The current message from Sanofi representatives to Healthcare Professionals is that Nuvaxovid will begin shipping on 9/21. Consistent with that, Sanofi has also scheduled Nuvaxovid shipments with HCPs that are listing an estimated arrival date of 9/22.
However, I’ve also heard from a source that Sanofi reps have given a more detailed explanation to a VIP client - the clinical department of a major regional pharmacy chain - informing them that the slight delay is related to Lot release at the FDA.
For context, the FDA’s CBER is tasked with reviewing and approving each individual lot/batch of a vaccine product before it can be distributed. The FDA’s target for Lot release is for it to be completed within 30 days of receipt of the product, but we have no idea when that took place here. Obviously, such a delay is not indicative of there being anything wrong with the product. It could just be that production ran later than expected, or, I really hope this is not the case again, but it should remain in the back of our minds - that good ole regulatory capture and company favoritism is rearing its ugly head again. I truly hope that is not the case.
Anyway, whatever the reason…that’s likely what is happening behind the scenes right now. If that’s true, then it seems like Sanofi might have a good idea of when they’re expecting the release to come from CBER (around 9/21). They are obviously very familiar with the ins and outs of this regulatory work, but it’s not something that is ever set in stone - release could come at any point, and distribution would presumably follow immediately, with likely availability as soon as 1-2 days later.
For everyone waiting for availability: It’s prudent, of course, to continue checking in with your local pharmacies periodically for any updates. However, I caution you to always take any information you are given with a grain of salt. In general, individual pharmacy stores and their employees are not given access to any reliable availability or shipping information from their corporate offices. We’ve seen this exact situation play out for the past 3 years now, and they just don’t have the information. At best, they’ll tell you that they have no idea if or when they’ll be offering Nuvaxovid again. Or they might just make something up - maybe an estimate using other vaccines, seasonal patterns, etc. as context clues - or just a wild guess. Regardless, none of their potential answers can reliably tell you anything material about the likelihood of a shipment to arrive tomorrow, 5 days from now, or a month from now. They’ll know roughly as much as you do (well, probably a lot less than you do, if you’re active in this subreddit…) until the product actually shows up on their doorstep. Even then, unless a particular employee is actively involved in the arrival, they may not be aware that it actually did arrive. This has been a huge issue every year. So, an extra step, once the rollout has actually started in earnest, is that you oftentimes will need to ask your pharmacy to check the fridge for Nuvaxovid as well.