FDA advisors are debating boosters today and tomorrow
The booster shot debate is back.
President Biden came into office promising to “follow the science.” But that’s not easy when researchers are divided and data conflicts. Throughout the vaccination campaign, no issue has sparked such fierce scientific divisions quite like the debate over whether Americans need coronavirus boosters.
The FDA’s advisory committee is set to meet today and Friday to dive into whether additional doses are needed for the Moderna and Johnson & Johnson vaccine. They’ll also discuss whether booster shots can mix and match vaccines.
We’ve been here before. Just three weeks ago, federal health officials greenlit a third Pfizer shot for Americans 65 and older, as well as those at risk of serious illness or those susceptible due to their jobs or because they live in a nursing home or other group setting. The effort was plagued with division over basic questions, like who should get a booster, to fundamental ones, like what is the overall goal of additional doses.
Here’s what you need to know ahead of the meeting:
1. Moderna (mostly) wants what Pfizer has.
The company is seeking approval for a booster for the same population eligible for Pfizer’s third shot. But there’s one key difference: Advisers will review data supporting a booster equivalent to a half-dose of the original shot.
The context: The vaccines from Moderna and Pfizer, both built on groundbreaking mRNA technology, are often mentioned in the same breath, but their composition isn’t the same.
- For example: Moderna’s dose of mRNA is over three times that of Pfizer's, and there is some evidence that it may be slightly more effective at preventing illness.
- One CDC study found Moderna’s shot was 95 percent effective in preventing hospitalization, while Pfizer-BioNTech’s vaccine was 80 percent effective, and Johnson & Johnson’s was 60 percent.
2. Don’t forget about J&J.
The single-dose Johnson & Johnson shot — which just over 15 million Americans have received — may be the vaccine regimen most in need of a booster. An FDA review of the data suggests that, while the shot still protects against severe disease or death, its initial protection is less than that of the vaccines from Moderna or Pfizer.
But that doesn’t mean a booster approval will be straightforward. An FDA analysis suggested that booster shots for the Johnson & Johnson vaccine may be beneficial, but the agency also didn’t have time to complete an independent analysis as it typically does, The Post's Carolyn Y. Johnson reports.
- Johnson & Johnson is looking for broader approval in the general population. The company submitted data on two possible booster intervals: A second dose two to three months after the single-shot primary dose, or a booster six months after the initial shot.
Another potential twist: Johnson & Johnson has asked the FDA to approve a second shot of its own vaccine, but the advisory committee is also set to hear data from a new National Institutes of Health study analyzing mix-and-matching vaccines.
- That data shows that people who receive an mRNA shot after a Johnson & Johnson vaccine have a stronger neutralizing antibody response compared with people who get a second Johnson & Johnson shot, Carolyn writes.
3. Scientists are at odds over the goal for vaccines.
Some coronavirus experts have dismissed boosters as unnecessary or premature, pointing out that existing vaccines already do a good job keeping people from dying or ending up in the hospital. While virus-fighting antibodies appear to wane over time, these scientists argue that the body’s immune system remembers the virus and can still protect against the worst effects of the virus.
But some of the administration’s top scientists say that’s not enough. Anthony Fauci, Biden’s chief medical adviser, has said boosters are important to keep people from getting sick — and that there is value in preventing even mild illness.
- Peter Marks, the FDA official overseeing coronavirus vaccines, recently said in a webinar that updated data may make a strong case that everyone over the age of 18 should be eligible for the additional shots.
“What is your end point?” asked Lawrence Gostin, who heads Georgetown University's O'Neill Institute for National and Global Health Law. “Is your end point just the antibody response, which does seem to wane? Is your end point the actual, full immune response with all of the body's mechanisms to remember the virus and attack it?”
WHO announces new team to investigate the coronavirus’ origins
The World Health Organization named 26 scientists to a new advisory body — a marked change in approach to one of the pandemic’s most politically sensitive issues, The Post’s Adam Taylor reports.
The background: More than 700 experts applied for a slot on the team, which includes scientists from the United States, China and 24 other nations. They’ll serve two-year terms, unpaid, with the possibility of their time on the body extended.
What’s on the agenda: The group will not only consider how the coronavirus infected humans, but will also work to create a framework for defining and guiding studies probing the origins of future pathogens with epidemic and pandemic potential.
Fauci: Other variants not expected to ‘outstrip’ delta
The highly infectious delta variant is the United States’ dominant strain of the coronavirus — and Fauci doesn’t anticipate that changing. This comes as another strain was sequenced last week from two samples collected from Baton Rouge, La., The Post’s María Paúl reports.
- That strain was first detected in the Dominican Republic in March — and is one of over a dozen of WHO’s “variants under monitoring.”
- Since May 2020, there have been a slew of variants, but none as potent as delta — which once again drove hospitals to their breaking points during this summer’s surge. There have been 79 of these variants reported in the country, but scientists say they’ll closely monitor the new one since it contains the type of mutation associated with increased transmissibility.
Democrats urge White House to consider sharing Moderna technology
A dozen congressional Democrats want the Biden administration to ramp up pressure on Moderna — and even potentially disclose details of the company’s mRNA vaccines — as tensions build over whether the vaccine maker has sufficiently shared its know-how with the developing world, The Post’s Dan Diamond reports.
- “Despite receiving huge sums of public funding from American taxpayers, Moderna has refused calls to share its technology, including from the U.S. government,” Sen. Elizabeth Warren (D-Mass.) and her colleagues wrote to Biden administration officials in a letter.
Moderna received nearly $10 billion in federal funding to expand its vaccine manufacturing, execute trials and produce shots. The federal government also helped with the company’s vaccine development, and the lawmakers contend those federal contracts appear to grant the government the power to disclose Moderna’s production details.
But Biden officials are skeptical the contract could compel disclosure.
- “The contract did not require Moderna to deliver information about the know-how necessary to make the vaccine,” a senior administration official, who spoke on the condition of anonymity to discuss internal deliberations, told Dan. “Even if the government were in possession of the manufacturing records, that information could not be shared publicly.”
The FDA wants to curb America’s salt intake
The agency is asking food companies and restaurants to cut sodium in their foods by about 12 percent over the next 2½ years.
- “The guidelines are voluntary, but experts say they signal a new willingness on the part of the FDA to crack down on food manufacturers,” The Post’s Laura Reiley reports.
Health advocates want the administration to make the sodium guidelines mandatory and require a warning label on products with high sodium content. Still, advocates have heralded this week’s announcement as a bigger deal than even the agency’s trans fat ban in 2015, given sodium’s role in nearly every food and the link between excess sodium consumption and high blood pressure.
- Health care industry leaders in California have leveraged their political clout and close ties with Gov. Gavin Newsom (D) to shape the debate over reducing health-care costs, Kaiser Health News’s Angela Hart and Samantha Young report.
- Doctors and health officials are bracing for a “twindemic” of coronavirus and flu this winter. While flu virtually disappeared in 2020, as Americans embraced mask-wearing, increased sanitation and social distancing, it could come back with a vengeance this year. The fact that so few were infected last year means that Americans have built up less natural immunity, The Post’s Ellen Francis reports.
- The archbishop of the U.S. military is arguing that Catholic troops should be allowed to claim religious exemption from the coronavirus vaccines, even though the Vatican itself has embraced a vaccine mandate and the Pope has described getting vaccinated as “an act of love,” The Post’s Andrew Jeong and Timothy Bella report.
- The Post’s fact-checker Glenn Kessler dug into what caused Southwest Airlines flight cancellations. The claim that they were the result of a walkout in protest over coronavirus vaccine mandates has circulated widely on right-wing social media and television, but has been denied by the airline, the Southwest pilot union and the Federal Aviation Administration.
Thanks for reading! See y'all tomorrow.