Agenda posted for FDA advisory committee meeting Friday on #covid19 boosters. Departing regulator Dr Marion Gruber kicks off the morning with an introduction of the topic (after this week co-authoring letter saying boosters not needed): fda.gov/media/152159/d…
Also interesting, on FDA’s agenda for Friday booster shot advisory mtg: presenters from UK & Israel on real-world evidence
In its briefing docs for Friday’s FDA booster mtg, Pfizer lays out the case for boosting at 6-8 months, citing data from Israel & US. Notes the erosion is likely due more to waning effectiveness than Delta escape: fda.gov/media/152161/d…
Alarming numbers here from Israel in Pfizer briefing docs ahead of Friday FDA mtg on boosters. Key is last point, on protection against severe disease: for 65+, dropped to <60% in late June/Aug for those vaccinated in Jan/Feb:
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FDA booster meeting Q&A begins w Dr Marion Gruber turning it over to Dr Phil Krause, who notes much of the data being discussed today is "not peer-reviewed and has not been reviewed by FDA."
Asks Pfizer whether Kaiser model accurately reflects true vaccine effectiveness
Dr Krause highly critical of Kaiser study supporting Pfizer conclusions
And Pfizer is having crazy audio issues responding to Dr Krause
Moderna says its vaccine shows durable 93% efficacy through 6 months, says it expects to complete FDA submission for full approval this month: investors.modernatx.com/news-releases/…
Pfizer research chief on quarterly earnings conf call just now: "We continue to believe it is likely that a third dose may be needed within six to 12 months of the full vaccination to maintain the highest level of protection." #covid19
Pfizer has contracts for 2.1B #covid19 vaccine doses in 2021, and plans to make 3B this year. CEO says on conf call just now co is in advanced discussions for many of the remaining doses and expects they'll all be allocated. Capacity for 2022 expected to be 4B doses.
Bernstein's Ronny Gal predicts an additional ~$10B in 2021 revenue for remaining #covid19 vaccine doses not yet contracted. Would mean $43.5B in total 2021 revenue from the Covid vaccine.
Pfizer plans to file for full approval of its #covid19 vaccine at the end of May, per its slide deck just posted for Q1 earnings. It now sees revenue from the vaccine this year of $26B. s21.q4cdn.com/317678438/file…
Pfizer plans to conduct study of pneumonia vaccine candidate w booster dose of #covid19 vaccine, w results expected in Q3 2021, in anticipation a potential booster of Covid vaccine will be authorized & recommended in US as early as fall/winter 2021: s21.q4cdn.com/317678438/file… (p13)
Pfizer plans to start phase 2/3 trial of oral antiviral for #covid19 in Q3, data in Q4, followed by EUA submission before year-end (presuming data are positive)
FDA says it concludes inspection of Emergent plant, issues 483 letter. Production of J&J vaccine remains stopped until issues are remediated. 483 letter here: fda.gov/media/147762/d…
FDA observations re Emergent plant:
1: Failure to conduct thorough investigations into unexplained discrepancies.
Specifically, cross-contamination of two viral vaccines. FDA: “there is no assurance that other batches have not been subject to cross-contamination.”
Note- FDA cites “cross-contamination of client [redacted] viral vaccine drug substance batch... with the virus from client [redacted].”
Emergent’s CEO April 1: “It wasn’t the case where an ingredient from one vaccine contaminated or impacted the other.”