And what about the Moderna/Lonza COVID vaccine Phase 3 delay?

Tagged: COVID / PharmaAndBiotech / SomebodyAskedMe

Somebody asked me — same troublemakers, in case you’re curious — about whether the Moderna/Lonza Phase 1/2 vaccine trial looked reasonable and if the delay of Phase 3 start for a protocol amendment was reasonable. Sure seems so! No, it’s not an investment signal.

Stat News on Moderna trial Since you guys seem to be interested in COVID-19 vaccine news, here’s an article from today about the Moderna vaccine. (Versions of it appear elsewhere, e.g., the venerable Boston Globe. But Stat News is actually pretty decent, at least as a starting point to figure out the facts without all the silly editorializing.)

D Garde, “Trial of Moderna Covid-19 vaccine delayed, investigators say, but July start still possible”, Stat News, 2020-Jul-02.

Actually their Phase 1/2 readout was a month or so back. This article is talking about how, even given the favorable Phase 1/2 readout, there’s a delay in starting Phase 3. To emphasize: this is an utterly normal sort of delay, for a protocol amendment: nailing down all the rules to be followed in the trial. Normal, responsible thing to see happen.

Things to think about

  • Moderna’s vaccine is an mRNA vaccine, as you might guess from the company’s name – they’re specialists in this exact thing, trying to make it work all the way to approval.

  • Their vaccine is ahead of everybody else. They did a Phase 1/2 readout a month or so ago, with favorable results comparable to the Phase 1/2 readout from Pfizer that you wanted me to look at, just much faster.

  • They are about to enter Phase 3 trials, which will be the last stage before submission to the FDA. This puts them on track to submit and NDA by the end of the year if the trial is successful.

  • However, this week they reported some protocol amendments for the trial (basically fussing with the rules for who’s in the trial, what the goals are, how they’re measured, etc.) that will delay the start by a couple of weeks, but still on schedule to begin recruitment in July; maybe early August.

  • As a consequence, Moderna shares fell 4%. Basically, lots of investors are apparently so illiterate that they saw “couple weeks delay” and assumed “never”.

So… attempting to parse the scientific news into investment advice is perilous. Even more perilous is to take investment advice from the talking heads who think they understand the issues.

It puzzles me why people even want this sort of financial advice, given that if it’s known in the media it’s already priced into the markets. But then, I’m a world index fund investor so they’re not trying to convince me, probably.

Written Sun 2020-Jul-05

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