- Pfizer and BioNTech announced Friday they've initiated plans to seek a standard U.S. approval for their coronavirus vaccine, making the partners the first developers to try to transition from an emergency use authorization to full clearance from the Food and Drug Administration.
- The agency won't set a decision deadline until all the documentation is in. However, FDA officials have signaled that they intend to review the filing quickly, and if the application confirms the early safety and efficacy that led to the shot's initial authorization the review will be shorter than the usual six months.
- A vaccine with full approval could help raise inoculation rates closer to herd immunity thresholds, because some employers and schools could begin requiring shots for workers and students. Nearly 109 million people in the U.S., or 33% of the population, have been fully vaccinated as of Thursday, according to the Centers for Disease Control and Prevention.
The three coronavirus vaccines being used in the U.S. today have been launched under emergency use authorizations, which require less evidence of safety and efficacy than those formally approved by the FDA. An EUA is also a special regulatory tool used during a public health crisis, meaning, in the case of coronavirus shots, their authorizations are only meant to last until the pandemic is over.
Transitioning to a full approval, then, is a key step for each vaccine maker, enabling them to keep their vaccines on the market for years to come — a likely scenario given the apparent need for booster shots. And a full approval could also help speed up the push in the U.S. towards herd immunity by giving many institutions the legal ability to mandate vaccination.
While some companies and schools require workers or students to receive certain vaccines as a condition of employment or enrollment, the legal authority to do so is less clear with shots that have only received an emergency clearance.
The FDA had asked vaccine makers to compile six months' worth of safety data before submitting their applications. Pfizer reported initial interim data from its massive 40,000-patient Phase 3 trial on Nov. 9 and gained emergency authorization on Dec. 11.
The partners have initiated a "rolling" submission, allowing the FDA to begin reviewing documentation that Pfizer and BioNTech completed while the companies continue to draft the remaining paperwork. It is a type of review saved for priority medical products, and if there are no setbacks along the way, usually permits a speedier approval than under the agency's standard procedures.
“Following the successful delivery of more than 170 million doses to the U.S. population in just a few months, the...submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” Ugur Sahin, CEO and co-founder of BioNTech, said in a statement. BioNTech, a German company, created the vaccine, based on mRNA technology, and partnered with Pfizer to scale up clinical trials and manufacturing to meet the demand for billions of doses.
The FDA has up to six months to review Pfizer's documentation once it's finalized, though the agency is likely to take less time than that. Speaking at a webinar hosted by the American Medical Association, Peter Marks, head of the FDA's biologics review division, said, "we're going to do our best to get this done faster."
"I can't say how much faster because there are so many other moving parts here," he added.