Moderna says its two-dose #covid19 vaccine series for kids 6mo-under 6yrs met study goals, will file with regulators in coming weeks

Primary goal was immune response, found to be similar in these ages w 1/4 dose (25mcg) as full dose in adults 18-25 Moderna kids trial was run when omicron was predominant in US, and vaccine efficacy against mild disease is similarly lower in kids w 2 doses as adults

6mo-2yrs: 44%
2-5yrs: 38%

No severe disease seen but Moderna says antibody response suggests protection similar to 18-25yo’s

I asked Dr Fauci at the White House #covid19 briefing today if he expects Moderna vaccine for kids 2-5 may see more success than Pfizer's initial data since it's a higher dose, and also how the cos will need to take into account that omicron is the dominant variant now. (1/5) Dr Fauci said: "The FDA will gather the data that will be presented to them by the company and will make a decision regarding the safety and the efficacy of this particular product..." (2/5)

Dr Fauci at Chamber of Commerce Foundation: "We're getting preliminary information that not all of the diagnostic tests will be accurate with omicron. Many of the commonly used ones appear to pick up and detect omicron quite well. But..." (1) Fauci: "we're hearing and we're in the process of doing large screening to determine which of these point of care rapid tests still maintain their accuracy of diagnosis. Clearly there are some that do. We're trying to find out those that don't reflect an accurate result." (2)

"I'm on record of being in favor of Medicare negotiating with the industry on prices," @califf001 tells @SenSanders in confirmation hearing to be FDA commissioner (setting aside the FDA doesn't touch pricing). Was it a mistake for FDA to approve OxyContin in 1995, @SenatorHassan asks @califf001.

Califf: "I think, if we look back, approving OxyContin with no long-term studies and no assessment of the addictive capabilities is something that could have been done differently."

.@ScottGottliebMD on @CNBCClosingBell now: Even if B.1.1.529 variant can evade vaccines to a degree, it won't necessarily negate their effectiveness completely. He notes it may be similar to the B.1.351 (beta) variant, where protection was still about 75% Gottlieb notes, though, that waning immunity among people who aren't boosted could leave many more vulnerable to a variant like this.

He says worst case, when delta wave wanes, this could cause more infection in Spring/Summer in US. But much is unknown, he says.

What vaccine makers are saying about B.1.1.529:

-Moderna notes it's shown it can get into clinic (human trials) within 60 days; question is regulatory process from there. Manufacturing new doses could take a few months.

-BioNTech expects lab data within 2 weeks (1/2) What vaccine makers are saying about B.1.1.529 (cont):

-lab data will tell BioNTech whether B.1.1.529 could be an escape variant

-Pfizer/BioNTech can adapt mRNA vaccine within 6 weeks, ship initial batches within 100 days in event of escape variant (2/2)

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/…

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

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)

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.

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

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

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…

Google to require all workers coming to campus be vaccinated against #covid19, delays return to offices until mid-Oct: wsj.com/articles/googl… Netflix to require #covid19 vaccines for cast & crew on set on US productions: deadline.com/2021/07/netfli…

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.

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)

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.”

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

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" investors.modernatx.com/news-releases/… 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.

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.

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: docs.house.gov/meetings/IF/IF… 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: docs.house.gov/meetings/IF/IF…

Pfizer says it's more than doubling to 13M+ doses per week by mid-March: docs.house.gov/meetings/IF/IF…