The leaders in the race to develop a Covid-19 vaccine say they could have pivotal data in October — but Trump claims FDA is slowing recruitment
Late Friday night Moderna tweeted that their Phase III study had come close to the halfway mark in recruiting the 30,000 or so subjects needed for the pivotal test of their Covid-19 vaccine mRNA-1273.
So I thought it was a good time to catch up with CEO Stéphane Bancel on the timing of the readout, which is of intense interest around the world — and particularly in Washington DC, where the top regulators and scientists involved repeatedly insist they won’t tolerate any political interference in pushing a premature announcement of a win ahead of the election November 3rd.
In response to my email query, Bancel observed:
We have said we should be done in September with enrollment.
Event driven read out.
So the 2 key drivers of when we will know is
Efficacy (a high efficacy vaccine will read out sooner than a low efficacy vaccine)
Base case scenario is November read out
Best is October
This is in line with what Pfizer and BioNTech execs have been saying about their mRNA candidate. On Thursday night Pfizer put out a statement saying that they had recruited more than 11,000 subjects for their pivotal and the investigators were in line for a read out as early as October.
The faster they recruit, the quicker they can get the second shot in, and assess efficacy. For Moderna $MRNA the second shot comes on day 29, and for Pfizer/BioNTech it’s day 21. And that leaves the leading players neck-and-neck.
It’s worth noting here that it typically takes years, not months, to get a vaccine through development and onto the market. Here’s our ranking of the 28 vaccines in or near the clinic.
At this point just about every prominent government official connected to this has completely rejected the idea that political influence from the Trump White House would be allowed to push a positive declaration ahead of the election. That was capped by Peter Marks, the CBER chief who flat out vowed to resign if he saw any meddling in the timeline.
But President Trump isn’t making it easy for the FDA. On Saturday morning Trump declared that the FDA was purposefully slowing down recruitment for vaccine and drug trials. And he suggested the “deep state” inside the agency could be pulling strings to trip up investigators, urging commissioner Stephen Hahn to speed things up in his remarks.
The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! @SteveFDA
— Donald J. Trump (@realDonaldTrump) August 22, 2020
There’s no evidence at all of any “deep state” anti-Trump group operating at the FDA.
Trump followed up with a tweet criticizing the FDA — again — for yanking the emergency use authorization for his favorite Covid-19 drug hydroxy, which has been widely panned after multiple trial failures. But so far, Hahn hasn’t budged on that. And any move now would instantly reignite charges of political influence.
Trump’s tweet earned a quick retort from House Speaker Nancy Pelosi, who called it a “dangerous attempt to inject himself into the scientific decisions” of the the FDA.
The FDA must approve drugs or vaccines based on their safety and effectiveness – NOT political pressure from the White House.
— Nancy Pelosi (@SpeakerPelosi) August 22, 2020
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