“If read conclusively … we will notify the public as soon as we have completed the necessary administrative work, which we estimate to be completed within a week from the time we know,” Bourla said during the call.
“Let’s all be patient,” he added. “I know how much stress levels increase. I know how badly needed the vaccine around the world. ”
Phase three trials are a crucial final step needed to obtain approval for vaccine distribution. Three other candidates supported by the United States are in phase three: Moderna, AstraZeneca and Johnson & Johnson. Pfizer plans to apply for emergency use authorization from the Food and Drug Administration next month.
The board will only conduct its analysis after 32 cases of Covid-19 diagnosed in Pfizer’s phase three trial. The board could recommend ending the trial if the vaccine proves to be at least 77% effective, which means it could reduce the risk of contracting Covid by 77%.
With no interim measures at this time, Pfizer’s infection rates “must be well below initial estimates given that they were previously” confident “of a conclusive response in October,” said Brad Loncar, biotech investor and CEO of Loncar Investments, in a tweet Tuesday.
Since early September, Bourla has repeatedly said the company may have data on advanced stage vaccine trials as early as October. The timeline sparked concern and skepticism from infectious disease experts and scientists who were also concerned that the process was being influenced by politics and not science. President Donald Trump has insisted that a Covid-19 vaccine could be ready before election day.
In a telephone interview with CNBC’s Meg Tirrell later Tuesday, Bourla said her October timeline created “unintended consequences.”
“But I never regret following the guideline that I am going at the speed of science,” he said. “If the speed of science tells me late October, so be it. But it is true that it created unintended consequences because some people linked it to the election. ”
He reiterated that Pfizer was unlikely to have results ready for release ahead of the election.
“It is not unlikely that we have events, it is unlikely that, given that it is now exactly a week before the election and we have nothing today, it usually takes up to a week. from the day the DMC announces something we are able to do a press release and given the importance of something like that it is unlikely to be before the election, “he said.
Earlier today, Pfizer said it had recruited more than 42,000 volunteers in its advanced stage trial. He said nearly 36,000 of the volunteers had already received the second of his two-dose Covid-19 vaccine. In September, Pfizer expanded recruitment for its phase three trial to a maximum of 44,000 volunteers, from an initial target of 30,000.
The trial update came as Pfizer reported a mixed quarter. Third-quarter sales fell 4.3%, impacted in part by lower demand for some of its drugs due to the pandemic.
Sales fell to $ 12.13 billion, from $ 12.68 billion a year earlier and below the $ 12.32 billion Wall Street analysts polled by Refinitiv were expecting. Still, the company’s earnings were slightly better than expected at 72 cents per share, more than the 71 cents expected by analysts.
The vaccine contains genetic material called messenger RNA, or mRNA, which scientists hope will trigger the immune system to fight off the virus.