Originally Posted by
percysmith
https://www.tribuneindia.com/news/na...s-stuck-275036
That struck me particularly odd, since I thought the SII product is based on the same formulation as the Astrazeneca product.
So let's say further down the road we get Biontech (boosters) from Fosun, it's not going to be treated the same as the German-manufactured product?!
Is US also practicing vaccine discrimination? I'm in a chat group where someone suggested US recognises vaccines but only those approved by FDA, but I am struggling to find where US even needs vaccine to enter at all (short of state passes like Excelsior pass)
The problem is not the formulation, the internal processes that SII use have to be audited and approved for QA in addition before the EU will accept them, and this is a requirement for each individual manufacturer. This is EU standard practice for all medicines.
I thought an EU team had visited SII earlier this year.
On the BionTech/Fosun, yes exactly the same audit would be required for approval because it is a distinct manufacturer.
The US made it clear pretty early on they had a 3 tier approach:
1. US vaccines first
2. FDA approved vaccines
3. All else need not apply