After the possibility of coronavirus vaccines was questioned for weeks through October, Pfizer's CEO said Tuesday that it was now nearly impossible.
The announcement by Dr. Albert Bourla came on the same day Pfizer announced third quarter results, and all but ruled out the possibility of early results ahead of next Tuesday's presidential election. President Trump had long tried to link the possibility of positive vaccine news to his own prospects for re-election.
In a conversation with investors on Tuesday, Wall Street analysts urged Dr. Bourla, to be specific about when the company would get early results that could demonstrate the effectiveness of its vaccine and how detailed the company would be. Pfizer is one of four companies with large, late-stage clinical trials in the United States.
In his remarks, Dr. Bourla expressed the urgency to develop a vaccine in the face of the global infection resurgence. The United States has had an average of more than 71,000 coronavirus cases a day for the past week, and hospital admissions are also increasing.
"Let's be very patient – I know how much the stress increases," said Dr. Bourla. "I know how much the vaccine is needed for the world." He also pushed back against any suggestion that politics motivate the pace of development, saying, "This is not a Republican or Democratic vaccine."
Pfizer's clinical trial will test the vaccine on 44,000 people, half of whom will receive a placebo. The study protocol or blueprint allows for a first look at the results after at least 32 people in the placebo or vaccinated group develop Covid-19. If more than 26 of these people are in the placebo group, the vaccine is considered likely to be effective.
Dr. Bourla had repeatedly predicted that the first analysis – carried out by an external panel of scientific experts – would come in late October. But on Tuesday, he said those 32 cases of Covid-19 had not yet occurred, a sign the process is progressing more slowly than the company estimated. He also said that it would take the external panel at least a week to analyze the results, making a response unlikely before the election. Dr. Bourla said the company would report results if the outside agency determined that the vaccine is either effective or not, but not if there is no final conclusion.
Even if there are initial results in the next few weeks, it is unlikely that most Americans will get the vaccine anytime soon. According to Food and Drug Administration guidelines, coronavirus vaccine developers are required to submit at least two months of safety data after half of study participants receive the second dose of the vaccine, which Pfizer says won't be given until the third week of November.
Dr. Bourla said the company had already made "hundreds of thousands" of cans. At least 40 million cans are expected by the end of the year and 100 million cans by next March.