Good morning and TGIF. ☀️ We have a lot of questions for an FDA commissioner — and I mean, a lot. But would he tweet? (read more to find out*)

Today, FDA's independent advisers will consider critical questions on J&J's booster shot, and we dive into what happened with Moderna's ask. But first:

Democrats might need GOP help to confirm Biden's FDA pick

President Biden is closing in on a pick to lead the FDA. But at least one Democrat is already voicing concerns, leaving White House officials to likely bank on Republican support to get the possible pick over the finish line. 

The administration has zeroed in on former Food and Drug Administration commissioner Robert Califf to once again assume the role, my colleagues scooped yesterday. For roughly nine months, the agency has lacked a permanent leader in the midst of a global pandemic, a critical vacancy that’s both alarmed and confounded public health experts. 

In choosing Califf, Biden would get somewhat of an old hand, who former officials say could very much be plug and play within the beleaguered agency. The administration would also add to its growing roster of Obama veterans, since Califf led the FDA under the former president for less than a year. He also previously worked as the agency’s deputy commissioner for medical products and tobacco for a year.

(The White House has not confirmed the possible FDA leader. White House secretary Jen Psaki said no final decision has been made.)

The Post's Dan Diamond

Califf and the Senate

Let’s look back to 2016. Califf faced resistance from a handful of Senate Democrats who opposed the longtime Duke University researcher’s ties to pharmaceutical companies that helped fund his work, as well as generally how the FDA had handled the opioid epidemic.

  • Sens. Ed Markey (D-Mass.), Joe Manchin (D-W.Va.) and Richard Blumenthal (D-Conn.) voted against his nomination on the Senate floor. Sen. Bernie Sanders (I-Vt.) also expressed serious misgivings but missed the vote.

Lawmakers’ offices largely declined to comment in the hours after Califf’s name surfaced yesterday. But at least one Democratic senator wasn’t shy. 

  • “I would have very grave reservations about this nomination – many of the same reservations I expressed when I voted against Dr. Califf’s confirmation in 2016,” Blumenthal (D-Conn.) said in a statement to The Health 202.

But still, Califf would be a seemingly safe choice for Biden. Despite some Democratic opposition, his first nomination sailed through the Senate in an 89-4 vote. 

Even if the process turns into a bruising battle, Califf’s allies believe he has the credentials to muscle through. The numbers may also be on his side. 

  • “Sixty-five of the 89 senators who originally voted to confirm Califf as FDA commissioner are still serving in the chamber, including Sen. Patty Murray (D-Wash.),” who chairs the committee charged with advancing the nomination, The Post’s Tyler Pager, Dan Diamond and Yasmeen Abutaleb write.
  • When it comes to opposition, the past isn’t always prologue, one longtime FDA observer, who requested anonymity to speak candidly, told The Health 202. Some holdout lawmakers may have approved of his time at the agency and may not oppose him this time around.

Other rumored contenders for the job had already drawn too much heat. 

  • Janet Woodcock — a longtime FDA regulator and current acting commissioner — had support for the permanent post from some inside and outside the administration. But concerns from a handful of vocal lawmakers over the potential nomination had already seemingly tanked it.
  • Other names floated were also contentious. For instance: Michelle McMurry-Heath, the head of a large biotechnology lobby, sparked accusations of being too entwined with the pharmaceutical industry.
Califf's background

Califf is currently a professor of cardiology at the Duke University School of Medicine. He’s advised Google and its spinoff, Verily Life Sciences, since leaving the federal government. 

In conversations with The Health 202, former colleagues described him as a steady hand, independent thinker and an advocate for good data . They also pointed to his expertise in clinical trials, a knowledge base critical for helping evaluate potential vaccines and therapeutics amid the pandemic

  • “I think it's good for the agency to have somebody that they've worked with before helming the the top leadership position,” said Stacy Cline Amin, a partner at law firm Morrison & Foerster and former FDA chief counsel.

*Past FDA commissioners have a history of tweeting. It even sparked a controversy after one FDA leader’s tweets were deleted. But would Califf tweet a lot? One former FDA official, Howard Sklamberg, thinks he would. (A very unscientific review of Califf’s account confirms he does, in fact, tweet.) 


Today in booster shot reviews: Johnson & Johnson

The FDA's advisers reconvene today to consider whether to recommend a booster dose of the Johnson & Johnson vaccine. 

The most divisive issue could be results from a small National Institutes of Health study that found that J&J recipients who receive an mRNA booster shot have a stronger vaccine antibody response. But there were limitations to the study.

  • In a statement, the FDA did not speculate on whether it would authorize the mixing-and-matching of doses for those who received J&J. However, the agency said it can revise an emergency use authorization “if the circumstances make a revision appropriate to protect the public health or safety.”

Cody Meissner, an infectious-disease specialist at Tufts and a member of the advisory committee, told The Health 202, that there's not enough information to determine whether it's better to get a booster from the same brand or a different one.

  • "The existing data is not sufficient to answer the question which is the best route to follow, it’s playing out in real time,” he said.

Moderna's booster shot gets the greenlight from FDA advisers

A panel of expert advisers to the Food and Drug Administration on Oct. 14 recommended a booster shot of the Moderna vaccine for certain at-risk groups. (Reuters)

The FDA’s advisory group voted unanimously to recommend a booster dose of Moderna’s coronavirus vaccine for adults 65 and older and for those at high risk of disease or susceptible because of their work, The Post's Carolyn Y. Johnson and Yasmeen Abutaleb report

  • Moderna’s two-dose vaccine regimen remains 93 percent effective in preventing all virus-related illness and 98 percent effective against severe illness at least five months out.
  • But the company noted an uptick in breakthrough infections this summer and pointed to evidence that anti-virus antibodies dropped six to eight months after vaccination.

While the committee endorsed booster shots for some people, a separate discussion about the possibility of approving boosters for the general population triggered objections.

  • “I don’t agree with doing this down to 18 years of age at all,” said Paul Offit, a pediatrician and vaccine expert at Children’s Hospital of Philadelphia.
  • “I am very concerned about the paucity of data,” said Archana Chatterjee, the dean of the Chicago Medical School.

What happens next: FDA officials will consider the nonbinding recommendation. An advisory committee to the Centers for Disease Control and Prevention will meet on Wednesday to discuss how the vaccines should be used, if authorized.

A point of tension: Moderna has been feeling the heat over the fact that it has sold few of its shots to low-income countries. The advisory meeting was no exception, as members of the panel raised concerns about global vaccine equity.

Reproductive wars

Texas's “heartbeat” ban is still in effect

A federal appeals court sided with the state of Texas, refusing the Justice Department’s request to reinstate an earlier court ruling that lifted the abortion ban, The Post’s Ann E. Marimow reports.

The panel of justices on the U.S. Court of Appeals for the 5th Circuit voted 2-to-1 to let the law, which bans abortions once cardiac activity is detected in the fetus, remain in effect as it considers the case. Their order is expected to be appealed to the Supreme Court. Meanwhile, the legal battles have effectively halted almost all abortions in Texas.

Biden will meet with Pope Francis

Biden will meet with the pope at the Vatican on Oct. 29 to discuss the coronavirus, climate change and caring for the poor.

The meeting between the Pope and Biden, the United States’ second Catholic president, comes as the Catholic Church is divided over whether politicians who favor abortion rights should be allowed to receive Communion, The Post’s Amy B Wang and Chico Harlan report. It's an issue that's expected to come to a head when bishops hold their annual meeting in November.

Quote of the week

In other health news

  • Biden announced the U.S. will send 17 million doses of the Johnson & Johnson vaccine to the African Union. The donation, which was announced during a meeting with Kenyan President Uhuru Kenyatta, comes in addition to the 50 million doses already sent to the African Union, The Post’s Felicia Sonmez and Cleve R. Wootson Jr. report.
  • As the world searches for the origins of the coronavirus, The Post’s Karin Brulliard and Ben Guarino take a deep dive into the origins of another deadly virus. The Nipah virus is viewed as a case study in the spillover of disease from animals to humans and still shapes the way scientists think of disease origins today.
  • It’s a revolving door. As Democratic lawmakers push to allow the federal government to negotiate the price of pharmaceuticals, they are confronting a lobbying push staffed by many of their former colleagues, the Intercept’s Lee Fang reports. Lee cites the example of former Senator Blanche Lincoln (D-Ark.) who touted the benefits of allowing Medicare to negotiate drug prices when she was running for reelection in 2004 but now serves as a lobbyist for Pfizer, arguing against that proposal.
  • Both e-cigarette groups and anti-vaping groups say they are confused by the FDA’s approach as it sorts through millions of marketing applications from e-cigarette manufacturers, Politico’s Katherine Ellen Foley reports. The FDA has already backtracked in its denial of one midsized manufacturer and it still hasn’t ruled on some of the biggest players, like Juul.

Sugar rush

Thanks for reading! See y'all Monday.