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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"
Quote from: Jolly2 on 06/02/2021 19:39:01The 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?
Quote from: Jolly2 on 06/02/2021 20:19:16Where is your evidence for that statement?I made no statement.
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.
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.
not being involved in the deal, I cant really comment.
I have little faith in the current regulatory set up.
Quote from: Jolly2 on 08/02/2021 23:50:48not being involved in the deal, I cant really comment.Don't let ignorance hold you back.
Quote from: Jolly2 on 08/02/2021 23:50:48not being involved in the deal, I cant really comment.Don't let ignorance hold you back.QuoteI have little faith in the current regulatory set up. This is a good forum to set out your alternative.