I have been asking the Health Department across multiple estimates a simple question. Every drug approved in Australia must be made using Good Manufacturing Practice (GMP), which is a detailed standard to ensure quality and consistency in manufacturing of pharmaceutical products.
If the “speed of science” prevented using GMP then say so. Instead, the TGA and Health Department has bobbed and weaved to prevent giving me a straight answer, and today is no different.
The last response I got was to send me a list of GMP certificates issued to Pfizer. There was no ability to check the certificates back to the injection batch numbers. This looks to me like there is a coverup to hide that the vaccines were not produced using GMP until late in the rollout. This was a decision that was not open to the TGA to make. Accepting products made in a rush may have been why the original doses were accompanied by such a high and unpredictable rate of harm. I will continue to pursue this matter.
Transcript
Senator ROBERTS: Let’s move to good manufacturing practice. I have just two questions left. At the last estimates, I tried to get to the bottom of whether every batch of Pfizer COVID injections was made using good manufacturing processes. If they were not, that may explain the huge variance in adverse events between batches. If they were made with good manufacturing processes, there is another cause we really need to understand for the huge number of excess deaths. In your answer on notice, you did not answer the question, but you gave me a list of entries in your manufacturing information database. This is a little confusing, because your answer does not allow me to check good manufacturing process certificates off against batch numbers. What your data tells me is that all of these good manufacturing process certificates were issued as a result of a desktop audit rather than an in-person inspection, which means you took the manufacturers’ word for it based on whatever it was they sent you. Is that correct?
Prof. Lawler : Thank you for the question. I would just highlight that we’ve received these questions regarding the batch testing of vaccines and the associated release a number of times before, and we’ve answered these questions—most recently, I think, SQ23-002145. Those answers are clearly on the record.
Senator ROBERTS: That’s not the one I have. Secondly, there are 44 good manufacturing process certificates for all COVID vaccines, yet there are 410 batches listed in your COVID vaccine batch release assessment. Some of those are duplications and some, admittedly, are for AstraZeneca, but the number seems off. Can you please give me on notice a full list of Pfizer batch numbers and the corresponding good manufacturing process—or is it true that good manufacturing process was only used from the bivalent vaccines onwards?
Prof. Lawler : Thank you for the question. I’m happy to either take that on notice or to return to that under outcome 1.8 when my—
Senator ROBERTS: Perhaps you could take it on notice.
Prof. Lawler : Absolutely.
Senator ROBERTS: Thank you.
