Chicago (Special to Informed Comment) – Despite more than 205,000 dead and 7.2 million infected, including him, Trump mendaciously claims that the pandemic “affects virtually nobody” while falsely promising a Covid vaccine by Election Day. His anti-science re-election propaganda not only jeopardizes trust in a vaccine, but eradicates faith in the very public health institutions that are responsible for evaluating and distributing that vaccine. The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have been reduced to little more than political tools.
Trump ordered the CDC to prepare for mass immunizations beginning on November 1 — a breakneck speed that defies credulity. The timetable is too short for full safety analysis of any vaccine. Laurie Garrett, Pulitzer Prize winning author of The Coming Plague, says she won’t take a vaccine that comes out before election day. “Like most experts closely watching developments, I have no confidence that a safe, effective vaccine will be ready for use by then.”
Embed from Getty Images
Research Centers of America in Hollywood, Florida, U.S., on Wednesday, Sept. 9, 2020. Drugmakers racing to produce Covid-19 vaccines pledged to avoid shortcuts on science as they face pressure to rush a shot to market. Photographer: Eva Marie Uzcategui/Bloomberg via Getty Images.
Desperate to take undeserved credit for a Covid cure to bolster sagging re-election prospects, Trump embraces the vaccination project because it appeals to his con man instincts for flashy salesmanship – branding it “Operation Warp Speed.” The federal government has funneled over nine billion tax payer dollars into private drug companies, scaled up manufacturing, and bought millions of doses well before a vaccine is proven viable. To be clear: no American or European putative vaccine against the coronavirus has completed Phase 3 clinical safety and efficacy trials, according to the New York Times’ Coronavirus Vaccine Tracker. Of the more than 150 vaccines in the world-wide research pipeline, only four American ones have even begun that final stage.
Most vaccines take years to develop and administer. Long-standing scientific protocols require massive testing of many thousands of people over a long period to ensure that a vaccine is safe, with minimal side effects, if any; and, effective, meaning it actually stops the disease, limits its spread or reduces its severity. Having a vaccine fully tested and ready for review on Oct. 22, when the FDA’s Vaccines and Related Biological Products Advisory Committee plans to meet will be next to impossible.
“Safety cannot be guaranteed,” says Garrett. “Life-threatening complications may not show up in a quick sampling of healthy adults.” That’s why vaccine clinical trials usually last for many months and involve far more volunteers than have been recruited for the Covid-19 products. Short-circuiting that process can be wasteful or even dangerous: a rushed vaccine for the swine flu in 1976 meant to help President Gerald Ford’s election campaign not only proved ineffective but also afflicted hundreds with a paralyzing side effect, Guillain-Barre syndrome, a rare neurological disorder.
Even if a vaccine looks safe and effective, rolling out a new one correctly is a major undertaking, requiring careful coordination across multiple state and federal agencies that play a pivotal role in evaluating the science
Trump’s fixation on declaring victory just ahead of Election Day results in political pressure on the FDA and the CDC to provide scientific cover to his propaganda. The FDA is considering whether to allow a vaccine to be used on an emergency basis before its formal approval process is finished and the CDC has told states to be ready to distribute the vaccine two days before the election. But Trump’s unrelenting bashing of these two agencies has left their credibility in tatters such that their recommendations cannot be trusted.
Embed from Getty Images
A lab technician uses a multichannel pipette dropper during the immune response analysis process of the coronavirus vaccine research at the Valneva SA laboratories in Vienna, Austria, on Thursday, Aug. 6, 2020. The U.K. has signed agreements to buy 90 million doses of vaccines in development by drugmakers including Pfizer Inc., BioNTech SE and Valneva SE, joining countries around the world racing to secure supplies of protection against Covid-19. Photographer: Akos Stiller/Bloomberg via Getty Images.
As he did with other “miracle cures,” Trump has publicly pressured the FDA to move quickly on authorizing a vaccine, demanding that it use its powers to permit Emergency Use Authorization (EUA) of an unapproved and unproven vaccine. For example, a vaccine could generate antibodies to Covid — an immune response, but it might not prevent infection or serious illness. Further, long term side effects would remain unknown. This is a much lower bar than standard FDA approval. Rather than the usual process of consulting experts, the FDA chief alone can make this determination and Commissioner Stephen Hahn has already signaled that he is willing to do so.
Caving to White House pressure is not new to Hahn, who issued emergency use for two products that Trump misleadingly called “breakthroughs”: the malaria drug hydroxychloroquine, which the FDA later revoked as being ineffective and harmful, and convalescent plasm — blood plasma from recovered Covid-19 patients. Standing next to Trump at press briefing, Hahn made scientifically misleading claims about plasma’s medical benefits — a disastrous series of public mis-statements, which he later withdrew and about which he apologized.
“For the first time ever, I feel like official people at the FDA grossly misrepresented data about a therapy,”
Hoping to reassure a suspicious public about the government’s biggest public health decision in years, Hahn pledged to a Senate Panel, “Science will guide our decisions. The FDA will not permit any pressure from anyone to change that.” He prepared a proposal that set morestringent standards for a coronavirus vaccine EUA. Incensed that Hahn’s new safety guidelines will slow the process, Trump launched an all-out crusade against the FDA.He blew up Hahn’s carefully laid plans – attacking “deep state” agency staff for trying to hurt him politically and vowing to have final say over procedures for authorizing a Covid-19 vaccine.
This authoritarian move would follow the examples set by Russia and China — both of whom rushed out a limited use vaccine that experts call stupid and risky because they cut corners on rigorous scientific vetting that would be expected for FDA vaccine approval. In response to this, New York Gov. Andrew Cuomo announced his state would independently vet any vaccines before distribution.
After pressuring the FDA on the approval process, Trump clashed with the CDC, once considered the world’s premier public health agency. He publicly slapped down congressional testimony by the head of the CDC. Dr. Robert Redfield estimated that a vaccine will not be widely available to the public until the middle of 2021 at the earliest — echoing recent comments by Dr. Anthony Fauci. Redfield also praised wearing masks as “the most important, powerful public health tool we have in fighting the pandemic, even more important than a vaccine.” Lashing out at Redfield, the moronic, anti-mask Trump said of both remarks: “I think he made a mistake when he said that. I think he was confused. It’s just incorrect information.”
The CDC’s reputation has taken the biggest hit because of its undeniable and seemingly unassailable prestige. Even in pop culture, CDC doctors often play smart, courageous, selfless heroes such as in the movie Outbreak. The front-line agency was created to stop deadly pathogens. It battled malaria, polio and Ebola and helped eradicate smallpox. Over the course of seven decades, it became the world’s most admired disease-fighting agency with an elite workforce of the world’s foremost microbiologists, pathologists, and other scientists dispatched world-wide to investigate new and mysterious illnesses. Though successfully leading the country’s response to countless threats over decades — the deadly emergence of HIV, SARS, and the H1N1 flu pandemic, the CDC has been manipulated, sidelined and silenced by the Trump administration just as another virus rampages across the planet. Even by Trump’s low standards, this is unconscionable.
Unfortunately, the CDC was placed in unreliable hands. Dr. Robert Redfield is a right-wing darling with a checkered scientific past. His early AIDS research was inspired by the Christian right, who have been instrumental in driving a global AIDS strategy centered on abstinence. Redfield first came to public attention when he stood next to Trump, at CDC headquarters on March 7, and nodded approvingly as Trump said, in one of his most egregious Covid lies, “Anyone who wants a test can get a test.”
The CDC’s nationwide response to the pandemic has not been faultless. The stumbles started with the botched rollout of test kits suspected of being contaminated at a CDC lab in late January. Under Redfield, the agency took weeks to fix the flawed tests. But Trump’s concerns about the CDC are not about its efficacy, but about the facts that it reports about the pandemic — facts that show the president’s abject failure and that, like his “debate” performance, demonstrate that Trump is un-tethered from evidence, reality, and truth.
In order to change perceptions of Covid reality, Trump and his enablers try to suppress or alter CDC data and advice to mask the true scope of the epidemic. The agency has endured false accusations, criticism, and interference. White House officials pressured the CDC to align more closely with Trump’s message that the pandemic is largely over. Whether it’s getting the CDC to effectively lower the death count, muzzling officials, or forcing the agency to change guidelines — including on mask-wearing and the reopening of businesses, religious institutions, and schools. The CDC has experienced a loss of institutional integrity — eroded by blunders and Trump attacks — at a time when the nation desperately needs to trust it.
Embed from Getty Images
A lab technician wearing a full body protection suit handles a bottle containing growth media for virus production during coronavirus vaccine research at the Valneva SA laboratories in Vienna, Austria, on Thursday, Aug. 6, 2020. The U.K. has signed agreements to buy 90 million doses of vaccines in development by drugmakers including Pfizer Inc., BioNTech SE and Valneva SE, joining countries around the world racing to secure supplies of protection against Covid-19. Photographer: Akos Stiller/Bloomberg via Getty Images.
For example, in late August as the daily Covid death rate spiked, the CDC shockingly changed its testing guidelines andposted altered guidance, saying that asymptomatic people “do not necessarily need a test” even if they have come in close contact with someone infected by the virus. This was effectively a recommendation to test fewer people, soon after Trump said he had asked his people to “slow the testing down, please” because, he claimed, more tests revealed more coronavirus cases and made him look bad.
In his article “Ignore the CDC,” the former director of the National Institute of Health Harold Varmus attacks the agency for altering its guidelines and bowing to Trump’s bullying. “These changes will undermine efforts to end the pandemic,” wrote Varmus, “slow the return to normal, and increase the loss of lives.” The CDC later reversed the heavily criticized recommendation against asymptomatic testing. But the damage was done: its scientific credibility had been undermined again.
Last week, apparently under political pressure, the CDC removed language from its website that said the novel coronavirus spreads via airborne transmission, the latest example of the agency backtracking from its own guidance. Sudden flip-flops on public guidance is antithetical to the CDC’s own rules for crisis management spelled out in a 450-page manual. It requires US leaders and the CDC to avoid “mixed and conflicting messages from multiple sources,” “overly reassuring and unrealistic communication,” and “public conflicts and confusion.”
But that’s not happening. Trump creates a chaotic hurricane of misinformation that stokes confusion about what scientists know about the virus and the timetable for when most Americans will have access to a safe, effective vaccine. In fact, a major new study conducted by Cornell University researchers concluded that Trump is the world’s largest source of misinformation about Covid-19.
At Tuesdays’ debate — amid Trump’s sweat-soaked, rabid, racist, sociopathic behavior — he claimed that the vaccine would be available in “weeks.” His constant drumbeat for a vaccine before election day drowns out months of careful scientific work, reducing the vaccine hunt to yet another presidential litmus test. Given months of capitulation to Trump, there’s little reason to have confidence in FDA or CDC vaccine recommendations. Would anyone besides a MAGA zombie shoot a Trump vaccine into their arms? “We’ve sown the seeds of distrust in this vaccine,” says epidemiologist Dr. Michael Osterholm. “The politicization could give us, in a sense, what it would be like to have a very ineffective vaccine. Because nobody will take it.” A vaccine will succeed only if Americans across the political spectrum trust that it is the result of careful and cautious scientific work that will not be completed until long after the November election that defeats Trump.
Bonus Video added by Informed Comment:
Realities Of Vaccine Testing Defy Trump Coronavirus Timeline | Rachel Maddow | MSNBC