The CEO of Pfizer, Albert Bourla, assured this Friday, October 16, that the firm will be able to know if its vaccine against covid-19 is effective at the end of this month of October, but it will not have enough data to request its emergency authorization from the US drug regulator until the third week of November.
“We could find out if our vaccine is effective by the end of October,” Bourla said in an open letter to Americans with the intention of being transparent and clearing up “the great confusion” about the approval process and mass distribution of the vaccine that he develops. Pfizer together with the German BioNTech.
He also considered that they may request emergency authorization from the Food and Drug Administration (FDA), which requires at least two months of clinical test data, in the third week of November.
Efficacy and safety data will be reviewed by FDA experts and an independent panel to ensure launch of the vaccine and reduce public misgivings about it as much as possible.
“Safety is our number one priority,” said the senior Pfizer manager, who said that for the vaccine to be available, the objectives set must be met in three areas: demonstration of effectiveness, safety and large-scale manufacturing.
Bourla believes that the investments already made in ensuring rapid manufacture of the vaccine within homogeneous quality standards will allow for guarantees in this regard while requesting emergency authorization for its distribution among the population.
The fact that Pfizer does not consider it possible to request authorization from the FDA before the third week of November is a setback for US President Donald Trump, who had suggested that the covid-19 vaccine could be ready before the US elections. November 3.
Pfizer had previously said that it hoped to present results and seek regulatory approval by the end of October, making it the top candidate for Trump to fulfill his electoral promise.
Earlier this month Bourla assured in a letter to employees that they will not “succumb to political pressure” and regretted that they have found themselves in the middle of the “crossroads of the US elections.”
In his letter this Friday Bourla assured that his entire calendar “operates at the speed set by science.”
Other pharmaceutical companies in the final stretch of their race for the COVID-19 vaccine, such as Johnson & Johnson or AstraZeneca have had to temporarily stop their phase 3 tests due to side effects in volunteers, while Moderna maintains a more conservative calendar in its tests.