Importantes puntos a tener en cuenta (wwilson_2003 en IV), coincide conmigo en que el cambio de las fechas es porque la reunión con MHRA no dio lugar a completar en septiembre y que UK se retrasará algo:
Our last guidance was for filing in the UK in September, with EU-Canada-Australia following in a few weeks, then USA about a month later. They also told us that there would be a meeting with UK's MHRA in August that was a mere formality, well.... we hope it is a formality...we hope it is the final meeting, how do you like my sweater?
Today Trizzino made a general comment that they had been meeting with the various w/w authorities and incorporating comments into the packages they would submit. He said that since it looked like the filing schedule was leaking into October, they would now like to say that filings will now happen in the "next couple of months" - MHRA, Australia, Canada.
So the MHRA was leading down the stretch, but comments from the meeting probably moved them back into the pack. Perhaps the UK remembered that it was supposed to be a Marathon, not a sprint. Other (from what I heard):
1. Glenn said they would have the UK/Southhampton hetero booster data soon.
2. Glenn mentioned that the UK/Southhampton booster studies were too small for the FDA and that they needed a larger trial in the USA to support a label for boosting.
3. He said that a trial with a variant vax would start in a month.
4. Trizzino said that all the vaccine that producers could make thru 2023 would be sold. I think that in a booster world in 2023, that is debatable, and doubtful if half doses are used.
5. No questions on the hold up or status of manufacturing. Nothing on the India delay rumor (good).
6. No questions on Full approval vs. EUA for the FDA.
7. Note that Pfizer received full approval 3-1/2 months after filing in May. This is lightning fast, but NVAX could probably do it in a couple of...........
Overall, I felt that the UK was a cornerstone and it looks like the UK schedule slipped. We should hope that the cause does not impact the other filings. Those are my impressions.