What happened

Shares of BioNTech (NASDAQ:BNTX) were up by 5.5% as of 11:34 a.m. EST on Wednesday after trading up by as much as 6.4% earlier in the morning. Those gains came after BioNTech and Pfizer (NYSE:PFE) announced that their coronavirus vaccine candidate, BNT162b2, had met all of the primary efficacy endpoints in a large phase 3 clinical study and achieved an overall efficacy of 95%.

So what

This news wasn't too surprising since BioNTech and Pfizer reported interim numbers last week showing that BNT162b2 had achieved an efficacy of more than 90%. However, investors certainly liked that in the final analysis, the vaccine edged out its leading rival, Moderna's mRNA-1273; an interim report for that COVID-19 vaccine candidate earlier this week showed it to have an efficacy of 94.5%.

Doctor holding a syringe and vaccine bottle

Image source: Getty Images.

Keep in mind that the efficacy numbers for both of these vaccines could fluctuate a little as more data is analyzed from their respective late-stage clinical studies. Still, BioNTech and Pfizer have every right to be pleased with the efficacy of BNT162b2.

What's especially worth noting with the two partners' latest update is that efficacy for BNT162b2 was "consistent across age, gender, race and ethnicity demographics." The drugmakers stated that the observed efficacy in people 65 and older was over 94%. This should dispel any concerns that the experimental vaccine might not be as effective for some demographic groups, which would limit its commercial potential.

In addition, BioNTech and Pfizer announced that it had met all the conditions required by the Food and Drug Administration in order to be allowed to file for an emergency use authorization for BNT162b2. The companies reported that BNT162b2 was well-tolerated in the late-stage study, and that there were no serious safety concerns observed among its participants. The only severe adverse events that occurred in at least 2% of participants were fatigue (3.8%) and headaches (2%).

Now what

The next big potential catalyst for this biotech stock should arrive very soon. BioNTech and Pfizer plan to file for an emergency use authorization for BNT162b2 "within days."

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