FDA's advisers have moved to the discussion period for J&J's request for a booster (the real tea)
Huge unanswered questions about why FDA was not able to do much analysis!
youtube.com
Huge unanswered questions about why FDA was not able to do much analysis!
youtube.com
There are concerns about the test J&J used to measure antibodies in some of the studies
VRBPAC's Chatterjee seems like she's had it with the gaps in J&J's safety data
I may be creating drama here, but sensing some awkwardness between FDA officials when asked how long it would take to review relatively small immunogenicity studies
FDA's Marks says "it's possible" that FDA could authorize Moderna and Pfizer vaccines for J&J folks even though FDA's advisers wont vote on it
No details though
No details though
Most important Q of the day: Are we going to be in VRBPAC hell? A 9 hour meeting on every single mix & match option?
CDC says more general language could be added to the J&J EUA allowing mix & match.
VRBPAC's pharma industry rep agrees!
CDC says more general language could be added to the J&J EUA allowing mix & match.
VRBPAC's pharma industry rep agrees!
Not out of the question that Moderna boosters could be cleared for people 40 and older, not just people 65 and older.
Marks suggests a vote.
Incredibly, the VRBPAC chair, who is always pushing to end early, disagrees.
Marks suggests a vote.
Incredibly, the VRBPAC chair, who is always pushing to end early, disagrees.
Cannot stress enough how confusing the goals of boosters remains even to scientists following this closely.
Poignant metaphor here that Marks' response at the end is totally unintelligible.
Poignant metaphor here that Marks' response at the end is totally unintelligible.
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