Clinical trials have demonstrated that monoclonal antibody treatments result in a 70% reduction in risk for hospitalization and death. In addition, these lifesaving but still investigational therapeutic treatments also proved to be 82% effective in reducing risk of contracting the virus for people who may have been exposed by other household members. (Florida Department of Health)
Since the beginning of August, President Joe Biden (POTUS) and Florida state Governor, Ron DeSantis, have been caught in a series of increasingly tense, very public, back-and-forth statements criticizing each other’s stance on alleviating COVID-19’s toll on America.
In September, the Biden administration announced it would take over the control of monoclonal antibody distribution, which were previously ordered directly from healthcare providers and fulfilled by AmerisourceBergen, arguably without any federal red tape.
Now, weekly distribution to states is determined by a formula maintained by the U.S. Department of Health and Human Services (HHS). The White House made this decision based on the claim that just a handful of states were ordering most of the monoclonal antibody products. They contended that it wasn’t fair to many other states that may be in need.
At the time Florida and a handful of other Southern states happened to be experiencing a bad Delta-variant-driven surge. The federal government was critical of this fact, declaring that the lower vaccination rates were the primary cause. DeSantis introduced a statewide program that essentially democratized monoclonal antibody treatment in a market-based model. Florida and a few other states ordered about 70% of the entire supply.
DeSantis accused Biden of seizing control of the supply calling it a “cruel” retaliation for DeSantis’ public opposition to and criticism of White House policies. While it is true that Southern states were using most of the therapies, Biden, on the other hand, pointed out that it was his responsibility to ensure an equitable distribution of these important investigational therapies authorized under emergency use.
Was this a case of pure good faith intentions concerned with equity, or conversely, was this further politicalizing of the COVID-19 pandemic? TrialSite internally has some insight and speculation, but no smoking gun evidence indicating one truth versus another has been obtained. What follows is a timeline breakdown of events.
DeSantis prohibits vaccine passports and calls for parent-directed freedom as paramount
At issue here are fundamental differences in points of view and perhaps even values. On the one hand is a centralized, federal mandate, and the other a decentralized state-based authority. With growing talk of vaccine passports and potential mandates as early as the start of the year, by March 2021, DeSantis was already drawing a line in the sand.
On March 9, 2021, the Florida governor’s office issued an executive order, “Prohibiting Vaccine Passports.” The order was issued, in part, to “protect the fundamental rights and privacies of Floridians” because vaccine passports “would create two classes of citizens based on vaccination status.”
The tension mounted as fundamental questions about the science behind the project afforded by masks became center stage. While there were few to any studies demonstrating that masks specifically prevented COVID-19 spread, some studies indicated possible benefits. Regardless of this lack, federal health authorities such as the Centers for Disease Control and Prevention (CDC) embrace masks to stop transmission.
DeSantis was opposed to any federal mandates. In a bid to reject any forced federal edicts, by July 29, 2021, the Florida governor issued another executive order, “Ensuring Parent’s Freedom to Choose – Mask Mandates.”
This order cites various reasons including, a lack of “well-grounded evidence” that mask-wearing in school settings drives community transmission. Mask-wearing can “inhibit breathing,” collect bacteria, and “adversely affect communications in the classroom and student performance…”
Another major opponent of the governor is Commissioner of Agriculture and Consumer Services, Nicole “Nikki” Fried. Fried announced in 2021 that she will run against the incumbent for the 2022 election. She often calls DeSantis out on social media, asking him to “please follow the data and facts.” On her department’s official site, she provides information to assert the effectiveness of masking school students in Florida, claiming DeSantis “blocked” the data from the public. Despite this claim from Fried, all data used by the Governor, and the Florida Surgeon General, Dr. Joseph Ladapo is publicly available on the FDOH website.
“Every way you look at the data, kids were better off in schools requiring masks than those that did not. School districts that did nothing suffered four times higher COVID-19 cases than school districts that required masks, in direct contradiction to the governor’s disinformation,” says Fried.
The FDOH refuted the data from each claim made by Fried in a press release on October 7, 2021. DeSantis’ Press Secretary Christina Pushaw, in an email interview with TrialSite News, states that Fried’s data was “cherry-picked” to paint an inaccurate picture of the mask-wearing in schools.
Fried’s department didn’t utilize the eight required steps of the epidemiological methodology. Some of the main issues with Fried’s conclusions were failure to adjust for county vaccination rates, previous infection rates, community infection rates, failure to determine if infection was acquired in school or out of school, and other miscalculations. Fried’s claims were not removed from her page and her social followers (232.6K) were enraged by her misinformation.
The mask debates
The Delta variant surged causing many new infections during the summer of 2021. By August 2 during a White House Press Briefing, Jen Psaki used mask mandates and mask encouragement synonymously.
For example, she declared “… There are steps and precautions that can be taken, including encouraging people to get vaccinated, encouraging people to wear masks, including allowing schools to mandate masks, and allowing kids to wear masks, which is not the current state of play in Florida.”
Interpreted one way, Psaki seemed to imply that Florida’s governor was not allowing kids to wear masks. However, based on an objective review, he was more accurately against mandates.
Pushaw addressed the distinction between the two terms, stating the governor “does not oppose masks, he opposes mask mandates.” Masking is not a “clinically proven” intervention, but rather a preference that no one has the right to impose on others.
Striking a Balance
A conflict between fundamental values and associated points of view mounted during the summer. On the one hand, the White House sought out a way to accelerate the demise of COVID-19 in uniform actions purportedly backed by science.
Several governors in conservative-leaning states sought out to ensure that any rules or policies originating from the White House didn’t impede the economy nor trounce on the rights of residents.
However, during a pandemic, this resistance caused serious tension. By August 3, 2021, during a White House Press Briefing, both Jen Psaki and POTUS emphasized that any state leadership resisting the CDC guidance should simply “get out of the way.” For example, the press secretary went on to declare “…most Republican governors are doing exactly the right thing…advocating for — and taking steps to advocate for more people to get vaccinated.” However, in communicating in this way, many considered this an attack on DeSantis—that the governor wasn’t encouraging preventive measures as were other Republican governors.
Yet the Florida governor is certainly not an “Antivaxxer:” TrialSite reviewed some of the steps that DeSantis took towards vaccination:
In January, with the beginning of the vaccine rollout, FDOH prioritized the first offerings of the vaccine to the 65+ population and led the nation in vaccination rates.
There are now hundreds of locations across 52 counties, including virtually every major retail pharmacy, (Publix alone has 500+) malls, parks, schools, clinics, mobile sites, and even the Hard Rock Stadium. Additionally, there is an abundance of testing locations as well.
DeSantis had over 50 events, in 27 counties, to promote vaccination and increase accessibility. Pushaw notes that he “devoted more time to COVID-19 vaccination than any other policy issues this year.”
DeSantis has repeatedly stated vaccination saves lives, and voluntarily disclosed his vaccination status. “I took it, I think it’s effective.”
Biden comes out swinging
By early August, POTUS became more concerned about any impediments to COVID directives at the state leadership level. So, by August 3, 2021, the President vowed to “take on” his opponents declaring “My plan also takes on elected officials in states that are undermining you in these life-saving actions. Right now, local school officials are trying to keep children safe in a pandemic while their governor picks a fight with them, and even threatens their salaries or their jobs. Talk about bullying in schools.”
Biden suggested that DeSantis was “a bully” for taking corrective measures against school boards who violated his executive order. After all, one could argue that local school boards should be able to take preventive actions at the local level.
Even though Biden was on the subject of bullying, he did not address abusive acts of violence to students exacerbated by the insistence of CDC guidelines. Innocent children were berated, sprayed with disinfectant, slapped, and even had masks taped to their faces, by teachers and other adults. While these incidents were most likely outliers, they were no less disturbing.
Another important point that Biden failed to address was the legitimate concerns that the vaccine-hesitant have about the possibility of adverse events. In his speech, the president singled out the unvaccinated, rhetorically asking “what more do you need to see? We’ve made vaccination free, safe, and convenient. The vaccine is FDA approved. Over 200 million have gotten at least one shot.”
The president then condemned the unvaccinated. “You have cost all of us.” He also stoked the flames of frustration among the vaccinated viewers and their complaints against those who remain unsure of the vaccine’s unknown long-term effects. “I understand your anger at those who haven’t gotten vaccinated,” POTUS stated.
The president continued speaking exclusively to the vaccinated, stating he also understood their worries about unvaccinated children. “For any parent, it doesn’t matter how low the risk of any illness or accident is when it comes to the safety of your child or grandchild, trust me, I know.”
Assuming this statement is sincere, it’s worth considering why President Biden does not also empathize with parents who are reluctant to vaccinate themselves or their children based on obscured adverse event data. To them he only states, “we’ve been patient, but our patience is running thin.”
DeSantis’s Responds “I am standing in your way.”
The nasty political conflict turned to allegations that questionable immigration trends were leading to even more risk during this pandemic. By the summer, news reports of significant increases in illegal immigration put more conservative-minded Americans on edge. Was it a factor that increasing numbers of illegal border crossings were threatening to worsen the pandemic? (Later in September, Psaki did admit that immigrants were not required to be vaccinated upon entry, even as American businesses with more than 100 employees were mandated.)
The former Border Patrol Chief Rodney Scott made claims that so far in 2021, under the Biden administration, there have been, at minimum, 400,000 border crossings sited in which the individuals were not caught or documented.
By August 4, 2021 DeSantis criticized Biden for possibly influencing the spread of COVID-19 and its vicious variants declaring “You have over one-hundred different countries where people are pouring through,…they’re then farming them out all…across this country. Putting them on planes, putting them on busses. Do you think they’re being worried about COVID for that? Of course not.” The governor’s proposed point concerning the border could be also considered more politicization of the pandemic, now including immigration as yet another topic contributing to the spike in cases. There was no proof that such is the case.
However, one trend was clear. Mounting pressure for a vaccination mandate over U.S. residents and citizens felt imminent. DeSantis shared that Biden wanted to enforce a stricter vaccination regimen over citizens and legal residents while there were seemingly few controls at the rapidly crowded border points.
Moreover, DeSantis continued to criticize POTUS’ COVID solution to “mask kindergarteners” and force the American people to prove vaccination to participate in society. By September that mandate became a reality. Yet DeSantis reminded all “But yet, if you want to vote, he thinks it’s too much of a burden to show a picture ID…”
The governor continued that in Florida, “People are going to be free to choose, to make their own decisions about themselves, about their families, about their kids’ educations, and about putting food on the table.”
While the state went through a terrible spike, the economy continued to move. After ending the Federal Unemployment Bonus, Florida employers hired 1.3 million new workers, and Florida’s economy has grown by more than 60 billion from pre-pandemic levels.
Biden on DeSantis: ‘Governor Who?’
When a journalist asked Biden to comment on DeSantis’ remarks on August 5, 2021, Biden replied, “governor who? That’s my response.”
DeSantis replied in another press conference the following day. “I guess I’m not surprised that Biden doesn’t remember me. I guess the question is what else has he forgotten?” Here’s his reminder. “I’m the governor who answers to the people of Florida, not to bureaucrats in Washington.”
Florida sees a decline in cases
In less than two weeks, Florida’s average cases began trending down. Pushaw explained that Florida’s cases declined with the governor’s tireless efforts to promote monoclonal antibody treatments. “More than 135,000 Floridians have received this lifesaving treatment at our state-run sites alone; this does not count the thousands who have received the treatment from other healthcare providers.”
This is roughly the same time that utilization of monoclonal antibodies by Florida and other red states in the southern region gained the attention of HHS and the Biden Administration. When the White House announced its intention to take over, the press had questions about what would happen next.
Psaki explains the mAb takeover
–In a White House Press Briefing, on September 16, 2021, the Press Secretary explained the administration’s stance on regulating the ordering of mAbs per state.
Psaki was questioned about why Biden was cutting 50% of mAb supplies in the 7 ‘red’ states even though he said he was purchasing 50% more for the US.
Psaki clarifies that the Biden administration would be purchasing an extra 50,000 doses for the country, on top of the weekly average of 100,000. But the reduction from the 7 red states was a different story. “I think people need to understand for clarity…those monoclonal antibodies are lifesaving therapies that are used after infection to prevent more severe outcomes,” Psaki explains. “So, clearly, the way to protect people and save more lives is to get them vaccinated so that they don’t get COVID to begin with.”
This last statement is saturated with inaccuracy.
It is unclear why Psaki described the treatment as a measure of care only used after a COVID-19 infection, when the FDOH states eligibility for the treatment includes preventative care as well. “Individuals 12 years and older who are high-risk, that…have been exposed to COVID-19,” and that they have proven to be 82% effective in reducing risk of contracting the virus for those at-risk individuals.
Psaki seems to suggest that more vaccination in Florida would solve the issue of reduced mAb supply. However, those who are already vaccinated comprise 40-45% of the patients benefiting from the treatment.
Countless studies now from around the world that vaccines are not preventing infection or transmission, which contradicts her claim that Florida’s efforts should be redirected back to vaccines “so that they don’t get COVID to begin with.”
POTUS and team essentially believed DeSantis was using mAbs to detract from vaccination which of course isn’t the truth. But did POTUS and the team seek to punish the Governor? Their actions seem to indicate that Florida shouldn’t be able to order mAbs as a backup for a less vaccinated population.
Why does the introduction of another life-saving treatment mean that the Florida governor is not “doing his part,” as Biden and Psaki seem to suggest? In all fairness to DeSantis, what more can the governor do to increase vaccination rates aside from forceful coercion in the form of state-enforced mandates?
COVID-19 Treatment Just as Important
Pushaw refutes the suggestion that efforts in promoting vaccination and mAb treatments must be “mutually exclusive.” Arguably, it would behoove the medical community to have more awareness about mAbs positive outcomes.
In fact, on August 24th, even Dr. Anthony Fauci, Senior Medical Advisor to the Biden Administration, said in a White House Press Briefing, that there needs to be more focus on the effectiveness of monoclonal antibody treatments. When asked why more doctors around the country aren’t utilizing them, Fauci replied, “I can’t explain that.”
As one of the few FDA emergency-use-authorized treatments for COVID-19, popularity was bound to increase, and unsurprisingly, red states, with leaders who gave extra effort in raising awareness, embraced them for constituents. Their increased orders, (which HHS Secretary Xavier Becerra explained were 20 times higher in August than in July,) gave the Biden Administration a reason to pull back the reins in those states and reassess distribution for equity purposes.
Psaki continued to explain the administration’s decision was because “our supply is not unlimited, and we believe it should be equitable across states, across the country.”
Psaki’s phrasing is somewhat ambiguous, “our supply is not unlimited.” The fact that a supply of anything is “not unlimited,” does not confirm that there was an actual shortage. Confirmation of an actual shortage would help in clearing the White House of the red states retaliation allegations.
When asked outright why the administration made this decision without any reports of supply shortage, Psaki ignored the question.
In reviewing the timeline, there seems to be a pattern emerging here. Psaki is inexplicably unable to answer pivotal questions, and Biden won’t address core issues. What can we glean from an arguable lack of transparency?
Instead, Psaki reiterates equity. “We’re not going to give a greater percentage to Florida over Oklahoma…”
Fair enough, but was Oklahoma in jeopardy of not getting orders filled? Were any states in jeopardy of not getting orders filled? Just because ordering increased doesn’t necessarily mean the three mAb manufacturers, (Regeneron, GlaxoSmithKline, and Eli Lilly) are not equipped to provide.
We asked HHS specifically for an answer. They did not confirm.
The Oklahoma State Department of Health, OSDH, has not responded to confirm supply issues either. However, a “Nursing LTC Provider Call,” summary on the OSDH site from September 9th, explained anticipated issues with the HHS takeover. Elyce Holloway, state hospital preparedness program (HPP) coordinator, wrote “there is not necessarily a shortage” but warned that after HHS takeover “you may have difficulty acquiring mAbs if you need them.” Unfortunately for Oklahoma, this came true.
On September 15th, Holloway issued another briefing on the status of mAbs for Oklahoma.
“OSDH will likely be unable to fill full requests for the next few weeks. We had roughly 11 days of most orders being denied, and the approved orders were not fully met. This has resulted in a statewide deficit for mAbs. As I stated in an earlier email, OK was allocated roughly a fifth of what had been ordered in those 11 days.”
Unfortunately, the White House’s intention to protect Oklahoma resulted in the opposite.
Still, in pursuit of an answer, we asked the three mAb manufacturers if they could confirm an issue. Eli Lilly didn’t respond, and GSK didn’t give an appropriate answer.
Associate Director, Product & Pipeline Communications, Tammy Allen, from Regeneron, said the manufacturer fulfills orders, but has no info on federal supply issues.
The good news. “We remain confident that we can fulfill this agreement and are actively making a new product to meet anticipated demands.” With the help of the world’s largest biotech company, Roche, Regeneron intends to increase global supply by 3.5 times.
Is there a verdict?
Ultimately, the case for equity turns up zero evidence other than the fact that most of the orders for monoclonal antibodies were from just a handful of southern states at the time. On the other hand, these states also faced significant spikes—higher than any of the other states. Now that Florida’s cases have plummeted, it is fair to assume that other parts of the nation experiencing increased infection rates, can utilize the nations’ supply as needed.
Concerning the case for retaliation, remember Biden’s “plan” to take on “elected officials in states that were undermining” those who comply with Biden’s mandates? That public announcement could be argued as an indicator of motive, coupled along with the means, and the opportunity to carry out his promise to the American people. “I’ll use my powers as president to get them out of the way.” This statement, made just over a month before the takeover certainly would give a detective a compelling reason to investigate, but without the smoking gun, it remains inconclusive.
Subscribe to the Trialsitenews "COVID-19" Channel
No spam - we promise