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Meg Tirrell Profile picture
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18 Oct, 6 tweets, 3 min read
I mean I guess it wouldn’t be a true Boston event without some beatboxing? #HLTH21
I’ll admit to being confused though about trying to tune into a panel with Moderna & Thermo Fisher CEOs moderated by @MichaelPellini and finding this
Thermo Fisher CEO says at #HLTH21 the US govt is paying for the company to build the world's largest pipette tip factory

(not new news, just interesting; had been previously announced here: prnewswire.com/news-releases/…)
Moderna CEO: "One story that is not enough told in the media is we're going to soon be swimming in vaccine around the world."

Says likely within 2-3 months the global supply situation will resemble the US's, where you can walk into any CVS and get a #covid19 shot. #HLTH21
Moderna CEO notes "the industry in the last 30 days has shipped 1.3 billion doses" of #covid19 vaccine globally.

"The biggest thing I worry about is logistics, in terms of vaccination of people in low income countries." #HLTH21
Moderna CEO sees flu + #covid19 combo booster potentially on the market in fall of 2023, "best-case scenario... but I will not bet against the team." #HLTH21

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More from @megtirrell

Meg Tirrell Profile picture
19 Oct
Phase 2 results on Atea/Roche #covid19 antiviral AT-527 just out. Didn't meet goal in reducing virus in mild to moderate Covid in overall study population, which co says was 2/3 patients at low risk w mild symptoms. But says there was a reduction for high-risk patients (1/2)
Atea says it and Roche are assessing modifications to their phase 3 #covid19 antiviral trial, and now expect results from it in the second half of 2022 (2/2)

ir.ateapharma.com/news-releases/…
Shares of Atea ($AVIR) are down 65% pre-market after a trading halt
Read 5 tweets
Meg Tirrell Profile picture
24 Sep
I just spoke with Dr Katherine Poehling from Wake Forest, one of the CDC advisory cmte members whose vote was ostensibly overruled by @CDCDirector Dr Rochelle Walensky on Pfizer #covid19 booster.

I say ostensibly, because Dr Poehling says she feels like Dr Walensky listened. (1)
ACIP member Dr Poehling:

“We’re an advisory committee, and I felt like our perspectives were clearly heard. And so I felt like the process actually worked well.” (2)
Dr Poehling says she voted no because she was concerned people in that last category (at occupational/setting risk) would feel they didn’t have a choice BUT to get a booster.

But Dr Walensky's recommendation added the word "may" for that category. (3)
Read 5 tweets
Meg Tirrell Profile picture
23 Sep
FDA notes at CDC advisory committee meeting that it has a Moderna submission for #covid19 vaccine booster, and “we are working diligently to get that completed.”
FDA says it’s working with partners including NIH to provide a solution about boosters for all - “I don’t know if I can provide a specific timeframe,” Dr Doran Fink says.
Dr Peter Marks joins: “We understand at FDA the relative urgency here of trying to have a solution for anyone who’s been vaccinated with any of the authorized or approved vaccines. Unfortunately we’re not in a place right now where I can give you an exact timeline… (cont)
Read 4 tweets
Meg Tirrell Profile picture
17 Sep
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

I am feeling so awkward
Read 29 tweets
Meg Tirrell Profile picture
15 Sep
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… Image
Also interesting, on FDA’s agenda for Friday booster shot advisory mtg: presenters from UK & Israel on real-world evidence Image
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… Image
Read 4 tweets
Meg Tirrell Profile picture
5 Aug
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/…
Moderna’s contracts for #covid19 vaccine doses this year and through 2023, from slides for 8amET earnings call: investors.modernatx.com/static-files/c…
Moderna efficacy at final analysis (median follow-up 5.3 months):

Against COVID-19: 93.2%
Against severe COVID-19: 98.2%
Against death caused by COVID-19: 100%

(Note, this was before delta variant was circulating widely)
Read 9 tweets

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