As the excitement over Pfizer and BioNTech‘s vaccine announcement ebbs, some harsh realities have started to set in. The vaccine candidate — while a marvelous feat of science — has some hurdles to overcome if it’s going to fulfill the promise of helping end the global pandemic.
Beyond regulatory approval, there are manufacturing, logistical, and efficacy questions to deal with. With the world waiting, there is no question human ingenuity will prevail. But getting this vaccine out to billions of people may not be the walk in the park the markets seem to assume. Let’s look at a few issues the potential Pfizer vaccine will have to overcome to reward shareholders and save lives.
Approval
Pfizer appears to have passed the most difficult technical barrier; the company has developed a vaccine that seems to be 95% effective in preventing COVID-19. However, this is only an interim analysis — an early look. While there were more than 40,000 participants in the overall trial, this reported efficacy is based on 170 individuals. I’ll be curious to see whether the efficacy rate holds up when more data is revealed.
We also don’t know how long this vaccine will remain effective. While vaccines are normally not approved unless they protect people for at least a year, these aren’t normal times. Pfizer has applied for emergency use authorization from the FDA, which should come in the next few weeks. Since the agency has noted that any vaccine with greater than 50% efficacy will be approved, I don’t see Pfizer having an issue with approval
