From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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It may have come a day late, but the FDA has finally posted the discussion items that its outside experts will review during tomorrow’s adcomm on the new wave of Covid-19 vaccines now in the clinic.

There are no specific vaccines or data to discuss. Instead, the agency wants feedback on its overall approach. And they’re willing to go late into the evening to get it.

Here’s the rundown:

1. Please discuss FDA’s approach to safety and effectiveness data as outlined in the respective guidance documents.

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Stéphane Bancel’s new estimated timeline for Moderna’s Covid-19 vaccine puts his company on track to score an emergency use authorization in December — given the interim Phase results turn out positive in November.

Per the trial protocol, the first interim analysis of the Moderna vaccine’s efficacy will happen when 53 people in the entire study, which is enrolling 30,000 volunteers, get symptomatic disease. The data safety monitoring board would then review the unblinded results and check the breakdown between the vaccinated and those given placebo.

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After nearly a year of public advocacy and often rancorous ethical debate, human challenge trials for Covid-19 vaccines are getting off the ground in London.

The UK government’s Covid-19 Vaccine Taskforce and the contract research firm Open Orphan announced today a £10 million ($13 million) plan to test experimental Covid-19 vaccines in volunteers who are intentionally exposed to the novel coronavirus. The studies, which won’t launch until early 2021, come after 9 months of debate over whether such studies were safe and would actually hasten vaccine development, and they follow a long history of researchers using challenge models to study other respiratory viruses, including flu and the coronaviruses that cause the common cold.

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With a medley of adverse events hobbling the late-stage development of vaccines and drugs, Pfizer CEO Albert Bourla’s latest — extended — timeline for the mRNA approach they’re working on with BioNTech is giving some top analysts added confidence that the pharma giant can come up with the regulatory goods next month.

Parsing Bourla’s language in his comments last week, SVB Leerink’s Geoffrey Porges notes that Bourla’s decision to say they “may” be able to nail down the positive efficacy of their vaccine in a matter of days — a big change from his earlier certainty — may also indicate a delay on that to early November.

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For weeks in late summer and early fall, Pfizer CEO Albert Bourla insisted they would likely know whether their vaccine works by the end of October and then “immediately” submit for an FDA OK, fueling concerns that President Trump could push through a politically motivated EUA on the eve of Election Day. But now, in the latest of a series of moves that appeared designed to distance his company from a potential political maelstrom, Bourla has made clear they won’t go to regulators for about another month.

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