Pfizer and BioNTech are off to the races. With early phase 3 data pointing to 95% efficacy, the companies have now confirmed they are gunning for an emergency use authorization for their COVID-19 vaccine.
This move was highly expected after BioNTech CEO Uğur Şahin, M.D., told CNN as much on Wednesday. That could mean an emergency green light in time for the new year, Şahin said.
“Depending on how fast this [review] is really accomplished, we might get an authorization, or conditional approval already in 2020 which might help us start distribution of the first vaccine batches already in 2020,” Şahin told CNN. That said, he added that he couldn’t say how long the process would take.
An early peek at the phase 3 data last week showed the mRNA vaccine candidate, BNT162b2, was more than 90% effective at preventing COVID-19 infections. Those numbers came from 92 patients, with the partners needing to collect data from at least 164 and build up at least two months of safety data before heading to the FDA for an emergency nod.
Those data arrived Wednesday, showing an efficacy rate of 95%. Of the patients who received placebo, 162 developed COVID-19, compared to eight people who got the mRNA vaccine.
The duo expects to produce up to 50 million doses of the two-shot vaccine regimen in 2020, with up to 1.3 billion doses to follow in 2021, Pfizer said earlier this month. Of the 1.3 billion, several million will come in the first four to five months of 2021, Şahin told CNN.
“I am confident that if everything goes well, and we have a very organized vaccine supply, that we could have a normal summer and winter 2021,” Şahin said.
Pfizer and BioNTech are the first to seek emergency use authorization, edging out Moderna, which reported phase 3 data on Monday. Its vaccine was 94.5% effective, with 90 cases of COVID-19—including all 11 severe cases seen so far in the study—striking the placebo group, compared to just five cases in the group who received its vaccine, mRNA-1273.