Moderna’s shares have been all over the place recently, not because of new data, but because regulators changed their minds.
The company’s mRNA flu vaccine has already been approved for review in the EU, Canada and Australia, but the US Food and Drug Administration (FDA), under health secretary and vaccine sceptic Robert F Kennedy jnr, briefly decided it was unworthy of review.
It then swiftly reversed course, following a reported intervention by US president Donald Trump, who was unhappy with developments.
Relieved investors cheered, but the stark reality for Moderna and its peers is that success now arguably depends less on clinical data than on political wind shifts.
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Indeed, Moderna chief executive Stéphane Bancel recently said the company won’t invest in new late-stage vaccine trials due to growing regulatory scepticism.
Pfizer’s Albert Bourla put it more bluntly in Davos last month, saying it’s a “different world when you start discussing vaccines, there’s almost like a religion there”. He lamented Kennedy’s “anti-science” stance.
Kennedy, described by biotech analysts at Cantor Fitzgerald last year as an “anti-vax conspiracy theorist with inadequate training”, once decried the Covid-19 shot as the “deadliest vaccine ever made”.
He has already disrupted mRNA innovation. Last August, he announced the cancellation of 22 projects worth nearly $500 million, citing safety concerns tied to Covid and flu vaccines.
The Moderna reversal may have steadied investor nerves, but the entire episode leaves a bad taste and does little to resolve the deeper uncertainty hanging over vaccine development in the US.
