Thanks again for pointing out commercial manufacturers, not military, produced the C19 injections! That’s interesting to hear that Oxford Biomedica is the commercial manufacturer for AstraZeneca. Your previous posts also covered Lonza and Catalent producing the C19 vaccines for Moderna. It’s apparent from their websites they are also commercial. I was under the impression for the longest time the military manufactured the C19 injections. I wonder why there is so much confusion? Maybe folks are conflating the military’s role in the distribution of the initial rollout 4 years ago? It would be easy to confuse the two if one is not an industry insider.
Just out of curiosity, who manufactures the Pfizer C19 injections? Does Pfizer still carry out some of their own manufacturing in house? My last question concerns 483s. My understanding from your posts, 483s are forms the FDA uses to write up manufacturing deficiencies when there is an issue with GMP or good manufacturing. The Catalent 483s were written up in the US. Does FDA have the ability to inspect outside the US and carry out their duties and write up 483s overseas? If a manufacture does not respond to 483s, as in the situation with Catalent/Moderna, is there an escalation process the FDA can implement?
Do you have any historical examples of FDA using their authority over a commercial manufacturer for not resolving 483s. Just trying to understand the process. I really appreciate everything you’ve shared as it clears up several pieces of the puzzle.
Thanks Alison - you really have been paying attention! The US is the only country advancing the military theory and yes, it is probably because of involvement i n the distribution logistics. The Pfizer C19 drug substance for the injections were first manufactured by Wyeth Biopharma, a company Pfizer bought in 2011. It had a scathing inspection by FDA but senior management took no action...hmmmm.
Yes FDA can write up 483 for overseas companies, here is an example: https://www.fda.gov/media/159164/download Rentschler manufacturers the drug substance as well as Wyeth. Pretty bad, eh, even with the redactions! FDA issued a consent degree against a J&J company (McNeil) in 2011. That means they go in and run the company for them, until remediation is completed.
Thanks Hedley for the explanation! It seems uncharacteristic based on the info you shared regarding J&J, the FDA would not issue consent degrees against the manufactures of the C19 injections. How odd that nothing has happened after 4 years when there is a mechanism in place in the event there are injuries due to problems with the GMP supply chain???
Thanks again for pointing out commercial manufacturers, not military, produced the C19 injections! That’s interesting to hear that Oxford Biomedica is the commercial manufacturer for AstraZeneca. Your previous posts also covered Lonza and Catalent producing the C19 vaccines for Moderna. It’s apparent from their websites they are also commercial. I was under the impression for the longest time the military manufactured the C19 injections. I wonder why there is so much confusion? Maybe folks are conflating the military’s role in the distribution of the initial rollout 4 years ago? It would be easy to confuse the two if one is not an industry insider.
Just out of curiosity, who manufactures the Pfizer C19 injections? Does Pfizer still carry out some of their own manufacturing in house? My last question concerns 483s. My understanding from your posts, 483s are forms the FDA uses to write up manufacturing deficiencies when there is an issue with GMP or good manufacturing. The Catalent 483s were written up in the US. Does FDA have the ability to inspect outside the US and carry out their duties and write up 483s overseas? If a manufacture does not respond to 483s, as in the situation with Catalent/Moderna, is there an escalation process the FDA can implement?
Do you have any historical examples of FDA using their authority over a commercial manufacturer for not resolving 483s. Just trying to understand the process. I really appreciate everything you’ve shared as it clears up several pieces of the puzzle.
Thanks Alison - you really have been paying attention! The US is the only country advancing the military theory and yes, it is probably because of involvement i n the distribution logistics. The Pfizer C19 drug substance for the injections were first manufactured by Wyeth Biopharma, a company Pfizer bought in 2011. It had a scathing inspection by FDA but senior management took no action...hmmmm.
Yes FDA can write up 483 for overseas companies, here is an example: https://www.fda.gov/media/159164/download Rentschler manufacturers the drug substance as well as Wyeth. Pretty bad, eh, even with the redactions! FDA issued a consent degree against a J&J company (McNeil) in 2011. That means they go in and run the company for them, until remediation is completed.
Thanks Hedley for the explanation! It seems uncharacteristic based on the info you shared regarding J&J, the FDA would not issue consent degrees against the manufactures of the C19 injections. How odd that nothing has happened after 4 years when there is a mechanism in place in the event there are injuries due to problems with the GMP supply chain???
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My favorite parts of Covid:
#29
The DeHumanity
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