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Indian government/drug regulator is requiring the phase 3 trials be repeated in India, and Pfizer got scared and left.
Quote:
India’s Central Drugs Standard Control Organization had declined to accept Pfizer’s request for approval without a small local trial on the vaccine’s safety and immunogenicity for Indians, Reuters has reported.
Quote:
“Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time,” it said in a statement to Reuters.
India won't approve until trials include people from India. That's all. Approval application was pulled cuz is not getting approved until people from India are included.
India won't approve until trials include people from India. That's all. Approval application was pulled cuz is not getting approved until people from India are included.
India doesn’t trust Pfizer’s phase 3 trials in the USA so demanding Pfizer redo them in India under Indian regulatory supervision or face losing their EUA. Pfizer just quit, knowing full well a properly regulated phase 3 (unlike the sham in the USA) would embarrass them internationally!
India doesn’t trust Pfizer’s phase 3 trials in the USA so demanding Pfizer redo them in India under Indian regulatory supervision or face losing their EUA. Pfizer just quit, knowing full well a properly regulated phase 3 (unlike the sham in the USA) would embarrass them internationally!
India won't approve until trials include people from India. That's all. Approval application was pulled cuz is not getting approved until people from India are included.
Not really that interesting. We do the same thing here. AstraZeneca didn't get approved until Dec 2021 as there's regulator favoritism to US and US related companes.
E.g., Moderna and J&J are American. Pfizer just did the trials, manufacturing, and distribution for BioNTech which is German. Over in India J&J and Moderna were only approved late in last year as well and like AstraZeneca here are not really in distribution in any meaningful numbers. India has the Bharat vax as well as they use AstraZeneca run through a local company same as we have Pfizer running BioNTech vax. In Russia they use Russian vaccines. If you want rushed, it's the Russian vaxes. They'e okay but they didn't bother with stage 3 trials to confirm that which is part of the hesitancy in Russia. But at this point half the population has been vaxxed which is a pretty good trial size and most of them can't afford to take a medical vacation to get vaccinated with a non-Russian vax.
Not really that interesting. We do the same thing here. AstraZeneca didn't get approved until Dec 2021 as there's regulator favoritism to US and US related companes.
E.g., Moderna and J&J are American. Pfizer just did the trials, manufacturing, and distribution for BioNTech which is German. Over in India J&J and Moderna were only approved late in last year as well and like AstraZeneca here are not really in distribution in any meaningful numbers. India has the Bharat vax as well as they use AstraZeneca run through a local company same as we have Pfizer running BioNTech vax. In Russia they use Russian vaccines. If you want rushed, it's the Russian vaxes. They'e okay but they didn't bother with stage 3 trials to confirm that which is part of the hesitancy in Russia. But at this point half the population has been vaxxed which is a pretty good trial size and most of them can't afford to take a medical vacation to get vaccinated with a non-Russian vax.
Moderna is not available in India.
Quote:
But during the book launch of ‘A Nation to Protect’ in New Delhi, health minister Mansukh Mandaviya revealed why the Indian government didn’t procure the vaccines manufactured by Pfizer and Moderna.
When Sudhir Chaudhary, Editor In Chief of WION, asked about the reasons, Mandaviya said that Moderna and Pfizer had placed a condition before the Indian government that it would only their vaccines if an indemnity clause is signed.
It means that if there is any side effect or if someone dies after taking the vaccine, then the company will not be held accountable and prosecuted under Indian law.
J&J didn't do that, so got approved very quickly, but it's not widely used. Indians prefer Covaxin, a locally made inactivated virus vaccine over J&J and Covishield (Indian made AstraZeneca).
Now, with Pfizer, Pfizer was still negotiating with the Indian government, when Indian demanded to redo their phase 3 trials in India, and Pfizer just gave up.
J&J didn't do that, so got approved very quickly, but it's not widely used. Indians prefer Covaxin, a locally made inactivated virus vaccine over J&J and Covishield (Indian made AstraZeneca).
Now, with Pfizer, Pfizer was still negotiating with the Indian government, when Indian demanded to redo their phase 3 trials in India, and Pfizer just gave up.
Exactly, no sense wasting the money on trials when the sales would just be blocked anyway. J&J and Moderna are both approved. That doesn't mean they see any meaningful sales numbers in India. They don't, they're near if not zero for both J&J and Moderna.
If you're Pfizer, why waste money on doing the trials. You'd at the least have to cut in a second middleman. E.g., BioNTech owns the vax, Pfizer is middelman and does production/distribution. In India you'd have to run the production and distribution through a local company. By the time you get through running expensive trials the demand surge from bossters/omicron would have certainly been met by the Indian vaxes so there'd be few sales left and little profit on them.
If you're India it's no great loss. Even if they didn't require stage 3 trials for Indians by the time Pfizer cut a deal and got production going it probably wouldn't be any faster than the Indian vaxes could handle the surge in demand. It's not really that big of a loss for India to not have J&J, Moderna, and Pfizer vaxes. They have their own vaxes. Allowing Moderna, J&J, and Pfizer to import foreign produced vaxes would have been faster, but that's not something that is politically viable in India which is why Moderna and J&J both have approval but are not sold. By the time they cut in an Indian company to make and distribute the vax it's just too much risk for too little profit to make any sense.
Exactly, no sense wasting the money on trials when the sales would just be blocked anyway. J&J and Moderna are both approved. That doesn't mean they see any meaningful sales numbers in India. They don't, they're near if not zero for both J&J and Moderna.
If you're Pfizer, why waste money on doing the trials. You'd at the least have to cut in a second middleman. E.g., BioNTech owns the vax, Pfizer is middelman and does production/distribution. In India you'd have to run the production and distribution through a local company. By the time you get through running expensive trials the demand surge from bossters/omicron would have certainly been met by the Indian vaxes so there'd be few sales left and little profit on them.
If you're India it's no great loss. Even if they didn't require stage 3 trials for Indians by the time Pfizer cut a deal and got production going it probably wouldn't be any faster than the Indian vaxes could handle the surge in demand. It's not really that big of a loss for India to not have J&J, Moderna, and Pfizer vaxes. They have their own vaxes. Allowing Moderna, J&J, and Pfizer to import foreign produced vaxes would have been faster, but that's not something that is politically viable in India which is why Moderna and J&J both have approval but are not sold. By the time they cut in an Indian company to make and distribute the vax it's just too much risk for too little profit to make any sense.
There are 1.3 billion people in India, it's one of the largest vaccine markets in the world, after the EU and China. If Pfizer could, it would. Even if it sold just 100 million doses, that's still over 1 billion in profits.
When Sudhir Chaudhary, Editor In Chief of WION, asked about the reasons, Mandaviya said that Moderna and Pfizer had placed a condition before the Indian government that it would only their vaccines if an indemnity clause is signed.
It means that if there is any side effect or if someone dies after taking the vaccine, then the company will not be held accountable and prosecuted under Indian law.
This caused problems for India.
The health minister said that it didn’t seem wise for the Indian government to accept their demands, and instead went ahead with the indigenous vaccines.
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