Emergency approval of vaccines is not guaranteed, FDA commissioner says

WASHINGTON –

The Food and Drug Administration will not automatically authorize emergency use of coronavirus vaccines before completing a rigorous independent review, despite heightened expectations that two vaccine candidates will be available to Americans this month,

Dr. Stephen Hahn, FDA commissioner, told Mcclatchy in an interview Tuesday.

The interview came hours before Hahn met with White House chief of staff Mark Meadows, according to an administration official, amid calls from President Donald Trump for the FDA to “act quickly” in the approval process.

The FDA is entering one of the most consequential periods in its history after two companies, Pfizer and Moderna, submitted requests for authorization of emergency use of their COVID-19 vaccine candidates. Public advisory meetings have been scheduled, and FDA scientists are reviewing internal company data “around the clock” preparing to deny or approve the applications within a matter of weeks, Hahn said.

“The urgency of the situation is a pressure that I think is substantial on all of us,” he said in the phone interview. “Our career staff recognize that and are working with great speed. But also we’ve maintained a commitment to using data and science, and we will continue to do that.”

Their reviews will not be based on public statements from the companies that say both vaccine candidates, which use similar biological platforms, demonstrated up to 95% effectiveness in advanced clinical trials.

Company results will have to be independently verified, and their safety profiles will be rigorously vetted despite company assurances that the FDA’S safety data milestones have been achieved, Hahn said.

The prospect of imminent vaccines has provided a light at the end of a dark tunnel to Americans facing uncontrolled spread of the pandemic disease and record cases, hospitalizations and deaths.

“The bottom line is we can’t determine at this point, despite the very optimistic reporting in the press and what we’ve heard,” Hahn said. “I couldn’t tell you at this point either way about authorization or not.”

Career scientists at the FDA are reviewing raw data from the Pfizer and Moderna trials for the first time, investigating any adverse events or side effects that transpired over the course of the trials, different levels of effectiveness among populations and age groups, and whether individuals who were already infected by the coronavirus might have had any unexpected reactions to the vaccine doses.

Hahn said they will also be looking for evidence that the vaccines lead to increased respiratory infections – a concern with vaccines researched and developed for other coronaviruses, such as SARS and MERS – and whether the use of a relatively new method of vaccine development, known as messenger RNA technology, poses any significant risks.

“We of course are cognizant of the fact that this is a relatively new platform,” Hahn said. “We want to make sure that what we see, short-term and longterm, is consistent with our current knowledge and does not pose any significant risk to the American public.”

A vaccine advisory committee will meet on Dec. 10 to review Pfizer’s application for emergency use authorization in an open, broadcast forum. The FDA will put questions to the independent panel “that we would like them to answer that will advise us on our decision,”

Hahn said. Another committee meeting has been scheduled on Dec. 17 to review Moderna’s application.

Emergency use authorizations (EUAS) were created by Congress after the September 11, 2001, terrorist attacks, providing the FDA with the ability to authorize medical products more quickly in times of crisis, based on their “likely” effectiveness and a riskbenefit assessment. The agency has used its EUA authority to approve several tools in the fight against COVID-19, including tests and therapies.

While EUAS require less paperwork and data than full licensure, the FDA has outlined stricter requirements for emergency use authorizations of vaccines.

The agency provided manufacturers with detailed guidance on its EUA requirements for COVID-19 vaccines on June 30. The companies have expressed confidence those criteria have been met, which increased hopes that the applications will be approved.

Trump administration officials have said that vaccine EUAS could arrive within days of those public advisory meetings. “We believe we’re going to have people getting vaccinated, millions of people, before Christmas this year,” Health and Human Services Secretary Alex Azar said Monday.

But there are circumstances that could delay the FDA decisions. Primarily, scientists at the FDA and on the advisory committee may request more time to complete their analyses.