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.…
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:… (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)
Pfizer says it plans to start human trials of two mRNA flu vaccine approaches in Q3 2021

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More from @megtirrell

21 Apr
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 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.”…
Read 15 tweets
26 Feb
WH #covid19 response briefing:

-@aslavitt46: Nearly 1 in 5 adults and nearly half Americans 65+ have received first shot
.@aslavitt46: Biden Admin asking businesses to:
-require masking & social distancing to protect workers, customers
-reduce barriers to vaccination, provide incentives (paid time off, compensation)
-communicate w customers, educate public about benefits of masking & vaccination
.@aslavitt46 on business contribution:
🔹Ford and the Gap producing & donating millions of masks
🔹Pro sports & live events offered 100+ stadiums, venues for vaccination sites
🔹Retailers like Best Buy, Target, Dollar General gave 500K+ workers PTO or compensation to get vax
Read 11 tweets
25 Feb
Moderna notes in earnings release this AM it's completed enrollment of its #covid19 vaccine study in kids ages 12-17 (study is called TeenCOVE); a phase 2 study in ages 6 months - 11 years (KidCOVE) will start "in the near-term"…
Along w boosters of original vaccine & B.1.351-tailored vaccine, Moderna says it's developing a next-gen vaccine encoding for portions of the spike protein critical for neutralization (RBD & NTD). Shorter antigen & hoped to be fridge-stable. Plans to test as booster and primary.
Moderna details #covid19 vaccine supply deals:
US: 300M (option for 200M more)
EU: 310M (option for 150M in 2022)
Japan: 50M
Canada: 44M
Korea: 40M
UK: 17M
Switzerland: 13.5M
Colombia: 10M
Israel: 6M
Taiwan: 5M
Singapore: undisclosed
Qatar: undisclosed
Read 4 tweets
24 Feb
White House #covid19 briefing now. @JeffZients says in March, govt will delivering millions of masks to food banks and community health centers around the country. In total, 25M masks to more than 1300 health centers and 60k food pantries nationwide. Free, American-made.
.@JeffZients: Masks will be well-fitting cloth masks available in children’s and adult sizes, and can be washed for reuse, all consistent with CDC guidance.
.@JeffZients on #covid19 vaccine allocation this week: 14.5M doses to states, 2.1M doses to federal retail pharmacy program. Notes pharmacy program “has performed well so far.”
Read 7 tweets
22 Feb
In written testimony posted ahead of Congressional hearing tomorrow, Moderna president Stephen Hoge notes the company is in the process of 'onboarding' another fill-finish partner (along w Catalent) for its #covid19 vaccine in the US:…
Written testimony also showing how mRNA vaccine supply is ramping up in US:

Moderna says it aims to double output to 40M+ doses per month by April:…

Pfizer says it's more than doubling to 13M+ doses per week by mid-March:…
J&J updates on expected #covid19 vaccine supply in written congressional testimony for hearing tomorrow: 20M+ doses to US by end of March, assuming necessary regulatory approvals re: manufacturing (100M total by end of June; 1-dose vaccine):…
Read 8 tweets
5 Feb
WH #Covid19 briefing:
@aslavitt46 says US govt using Defense Production Act to:
-increase supply of vaccinations
-scale tests
-reduce dependence on foreign supplies
.@aslavitt46: 6 more cos will surge manufacturing of at-home test kits, with goal of by summer millions of Americans being able to access at-home tests
.@aslavitt says Defense Sec ordered first contingent of 1000+ active duty military personnel to support state vaccination sites. Part of group will start to arrive in CA within next 10 days to begin operations around Feb 15, with additional vaccination missions soon to follow
Read 8 tweets

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