Pfizer CEO Albert Bourla said Thursday that late-stage study results could be available by the end of October for a coronavirus vaccine it is co-developing with BioNTech, adding "we should have enough [data]…to say whether the product works or not." His remarks come in the wake of the Trump administration asking states to be prepared to distribute a vaccine, should one be approved, by November 1.
Bourla noted that a global trial of the candidate vaccine dubbed BNT162b2, which began in late July, has already enrolled 23,000 participants out of a target of 30,000 people between the ages of 18 to 85 years. If successful, the companies have said they expect to submit the vaccine for final regulatory review as soon as October, with plans to supply up to 100 million doses by the end of this year and approximately 1.3 billion doses by the end of 2021.
According to documents released by the US Centers for Disease Control and Prevention (CDC) this week, the agency asked state public health officials to prepare to distribute a potential coronavirus vaccine to high-risk groups as soon as late October.
In a recent letter to state governors, CDC director Robert Redfield urged that local officials remove barriers to building permits for vaccine distribution sites for use by McKesson, which has signed a deal with the federal government to distribute a vaccine when it becomes available. The August 27 letter asks states to speed up applications for these distribution facilities, and possibly even waive requirements "that would prevent these facilities from becoming fully operational by November 1," which is just days before the US presidential elections.
The deadline is raising concerns among some public health experts that approval of a vaccine would be politically motivated. However, Bourla indicated that Pfizer "would never" submit any vaccine for authorisation before "we feel it is safe and effective." The executive said "our Phase III study will be the only one that will allow us to say if we have a safe and effective vaccine. If we don't have results from [that], we would not submit…we will not cut corners."
Francis Collins, director of the US National Institutes of Health (NIH), has said it is "unlikely" a vaccine will be ready before November, while Anthony Fauci, who heads the NIH's infectious diseases branch, said there could be enough data to know by November or December whether one is safe and effective, although it is "conceivable" that there could be an answer before then.
FDA Commissioner Stephen Hahn recently said he would be willing to consider granting emergency authorisation for a COVID-19 vaccine even if clinical trials have not been completed, if the agency determines that benefits outweigh the risks. An FDA advisory committee is scheduled to meet on October 22 to discuss the issue of coronavirus vaccines, although the focus will not be on any specific application.
In July, the US government agreed to pay nearly $2 billion to secure an initial order of 100 million doses of Pfizer and BioNTech's mRNA-based COVID-19 vaccine, with an option to acquire up to 500 million more doses.
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