FDA Biologics Chief on Crusade to Defend Covid Vaccine Safety

Peter Marks is becoming the poster child of Covid-19 vaccine promotion. He’s made virtual appearances at conferences every day this week touting the robust requirements the FDA places on any vaccine that will be approved for general public distribution.

The director of the FDA’s Center for Biologics Evaluation and Research is a career scientist who told the American Society of Hematology he’s an idealist who left the pharmaceutical industry to pursue public health and patient care. He’s made confidence in the Covid-19 vaccine his personal mission.

Other health officials, including Health and Human Services Secretary Alex Azar, are touting the safety of the Food and Drug Administration’s process, stating the Covid-19 vaccines in development are receiving as much, if not more, scientific scrutiny than in other clinical trials.

Marks said it “keeps me up at night” worrying that too many people in the U.S. will decline vaccinations because they don’t trust them. That would mean the country will fail to reach “herd immunity,” in which a sufficiently high percentage of the population is immune to the disease such that the virus can no longer spread.

The recent FDA guidance for an emergency use authorization of a vaccine for Covid-19 faced backlash on several fronts. President Donald Trump tweeted the standards will “make it more difficult for them to speed up vaccines for approval before Election Day.” On the flip side, a group of prominent public health experts said in a letter to FDA Commissioner Stephen M. Hahn and Marks that the bar for safety needs to be higher.

To receive emergency authorization for distribution of a Covid-19 vaccine, the FDA requires that a vaccine be at least 50% effective. That’s unusual for vaccine development in less widespread outbreaks. “We did something we don’t usually do—we put a marker down,” Marks said Thursday at Food and Drug Law Institute’s annual conference.

The FDA also requires that manufacturers collect safety data on trial participants after they receive the second dose to identify any post-shot adverse effects. The time frames can vary per participant, but the median must be at least two months for the entire dataset. Some researchers say that isn’t stringent enough.

A group of leading medical and public health experts asked Hahn to require at least two months follow-up—not a median of two months’ follow up—in an Oct. 6 letter. It is largely the same group that asked Pfizer Inc. a few weeks ago to wait two months before submitting its application to the FDA.

Marks and other health officials are touting the FDA’s focus on safety and effectiveness of a forthcoming Covid-19 vaccine in response to reports of political pressure to have it on the market before Election Day, which has dropped confidence in the vaccine.

“At FDA, our goal is to get the word out,” Marks said Thursday.

Nearly half of Americans said they are unlikely to get vaccinated, according to a Pew Research survey released in September.

Polio, Smallpox

A number of factors have dropped vaccine confidence to an all-time low, Marks said. The nation no longer feels the immediate benefit because diseases such as smallpox and polio, eradicated by vaccines, are a distant memory. “This issue, combined with the fragmentation of society with social media etc., has led to this real crisis in confidence of vaccines,” Marks said Wednesday during an American Medical Association webinar.

Marks has underscored the need to boost public confidence in a Covid-19 vaccine in a blitz of recent events from FDLI to the AMA and others. He is further scheduled to speak at the to the National Organization for Rare Disorders conference on Friday.

“Our process must end up ultimately increasing trust in vaccines. Because without that vaccine confidence, we’re not going to get to where we need to,” Marks said Oct. 6 at a Johns Hopkins-University of Washington symposium.

Two Months of Data

The FDA’s standard requirements for an emergency use authorization for a Covid-19 vaccine are close to what the agency requires for a full regular vaccine approval.

The agency settled on a two-month median for follow-up data because most adverse events happen in that window. Marks pointing to vaccine for Guillain-Barré syndrome and transverse myelitis as corollaries Wednesday. The time frame was neither too aggressive nor too conservative, Marks said at the Oct. 6 symposium.

Some researchers are questioning whether a median of two months is enough.

“We respectfully urge you to require a high bar for safety. The FDA should require a minimum of two months of safety observation for all trial participants. Trial participants are already a sample of the population; to diminish the weight of some trial participants does not make sense,” they wrote in the Oct. 6 letter.

Marks acknowledged their concerns. “Some people would like longer than that, some people would like shorter than that,” he said Wednesday.

“Ideally you’d like to have longer-term safety follow-up,” he said Oct. 6. Instead, the FDA will conduct robust follow-ups after an emergency authorization using health claims and electronic health records that can capture safety data in real time.

“After all we are in the middle of a pandemic and there does have to be a little bit of balancing here,” he said Oct. 6. “Obviously we’re not going to allow anything to receive approval that has any significant concerns for safety.”

On Thursday, Marks appealed to a broader vision. “We are just going to keep our heads focused on doing the right thing for people in this country. Because everyone—everyone—deserves a quality safe and effective vaccine. Because everyone deserves to get back on doing what they want to be doing in life.”