Pfizer CEO has some thoughts on RFK Jr., vaccines

Pfizer CEO Albert Bourla used a Davos appearance yesterday to deliver a blunt message on HHS Secretary Robert F. Kennedy Jr., calling his vaccine stance "anti-science." He suggested that progress on U.S. immunization policy would require President Trump to choose a new health secretary, the Wall Street Journal writes — a pivot from Bourla's more conciliatory tone in late 2024.

"I have very productive discussions when it comes to cancer cures, when it comes to the 'most-favored nations' deal, et cetera," Bourla said during the event at the World Economic Forum in Switzerland. "It's a different world when you start discussing vaccines, there's almost like a religion there."

The comments come amid mounting industry frustration with Kennedy's tenure, including his remaking of the CDC's vaccine advisory committee, controversial changes to the childhood vaccine schedule, and the ouster of senior FDA vaccine regulator Peter Marks. Bourla also warned that the Trump administration's cuts to university research funding risk undermining U.S. competitiveness, given the pace of Chinese biomedical innovation — and that these moves are counterproductive to global health.

drug pricing

After Trump claims drug-pricing victory in France, France scoffs

From STAT's Damian Garde: President Trump wants Europe to pay more for prescription drugs. It's a cornerstone of his grand bargain with the pharmaceutical industry, which traded some loosely defined vows to lower U.S. drug prices for a reprieve from tariffs and a vague promise from the White House to crack down on the "freeloading," in Trump's words, that makes branded medicines considerably cheaper overseas.

And if you ask Trump, the administration is already following through. In his expansively woven remarks at the World Economic Forum in Switzerland yesterday, Trump recounted a cajoling conversation with Emmanuel Macron in which the French president, initially resistant to raising drug prices in his country, folds under the threat of a 25% tariff on exports to the U.S. and a 100% levy on Champagne. "No, no, Donald, I will do it," he said, according to Trump. (The American president didn't reprise his earlier Macron impression, which rings a little more more John Cleese than Charles de Gaulle.)

But that never happened, according to France. The official account of the office of president posted that Macron did not raise the price of medicines, as that is something he cannot do, and furthermore those prices have remained stable. "Anyone who has set foot in a French pharmacy knows this," according to the post, which includes an animated GIF of Trump saying "fake news."

vaccines

CEPI, Merck fund fridge-stable Ebola vaccine upgrade

From STAT's Helen Branswell: A collaboration between the Coalition for Epidemic Preparedness Innovations and vaccine maker MSD — known as Merck in the U.S. — could lead to a 2.0 version of a vaccine to protect against Zaire ebolavirus.

CEPI announced yesterday it was providing MSD with $30 million in funding to develop an updated manufacturing process for its Ebola vaccine, one that would make the product more affordable, easier to make at scale, and fridge stable. The current vaccine, Ervebo, requires ultra-cold storage, a challenge in the remote and low-resource settings where Ebola outbreaks often occur. The work will be done in conjunction with Hilleman Laboratories.

Ervebo was tested in the largest Ebola outbreak on record, the West African outbreak that ran from 2014 to 2016. "In a single decade the world has transformed Ebola from a global emergency to a disease that can be stopped in its tracks – and now CEPI's support will help to enable a sustainable and accessible supply of MSD's Zaire ebolavirus vaccine for years to come at a more affordable price," Richard Hatchett, CEPI CEO, said in a statement.

gene therapy

RegenxBio tests FDA consistency under Vinay Prasad

RegenxBio is emerging as another test case for how the FDA's gene therapy reviewers, now under the supervision of Vinay Prasad, will treat prior regulatory commitments, STAT's Adam Feuerstein writes in his Biotech Scorecard newsletter (sign up here!). A decision on its Hunter syndrome gene therapy is due Feb. 8, and pivotal Duchenne data is expected in the second quarter.

While the Hunter review was shaped under the previous CBER leadership before Peter Marks' abrupt exit, attention is increasingly focused on RGX-202. This gene therapy for Duchenne muscular dystrophy is designed to hit the same accelerated approval benchmark — 10% microdystrophin expression — that cleared the way for Sarepta's Elevidys.

The company expects RGX-202 to meet that bar, but the open question is whether the FDA will still honor it, given Prasad's recent willingness to revisit earlier agreements, including with Atara Biotherapeutics.