by Greg Piper
Harris campaign requires staffers to be "up to date" on COVID vaccines. No COVID outbreak during Democratic convention as widely claimed, Chicago says. Former FDA reviewer says new approval is like "reopening an old wound."
The Centers for Disease Control and Prevention is pushing new COVID-19 boosters, claiming that people who don't stay "up to date" with shots – regardless of how many they've already taken – "are more likely to get very sick" while those who take them annually are "much less likely to get very ill, be hospitalized, or even die" from COVID.
The Democratic nominee for president is so committed to staying up to date on jabs that Vice President Kamala Harris made COVID boosting a requirement to work on her campaign, "unless otherwise prohibited by applicable law." They can also ask the human resources department for a "reasonable accommodation … prior to reporting to an office location."
What's the evidence for these interventions recommended to Americans and required of those who would work for the de facto incumbent?
That's what critics of the public health agencies are asking as officials and mainstream media hype a rise in positive tests for SARS-CoV-2 and some schools shutter – in red states, no less – rather than let the demographic at the lowest risk from COVID learn in person.
The Democratic National Convention is even under fire in the wake of an alleged COVID outbreak that reportedly included two Harris campaign staffers, both presumably boosted, for not requiring attendees to mask up, despite little rigorous evidence that masking makes much difference to infection and transmission.
"While it is not surprising at an event this large that some people would test positive for COVID-19 over the course of the week, there is so far no evidence to suggest that an outbreak occurred," the Chicago Department of Public Health told Just the News in an uncredited statement.
The city, state and federal agencies "established an enhanced public health surveillance strategy to monitor" for COVID at the convention and nearby amid the surge, and "guidance and masks were also provided" to attendees, but "the risks associated with COVID-19 are very different now than they were during the height of the pandemic," CDPH said.
Chicago's most recent publicly available infection rate estimates, using wastewater testing and PCR testing at hospital and commercial labs, as of Tuesday don't include the week it hosted the four-day convention.
The Food and Drug Administration, which fact-checked Robert F. Kennedy Jr.'s claim about its heavy funding by the pharmaceutical industry by saying he was 3% off, granted emergency use authorization to new COVID jabs during the convention.
You actually can’t make this up.
In response to the claim that 50% of the @US_FDA’s budget comes from pharma (a terrible incentive…), the agency released an official statement saying it is only 47%…
An executive order should be signed tomorrow making this 0. https://t.co/1UaePHO64F pic.twitter.com/QWgVURpq6r— Calley Means (@calleymeans) August 25, 2024
Notably, Moderna CEO Stéphane Bancel didn't go as far as the CDC in his claims about jabs by his own company and competitor Pfizer, formulated to target the KP.2 strain, calling them "one of the best ways" to stay "protected and prevent severe illness."
The CDC and FDA also use different adjectives.
The former's COVID treatment page says "you are protected best when you stay up to date" and Director Mandy Cohen recommended boosting all ages 6 months and up as "the best protection against severe illness," while the FDA and its Center for Biologics Evaluation and Research Director Peter Marks say new jabs offer "better protection."
Asked for granular evidence that the updated vaccines offer "better protection" against circulating variants and serious consequences even for people who took every prior formulation, FDA press officer Cherie DuvallJones cited the June 5 discussions of the FDA's Vaccines and Related Biological Products Advisory Committee, CDC presentation on the effectiveness of the 2023-2024 formula and decision memos.
She also pointed to the CDC's COVID vaccine effectiveness page and vaccine effectiveness studies page, but neither appear to focus on the new formulation.
The CDC linked the treatment page in an X post Monday that wasn't even about vaccines but rather "early treatment" for people "more likely to get very sick" from COVID: the antivirals Paxlovid, remdesivir and molnupiravir.
Georgia-based COVID analyst Kelley Krohnert, known for documenting repeated COVID data errors by the CDC, flagged the agency's "up to date" statements below the "early treatment" section of the page.
"That seems like quite a big claim — one that would require good data," Krohnert wrote on X, referring to a much higher risk for those who took every booster save the most recent.
Paxlovid's abilities have taken critical hits this year due to studies that involve employees of its maker, Pfizer.
The New England Journal of Medicine found "sustained alleviation" from COVID did not "differ significantly between" Paxlovid and placebo patients, and a Journal of the American Medical Association publication found no difference in long-COVID results between the two.
🚩 Dr. Marty Makary & Dr. Vinay Prasad on How Inconvenient Paxlovid Data Was Suppressed for Nearly Two Years
"A study came out in the New England Journal of Medicine on Paxlovid. Two big studies in the same issue. This was a couple months ago. No benefit in people under 65.… pic.twitter.com/tDih0gmdQt— Chief Nerd (@TheChiefNerd) August 26, 2024
The CDC estimated the KP.2 strain was already plummeting as the share of COVID infections when the FDA authorized new boosters, with the KP.3 strain representing more than half in its latest "Nowcast" estimate for the two weeks ending Aug. 17.
The FDA did not require "any studies measuring the impact on severe disease or hospitalization or death," and Marks picked the KP.2 strain "from his a**," University of California San Francisco epidemiologist Vinay Prasad wrote of the "dishonest booster campaign" in his newsletter.
Marks overruled the agency's VRBPAC, which had picked the JN.1 strain, in June. Moderna and Novavax had already submitted applications for that strain, and the latter said it couldn't meet the fall target with the late change, Reuters reported at the time.
The strain switch also left Moderna empty-handed when the FDA issued EUAs last week, though it said jabs would be ready in "coming days." Novavax fans raised their voices against the FDA when it announced only the mRNA vaccines had been approved this month.
Marks told VRBPAC he wanted "the freshest vaccines" based on the "incredibly high premium" the feds were paying for them, comparing them to milk from the store, NBC News reported. "Forget price negotiation," Prasad responded to the EUAs on X. "Biden admin works for Pfizer."
The FDA's DuVallJones told Just the News it chose KP.2 as the "preferred JN.1-lineage ... if feasible" based on "the most current available data" and recent rise in cases in some places, to "more closely match" circulating strains.
"The FDA will continue to monitor the safety and effectiveness of the COVID-19 vaccines and the evolution of the SARS-CoV-2 virus," she wrote in an email.
Current prevalence of all KP.2 variants (on which this booster is based): 20% and dropping fast. pic.twitter.com/oWAR90D5jP
— David McCune (@davidemccune) August 22, 2024
Former FDA regulatory review officer Jessica Adams, who has long chronicled the work of the agency's advisory committees, said the booster EUAs for her were like the "reopening of an old wound" because of how the FDA has regulated, communicated and promoted them for three years.
It pushed out "veteran vaccine expert career staff," ignored outside advisors and overruled them with "boosters for all," waved off natural immunity, did not establish "a real correlate" of protection or push for "timely completion of postmarket studies," and does not routinely convene outside advisers to address vaccine concerns, Adams wrote "off the top of my head."
Former FDA vaccine regulator Philip Krause, who resigned three years ago in part because top brass sidelined his office to rush full approval of Pfizer's vaccine and issued a booster EUA over VRBPAC's objections, told Congress in June he didn't get that booster.
what am I talking about?
-pushed out veteran vaccine expert career staff
-skipped adcoms on some of the key decisions
-overrode initial adcom input on boosters for all
-ignored natural immunity
-didn't push to establish a real correlate or protection
-didn't push for timely…— Jessica Adams (@RxRegA) August 23, 2024
Recommending a product for all ages, "many of whom have just had COVID, without evidence that benefits exceed harms" and against the practice of "most European nations" is close to "malpractice," said Prasad, who specializes in randomized controlled trials. The CDC's Cohen has "the clout to demand or even run" such a study yet has not, he said.
Prasad said he won't get the new booster, and UCSF medical professor Eric Widera said he "probably won't" either because Widera is "not convinced it adds anything," emphasizing he publicly documented his bivalent COVID booster two years ago.
"I’d really like to see the data" that "yearly fall boosters targeted at the spring/summer strains actually reduces COVID related outcomes like hospitalization and death," Widera wrote on X. "Isn’t it time for an RCT?"
Greg Piper
Source: https://justthenews.com/government/federal-agencies/pro-vaccine-doctors-skeptical-new-covid-19-boosters-id-really-see-data
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