Analysis & Comment

Why Aren’t the Vaccines Approved?

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.”

Related:

The F.D.A. recently abandoned its usual caution when approving a different product — Aduhelm, an Alzheimer’s drug — despite evidence it might not work, a Times investigation found.

A study estimates that three million people have died of Covid in India, nearly 10 times the official toll.

Many elected Republicans have allowed vaccine skepticism to flourish in their party. On Fox News, Sean Hannity and Steve Doocy encouraged viewers to get vaccinated.

Apple is delaying its return-to-office plans by at least a month.

THE LATEST NEWS

Climate

Smoke from wildfires in the West cast a haze over New York City. This map shows how.

Droughts made water so scarce in Oakley, Utah, that officials have restricted the construction of new homes.

Severe flooding in central China has killed at least 12 people inside a subway in the city of Zhengzhou.

A California couple are facing manslaughter charges over a wildfire last year that started at a gender reveal party.

Politics

Federal officials arrested Thomas Barrack, chairman of Donald Trump’s inaugural committee, on charges of failing to register as a foreign lobbyist and obstruction.

Celebrating Tampa Bay’s Super Bowl victory at the White House, Tom Brady took a jab at Trump, joking: “I think about 40 percent of the people still don’t think we won.”

Other Big Stories

Jeff Bezos briefly flew to space. Afterward, he drew criticism for saying that Amazon employees and customers “paid for all of this.”

Americans’ medical debt is much bigger than was known and is increasingly concentrated in states that have not expanded Medicaid.

Haiti’s police arrested three officers over the assassination of President Jovenel Moïse.

The Milwaukee Bucks beat the Phoenix Suns to win their first N.B.A. championship in 50 years.

Brisbane, Australia, will host the 2032 Summer Games. In Tokyo, the first Olympic events have started, including a win for the U.S. softball team. Here’s the latest.

Opinions

Bret Stephens interviewed Eric Adams, the Democratic nominee for New York City mayor.

Billionaires going to space is an expensive waste, Jacob Silverman argues in The New Republic. Liz Wolfe of Reason disagrees, writing that the feats will yield spinoff technologies that will improve life on Earth.

MORNING READS

Stranded: People in suburbs are caring for wildlife, as these pictures of baby animals show.

Sacred undergarments: Mormon women are asking for better — “buttery soft” — underwear.

Rebrand: Scientists want you to stop saying “shark attacks.”

A Times classic: Tips to improve your work-life balance.

Lives Lived: Marjorie Adams devoted her life to getting her great-grandfather — the baseball pioneer Doc Adams — inducted into the Hall of Fame.“Her great-grandfather’s day is coming,” baseball’s official historian said. She died at 72.

ARTS AND IDEAS

A forgotten queen of 19th-century opera

Pauline Viardot was one of the premier opera figures of her time, a talented singer, composer, teacher and entrepreneur. A London journal in 1848 wrote: “Her technical skill alone is immense; in the completeness of her chromatic scale she is, probably, without a rival.”

So why have we barely heard of her?

“Like so many influential women of her time, her fame has been eclipsed by that of the men around her,” The Guardian wrote in 2006.

Now, 200 years after her birthday, her works are enjoying a resurgence as part of a wave of interest in long-neglected composers. She is a “perfect example of an artist who should be much better known today,” an opera conductor told The Times. Read more about Viardot and discover her music. — Claire Moses, a Morning writer

PLAY, WATCH, EAT

What to Cook

This grilled burger recipe puts flavor over volume.

What to Watch

Here are this month’s picks for action films to stream.

Alfresco

Here’s a guide to what to pick up, and how to pack it, for a perfect summer picnic.

Late Night

The hosts joked about Bezos.

Now Time to Play

The pangram from yesterday’s Spelling Bee was privacy. Here is today’s puzzle — or you can play online.

Here’s today’s Mini Crossword, and a clue: Steaming mad (five letters).

If you’re in the mood to play more, find all our games here.

Thanks for spending part of your morning with The Times. See you tomorrow. — David

P.S. Greetings from a ghostly newsroom.

You can see today’s print front page here.

“The Daily” is about Chinese cyberattacks. On “The Argument,” if aliens exist, should we make contact?

Claire Moses, Ian Prasad Philbrick and Tom Wright-Piersanti contributed to The Morning. You can reach the team at [email protected].

Sign up here to get this newsletter in your inbox.

Source: Read Full Article