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The Readout Damian Garde & Meghana Keshavan

Sanofi entering the mRNA vaccine game

Sanofi has been developing an mRNA vaccine of its own, collaborating with Translate Bio to add another Covid-19 inoculation to the global arsenal. The catch: It’s just beginning its Phase 1/2 trials, whereas mRNA vaccines from Moderna and Pfizer/BioNTech have been distributed around the globe for months. 

The Sanofi trial will enroll 415 participants, and interim results are expected in the third quarter of this year. The company said in a statement this morning that it is also working on preclinical trials to test additional mRNA candidates against emerging variants of SARS-CoV2. 

So why so tardy to the mRNA party? Our best assumption: Sanofi may be operating under the (fair) assumption that Covid vaccines are here to stay, with boosters injected perhaps yearly. So although they missed the boat with the first go-round, there could be plenty of future opportunities to be had. 

Strong results for Novavax’s Covid-19 vaccine

Final results from Novavax’s pivotal Covid-19 vaccine trial confirmed what we'd seen in an interim look: 89.7% vaccine efficacy in the U.K., and 55% efficacy South Africa, where a new variant of the coronavirus is circulating.

But the real news was in the potential for the vaccine to prevent severe disease, data that were not previously available. There were five cases of severe Covid in the U.K., and five in South Africa, all in the placebo group. There were 0 deaths and one hospitalization in the U.K. study. In South Africa, all five severe patients were hospitalized and two died, Novavax told STAT's Matthew Herper.

Some big questions loom. Will the FDA want to wait for the U.S. study to be completed before approving it here? And will Novavax be able to keep up with manufacturing demands?

Can cracking down on patents lower drug prices?

The Biden administration has some key decisions ahead that could impact the pricing of drugs. One of them is the appointment of a new director of the U.S. Patent and Trademark Office, opines Matthew Lane, who leads the Coalition Against Patent Abuse. Large pharmaceutical players, he says, have every reason to want to block lower-cost generic drugs from entering the market — using and extending patent protections as long as they possibly can. A PTO chief has the ability to crack down on these efforts — and could ultimately make medications more accessible to patients, he writes. 

But on flip side, noted patent law professor Jacob Sherkow argues that cracking down on drug patents isn’t some panacea against high drug prices. Too many other variables go into the algorithm that establishes a drug’s price, and patents play only a minor role in the final cost, he says. And they’re only relevant when there’s a great deal of generic competition. Drugs for more rare diseases can cost hundreds of thousands of dollars with no competitors, and no amount of fiddling with patent protections will change that. 

What went wrong with IBM’s AI health care business? 

Who is better at making and distributing Covid vaccines, the U.S. or the U.K.? And what the heck is synthetic biology? 

We discuss all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we’re joined by Natasha Loder, the health policy editor at The Economist — and a London resident — to get her home-country perspective (read the transcript here) on the U.K.’s Covid vaccine development efforts. Next, we’ll talk with STAT national technology correspondent Casey Ross about his yearslong investigation into the demise of Watson Health, IBM’s AI health care initiative. Finally, STAT’s Meghana Keshavan joins us for a primer into synthetic biology, including its role in making the mRNA-based Covid vaccines.

Listen here.

More reads

  • Medicare spending on neurology drugs jumped, while number of claims barely budged. (STAT)
  • Three-day FDA adcomm to feature unprecedented review of Merck, Roche, and BMS accelerated approvals. (Endpoints)
  • Abbott launches pandemic defense coalition to detect future variants, outbreaks. (FierceBiotech)

Thanks for reading! More next week,

Damian

Friday, March 12, 2021

STAT

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