Coronavirus Files: FDA plans to vaccinate youngest children; Spotify misinformation stirs controversy
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COVID is devastating Black oral history
People of color are at least twice as likely to die of COVID as white people. In the Black community, the loss of so many lives also means the loss of oral history, as Janell Ross writes at Time.
“As we mark Black History Month, we know that a crucial part of that history has, in these last few years, been lost,” Ross writes. “Eyewitness accounts of the civil rights movement go un-gathered. Recipes passed down through the generations but never written down will never be cooked again.”
And the Black midwives she focuses on won’t be able to learn about post-birth rituals from their elders.
Oral history is essential to Black communities, tracing back to the time when Black people were not allowed to read or write, Ross explains.
“Oral history can tell us things that written records often cannot,” said Kelly Elaine Navies of the Smithsonian’s National Museum of African American History and Culture. “Not just when something happened or that someone was at a certain place but how did they feel about it?”
FDA seeks to speed up vaccination of youngest children
The FDA wants vaccines for younger children, and it wants them ASAP. In a move that’s been described as “highly unusual,” “extraordinary” and “bizarre,” the agency asked Pfizer to request emergency authorization for its two-dose protocol for children younger than 5 — even though the trial didn’t meet its goal for robust antibody production the 2 to 5 age group.
Pfizer’s original plan, back in December, was to try a third dose in those children to boost immunity, with data expected in late March.
The new plan is to authorize two shots now, with the assumption that a third will be necessary, effective and authorized shortly after the trial data arrives.
What’s changed? Omicron, an FDA spokesperson told STAT’s Helen Branswell.
More than 3.5 million children tested positive for COVID in January, according to the American Academy of Pediatrics.
Omicron also tends to settle in the upper respiratory tract, causing mucus and swelling to clog kids’ smaller windpipes, leading to wheezing and croup, reports Marla Broadfoot at Scientific American.
But all those cases might have made it easier and faster for Pfizer to collect data on the vaccine’s real-world efficacy in kids who fell ill.
“Maybe Pfizer found that fewer kids among those who received the actual vaccine in the trial were getting infected or sickened by the virus,” speculates Katherine J. Wu at The Atlantic.
We don’t know yet, because the data have not yet been made public. But an anonymous source told The New York Times that efficacy against infection was 50% for children between 6 months and 2 years old, and 57% for children between 2 and 4. This was based on fewer than 100 symptomatic cases total in the study, add Times reporters Sharon LaFraniere and Noah Weiland.
The FDA’s vaccine advisory committee will meet Feb. 15. Thus far, the committee has been conservative about giving the nod to vaccines without strong evidence of benefits outweighing risks.
Side effects from Pfizer’s two-dose study in this age group, such as fever and chills, were generally mild and comparable to those of other childhood vaccines.
Dr. Paul Offit, a member of the vaccine committee, told Kristina Fiore at MedPage Today that the group will want to see “clear evidence” that two doses provide protection. “We wouldn’t say yes on the promise that three doses [will be] of value.”
But the plan has potential to backfire if parents think the vaccine was rushed through without all the proper testing. Parents are already skeptical about vaccinating their children.
Vaccine uptake in older kids has been lackluster. Only one-third of parents say their 5-to-11-year-olds have had at least one shot, according to the latest data from the Kaiser Family Foundation Vaccine Monitor, and Pfizer’s vaccine has been authorized for that age group since November. And 31% of parents of children younger than 5 said they’d schedule a vaccination as soon as possible. (That was before this authorize-first, data-later plan was on the table, though.)
“The FDA must be crystal clear and leave no gaps or uncertainties,” wrote the Editorial Board of The Washington Post. “A vaccine should never be a shot in the dark.”
The story of kids’ vaccines overshadowed other vaccine news last week: Moderna’s vaccine, Spikevax, is now fully approved for adults, though still delayed for teens and younger children while the agency assesses risk of myocarditis.
And Novavax, after its own series of delays, has now officially requested emergency authorization — only for adults at the moment, though trials in children are underway.
Spotify mired in misinformation mess
Musician Neil Young headlines a growing list of artists and podcast hosts departing Spotify’s streaming service over the COVID misinformation aired by the platform’s Joe Rogan podcast.
Among the claims made on Rogan’s popular podcast: that a COVID vaccine will alter a person’s DNA, that ivermectin cures the disease, and that young people risk more from vaccination than COVID infection. None of those are true, notes BBC News’ Reality Check team.
But the misinformation out there has real effects; Adrianna Rodriguez at USA Today reports that hundreds of doctors are still prescribing ivermectin for COVID. And according to a recent paper in JAMA, insurers are bearing the cost.
Reuters also landed in hot water last week when it mistakenly reported that a Japanese clinical trial found ivermectin works on COVID; the error was swiftly corrected.
In response to the outcry from the likes of Joni Mitchell and the Duke and Duchess of Sussex, not to mention hundreds of medical experts, Rogan says he’s “not trying to promote misinformation” and Spotify has promised to put a content warning, linking to factual information, on all podcasts that touch on COVID-19.
The creators of the “Science Vs.” podcast, also hosted by Spotify, called the lack of sanctions for Rogan’s program a “slap in the face.” They promised to focus all new episodes on debunking misinformation from Rogan and other Spotify hosts until the company makes bigger changes.
As Mathew Ingram explains at Columbia Journalism Review, the issue comes down to whether Spotify is a platform, with no remit to moderate or censor content, or a publisher that should selectively curate its content.
Other platforms-cum-publishers have come up against the similar issues with COVID misinformation, and there are big bucks at stake. Anti-vaccine newsletters hosted by Substack earn the company about $2.5 million annually, reports Kristina Fiore at MedPage Today. Rogan’s exclusive deal with Spotify is reportedly worth more than $100 million.
“In that sense, Spotify is his publisher,” writes Ingram.
It’s the financial stakes that complicate Spotify’s position as a platform, write Lauren Hirsch and Michael J. de la Merced in The New York Times. While other hubs like Facebook don’t pay people to post less-than-verifiable ideas, Spotify does. “To some,” the pair write, “that puts an extra onus on Spotify to act like a media company and take responsibility for content.”
And it seems like the company is taking some publisher-like responsibility: it was reported over the weekend that Spotify has quietly removed dozens of episodes of Rogan's podcast over his past use of a racial slur.
Opinion writer Roxane Gay has also removed her podcast from Spotify. “Spotify does not exist in a vacuum, and the decisions it makes about what content it hosts have consequences,” she writes in The Times. “To say that maybe Mr. Rogan should not be given unfettered access to Spotify’s more than 400 million users is not censorship, as some have suggested. It is curation.”
White House, HHS Secretary under fire for pandemic response
A handful of articles last week criticized the federal government’s pandemic approach.
Steven Phillips, vice president of science and strategy for the COVID Collaborative, writes in Time that ongoing “chaos and conflict over the reopening of American institutions and commerce reflect the absence of a coherent national plan.” The first step, he suggested, was to set a clear definition of what “public safety” even means.
In The Washington Post, reporters Dan Diamond, Yasmeen Abutaleb and Tyler Pager take aim at Health and Human Services Secretary Xavier Becerra, who has been widely criticized for his job performance during the pandemic. Physician-scientist Eric Topol told the trio he’s been “like a ghost” during the pandemic.
Unlike past HHS secretaries and other top officials in the COVID response, Becerra hasn’t appeared on any Sunday morning television programs, and the Association of Health Care Journalists complained in November that Becerra wasn’t making himself available for questioning during regular press briefings.
According to Post reporters, White House officials have never had a tight relationship with Becerra and his role in the pandemic response was never fully delineated.
“It is sometimes unclear who makes final decisions or is in charge of carrying out initiatives, with [White House COVID coordinator Jeff] Zients absorbing much of the portfolio that would have gone to an HHS secretary in previous administrations,” they write.
White House support for Becerra has reportedly diminished. Despite these criticisms, Biden is reportedly unlikely to fire anyone.
Meanwhile, Biden’s nominee to head the FDA, Dr. Robert Califf, has hit stumbling blocks in Congress. Senators have questions about his past record on abortion drugs, the opioid crisis, and his financial ties to the pharmaceutical industry.
Free COVID tests for Medicare beneficiaries coming soon
The Centers for Medicare and Medicaid Services announced last Thursday a promise to provide up to eight at-home rapid tests per month to people enrolled in Medicare.
The move closes an important gap because people with private insurance are already able to have the tests paid for or request reimbursement. The Medicare change is expected to come in spring.
Medicare doesn’t do reimbursement, but the upcoming plan will pay pharmacies directly for the tests, reports Joyce Frieden at MedPage Today.
Scientists deliberately exposed people to COVID
Researchers in the U.K. intentionally exposed 34 young, healthy adults to the coronavirus in an attempt to understand the course of disease from beginning to end.
Only half of the subjects got infected, and there was no serious illness.
The results, which have not yet been peer-reviewed, suggest that similar human-challenge trials can be done safely, perhaps to test vaccines and antiviral medicines, reports Ewen Callaway at Nature.
However, this trial did not test such interventions, leading some to question whether it was ethical to infect people just to learn about the disease process.
The study also found that people developed their first symptoms and tested positive by PCR within two days of exposure.
Subjects’ viral loads peaked around five days in, and antigen tests reliably identified when people were likely to be contagious, report Josephine Mason and Jennifer Rigby at Reuters.
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What we're reading
- “COVID-19 widows struggle to get benefits as Social Security offices remain closed,” by Chabeli Carrazana, The 19th
- “Where did omicron come from? Three key theories,” by Smriti Mallapaty, Nature
- “In New York City sewage, a mysterious coronavirus signal,” by Emily Anthes, The New York Times
- “State COVID testing programs may show the way for daycare,” by Jane Roberts, Undark
- “How Pfizer made an effective anti-COVID pill,” by Antonio Regalado, MIT Technology Review
- “All-out effort to keep Biden COVID-free; no ‘normal’ yet,” by Zeke Miller, AP News
Events and Resources
- Feb 7, 10 a.m. PT: STAT hosts a video chat today on “The exhaustion epidemic: Examining the COVID-19 burnout crisis in health care.”
- Feb. 10, 6 p.m. PT: Town Hall Seattle hosts a live Q&A online with The Atlantic’s Pulitzer Prize winner Ed Yong, who’s been writing about pandemics since before we had one. Tickets carry a $25 suggested price.
- Channel e2e lists companies that require employees to get a COVID vaccine (h/t COVID Data Dispatch).
- The Sabin Vaccine Institute offers a Journalist Resource Hub on vaccines and immunization, including informational videos and a database of expert sources.
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