The head of US drug maker Pfizer said today that his company would not submit a COVID-19 vaccine for approval or emergency use authorization (EUA) if its scientists don't have data from large phase 3 trials showing safety and efficacy.
"We will never submit for authorization or approval any vaccine before we feel that it is safe and effective," Albert Bourla, DVM, PhD, chairman and CEO of Pfizer, said in a press briefing organized by the International Federation of Pharmaceutical Manufacturers and Associations. "We will not cut corners."
The comments come amid growing concerns that the Food and Drug Administration (FDA) could issue an EUA for a vaccine prior to the Nov 3 presidential election without enough data from phase 3 trials. President Donald Trump, in his bid for re-election, has said that a vaccine could be available before the end of the year.
Those concerns have been heightened by statements made recently by FDA Commissioner Stephen Hahn, MD, who told the Financial Times that the agency would consider an approval application based on preliminary data from a phase 3 trial.
A letter sent last week by the Centers for Disease Control and Prevention (CDC) to state public health agencies urging them to prepare a distribution plan for a COVID-19 vaccine by Nov 1 has also raised eyebrows. The presidential election is Nov 3.
Data could be available by end of October
The COVID-19 vaccine that Pfizer has developed with German biopharmaceutical company BioNTech is being evaluated in phase 3 trials in the United States, with approximately 23,000 people enrolled so far, Bourla said. The companies hope to enroll 30,000 people, with 15,000 receiving two doses of the mRNA-based vaccine, and 15,000 control patients receiving a placebo.
The New York Times reports that the two vaccines described in planning documents that accompanied the CDC letter to health departments appear to match well with the vaccines being developed by Pfizer/BioNTech and Moderna.
Bourla said he does expect there to be enough data by the end of October to determine whether the vaccine prevents infection with SARS-CoV-2, the virus that causes COVID-19, and is safe. But the company will not submit the vaccine to the FDA or any other regulatory agency for approval or EUA without phase 3 results.
"If we do not have results from the phase 3 study, we will not submit for approval, nor for authorization," he said.
Bourla's comments came in response to questions about the condensed timeline for COVID-19 vaccine development, and how companies can ensure the safety of COVID-19 vaccines while accelerating the process. Vaccines typically take several years to go from discovery to distribution. Approval for a COVID-19 vaccine by the end of the year, or early 2021, would by far be the fastest a vaccine has ever been approved.
Ken Frazier, JD, chairman and CEO of Merck, which will soon begin human trials on a COVID-19 vaccine candidate, said the most important thing for pharmaceutical companies to do at this moment is reinforce their commitment to safety. He added that safety is especially critical at a time when public skepticism about vaccines is on the rise.
"I think we all understand the need to move with urgency, given the pandemic, but we will not sacrifice safety under any circumstances," he said.
Top executives with Eli Lilly, Gilead Sciences, and Roche Group were also at the press briefing. Eli Lilly Chairman and CEO David Ricks, MBA, said it was important to address the issue of vaccine and drug approval, given how much the pandemic has accelerated this process.
"This industry, and certainly our company, has no intention of pursuing approvals for products that we don't think meet the standard for safe and effective," Ricks said.
Bourla acknowledged the fears about politicization of the vaccine approval process, calling it "the worst situation society can be in."
Transparency needed
Michael Osterholm, PhD, MPH, director of the University of Minnesota's Center for Infectious Disease Research and Policy, which publishes CIDRAP News, welcomed the remarks. Osterholm has been among the public health experts who've expressed alarm about the FDA potentially granting an EUA for a COVID-19 vaccine without sufficient data.
"I do believe that the companies understand the implications if they were to move a product forward for which we had inadequate safety or effectiveness data," Osterholm said. "I'm encouraged by these types of discussions, and I think we need to keep having them."
Bourla and Frazier both said they would support extra transparency measures around the EUA process, such as a public FDA advisory committee meeting. Frazier said any data submitted to the FDA for an EUA should be made fully available for review by the scientific community and any advisory committee in place.
Osterholm believes transparency will be important for instilling public confidence in the process.
"Transparency and a predetermined protocol that is obvious to everyone will be extremely helpful," he said.
