This coronavirus story is getting old.
Failing businesses, online schooling, limited contact with others has gotten ridiculous. However, we may be nearing a potential treatment this November 2020.
According to Pfizer (PFE) and BioNTech (BTNX), they could be ready to file for emergency use authorization by the third week of November.
“We are operating at the speed of science. This means we may know whether or not our vaccine is effective by the end of October. To do so, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo. Since we must wait for a certain number of cases to occur, this data may come earlier or later based on changes in the infection rates,” said Pfizer CEO Albert Bourla.
“As Pfizer is blinded to who received the vaccine versus the placebo, a committee of independent scientists will review the complete data and they will inform us if the vaccine is effective or not based on predetermined criteria at key interim analysis points throughout the trial. Pfizer will continue running the trial through its final analysis point even if it is declared effective at an earlier stage. In the spirit of candor, we will share any conclusive readout (positive or negative) with the public as soon as practical, usually a few days after the independent scientists notify us.”
The companies also need to make sure the vaccine is safe. With the US FDA needing two months of safety data on half of the trial participants following final dose of vaccine, the companies could meet that milestone by mid-November 2020.
Also, the companies need to achieve positive efficacy and a solid safety profile. Then, they can submit manufacturing that shows quality and consistency of the vaccine.
Once the companies have all the positive data needed, they can file for emergency use.
With excitement building, keep an eye on Pfizer and BioNTech. Both could explode from here.