As the nation's most powerful and twice-boosted infectious disease doctor battles a COVID-19 "rebound" two weeks after testing positive, new research from the public health schools at Harvard and Yale suggests the boosted fared worse against the first Omicron subvariant than the non-boosted.
The FDA is so alarmed by the "waning effectiveness" of boosters, whose formulation is still based on the ancestral Wuhan strain, that it asked manufacturers Thursday to add a "spike protein component" from the fourth and fifth Omicron subvariants to this fall's boosters.
Along with candid testimony by then-President Trump's coronavirus response coordinator, the developments raise questions about the basis for COVID vaccine mandates, particularly requiring low-risk populations to stay "up to date" with boosters, as some colleges demand of students.
They also lend support for Florida's cautious approach, under fire by the Democrat-led U.S. House coronavirus subcommittee.
The June 22 preprint, which has not been peer-reviewed, analyzed about 3,000 infections determined by longitudinal PCR tests with cycle thresholds under 30. Thresholds of 35 and higher have been widely used throughout the pandemic despite acknowledgments from top federal health officials that they tend to catch dead or noninfectious viral loads.
The tests came from the NBA's "occupational health cohort" from July 2020, when the league's so-called "bubble" started, through January this year. About half were Omicron BA.1 infections.
"Vaccination and infection history information were available for most individuals, allowing us to stratify the viral trajectories and probability of Ct<30 by exposure history and lineage," coauthor James Hay, postdoctoral researcher in Harvard's Center for Communicable Disease Dynamics, wrote in a tweet thread summarizing the results.
Researchers found the same pattern after excluding the players, the youngest members of the "relatively young cohort" and a minority of tested individuals.
"Viral rebounds rare but more frequent BA.1/booster era," Hay said. Boosted individuals with BA.1 infections "had longer [viral] clearance times than non-boosted" and lower "spike antibody titers" from the Wuhan strain before boosting, though Hay noted the researchers' prior NBA study showed the boosted were less likely to get BA.1 infections.
He questioned whether "original antigenic sin" from repeated doses of the same formulations against evolving variants could explain why the boosted took longer to clear infections.
A better explanation is the NBA cohort they studied has a "survival bias," Hay said. Looking at past antibody titers to the Wuhan strain, the researchers found many individuals with titers in the fall, between their second dose and the booster.
They concluded individuals with "low pre-booster" titers are "poor responders." Hay said this was affirmed by their finding that boosted BA.1 infectees had lower average pre-booster titers than non-boosted BA.1 infectees.
National Institute of Allergy and Infectious Diseases Director Anthony Fauci told the Foreign Policy Global Health Forum this week that he tested negative for three days after clearing his mid-June COVID infection, but the positives came back on the fourth day.
Fauci said he then "started to feel really poorly, much worse than in the first go-around," according to Spectrum News. He had been taking Pfizer's antiviral Paxlovid, which the CDC says has been associated with rebounds.
"So I went back on Paxlovid, and right now I am on my fourth day of a five-day course" and "certainly don't feel acutely ill," Fauci said, apparently ignoring FDA guidance.
After Pfizer CEO Albert Bourla recommended another course of Paxlovid to treat rebounds in May, FDA Office of Infectious Diseases Director John Farley said the agency had "no evidence of benefit" from a second course in patients with recurrent symptoms, Fierce Pharma reported. NIAID didn't answer Just the News queries about Fauci undermining the FDA.
Former coronavirus coordinator Deborah Birx also helped feed mistrust in federal pronouncements and directives in a viral exchange with Rep. Jim Jordan (R-Ohio) last week.
President Biden and CDC Director Rochelle Walensky repeatedly said vaccinated people couldn't get reinfected last year, even as breakthrough infections became common, prompting Jordan to ask if federal officials were "guessing ... or lying."
Birx responded, "I don't know," while conceding that natural immunity was at least as protective as vaccine immunity. Fauci's own agency contributed to global research suggesting natural immunity is broader and longer-lasting.
Apparently referring to mask-wearing and social distancing, Birx said her own vaccinated family "used layered protection during surges" because "every four months reinfection was reoccurring in South Africa," where Omicron was discovered.
Federal claims that the vaccinated couldn't transmit COVID were based on "hope," she said. Jordan answered: "So they were either guessing, lying or hoping."
As comments by Birx and Fauci fueled further skepticism of federal claims, Rep. Jim Clyburn (D-S.C.) accused Florida of working to "impede access to lifesaving coronavirus vaccines" to young children by not preordering products that have newly received emergency use authorization (EUA) from the FDA.
While the chairman of the House Select Subcommittee on the Coronavirus Crisis said Republican Gov. Ron DeSantis promoted "anti-vaccine misinformation," Clyburn implied COVID vaccines would reduce "the risk of severe illness, hospitalization, and death" for young children, which was not studied in the Pfizer and Moderna trials for ages as young as 6 months.
Florida Surgeon General Joseph Ladapo fired back at Clyburn for his "blatantly false statements" in a press release Wednesday, saying they illustrate "why people trust Florida — and not the federal government."
The state didn't preorder pediatric vaccines because it's an "unnecessary relic" of a time when "supply was low and demand was high among high-risk populations," Ladapo wrote to Clyburn, noting the lack of evidence for the Democrat's claims about COVID vaccines and children.
Ladapo said his department observed "inefficiencies" in previous vaccine authorization preorders but has "never restricted" private providers from ordering, as did some pediatricians the day the EUA was approved. States that preordered "will likely be left holding" a surplus "due to the lack of demand."