Half a year after the wildly successful development of life-saving vaccines, the United States is closer than ever to getting one of its COVID-19 shots fully approved, as opposed to merely authorized for emergency use during a raging pandemic.
The only problem is that the agency has been outrun by conspiracy theorists and, most recently, an extremely dangerous new variant.
The U.S. Food and Drug Administration on Friday granted Pfizer and BioNTech priority review designation for their COVID-19 vaccination for individuals ages 16 and older. The vaccine was the first of the three currently available in the U.S. to be authorized for emergency use in December. The emergency grant, however, only cleared the way for the vaccine to be shipped to hospitals, clinics, and pharmacies to combat the deadly pandemic, as opposed to distributed and marketed widely even after the public health emergency ends.
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To get full FDA approval—and, experts hope, reduce vaccine hesitancy and lax workplace inoculation mandates—the New York pharmaceutical giant must go through a rigorous review process that is expected to be completed in January 2022. But while the process has been expedited from its normal 10-month length, experts are nervous about the delay as the highly transmissible Delta variant of the novel coronavirus fuels a nationwide surge in cases, hospitalizations, and deaths.
“The good thing about this news is that [the FDA] is going to give them a priority review. The concerning thing is that it’s going to take until January,” Peter Hotez, a pediatrician and virologist at Baylor College of Medicine in Houston, told The Daily Beast on Friday, adding, “I would have thought this would have gone faster given our national situation.”
The pressure for a fully FDA-approved vaccine is as high as ever as cases surge in almost every state nationwide. At least 31 states have seen a 50 percent increase in cases in the last week—and a 26 percent increase in deaths, according to the Centers for Disease Control and Prevention. Hospitalizations have increased 36 percent in the past seven days.
The vast majority of those cases, hospitalizations, and deaths stem from unvaccinated residents and the Delta variant, which was first detected in India and has since become the dominant mutation of the coronavirus. In a Friday press briefing, CDC Director Dr. Rochelle Walensky even went as far as to warn Americans: “This is becoming a pandemic of the unvaccinated.”
After all, despite fears to the contrary, early evidence suggests the vaccines in use in the United States are highly effective against the new variant.
But despite the variant being highly transmissible and possibly carrying double the risk of hospitalization compared to the Alpha, or U.K., variant, vaccination rates have lagged across the country. The deadly combo has caused local leaders to revert to COVID-19 lockdown guidelines, from mandated mask-use indoors in California to discouraged indoor activity for residents over 65 years old in Austin.
Dr. Peter Marks, director of FDA's Center for Biologics Evaluation and Research, said in a letter to The New York Times this month that full approval was one of their “highest priorities.” But he said it requires an exhaustive look into the mechanics and clinical trial of the fairly new jab that should not be delayed.
“Any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the F.D.A.'s statutory responsibilities, affect public trust in the agency, and do little to help combat vaccine hesitancy,” Marks wrote.
“If we truly want our lives to return to normal, the fastest way to do so is simple—get vaccinated right now,” he added.
The problem is that surveys and the publicly available evidence—cases and deaths—make clear that millions of Americans still don’t want to do that. And anti-vaxxers, along with more even-keeled skeptics, often cite the fact that the shots have merely been authorized for emergency use, as opposed to fully approved, as a reason why. (This despite rigorous trials that have shown them to be safe and effective.)
For her part, Genevieve Kanter, an assistant professor at the University of Pennsylvania Perelman School of Medicine who studies disparities in health care, believes that Pfizer’s full approval is the “necessary push to persuade those on the fence to get vaccinated.”
Noting that there is not “much difference” in the criteria between granting a vaccine emergency-use authorization and full approval, Kanter told The Daily Beast the final step might reassure some hesitant Americans that the shot is completely safe.
“With this vaccine and any vaccines, really, the health risk occurs shortly after getting it,” Kanter explained, noting that some anti-vaccine hesitancy revolves around the long-term effects of the relatively new shot. “Adverse effects rarely come up after. So if we were going to see an effect, especially given the number of people who have gotten these vaccines, it would have happened already. If there is any lurking chronic effect, it feels like a low probability.”
The professor added that while some may be concerned that it took the FDA two months to accept Pfizer’s application to begin the review process for full approval, past data shows they are on a normal pace for safe vaccine approval.
“Looking through the last 20 years of vaccine applications, the medium time for approval was about a year. The minimum time was about 98 days, which is around three months,” Kanter said. “So we’re moving quickly on this. [But] it is not concerning to me, and if anything, shows that no corners are being cut for this vaccine.”
“The FDA knows they are under a microscope,” she added.
In a Friday statement, FDA commissioner Dr. Janet Woodcock insisted that “the review of this [Biologics License Application] has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the… Goal Date” of 2022.
The Pfizer vaccine’s pending approval also provides a clear pathway for the other two vaccines that have been given emergency-use authorization: those by Moderna and Johnson & Johnson. Last month, Moderna filed their application for full approval status—which if the FDA follows their own timeline, should be advanced in the next month or so.
Johnson & Johnson, however, has been plagued with multiple setbacks and even an FDA warning about vanishingly rare instances of the one-dose inoculation triggering Guillain-Barré syndrome, a rare neurological disorder. The company behind the vaccine—which has nonetheless proven to be almost universally safe and effective—has not yet submitted their application for full approval.
Kanter noted that if Pfizer—and, eventually, Moderna—did seek to create a booster shot for their inoculations, as some experts suspect is likely, they would not need to go through another application process. Instead, once they have full approval, they would merely need to submit a supplemental application, as pharmaceutical companies do for flu shots.
She added though Americans could soon see three fully-approved coronavirus vaccinations, there is no precedent on what that will mean for mandates, which have begun popping up piecemeal at employers large and small. While “employers and schools could definitely use this to impose a mandate,” Kanter said she found it hard to believe it would become a federal requirement.
After all, the Biden administration has signaled that federal agencies should not, as a rule, tend to require employees get shots, enraging some health experts.
Hotez agreed that the full approval may force employers that have not made vaccines a requirement to change their tune, and expressed some hope that one of the major talking points for anti-vaxxers would be taken off the table. But he bemoaned the lag for the review as past progress against the pandemic risks being upended in the summer of the delta variant.
“This timeline is common, sure, that’s not the unusual part. But we are in unusual circumstances,” he said.
“I think it would have been a game-changer if they had approved the vaccine this summer.”
