Pfizer CEO Albert Bourla assured this weekend that the firm will know if its vaccine against COVID-19 is effective at the end of this month of October, but they will not have enough data to request their emergency authorization from the US drug regulator until the third week of November.
“We could know if our vaccine is effective at the end of October”, assured Bourla in an open letter to the Americans trying to make the process transparent and clearing “the great confusion” about approval and mass distribution of the vaccine being developed by Pfizer with 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.
In this way, experts from the FDA and an independent panel will analyze its efficacy and safety data to guarantee the launch of the vaccine and reduce public mistrust.
“Safety is our priority one,” said the top Pfizer manager. Additionally, the executive illustrated in this regard, ensuring that For the vaccine to be available, the objectives set in three areas must be met: demonstration of effectiveness, safety and large-scale manufacturing.
Bourla believes that the investments already made to ensure 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.
That Pfizer does not consider requesting authorization from the FDA before the third week of November is a setback for US President Donald Trump, who suggested that the vaccine could be ready before the November 3 election.
Pfizer had said it hoped to see 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 said in a letter to his employees that they will not “succumb to political pressure” and regretted that they were in the middle of the “crossroads of the US elections.”
In his letter this weekend, 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 temporarily stopped their phase 3 tests due to side effects in volunteers, while Moderna maintains a more conservative calendar in its tests.