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The Readout Damian Garde & Meghana Keshavan

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The FDA won’t hold up Covid-19 booster shots

Vaccine makers racing to develop booster shots that protect against emerging Covid-19 variants won’t have to go through the lengthy, expansive clinical trials normally required, the FDA said yesterday.

Instead, the agency will consider data from a few hundred patients followed for a handful of months. The FDA spelled it all out in a new guidance, explaining that it will accept data on how vaccines prime the immune system rather than holding out for results on protecting against Covid-19.

That’s unsurprising but no less welcome news for the likes of Moderna, Pfizer, and Novavax, each of which has committed to developing follow-on versions of its original Covid-19 vaccine to deal with the emergence of viral variants that appear to dampen vaccine efficacy. It also might be a glimpse at the future of the pandemic, in which the scramble to identify a working vaccine evolves into a constant game of inoculating against the latest strain of a wily pathogen.

How much is Moderna’s Covid-19 vaccine worth?

Amid swirling questions about viral variants, production timelines, and FDA standards, Moderna is poised to give Wall Street the answer all the analysts are seeking: How much money is its Covid-19 vaccine going to make in 2021?

On Thursday morning, Moderna will present its annual earnings report and look-ahead for the year to come, a conference call that might include the company’s estimate for Covid-19 vaccine revenue. Moderna has to date been cagey about its future sales, saying only that it had signed supply agreements that would total about $12 billion in 2021, a figure that neither includes follow-on deals nor accounts for any potential delays in manufacturing.

Wall Street’s estimates of the company's business are all over the place. The revenue consensus for 2021 is around $11 billion, but there are outliers that varyingly double or halve that figure. Pfizer projected $15 billion in 2021 sales for its competing Covid-19 vaccine, but that disclosure came with enough caveats and asterisks to allow analysts to reach diverging conclusions. 

The question of Moderna’s revenue has more immediacy, as the company’s $63 billion valuation is based in part on the idea that it can quickly build a formidable business from Covid-19 and then leverage that success for other vaccines. Doing well in 2021 is the first step.

Brainstorm’s ALS data fail to convince the FDA

Brainstorm Therapeutics failed to convince the FDA to consider its positive spin on a negative result from a clinical trial on the company’s cell therapy for amyotrophic lateral sclerosis.

As STAT’s Adam Feuerstein reports, regulators said Brainstorm’s analysis, which concluded that its therapy showed a benefit for patients with milder ALS, did “not provide the threshold of substantial evidence” to support filing for approval. In the trial, three spinal injections of Brainstorm’s treatment failed to slow the neurological decline of ALS patients compared to placebo.

The question now is what Brainstorm does next. The FDA suggested the company gather more clinical data to support its treatment’s purported benefit, but Brainstorm CEO Chaim Lebovits has in the past said the company would not run another clinical trial and instead pressure the FDA to approve it based on the existing evidence.

Read more.

Vaccine makers head back to Washington

The last time pharma executives went before Congress to talk about Covid-19 vaccines, the questions focused on safety, equity, and public trust. Today, when a similar cast speaks before the same House committee, the conversation is likely to be more focused on just how fast they can churn out doses.

Representatives from Pfizer, Moderna, Johnson & Johnson, AstraZeneca, and Novavax are due before a House subcommittee at 10:30 ET this morning, which you can watch live here

Scrolling through each executive’s prepared remarks, the major talking points are going to be the pace of manufacturing and the ability of each vaccine to protect against emerging variants of the virus that causes Covid-19. But each company is certain to face questions as to why it can’t move faster to meet U.S. demand for vaccine doses. 

Stay tuned to STAT for coverage of how the hearing goes.

More reads

  • ‘Held to ransom’: Pfizer plays hardball in Covid-19 vaccine negotiations with Latin American countries. (STAT+)
  • Biotech is acting ‘more and more like’ Bitcoin, Evercore says. (Bloomberg)
  • ‘Following the Amazon playbook’: As digital pharmacy grows more crowded, startups scramble to stand out. (STAT+)

Thanks for reading! More tomorrow,

Damian

Tuesday, February 23, 2021

STAT

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