- BioNTech and Pfizer announced that the The European Medicines Agency's drug review committee has begun evaluating data for their experimental coronavirus vaccine.
- The Committee for Medicinal Products for Human use is conducting what's known as a "rolling review" of the vaccine, a tool that enables European regulators to quickly analyze results as they come available, rather than wait for a full application. It is the second such review the CHMP has started for a coronavirus vaccine; it began evaluating a rival shot from AstraZeneca and the University of Oxford last week.
- The two reviews come as tensions among U.S. government agencies escalate over the standards for a vaccine approval. BioNTech and Pfizer could be first to file for an emergency clearance, with initial data from their Phase 3 trial expected potentially by the end of the month. But the White House and Food and Drug Administration have reportedly disagreed on the requirements of an emergency authorization.
With multiple experimental coronavirus vaccines now in their final tests, developers are figuring out how and when to approach regulators, at the same time that health authorities are trying to assure citizens that thorough reviews will take place.
Those plans are taking shape differently in Europe than they are in the U.S., where the upcoming presidential election has politicized the progress of vaccines. But both regions are trying to proceed cautiously, wary of eroding trust with a skeptical public.
In late September, for instance, European Ombudsman Emily O'Reilly, a watchdog for European institutions, called for transparency in the EMA's COVID-19 work and to guarantee the independence of any regulatory review.
EMA executive director Guido Rasi responded that the agency is speeding up standard data publication timelines, providing more insight into the process than usual, and ensuring that there is a "separation" between those offering scientific advice to developers and those reviewing the same medicines.
"I trust this letter reassures you of the continued scientific rigor and independence of our regulatory processes as well as our commitment to transparency, openness and data sharing, particularly in relation to COVID-19, where public trust will be of utmost importance for controlling the pandemic and saving lives," Rasi wrote.
In the letter, Rasi promised to announce rolling reviews of new COVID-19 treatment applications no more than a day after they begin. That has now happened twice in less than a week. On Oct. 1, the CHMP began a review of laboratory data for the vaccine being developed by AstraZeneca and the University of Oxford. Tuesday, it followed up by starting an evaluation of BioNTech and Pfizer's shot.
Those reviews have begun only based on proof that both vaccines can trigger potentially meaningful immune responses, not protect against COVID-19, reflective of an all-hands-on-deck approach to evaluate information as quickly as possible during the pandemic. But they aren't meant to cut corners, just speed up the process and incorporate data from large-scale trials when available.
The EMA approved Gilead's COVID-19 antiviral Veklury, for example, in late June. That decision came two months after the CHMP had begun a rolling review and included key data proving it can shorten hospital stays for certain patients.
The Food and Drug Administration has aimed to show the U.S. public it is striking the same balance between speed and scientific rigor. The FDA has scheduled an advisory committee meeting for Oct. 22 to discuss the parameters of an emergency use authorization for a vaccine, a special approval granted during a public health emergency. It's vowed to schedule separate expert panel meetings for each EUA application that arises. And after releasing initial guidance to vaccine developers in June, it's pushed for stricter measures mandating at least two months of follow-up from vaccinated participants to properly judge a shot's potential risks and benefits.
But those plans have been complicated by the presidential election in November, which will occur shortly before or after the first interim results from a coronavirus vaccine efficacy trial — likely from Pfizer and BioNTech — are released. The agency has come under heightened pressure amid repeated predictions from President Trump that a vaccine will be available before the election, contradicting estimates from public health officials. Trump, without evidence, has called the FDA's push for newer, stricter vaccine guidance a "political move" and the tension escalated late Monday when the White House reportedly blocked public release of the documents.
The FDA on Tuesday, however, published briefing documents ahead of the Oct. 22 panel that reiterated its emergency approval requirements, which have already been communicated with the most advanced vaccine developers.