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Originally Posted by tweetiepooh
I do have to agree that the EU dropped the ball. If they knew that the suppliers needed to make applications and hadn't they should have reminded the companies to get all their ducks in order. Just sitting back and then saying that it's up to the company (if that's what happened) really isn't an acceptable situation.
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As jonbxx has outined, all Covid 19 manufacturers need to apply to the relevant authority to be licensed but this can only be done once the vaccine is being produced. It's not something the manufacturers need reminding about nor is it something that can be done until the factory is producing the vaccine in question. Which no factory was doing when the contracts were signed.
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jonbxx From a regulatory point of view, AZ need to prove that the vaccine produced at a site (in this case Halix) is the same as the one submitted for approval. If the analysis results during production and the final product is different from what was submitted for approval, it is not the same drug and will not be approved. The stage Halix (and Novasep) are at is trying to get to the stage of churning out vaccine that matches the approved product. They can't submit for approval by the EMA until this happens.
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