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Coronavirus Files: FDA, CDC back boosters with more vax authorizations likely soon

Coronavirus Files: FDA, CDC back boosters with more vax authorizations likely soon

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Since April 2020, the Center for Health Journalism has been publishing a special newsletter geared to journalists as they report on one of the biggest and most complex stories of our times. Each Monday, while the pandemic runs its course, The Coronavirus Files will provide tips and resources and highlight exemplary work to help you with your coverage. This week, The Center for Health Journalism’s Coronavirus Files Monday newsletter is curated and reported by science writer Amber Dance, PhD. Have a suggestion or a request? Write us at editor@centerforhealthjournalism.org.

Race gap persists in breakthrough cases, but data is scarce

Structural racism, which has made the pandemic worse for Black, Latino, and Indigenous American populations, appears to be creating a racial disparity in breakthrough infection rates, write a trio of experts in The Washington Post. Dr. Oni Blackstock of Health Justice and Alexandra Skinner and Julia Raifman of the Boston University School of Public Health write that breakthrough cases appear to be more likely in people of color. “For example,” they write, “data from King County, Wash., suggest that hospitalization rates among fully vaccinated people are higher for Black, Indigenous and Pacific Islander residents than their White peers.” But, they add, it’s hard to understand the scope of the problem because of limited data collection; the CDC stopped tracking all breakthrough cases last spring. “This is unacceptable,” write the authors. “There is minimal information about whether the protection vaccines confer differs by race or ethnicity and no data to guide potential policies to address inequities.”

CDC and FDA back boosters, mix-and-match

Last Wednesday, the FDA officially authorized boosters for some Moderna and all Johnson & Johnson vaccine recipients. The CDC’s advisory committee, which met Thursday, endorsed the boosters as well, but modified the guidelines for the Moderna and Pfizer shots. The committee recommended boosters for people older than 65, older than 50 with certain medical conditions, and those in long-term care. The CDC advisors offered more qualified support for boosting younger adults with medical indications and people whose work or living situation increases their risk of exposure: it’s allowed, but they did not officially recommend it. “Some members of the committee also made it clear they are not convinced that all the people who meet the eligibility criteria actually need to be boosted at this time,” writes Helen Branswell at STAT.
 
The agencies also endorsed mix-and-match boosting, allowing people to select a different brand of vaccine for their booster than they received initially. Further guidance from the CDC on how to choose the right booster is expected next week, reports The Washington Post. Right now, there’s little evidence to guide those decisions, other than a single study of 458 people who each received one of nine potential combos. That research suggested one of the mRNA shots, from Moderna or Pfizer, would be most likely to raise antibody levels for people who started with either an mRNA or J&J shot. (Pfizer also recently announced that a third dose of its vaccine brought efficacy back up to 95.6%.) U.S. Surgeon General Dr. Vivek Murthy told CNBC that people who started with either of the mRNA vaccines may choose to continue with the same but those who started with Johnson & Johnson might consider a switch for the boost. Individuals may also wish to weigh the benefits of a given vaccine against the risks of each for their particular demographic, writes University of Texas epidemiologist Katelyn Jetelina on her blog. For example, the mRNA shots have been linked to a risk for heart inflammation that’s rare but greater among young men, while the Johnson & Johnson vaccine has been associated with rare instances of a certain type of blood clot especially among women between 30 and 49.
 
Plans to vaccinate kids under 12 take shape
 
Smaller doses, smaller needles, smaller clinics: These are core elements of the White House’s new plan, released last Wednesday, to vaccinate children aged 5 through 11 against COVID-19, pending authorization of Pfizer’s shot by the FDA and CDC. Pfizer’s data, made public on Friday, suggests its two-shot series was 90% effective against symptomatic infection during the summer delta wave. The NIH’s Dr. Anthony Fauci, at a White House briefing, said vaccinating children could “play a major role in diminishing the spread of infection.”
 
There are 28 million children in this age group who would become eligible for shots if the FDA and CDC sign off. And many of them are getting sick: According to the American Academy of Pediatrics, more than 1.1 million children tested positive for COVID-19 in the past six weeks. Data from the Kaiser Family Foundation suggests about one-third of families will want the vaccines for their kids as soon as possible.
 
The White House roadmap includes issuing doses at pediatrician’s offices and other sites where parents and kids should feel comfortable, instead of the mass vaccination sites used for adults earlier this year. There are plenty of kid-sized doses on hand, and the administration expects to make 15 million of those available during the first week after authorization.
 
With this move, the administration is opening itself up to criticism that it’s putting the cart before the horse by announcing distribution plans before scientists have weighed in, as happened with the adult booster rollout, notes Katie Rogers at The New York Times. But there seems to be more clarity here. As Adrianna Rodriguez at USA Today writes, “It’s all but certain the FDA committee will recommend the vaccine for children 5 to 11.” The FDA’s committee will take up the matter Oct. 26 and the CDC’s advisors Nov. 2–3. The Biden administration and outside experts say it’s smart to plan now. “They would be absolutely foolish not to have a well-detailed plan prepared,” Dr. Howard Forman, a public health policy expert at Yale University, told Rogers. 
 
Next up: Boosters for anyone over 40?
 
Rumor has it that the FDA is already considering booster shots for people as young as 40. CNN broke the story based on what an anonymous government source told senior medical correspondent Elizabeth Cohen. The potential move is apparently based on “growing concern within the FDA” about rising hospitalization rates in fully vaccinated adults younger than 65. Laurie McGinley at The Washington Post, who also spoke with anonymous officials, reports that the FDA will focus on initial shots for children aged 5­ to 11 before returning to this topic. Several members of the FDA’s vaccine advisory committee have already expressed support for lowering the booster age. “We don’t want to wait until we see some more severe infections in the under-65-year-old general population, because getting this vaccine out takes time and requires extreme logistic efforts,” said committee chairman Arnold S. Monto, an epidemiologist at the University of Michigan.
 
Vaccine rollout gets complicated
 
With the growing number of vaccines and boosters at different doses and different times for different age groups, pharmacies and clinics are facing a logistical nightmare, explains STAT’s duo Andrew Joseph and Helen Branswell. Consider Moderna’s vaccine: People who are immunocompromised can get a full-dose third shot, but others getting boosters should receive half a dose. Some of the company’s vials hold up to 30 half-doses — but Moderna recommends only piercing the stopper to draw a dose up to 20 times. The arrival of mix-and-match boosters, allowing people to get a different booster than their initial shots, further complicates inventory management. If and when Pfizer’s vaccine is approved for children aged 5 to 11, those doses — one-third of the adult amount — will come in different vials and federal officials are considering different-colored caps as well, reports Sasha Pezenik at ABC News.
 
From the Center for Health Journalism
 
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The USC Center for Health Journalism's Impact Funds provide reporting support — funding and mentoring — to journalists who think big and want to make a difference.
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What we're reading
  • “In secret vaccine contracts with governments, Pfizer took hard line in push for profit, report says,” by Adam Taylor, The Washington Post
  • “Politics is derailing a crucial debate over the immunity you get from recovering from COVID-19,” by Lev Facher, STAT
  • “The federal government gave billions to America’s schools for COVID-19 relief. Where did the money go?” by Annie Waldman and Bianca Fortis, ProPublica
  • “COVID vaccine makers brace for a variant worse than delta,” by Emily Waltz, Nature
  • “Monica Gandhi is S.F.’s outlier COVID expert. Her view on it: ‘I’m not saying anything crazy’,” by Ryan Kost, San Francisco Chronicle
  • “A cancer survivor had the longest documented COVID-19 infection. Here’s what scientists learned,” by Jennifer Couzin-Frankel, Science

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