Beur schreef op 9 november 2020 18:35:
Pfizer's data lift global faith in Covid-19 vaccines, but set 'extremely high bar' for competitorsJason Mast Associate Editor
After data from early studies came out, scientists were cautiously optimistic that the first Covid-19 vaccines would prove effective, but they had no idea how effective. Given their experience with other respiratory virus vaccines, they cautioned it wouldn’t be a “magic wand.” The FDA set the bar at only 50%.
Now, the first batch of data from a Phase III trial is in, and, according to Pfizer, it shows the inoculation can reduce the risk of contracting a symptomatic case of Covid-19 by more than 90%. The results floored experts, including NIAID chief Anthony Fauci, but one company can’t vaccinate the world. What does it mean for the rest of the candidates in mid and late-stage trials?
For one, analysts, it boosts the odds that those vaccines will ultimately succeed. Covid-19 vaccine development contained a bevy of unknowns. Moderna and Pfizer were using mRNA, a genetic platform technology that sparked great hope and raised billions of dollars but which had never been tested on more than a couple hundred people. Virtually every candidate was trying to confer protection by inducing antibodies against the spike protein, a thesis with strong evidence from SARS and MERS but which had also never been put to the test.
Pfizer has now shown that that technology and that target can, at least for a time, confer protection against the virus. That’s good news for every developer, especially Moderna.
This result provides proof of concept for mRNA vaccines and bodes well for Moderna (data possible in Nov or Dec),” Cowen’s Yaron Werber wrote in a note to investors. “However we deduce that vaccines can be effective when targeting the receptor binding domain (RBD) of the virus and so this also has positive crossreads to vaccines from AZN (with data in late ‘20/early ’21) and JNJ (with data possible in Q1:21).”
Moderna’s stock $MRNA accordingly rose 6.5% on the news, from $72 to $77.
SVB Leerink’s Mani Foroohar cautioned, though, that the business outlook was complex.
On one hand, Pfizer’s data means Moderna has a good shot at proving to make a dent in a global crisis. And it means that the biotech will likely read out soon, as they probably saw the same uptick in cases that Pfizer did. On the other hand, what happens if Moderna’s data suggests it’s ‘only’ 70% effective?
This “sets an extremely high bar for MRNA,” Foroohar wrote in a note to investors. “We anticipate MRNA shares to be up materially today with this positive read across, given the similar mechanism of action for both vaccines, but see risk/reward into MRNA’s own data release as skewed to the downside given cross-trial comparisons to PFE/BNTX’s (excellent) data released today.”
Yet this also sets up an opportunity for mRNA to differentiate itself as a modality over other technologies. Calling the Pfizer data a “home run for medicine and mRNA-based technology,” he argued that Moderna was likely to reach a similarly high degree of efficacy. Moderna may then have room to differentiate on the elderly, where they showed promising neutralizing antibody data in a Phase I study.
Of course, questions still loom for all the vaccines. Pfizer was more than 90% effective at preventing mild cases of Covid-19, but no one knows how good they are at preventing infection or severe cases, or how long immunity will last.
And no matter how effective they are, Pfizer will only be to vaccinate around 500 million people at most next year. Effectiveness was a major question for mRNA vaccines entering this year but so was scalability — and that one remains unresolved.
“That’s probably the best they can do next year,” Evercore ISI’ Umer Raffat told investors of Pfizer’s billion dose target. “But if Pfizer can do north of a billion doses, Moderna probably can as well.”