The federal government is now in charge of allocating and distributing life-saving monoclonal antibodies for the American people. The Biden administration’s U.S. Department of Health and Human Services (HHS) on Sept. 13 announced it would switch the distribution for the Regeneron (Bamlanivimab-etesevimab) monoclonal antibody (mAbs) products from a “direct ordering process to a state/territory-coordinated distribution system similar to that used for the distribution of mAbs from November 2020 to February 2021.”
“This system will help maintain equitable distribution, both geographically and temporally, across the country—providing states and territories with consistent, fairly distributed supply over the coming weeks.”
During the six months between February and September, the distribution was managed with a direct ordering process through AmerisourceBergen. A phone call with Regeneron confirmed the distribution service handled by AmerisourceBergen by UncoverDC on Sept. 15.
The “Public Emergency Update” cites as a reason for the shift to governmental control of distribution the “substantial surge in the utilization of monoclonal antibody (mAb) drugs, particularly in areas of the country with low vaccination rates.”
Per reporting by NPR, the original deal with Regeneron was made public on Nov. 5—a “$450 million federal contract to supply up to 300 million doses of the medicine to the government for national distribution.”
Incidentally, the White House website still states its commitment to increasing the pace of shipments of the “free” mAbs to states by “a further 50 percent” in September. Some wonder how the change in distribution will affect that promise.
The chart below shows the distributions of the Regeneron products for the week of Sept. 13.:
Notably, Regeneron announced on Sept. 14 a new U.S. Government agreement. The announcement said, in part:
“[N]ew agreement for 1.4 million doses of REGEN-COV, brings total purchased by the U.S. government to nearly 3 million doses. The government will continue to provide REGEN-COV at no cost to patients. Under the new agreement,” the announcement continues, “Regeneron will supply an additional 1.4 million 1,200 mg doses of REGEN-COV to the U.S. government by January 31, 2022, at a cost of $2,100 per dose. This new agreement follows two earlier agreements with the U.S. government announced in July 2020 and January 2021.
Looking back, the January 2021 agreement states:
“Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021, up to 1.25 million doses. Under a previous agreement, Regeneron is already supplying doses to treat approximately 300,000 people, bringing the total potential purchase to over 1.5 million doses.”
The Regeneron Contract
According to the NPR article, the original November 2020 deal between the HHS and Regeneron was carefully crafted. NPR reported:
“Clauses laid out by the Bayh-Dole Act, enacted in 1980, [allow] the government to “march in,” as the law puts it, and take control of a drug or vaccine if a manufacturer that received federal funding can’t or won’t make the product or sets an unreasonably high price.”
Regeneron stipulated in its contract that it would exclude the Bayh-Dole Act “narrowing when the government can march in and take control.” Per NPR, a spokesman for the company said that Regeneron is well prepared to meet the needs of the public concerning the supply of such life-saving protocols. Specifically, the spokesman explained:
“For many years now, we have been developing our rapid response capabilities to address pathogens that pose significant risk to public health. We have successfully worked with the Government to help fight diseases like Ebola and COVID-19, and we’re proud to continue those efforts together.”
A significant statement by the company should not be overlooked. NPR reported:
“According to the contract, the government can only march in during a formal public emergency, not once the coronavirus becomes endemic, as it’s expected to. And it can only do that if Regeneron is unwilling or unable to make the antibody cocktail—not if it raises the price in an unreasonable way.”
Both Regeneron and Lilly products have a supply deal with the government. Other suppliers like GlaxoSmithKline and Vir Biotechnology do not. Detailed information on the various immunomodulators, of which monoclonal antibodies are a subset, can be found here.
According to FiercePharma, “Eli Lilly also said that it will supply America with 388,000 additional doses of its antibody therapy. The deals are worth nearly $3 billion and $330 million, respectively.”
In the UncoverDC interview with the spokeswoman from Regeneron, she essentially repeated the announcement. When asked how the product was distributed before this “temporary” change, the spokeswoman said that “health providers would order directly through AmerisourceBergen.“
“The government is taking over control of how those doses are distributed,” she continued, and health care providers will refer to their state or territory health department in order to get allocated inventory and this is just going to be based off of need. The states will then send that up to the federal government—the Department of Health, who will then decide how to distribute [the] product.”
The allocation of product, she said, “will be based on weekly reports of new COVID-19 cases and hospitalizations and on the inventory data that health care providers currently have.”
Indeed, the phe.gov website posts a graphic confirming the information given by the Regeneron spokeswoman said:
What People are Saying
Fortune.com contacted Diana Berrent, “an advocate who has worked on distributing the therapies.” She says the change in distribution method may make it harder for patients to obtain treatment, penalizing states with high vaccinations.
“She is concerned that the change will only make it harder for patients to find monoclonal antibodies, an already-difficult process in many parts of the country. ‘It’s penalizing states that have high vaccinations,’ Berrent said.”
The article also states that places with low vaccination rates “are relying on antibody therapies to try to keep patients out of strained hospitals.”
Vaccination Status of States and U.S. Territories
A link from Becker’s Hospital Review shows the “most vaccinated states by percentage.” As an example, Vermont is in the number one position, with 68.72 percent vaccinated. Florida is in the middle at twenty-one, with 55.41 percent vaccinated. Texas is ranked 33rd, with 49.37 percent fully vaccinated. West Virginia ranks last with 40 percent of its population fully vaccinated. As of July, roughly half of the veterans treated at VA hospitals are vaccinated, according to USA Today. As of Sept. 15, a total of 180,086,143 Americans were fully vaccinated, or 54.2 percent of the country’s population, according to the CDC’s data at the time of this report.
A Sept. 13 letter from Rep. Chip Roy (R-TX) to Health and Human Services (HHS) Secretary Xavier Becerra indicates his concern over the change in distribution. He had several questions for the federal agency concerning the coming availability of the treatment for Americans. The letter in full is pictured below:
Roy believes that treatments have become a political issue and speaks about doctors’ difficulties in obtaining life-saving treatments. He sent the letter to HHS because doctors told him that the supply of Regeneron mAbs is now restricted. He also recounts a story from a Montgomery County judge in Houston who is “furious” because HHS is “metering the number of doses” Texas is receiving and actively limiting his county’s number. Roy also stated that the antibodies are saving the lives of “both vaccinated and unvaccinated” patients. Both HCQ and Ivermectin have faced similar restraints and hurdles, potentially costing many lives.
Roy’s Sept. 16 interview with Dana Loesch is below:
Phil Kerpen’s Twitter account posted this timeline for the roll-out of distribution change:
Timeline of Biden/HHS blindsiding Florida with monoclonal antibody supply restriction. pic.twitter.com/Jiu26cDaCB
— Phil Kerpen (@kerpen) September 16, 2021
Monoclonal Antibodies: Regeneron is Not the Only Option
There are three options for monoclonal antibody treatments: According to the nih.gov website as of Aug. 4, 2021:
“Three anti-SARS-CoV-2 monoclonal antibody products currently have Emergency Use Authorizations (EUAs) from the Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 in non-hospitalized patients with laboratory-confirmed SARS-CoV-2 infection who are at high risk for progressing to severe disease and/or hospitalization. The issuance of an EUA does not constitute FDA approval.”
The screenshot below lists the three life-saving options:
The Sept. 2021 Department of Defense extensive “playbook” on therapeutic treatments, including Remdesivir, can be found here. The Centers for Medicare and Medicaid website shows the specific EUA dates for the various products. It also details the specifications for use for each of the products. Each has its own set of guidelines. The coverage for Medicare and Medicaid patients can be found here.
A letter dated Sept. 16 from the FDA to Eli Lilly and Company confirms its multiple reinstatements of the EUA for the Eli Lilly monoclonal antibodies. Eli Lilly’s global response timeline on the treatment protocol can be found here. In late June, the FDA revoked Lilly’s authorization of the antibody combo because of its ineffectiveness against coronavirus variants but then cleared it for use later because the FDA said it could “take on the dominant Delta variant.” The original October contract for the Eli Lilly product can be found here.
In May, the FDA authorized a third antibody drug from VirBiotechnology Inc. and GlaxoSmithKline PLC. The FDA’s EUA website can be found here. Important updates on the products and their distribution can be found at phe.gov.
What Does AmerisourceBergen Do?
AmerisourceBergen had been managing the distribution of the mAbs prior to the government’s decision. Among AmerisourceBergen’s key services is the company’s specialization in:
“Channel strategy and distribution“ whereby they “improve access to care. Utiliz[ing] a proven network and innovative channel strategies to help patients access the medications they need, when and where they need them with an unsurpassed network of 30+ DSCSA-compliant distribution centers.
Where to Find Monoclonal Antibody Treatments
The FDA updates the states, territories, and U.S. jurisdictions locations authorized for the treatment’s use regularly. The FDA’s Sept. 15 update of the territorial locations where the antibodies can be administered can be found here. The treatment centers for the monoclonal antibody treatment can be found here. The website states it was last updated on 09/09/21. A screen capture of the site’s interactive map is below.
The National Infusion Center Association also provides location tools for treatment.
Notably, there are two delivery methods for the treatments; one is through infusion centers, and the other is with a series of four subcutaneous injections in one sitting. The injection is an important alternative when a referral for the much more staff-intensive infusion is not available quickly enough to receive treatment or in places that may not have infusion centers. The antibodies must be administered, according to the protocol, within ten days of symptom onset of COVID-19.
The U.S. Has Been Slow to Adopt Treatment with Monoclonal Antibodies
Unfortunately, in many cases, patients are not aware of the therapeutic until later stages of illness. When UncoverDC asked why there is a 10-day symptom onset deadline for use, the Regeneron spokeswoman either did not know the reason or couldn’t answer the question.
It took many months for the public to become aware of the treatment even though President Trump praised its “powerful” impact in his remarkable rapid recovery when he had COVID in October. The Wall Street Journal reported in December that demand from doctors was low at the time. Many people are still not aware of the treatment. WSJ reported:
“Physicians are not ordering the drug,” said Michael Ison, an infectious-disease physician at Northwestern Memorial Hospital who is helping lead the monoclonal-antibody rollout there and in the wider Northwestern Medicine health system, which includes 10 hospitals across the Chicago area and northern Illinois.”
“Demand from doctors in the Northwestern system has been relatively low and many patients aren’t all that interested, he said. Although several hospitals have set up spaces for the infusions and have made arrangements for staff to deliver them, some physicians just aren’t comfortable with prescribing the therapy because it is so new and it is hard to discern which patients will benefit from it; Dr. Ison said.”
Some of the increased demand for the antibodies may be because of Florida Governor Ron DeSantis’ recent press conferences. He has heightened the profile of the antibody treatment as one that is highly effective and life-saving. Tampa General Hospital’s CEO and President John Couris stated:
“This is a therapy that is effective, but this is a therapy that is less known. This is a therapy that needs to be taken advantage of, and Tampa General Hospital, USF, and our private practice physicians are using it very successfully on positive COVID-19 patients.”
Despite being available for all of 2021, DeSantis remarked that the antibodies had gotten little attention. Many lives could have been saved had they known about the antibodies. Instead, the government and legacy media have aggressively pushed COVID-19 shots with increasing numbers of vaccine injuries or deaths related to the shots themselves. In early December, The Biden administration announced his six-point plan to fight COVID-19 mandating vaccines for all federal employees and the military.
Life-saving therapeutics like HCQ, Ivermectin continue to be difficult to obtain, and preventative measures that have now proven track records to help people avoid hospitalization and death are rarely referenced. Remdesivir also continues to be pushed in hospitals—even with the growing evidence that it can cause kidney failure and death. The WHO said in November 2020, it shouldn’t be used on hospitalized patients with COVID-19. A massive study found the drug had no efficacy in treating the illness.
DeSantis wants to ensure Floridians have easy access to the Monoclonal Antibodies treatment. Notably, he also explains that the antibodies can also be used as a prophylactic treatment in nursing homes to help protect the elderly from getting sick or dying.
In April of 2021, the Wall Street Journal reported, “In studies, the drug reduced the risk of hospitalization or death by about 70%. A CDC video explaining how monoclonal antibodies work can be found below: