In accelerating the approval process for a coronavirus vaccine, the Trump administration’s Operation Warp Speed is pushing the Food and Drug Administration to do the unprecedented. While drug approval has been rushed out the door before, the FDA has never done so while revamping the entire process. Yet many experts say that the expedited process is not likely to exacerbate the safety risks.
“I don’t think they are throwing out the playbook, more like writing a new playbook in real time,” said Jason Schwartz, a professor in the Department of Health Policy and Management at the Yale School of Public Health. “To be clear, [Operation Warp Speed] is the new playbook. FDA’s specific work seems to be trying as much as possible to stick to their time-tested approaches for regulation.”
Of course, not everyone agrees.
“This vaccine is being expedited in a way that no other vaccine has ever been handled,” said Jennifer Reich, a sociologist at the University of Colorado, Denver and author of the book Calling the Shots: Why Parents Reject Vaccines.
Reich noted that in the case of the coronavirus vaccines, the different testing phases have overlapped, leaving less time to look at the data between each phase. “That has raised some concern about whether there might have been some subtle signals about safety that weren’t looked at closely,” Reich said.
On rare occasions, a vaccine has been rushed to market.
In 1957, Maurice Hilleman, a virologist at Walter Reed Army Institute of Research, recognized a potential threat from an Asian flu virus and, after obtaining samples of the virus, sent it to vaccine manufacturers. A vaccine was produced in four months. In 2005, the FDA issued an emergency use authorization so that members of the military could get early access to an anthrax vaccine.
But actually reworking the FDA process during the drug approval process is all but unprecedented.
A vaccine goes through three phases before receiving approval from the FDA, a process that usually takes at least five years. Phase one involves small trials of usually healthy subjects to assess possible differences in dose and safety. Phase two involves larger trials that are expanded to examine the impact of the vaccine on different age, ethnic, gender, and other groups. The larger group of participants are expected to yield statistically meaningful results on safety and efficacy. In phase three of the trial thousands of participants are enrolled to test how the vaccine performs in the broader population.
According to Reich, researchers typically go through the phase two data before beginning phase three. In this case, phase three began before that could happen.
“My understanding is that there is a very high rate of side effects with the vaccine, and most of those have involved pain at the injection site or high fevers,” said Reich. “Because of the enthusiasm for getting a vaccine to market quickly, it’s possible that there wasn’t adequate time to think through what those side effects might mean.”
But others think that extra time is not necessary.
“We can still rely on the fact that for most vaccine-related safety problems, if they are going to emerge, they will emerge in the days and weeks after a vaccine is delivered,” said Schwartz. “That means we don’t necessarily need months and months or years of following patients in the vaccine trials to be confident that there aren’t significant safety issues.”
Secretary of Health and Human Services Alex Azar has said that some parts of the process that have been eliminated are superfluous. Operation Warp Speed was “going to compress and wring out every inefficiency in the process, take away every unused day,” Azar said in a video.
But Reich is not convinced.
“On the one hand, that sounds really efficient, but the flip side is that the days he sees as unnecessary might actually be days that provide important opportunities to really understand some of the nuance,” she said.
Some claim that expediency, and not nuance, should be the priority.
“Given that there has been almost 200,000 deaths from this disease … in the space of eight months, I think we can tolerate a pretty high side effect profile,” said George Rutherford, a professor of epidemiology and biostatistics and director of the Prevention and Public Health Group at the University of California, San Francisco. “I come down on the side of the perfect is the enemy of the good. We need to put the brakes on this thing.”
One important nuance is the ability to understand who is most likely to suffer a serious adverse reaction to the coronavirus vaccine. While such reactions are rare, they tend to follow certain patterns, such as affecting particular demographic groups or those with preexisting conditions.
“We can think about different ways we can learn about predispositions to reactions or who vaccines are most successful for. And that requires analysis,” said Reich. “Have we had adequate time to think through all of this and understand the nuances of what is happening? Whether the public perceives that there has been adequate time to understand enough about these vaccines will go a long way in whether people want these vaccines.”
Dr. Peter Pitts, president of the conservative Center for Medicine in the Public Interest and former associate commissioner for external relations at the FDA, argues there has been adequate time.
“No steps are being skipped, no science is being trivialized, politics is not involved. It’s simply about spending a lot of money [on] the task with the best brains available,” Pitts said.
He acknowledged, though, that getting certain segments of the public to accept the vaccine could be a challenge.
“We do need a really serious public education campaign geared to different groups because a vaccine that nobody uses is not a public health victory.”
