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Meg Tirrell Profile picture
@megtirrell
Aug 5, 2021 • 9 tweets • 5 min read • Read on X
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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)
Moderna breaks down efficacy by 2-month segments post 2nd dose; says at month 4+, efficacy is 92.4%

(Pfizer says by months 4-6 its efficacy is 84% - though against severe disease maintains 97%)
Nonetheless, Moderna says it expects antibody levels will start to wane, and with delta there will be an increase in breakthrough infections in fully vaccinated; it sees need for boosters before winter:
Moderna says lab studies show a booster w half the dose of its #covid19 vaccine increases antibody levels against delta by 42-fold
Moderna reports top-line findings from phase 2 study of booster shot, noting neutralizing antibody titers had waned significantly by 6 months; safety profile of dose 3 was similar to that of dose 2
Here's what Moderna CEO Stephane Bancel said this AM when we asked on @SquawkCNBC if their 93% efficacy at 6 months is directly comparable to Pfizer's 84% (neither of these datasets included delta):
The @WHO's @DrTedros yesterday called for a moratorium on boosters until September to enable countries that haven't had vaccine access to be able to administer first shots. We asked Moderna's CEO how the company is responding to that call:

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More from @megtirrell

Meg Tirrell Profile picture
Mar 23, 2022
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
Moderna says vaccine tolerability was similar to other commonly used pediatric vaccines

Rate of fever 100.4F+: 15-17%
Rate of fever 104F+: 0.2%

No new safety concerns identified, no myocarditis reported in trial

Also evaluating booster dose in all pediatric groups
Read 4 tweets
Meg Tirrell Profile picture
Jan 21, 2022
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)
Fauci (cont): "I don't foresee any differences in the differentiation of the effectiveness or not against the different variants between the adults and younger children..." (3/5)
Read 5 tweets
Meg Tirrell Profile picture
Dec 16, 2021
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)
Fauci: "Hang in there, this will end. We can get through even a winter surge by implementing the countermeasures that we have: vaccinations, boosters, masking, being prudent about wearing a mask indoors." (3)
Read 5 tweets
Meg Tirrell Profile picture
Dec 14, 2021
"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."
.@SenTuberville asks @califf001 about new #covid19 antiviral.

Califf: There's there's a saying, "In God We Trust, all others must bring data" when it comes to the FDA. So the press release was out this morning on something that looks really exciting..." (cont)
Read 4 tweets
Meg Tirrell Profile picture
Nov 26, 2021
.@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.
Gottlieb notes increased transmissibility isn't clear yet; could be a founder effect, and bc it's detectable by PCR, researchers could be oversampling.

Suggests it's possible large # of mutations could lead to less transmissibility.

But says "way early" to draw conclusions.
Read 4 tweets
Meg Tirrell Profile picture
Nov 26, 2021
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)
What vaccine makers are saying about B.1.1.529 (cont):

-J&J says it's closely monitoring new strains and is "already testing the effectiveness of our vaccine against the new and rapidly spreading variant first detected in southern Africa." (3/2)
Read 5 tweets

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