. Assuming that the Indian government is no less corrupt than any other, we can guess that some brown envelopes were exchanged to delay the competition.
The Indian regulator
"The drug regulator said on its website its experts did not recommend the vaccine because of side effects reported abroad were still being investigated"
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The Indian regulator
"The drug regulator said on its website its experts did not recommend the vaccine because of side effects reported abroad were still being investigated"
Well, did you expect them to say "We don't recommend the vaccine because we got a backhander from their competitors"?
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The Indian regulator
"The drug regulator said on its website its experts did not recommend the vaccine because of side effects reported abroad were still being investigated"
Well, did you expect them to say "We don't recommend the vaccine because we got a backhander from their competitors"?
Where is your evidence for that statement?
They cited issues with side effects there have been side effects , hence there statement makes more sense then your suggestion
Pfizer refusing to allow a trail shows a concern about is efficacy
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Where is your evidence for that statement?
I made no statement.
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A major challenge in India is distributing the Pfizer vaccine outside major city hospitals.
- The -70C cold chain infrastructure is unique
- The Astra-Zeneca vaccine can be stored in ordinary vaccine fridges, so it's probably a better choice for most of India's population
- At about 10x the price, the Pfizer vaccine would be unaffordable for most of the population (if they had to pay full price)
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Where is your evidence for that statement?
I made no statement.
You implied India was taking money to reject Pfizer, why?
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Like Alan, I was "Assuming that the Indian government is no less corrupt than any other,"
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Though Evan's observation also makes sense. Supply contracts generally end at "Freight on Board", when the supplier hands a package and instructions to the customer's nominated carrier.
In order to use the Pfizer material you have to ensure a -70 degree cold chain pretty much to the end user, so whilst it will work in a major hospital close to a large cargo airport, the stuff that actually gets delivered to 90% of the Indian population probably won't, without a huge investment in chilled distribution and process control.
So the trial would have to be more about the part that Pfizer don't control and can't fund, than the already proven efficacy of the material when delivered correctly.
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Though Evan's observation also makes sense. Supply contracts generally end at "Freight on Board", when the supplier hands a package and instructions to the customer's nominated carrier.
In order to use the Pfizer material you have to ensure a -70 degree cold chain pretty much to the end user, so whilst it will work in a major hospital close to a large cargo airport, the stuff that actually gets delivered to 90% of the Indian population probably won't, without a huge investment in chilled distribution and process control.
So the trial would have to be more about the part that Pfizer don't control and can't fund, than the already proven efficacy of the material when delivered correctly.
Supply chain issues Pfizer was well aware of before they requested authorisation, its seems to solely be a refusal to allow an independent trail. I mean the bodies engaged in western trails are suffering under corporate capture.
Expressly the India health authority wanted a trial due to concerns with side effects, for Pfizer to withdrawn implies they have concern about the potencial results.
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Authorisation means a licence to supply to your chosen customers. There would obviously be no need for a trial if Pfizer chose only to supply those who could and would comply with their Instructions For Use. Therefore the trial specification must have gone outside the published IFU and they were right to withdraw.
Common and occasional side effects have been established and published from the existing clinical trials. "Rare" side effects and late complications will be revealed by worldwide postmarket surveillance.
Either the Indian authorities demanded a trial outside the IFU scope, or they insisted on a unique Phase 3 trial to protect the commercial interests of the OAZ licensee. Either requirement is unethical and Pfizer is not a charity, so withdrawal is entirely justified.
Not sure what "corporate capture" means. All the trials I have reviewed were funded by the manufacturer but undertaken under the scrutiny of a government agency (MHRA in the UK, FDA in the USA) and independent research ethics committees.
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Authorisation means a licence to supply to your chosen customers. There would obviously be no need for a trial if Pfizer chose only to supply those who could and would comply with their Instructions For Use. Therefore the trial specification must have gone outside the published IFU and they were right to withdraw.
Speculative, not being involved in the deal, I cant really comment.
Common and occasional side effects have been established and published from the existing clinical trials. "Rare" side effects and late complications will be revealed by worldwide postmarket surveillance.
Still more then Covac.
Either the Indian authorities demanded a trial outside the IFU scope, or they insisted on a unique Phase 3 trial to protect the commercial interests of the OAZ licensee. Either requirement is unethical and Pfizer is not a charity, so withdrawal is entirely justified.
Not sure what "corporate capture" means. All the trials I have reviewed were funded by the manufacturer but undertaken under the scrutiny of a government agency (MHRA in the UK, FDA in the USA) and independent research ethics committees.
Funded by them, and then watched over by a government regulator. You know government regulators also watch the stock market, supposedly. Trouble is that there has been a concerted effort since Thatcher to privatise regulators, 2008 hence was not a suprise, a badly monitored trial wouldn't be either, especially when its rushed.
I have little faith in the current regulatory set up.
And we now see also that south Africa after conducting a trail of astrozenica vaccine have put its use on hold as its efficacy is way under the 50% required.
https://www.reuters.com/article/us-health-coronavirus-safrica-idUSKBN2A70PY
A perfect example of why each countries should do their own trails and not simply allow a vaccine because another country has authorised it.
I ponder what the Indian study made have found, sadly we now, because of the actions of Pfizer, wont know.
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not being involved in the deal, I cant really comment.
Don't let ignorance hold you back.
I have little faith in the current regulatory set up.
This is a good forum to set out your alternative.
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not being involved in the deal, I cant really comment.
Don't let ignorance hold you back.
I've already speculated Pfizer considered it too risky to allow. They got an authoritarian, they will try and use that everywhere, and resist further trails.
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not being involved in the deal, I cant really comment.
Don't let ignorance hold you back.
I have little faith in the current regulatory set up.
This is a good forum to set out your alternative.
An actual regulator that is independent of government and business, would be a good start.