Pfizer’s Bourla: State of US Presidential Transition Not ‘Ideal’ For Vaccine Rollout
Executive Summary
Pfizer and BioNTech have accumulated enough safety data to submit an emergency use authorization, and Pfizer CEO Bourla says at the Stat Summit that he is ‘comfortable’ US distribution of the vaccine will go well despite the unusually complicated government transition.
Pfizer Inc. CEO Albert Bourla said the current state of the US presidential transition is not the “ideal” situation for rolling out a massive COVID-19 vaccination campaign but remained “comfortable” that the distribution of the company’s vaccine, partnered with BioNTech SE, will go well.
President-elect Joe Biden and his transition team are right now limited in their ability to receive information from the current government due to refusal of the Trump administration to declare that Biden has won the election. Without that formal action, the Biden team can’t access office space or receive funding for the transition to hire additional personnel.
The restrictions also include the inability to receive classified information including potential vaccine rollout plans.
“Of course, when you are in front of a major vaccination schedule that is about to be deployed, you prefer that you have clear accountabilities on the government side, so I don't think it’s ideal, what is happening in the transition period between the two administrations,” Bourla said on 17 November during the STAT Summit. “But I am very comfortable that things will go well,” he added.
Bourla said Pfizer was in touch with the Biden campaign before the election and continues to keep the incoming leadership informed, along with the current White House.
Pfizer did not respond to a follow-up inquiry for more specific information about how the transition is impacting or could impact their vaccine’s review and rollout but said the company is in “regular communication with all relevant stakeholders at the federal and state levels, and from both sides of the aisle,” and that it “will do everything in our power to ensure a smooth rollout of our potential COVID-19 vaccine, pending authorization.”
The company announced on 16 November that it is launching a “dry run” distribution pilot in four states to ensure it is ready to deploy the vaccine to regions of different sizes, and populations and with different immunization infrastructure. (See sidebar.)
Pfizer reported a 90% efficacy rate from an interim analysis of its mRNA vaccine candidate on 9 November. (Also see "The World Celebrates Pfizer's 90% COVID-19 Vaccine Efficacy Data, With Cautious Caveats" - Pink Sheet, 9 Nov, 2020.)
At the STAT Summit, Bourla announced the company has reached the safety data threshold specified in FDA’s emergency use authorization guidance and said it is “very close” to submitting for an EUA, though he declined to say whether that could come as soon as this week. (Also see "US FDA’s Two-Month Safety Window For COVID Vaccines Based On Adverse Events In Other Products" - Pink Sheet, 28 Sep, 2020.)
Bourla said one of the reasons the company decided not to take research and development money from US government’s Operation Warp Speed effort was because he knew the situation would become “very political” and he wanted “to keep Pfizer out of politics as much as possible.” That explanation is a departure from the company’s usual description of why it didn’t accept Warp Speed development money: Pfizer didn’t want to be slowed down in any way as it raced to design and test the vaccine.
Pfizer does have an agreement with the US government to provide 100 million doses to the US in exchange for $1.95bn, with an option for the US to acquire an additional 500 million doses, but Bourla said the company doesn’t get that money until the doses are delivered.
Interim Analysis Delayed To Build Confidence, Stronger EUA
Bourla pushed back on claims that Pfizer delayed the interim analysis of its Phase III trial from 32 events to 62 events so that the results wouldn’t be available until after the US presidential election on 3 November. The company had long said it expected results in October, but announced in the middle of last month that it would not meet that timeframe. (Also see "Pfizer’s COVID-19 Vaccine Will Miss US Election, Bourla Clarifies" - Pink Sheet, 16 Oct, 2020.)
Speculation around whether Pfizer pushed back its interim analysis due to the election might have been even worse if the company had taken government money, Bourla argued.
He said he decided that an EUA application and the public perception around it would be stronger if the company waited for additional data to accrue before the interim analysis.
“My number one responsibility was to create a safe and effective vaccine. And my number two responsibility was to create a vaccine that people think is safe and effective, in addition to the scientists. And it was very clear to me that from multiple scientific voices, that the 32 number was considered a small number to base emergency use authorization and I knew that we will only have one chance for a first interim analysis,” Bourla said.
The company ended up accumulating 94 cases of COVID-19 for the interim analysis.
“In retrospect it was, ‘thank God,’ I made this decision, because it’s very different to announce to the world that we have over 90% efficacy based on 32 cases, then to announce to the world that we have over 90% efficacy based on 94 cases,” he said.
Bourla said he pushed his team to aim for an ambitious October 2020 timeline for a vaccine when they first started this work last spring.
“I told them, you don’t have to worry about any of the things that we usually worry about. It’s an open checkbook. Don't worry about money, no bureaucracy, come straight to me for whatever you want. And just go and do it. And don't do things sequentially, do things in parallel. I want manufacturing to produce without knowing if we have vaccine.”