Pfizer could be just weeks away from reporting early phase 3 data for its coronavirus vaccine—a remarkable feat amid a global pandemic—but as the company nears its goal, politics is increasingly threatening the process, CEO Albert Bourla warned.
As he watched Tuesday night’s presidential debate, Bourla was “disappointed that the prevention for a deadly disease was discussed in political terms rather than scientific facts,” he wrote in an open letter this week.
Pfizer set out early in the pandemic to quickly develop a vaccine and mobilized “any and all resources” needed to achieve its goal, Bourla wrote. The company has put $2 billion on the line and expects to report early efficacy data later this month. But “in this hyper-partisan year, there are some who would like us to move more quickly and others who argue for delay,” Bourla wrote.
At Tuesday’s debate, President Donald Trump and Democratic presidential nominee Joe Biden sparred over the vaccine development process and concerns about politics affecting scientific decisionmaking. But in his letter, Bourla stressed several facts about the company’s vaccine program and Pfizer’s priorities.
Pfizer is “moving at the speed of science,” driven by the deadliness of the disease and urgent need for a vaccine, he wrote. Further, the company won’t be affected by politics, and will “never cut a corner.”
“The only pressure we feel—and it weighs heavy—are the billions of people, millions of businesses and hundreds of government officials that are depending on us,” Bourla wrote.
Still, while Pfizer is moving at the speed it feels is appropriate, a group of experts this week urged the company to wait until late November for more safety data. They wrote to Bourla that a “rigorous safety standard based on science” is critical during the process. They called on the company to wait for two months of safety data—after participants receive their second doses—before moving on to an FDA emergency application.
Acknowledging the grave threat of COVID-19, Pfizer and many other companies responded to the outbreak early on. The company and its partner BioNTech moved through early research swiftly and pushed their vaccine into phase 3 in July. Bourla has said Pfizer expects to know whether the vaccine works in late October.
But the research is happening amid the U.S. presidential campaign, and President Donald Trump has said repeatedly that he expects a vaccine before the end of the year, or sooner. Concerns that politics could be affecting the process have weighed on public trust, with a recent Pew survey finding that 51% of Americans would get a vaccine if it were available now, while 49% would not. More than three-fourths (78%) believe the process will move too quickly, the survey found.
In the wake of the debate, Bourla asked people to “imagine the compounded tragedy if we have a safe and effective vaccine that many people didn’t trust.”
“That is a risk none of us should accept,” he wrote.
By: Eric Sagonowsky
Source: Fierce Pharma
Coeliac disease causes long-term damage to patients’ small intestine and puts them at risk of other medical conditions. Treatment options are urgently needed. Allie Nawrat explores the promise of larazotide, the drug in development currently leading the pack.
Bone Therapeutics has announced positive 24-month follow-up results from its phase IIa study of Allob, its allogeneic cell therapy, in patients undergoing lumbar spinal fusion procedures.
Belgian pharma company UCB has agreed to acquire a new campus to further support its operations in the UK.