How FDA's Failure To Certify Covid Vaccines Has Increased Hesitancy

The FDA's plodding, bureaucratic approach to formal approval (versus emergency use authorization) has fueled vaccine hesitancy. It leaves some organizations in a legal quandary about requiring vaccination and it feeds misinformation and legitimate uncertainty about the safety of the vaccines. 

It is safe to say that the FDA's performance during its greatest crisis in over a century has been at best inadequate and at worst, counterproductive. JL

David Leonhardt reports in the New York Times:

The FDA has given only “emergency use authorization” to the shots from Moderna, Pfizer and Johnson & Johnson. The difference between emergency authorization and full approval matters. Right now, the military, schools and other organizations cannot easily require vaccinations. The “lack of F.D.A. licensure leave schools, colleges, businesses in a legal quandary.” The situation feeds uncertainty and skepticism among some who have not yet gotten a shot. The F.D.A.'s official position is that “they don’t have enough safety data yet.” The F.D.A.’s lack of approval has neither protected its reputation for caution nor maximized the number who have been protected from Covid.

It is the most discordant part of the U.S. government’s response to Covid-19.

Even as President Biden, the C.D.C. and virtually the entire scientific community are urging — pleading with, even — Americans to get vaccinated, the government has not formally approved any vaccine. The Food and Drug Administration has instead given only “emergency use authorization” to the shots from Moderna, Pfizer and Johnson & Johnson. That’s a temporary form of approval that allows people to receive shots while the agency continues to study their effectiveness and safety.

The difference between emergency authorization and full approval matters. Right now, the military, schools and other organizations cannot easily require vaccinations. The “lack of F.D.A. licensure leave schools, colleges, businesses in a legal quandary,” Dr. Jerome Adams, a former surgeon general, recently wrote. Adams argued that lives were at stake and that the issue should be receiving more media coverage than it has.

The situation also feeds uncertainty and skepticism among some Americans who have not yet gotten a shot. Those skeptics, as Matthew Yglesias of Substack wrote yesterday, are effectively taking the F.D.A. at its word. The F.D.A. leaders’ official position is that “they don’t have enough safety data yet,” Yglesias noted.

The strangest part of all this is that the F.D.A.’s official position does not reflect its leaders’ actual views: They agree with the C.D.C. and other scientists that Americans should be getting vaccinated as soon as possible.

Dr. Janet Woodcock, the F.D.A.’s acting commissioner, has said that the F.D.A. “conducted a rigorous and thorough review” of the vaccines before allowing them to be given to people and that the Pfizer vaccine “meets F.D.A.’s high standards for safety and effectiveness.” She also said, “Getting more of our population vaccinated is critical to moving forward and past this pandemic.”

Hurry up and wait

Why, then, hasn’t the F.D.A. taken the final step of formal approval?

It is following a version of its traditional, cautious process for vaccine approval. That process has historically had some big advantages, reducing the chances that Americans end up taking a faulty drug. To move much more quickly would risk undermining the public’s confidence in the F.D.A. and, by extension, the medicines it approves, Dr. Peter Marks, who oversees the process, has argued.

But I think the F.D.A.’s leaders have failed to understand how most Americans really think about the vaccines. It is different from the way that scientists and epidemiologists do. It’s less technical and based more on an accumulation of the publicly known facts.

It reminds me of another example of expert miscommunication, early in the pandemic. Back then, public health officials made highly technical statements about masks that many people interpreted as discouragement from wearing them. These statements ignored the many reasons to believe that masks could make a difference (like their longtime popularity in Asia to prevent the spread of viruses) and focused instead on the absence of studies showing that masks specifically prevented the spread of Covid.

Later, officials insisted that they were merely “following the data.” In truth, though, they were basing their advice on a narrow reading of the data — and not understanding how most people would interpret their comments.

The long wait to approve the vaccines is similar. F.D.A. officials are acting as if most Americans are experts in the nuances of their approval process and will be shocked if the agency expedites it. In reality, many Americans know almost nothing about that process. But some are understandably confused by the mixed messages that the F.D.A. is sending.

Hundreds of millions of people around the world have been vaccinated. Tens of thousands of them were followed for months in clinical trials. And F.D.A. officials have repeatedly urged other Americans to get vaccinated. “In the history of medicine, few if any biologics (vaccines, antibodies, molecules) have had their safety and efficacy scrutinized to this degree,” Dr. Eric Topol of Scripps Research wrote in The Times.

Yet the agency still has not given formal approval to those same vaccines.

Big costs, few benefits

Think of it this way: In the highly unlikely event that the evidence were to change radically — if, say, the vaccines began causing serious side effects about 18 months after people had received a shot — Americans would not react by feeling confident in the F.D.A. and grateful for its caution. They would be outraged that Woodcock and other top officials had urged people to get vaccinated.

The combination means that the F.D.A.’s lack of formal approval has few benefits and large costs: The agency has neither protected its reputation for extreme caution nor maximized the number of Americans who have been protected from Covid. “In my mind, it’s the No. 1 issue in American public health,” Topol told me. “If we got F.D.A. approval, we could get another 20 million vaccinated,” he estimated.

Rebecca Robbins, who covers the vaccines for The Times, says she is less sure about the size of the impact. But she agrees that full approval, whenever it happens, is “probably going to be the catalyst for many new mandates.”

My colleague Noah Weiland says: “Right now, it appears a full approval for the Pfizer vaccine could come in September, with Moderna not far behind.”

In the meantime, more Americans may get sick from Covid. About 34 percent of Americans who are eligible for the vaccines have not yet gotten a shot. The number of new cases has roughly tripled this month, largely because of the Delta variant. The number of deaths has almost doubled in the past two weeks.

If you want to read the F.D.A.’s explanation, I recommend a letter Marks wrote to The Times: “We want to assure the public that the review of applications for full approval of Covid-19 vaccines is one of the highest priorities at the Food and Drug Administration.”