The world needs a vaccine against COVID-19, and with some 200 vaccine candidates in various stages of development, and more than 30 of these vaccines already in Phase 3 clinical trials, odds are we will get a vaccine — probably several — sooner than you might expect.
Cory Kasimov focused in on two of the leading candidates: mRNA-1273 from Moderna (MRNA), and BNT162 from BioNTech (BNTX), laying odds on which of the two has the best chance of success — and which might win FDA approval first.” data-reactid=”13″>J.P. Morgan analyst Cory Kasimov focused in on two of the leading candidates: mRNA-1273 from Moderna (MRNA), and BNT162 from BioNTech (BNTX), laying odds on which of the two has the best chance of success — and which might win FDA approval first.
Kasimov’s note, it should be pointed out, is not intended to be an exhaustive discussion of all 30 leading vaccine candidates, or even a thorough review of the two vaccines focused on. Rather, explained the analyst, he just “wanted to get a better sense of the likelihood of success in Phase 3 for two of the front runners in the vaccine race.” As such, the report should perhaps be best viewed as a sort of first look at two good prospects to rank among the winners of this race.
So what did Kasimov come up with from this review? Several observations, actually, and several which should constitute good news for investors in Moderna and BioNTech.
Simulating potential results of the Phase 3 trials, Kasimov notes first and foremost that “both trials should ultimately be successful if efficacy rates are anywhere north of 60%.” (I.e. The FDA will probably approve both companies’ vaccines if they produce high levels of neutralizing antibodies in 60% of patients injected). It appears that the FDA could approve vaccines with efficacy rates of 50% or even as low as 30% — but 60% is preferable, and 70% or better would all but assure approval of both companies’ vaccines.
That’s the good news. Now here’s the better news: Kasimov is particularly interested in the companies’ chances of winning early termination of their Phase 3 trials, and early approval of their vaccines based on “overwhelming efficacy.” In this regard, 70% or better efficacy, in the analyst’s opinion, would not only close to guarantee ultimate approval, but also potentially win early termination and early approval.
How early is “early”?
“We see a low probability that … a study would stop for overwhelming efficacy … in October” for either vaccine. Early termination / early approval could come as soon as November if either vaccine is wildly successful, however.
But even so — fingers crossed.
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