Here the Moderna flu data the FDA refused to review.

This is the most important slide from the company's study of its experimental flu vaccine-- exactly the data FDA said it wouldn't even review.

And below is a thread of relevant slides from that presentation and links to other relevant studies I wanted to bookmark. (I'm a reporter who covers this stuff.)🧵1/14 As you can see, volunteers who received Moderna's flu shot, mRNA-1010, had about 26% less influenza-like illness in a 40,000 patient study.

These slides were presented to Moderna investors in November. Vinay Prasad, a top FDA official, told the company the vaccine would not be reviewed because the company compared to a standard, not high-dose, flu vaccine, and high-dose vaccines are standard for people over 65. 2/14
$MRNA $PFE

Is Trump's EO a reprieve for biotech? Maybe.

Since last week, there have been rumors and reports that President Trump would sign a executive order making dramatic cuts in the HHS, including at CDC and FDA.

This evening, Trump signed a much broader EO directed at re-affirming the Department of Governmental Efficiency's authority to trim costs and jobs across the government. You can read the full EO below.

Health care observers I've conversed with, including people who had gotten wind that something was coming, don't really know what to make of this. If this is *the* EO, it's a lot better than many feared.

whitehouse.gov/presidential-a…

I'd like to share a little story about Jimmy Carter, starting with a reporter's keepsake.

These are the notes President Carter handed me after I met him at a $MRK event to celebrate the company's collaboration with the Carter Center to end river blindness. A thread. 1/7 In 1987 Merck's CEO, Roy Vagelos, came to visit Carter with an offer.

Merck's Mectizan (ivermectin) could treat river blindness, a serious parasitic condition. If Carter could get the drug where it needed to be, Merck would donate it. Here's a picture of the two of them. 2/7

So I wanted to talk a little bit about Geron ($GERN, for the stock ticker types.)

The morning had some positive data this morning, which was ably covered by STAT's @Jasonmmast.

Story here: statnews.com/2023/01/04/ger…

But it also, as Jason notes, has a history. 🧵 TLDR on the data: the drug has some activity against myelodysplastic syndromes, but also safety baggage.

But I want to talk about something else: the way big ideas in biology often turn into small, very incremental innovations.

This is a common thread in biotech history.

Today I'm watching the FDA advisory committee panel regarding expanding the authorization for the Moderna vaccine to children aged 6 years through 17 years.

I'm going to keep my observations in this thread. We're not live-blogging this one; tomorrow, @HelenBranswell and I will liveblog the panel on vaccines for younger kids.

Voting and discussion, the really important part of the day, won't happen until after 3. Right now they're reading the roster and the conflicts of interest.

I'm watching today's Advisory Committee on Immunization Practices meeting.

This is a slide that's previously been presented at ACIP, but I think it's very useful for understanding the issue of myocarditis. This is when it occurs without vaccines. CDC slides are all here:
cdc.gov/vaccines/acip/…

How was my holiday break? Well, a bit panicked. Both my kids, who are adolescents, developed Covid.

Both are fine. My daughter had a fever for two days; my son has seemed asymptomatic. 1/10 It feels like a defeat. We did decide to travel over the break, via train, but avoided high-traffic days and work KN-95s the entire time.

Apparently wasn't enough. Although they could have picked it up at school. Or getting rapid or PCR tests before we traveled. 2/10

I listened in on the $ZY call. Some observations. (Stock is down 68% after hours.

(1) Using synthetic biology to make non-biotech products was always going to be hard. So it's not surprising that it would be difficult to understand how such a product would sell. (2) Still, the facts here are surprising: a company that just IPO'd predicted it would have a market in the near-term, and that market evaporated.

"We default quickly to thinking this conversation is about black and brown individuals," says Clyde Yancy. "That is not correct."

Rural people are underrepresented. So are adolescents.

statnews.com/2021/04/28/vir… Echoing Jonathan Jackson, Yancy says: "This is a science problem. This is not a political problem."

Jackson responds that we need to rely on infrastructure, not hope. Systemic problems require systemic change.

We have a virtual event happening today at 2 that's got me really excited. It's about diversity in clinical trials, and will be moderated by @SciFleur.

You can sign up here:
marketing.statnews.com/increasing-div…

1/5 The Covid-19 trials may well represent a sea change for recognizing the need to get diverse populations of people into clinical trials. Because, maybe for the first time, companies and investigators had to sacrifice speed for quality.

What do we have to add today?

2/5

From FDA: "At this time, there have been no reports in the U.S. of CVST occurring with thrombocytopenia in mRNA vaccines."

https://twitter.com/matthewherper/status/1384563878693163008

From Pfizer: "With more than 200 million doses of the Pfizer-BioNTech COVID-19 vaccine administered globally, we have not observed a higher rate of thrombocytopenia and thrombosis than what would be observed in the general population....

There's a lot of Twitter discussion about the EMA saying it had seen 25 cases of thrombotic thrombosis with the Pfizer-BioNTech vaccine. I'd like to explain, because responses are showing some confusion. FDA's Peter Marks, 4/13:

"You asked if there were similar cases with the Moderna or Pfizer vaccines. & there have been over 180M doses of these vaccines administered & at this time we’ve not found any reports of cerebral vein sinus thrombosis combined with thrombocytopenia."

A couple thoughts on what numbers to use when comparing the relative risks of the $JNJ and $AZN vaccines and blood clots associated with low platelets. (Thrombotic thrombocytopenia, natch).

Figuring out the right numbers to use is one of the hard parts, here. 1/5 Be careful with all these numbers. It's easy to say "1 in a million" but that estimate can swing as researchers find more cases or decide that a smaller group (women? young women?) should be used as the denominator. 2/5

More good news from $PFE + $BNTX. The companies issued a press release on the cases that occured in their clinical trial since the vaccine EUA was submitted to the FDA. Bottom line: the data mesh with what we’ve seen before. 1/7

Press release: businesswire.com/news/home/2021… The original analysis of the trial included 170 cases of Covid-19. Through March 13, cases now total 927. Of the 44,000 participants, 12,000 have six months follow-up after their first dose. $PFE/$BNTX say side effects were consistent with previous results. 2/7

A few points on the FTC's challenge of $ILMN's purchase of Grail, ably covered last night in this story by @pharmalot. (Thread) /1

statnews.com/pharmalot/2021… First, this is obviously a test for CEO Francis deSouza. His last big deal, the purchase of $PACB, fell apart after FTC scrutiny. For another transformative deal to not go through would be a blow. $PACB shares have soared. /2

You probably need some fun. Well, @rtnarch is starting a company, raising $800 million. Yes, $800 million.

The goal? Transform biotech manufacturing. The name? Resilience.

“We want to own the next generation of manufacturing technology." 1/5

statnews.com/2020/11/23/rag… You see, the state of manufacturing during the pandemic pissed Nelsen off.

Fun fact not in the story: Bob told me he started this company entirely on a cell phone.

Fact that is in the story: @SueDHellmann, @ScottGottliebMD, and Bob Kerrey are all on the board of directors. 2/5

So it's been the kind of Monday where it took until 3 to write the thread I meant to write this morning.

But here are some points from this morning's story on vaccine development that I want to emphasized.

Read the whole thing here:

statnews.com/2020/09/28/a-l… /1 (A) When talking about an "October surprise," we're really talking about the Pfizer/BioNTech vaccine. None of the other vaccines work on this timeline, unless we posit that an AstraZeneca study outside the US hits. (Remember, US study has not restarted.

/2

A point on the data, re this sentence about the apparent reduction in hospitalizations:

"Lilly declined to confirm the difference is statistically significant, citing the need for full publication of the results."

statnews.com/2020/09/16/lil… I think this is just silly PR shenanigans, but I asked repeatedly (after my interview) and all Lilly would say was that they will not discuss results further before publication.

Now, not discussing results beyond what is in a press release is fine. /2

Here we go! Inside the Teladoc-Livongo merger!

How do you hammer out a deal in a pandemic?

#STATHealthTech Jenny + Jason were in a virtual fireside chat as the pandemic was happening. "This was a different deal...doing it over late night zoom," Gorevic says. "There was an interesting walking meeting" between two executives.

On of my personal mantras about covering the development of new medicines is this:

The drugs don't care.

They don't care whether their developers are crooks or saints, whether you need them desperately to live or have a minor headache.

https://twitter.com/matthewherper/status/1303304622866608129

We put these molecules into our bodies and, miraculously, they change our lives.

But you can't tell whether a medicine works by how crazy the people who believe in it are, or how wise the physician touting it looks, or really anything but studying it thoroughly.

Putting on my event organizing hat for a moment, next week is going to be a big one. On Sept. 9 and 10, we're holding #STATHealthTech, our first Summit since the pandemic began.

More here: statnews.com/summit/

Here's a rundown. /1 This was originally going to be a live event in May. Now it will be entirely virtual. But @brittcip and I have tried to think things through so that selected attendees will be able to interact with each other and the speakers, much as they would at a live event. /2