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The FDA recently revoked its emergency use authorization on two monoclonal antibody treatments. Eventually delta-positive COVID-19 patients will likely be unable to get them.
The drugs were found to be ineffective against the omicron variant, which makes up nearly 100% of cases in the U.S. The FDA still allows four other drugs that remain effective for both variants, including another monoclonal antibody treatment called sotromivab.
Gabbard’s estimate of daily delta patients appears to be way off, with national surveillance data putting the average closer to 1,000 a day.
The U.S. Food and Drug Administration removed a pair of monoclonal antibody therapies from the list of COVID-19 treatments after they were found to be ineffective against the omicron variant. The federal government notified states Jan. 24 that the medications, made by Regeneron Pharmaceuticals and Eli Lilly, would no longer be distributed.
Some Republican governors, like Florida Gov. Ron Desantis, rebuked the move, claiming that the therapies were "lifesaving" and could still help patients with other variants, like delta.
Former Democratic congresswoman Tulsi Gabbard, who ran for the Democratic presidential nomination in 2020, took up a similar position on social media.
"Biden won’t allow Delta-variant COVID patients to get proven and effective monoclonal treatments even though there are 50,000-100,000 Americans infected by Delta EVERY DAY— many of whom will be hospitalized or die without such access," Gabbard wrote in a Jan. 26 Facebook post.
"Bottom line is, Biden should stop undermining the health of the American people by interfering with our access to proven therapeutics like monoclonals, and stop your cruel joke of telling us we can take the highly effective therapeutic Paxlovid when you know it isn’t really available."
A spokesperson for Gabbard told us that delta patients will not be able to get monoclonal treatment, like Regeneron, because COVID-19 tests don’t make the distinction whether a person has the delta or omicron variant.
But the therapies were pulled because they are ineffective against omicron, which currently makes up more than 99% of cases in the U.S. The FDA still allows four other drugs that remain effective for both variants, including another monoclonal antibody treatment called sotromivab.
We wanted to check Gabbard’s numbers. Is the delta variant still infecting between 50,000 and 100,000 people per day?
Her team told us she got her estimate from a CNN article that cited data from Dec. 19. It said 95% of cases in the Southern region of the U.S. were omicron. Approximately 700,000 new COVID-19 cases were being reported per day at the time, but Gabbard’s spokesperson said case numbers were likely "much higher," and estimated 1 million per day with 5% being the delta variant and got to at least 50,000 Americans.
This is way off the reported numbers and exaggerates outdated data from a portion of the country.
Some health systems, including ones in New York City, stopped using the antibody treatments weeks before the FDA’s announcement. The drugmakers Regeneron and Eli Lilly had announced in December that the treatments had "diminished potency" against the omicron variant.
Several other approved treatments remain effective against both omicron and delta, including sotrovimab, a monoclonal antibody made by GlaxosSmithKline and Vir Biotechnology; paxlovid, an antiviral pill by Pfizer; molnupriavir, an antiviral pill by Merck, and the antiviral drug remdesivir, which is given by infusion. As of now, they are harder to get.
A recommendation from the National Institutes of Health said health providers can use the restricted monoclonal treatments if others are unavailable in a region where delta is still prevalent.
"If we knew we had a delta case, there’s no reason that we couldn't use it," said Dr. Marissa Levine, a health professor at the University of South Florida. "It’s not an all or nothing, it’s just that there really isn’t any delta in the U.S."
FDA spokesperson Chanapa Tantibanchachai told PolitiFact that the NIH panel recommended against the treatments’ use because of "markedly reduced activity" against omicron and because real-time testing to identify less-common variants like delta isn’t routinely available.
"CDC data indicate that the omicron variant of SARS-CoV-2 is estimated to account for more than 99% of cases in the United States as of Jan. 15," Tantibanchachai said. "Therefore, it’s highly unlikely that COVID-19 patients seeking care in the U.S. at this time are infected with or were exposed to a variant other than omicron."
Some medical providers have complained that some of the other COVID-19 treatments, like Pfizer’s paxlovid pill, are in short supply and proving difficult to get for patients.
But multiple medical experts said that they believed the supply tides were turning, and they agreed with the FDA’s pivot.
"Why would you use something that doesn’t work?" said Dr. Aileen Marty, an infectious disease and disaster medicine specialist at Florida International University. "You don’t want to give something that causes no benefit, and then there's economic costs, there’s stress to the individual, and with a monoclonal antibody — it’s invasive, and although minor, there’s always a risk of an infection or complications."
Monoclonal antibodies are laboratory-made molecules that act as substitute antibodies that can mimic the immune system's ability to fight off pathogens such as viruses. The therapy, typically given via IV infusion, has helped eligible patients fend off the virus and avoid hospitalization.
These therapies were issued in late 2020 and early 2021 under the FDA’s emergency use authorization, which stipulates that a given treatment’s benefits outweigh any risks it may pose. The use by anyone with COVID-19 was revoked once it was determined that the benefit no longer existed.
Monoclonal antibodies can cause stress on the body and, while rare, can cause infections or other side effects like shortness of breath, nausea and vomiting.
Medical experts told us that most run-of-the-mill COVID-19 tests cannot differentiate between variants. More sophisticated testing, such as gene sequencing, can give more clear answers.
We couldn't find any evidence for Gabbard’s estimate of 50,000 to 100,000 Americans being infected with the delta variant "every day."
The current projection is that only 0.1% to 0.2% of sequenced variants in the U.S. are delta, said Cindy Prins, a clinical associate professor of epidemiology at the University of Florida. If you take the daily average of U.S. COVID-19 cases on Jan. 26 — which was 618,231 — and use the higher end 0.2% delta estimate, then only 1,236 of those cases that day were delta, she added.
"Even though I’m using an estimated percentage for the current proportion of variants that are delta, it’s very reasonable to believe this is accurate because omicron has quickly outcompeted delta to become the dominant variant," Prins concluded.
Nicholas Spinelli, a spokesperson at the CDC, also said that national estimates for delta appear to be much lower than Gabbard’s figures.
"SARS-CoV-2 sequencing does not occur for every positive case," Spinelli wrote in an email. "However, based on the surveillance data, in the cases tested the week ending Jan. 22, 0.1 - 0.2% were projected to be delta, and 4,852,998 new cases (were reported) nationally over the same time period. That levels out to approximately 4,853 delta cases for that week, or about 693 per day on average. Case numbers fluctuate, so using figures from another week would result in a different answer."
Others agreed, saying that omicron is, by far, the dominant strain.
"In Florida, we monitor the concentrations of SARS-Cov-2 RNA in wastewater," Marty said. "Back in December, we did have some delta circulating, but the only thing they are finding in the sewers now is omicron."
Gabbard said, "Biden won’t allow Delta-variant COVID patients to get proven and effective monoclonal treatments even though there are 50,000-100,000 Americans infected by Delta EVERY DAY."
Gabbard’s estimate of daily delta patients appears to be way off, with national surveillance data putting the average estimate closer to 1,000 cases a day.
While the Biden administration has limited two monoclonal antibody treatments over their ineffectiveness against omicron,the FDA still allows four other drugs that remain effective for both variants, including another monoclonal antibody treatment called sotromivab.
A person with the delta variant has a harder time now finding treatments for the disease; but the best data show that the number isn’t nearly as high as Gabbard said. Because this claim contains an element of truth but ignores critical facts that would give a different impression, we rate it Mostly False.
Tulsi Gabbard, Facebook post, Jan. 26, 2022
U.S. Food & Drug Administration, Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant, Jan. 24, 2022
The U.S. Centers for Disease Control and Prevention, Monitoring Variant Proportions, Accessed Jan. 27, 2022
Journal of the American Medical Association, Association of Convalescent Plasma Treatment With Clinical Status in Patients Hospitalized With COVID-19, Jan. 25, 2022
National Institutes of Health, The COVID-19 Treatment Guidelines Panel’s Statement on the Use of Anti-SARS-CoV-2 Monoclonal Antibodies or Remdesivir for the Treatment of COVID-19 in Nonhospitalized Patients When Omicron Is the Predominant Circulating Variant, Updated Dec. 23, 2021
New York Times, Hospitals Scramble as Antibody Treatments Fail Against Omicron, Dec. 23, 2021
New York Times, U.S. officials limit treatments that don’t work on Omicron, but doctors say alternatives are scarce, Jan. 24, 2022
Washington Post, FDA ends for now use of two monoclonal antibodies, spurring a halt in federal shipments of the covid-19 treatments, Jan. 24, 2022
Email interview, Erika Tsuji, spokesperson for Tulsi Gabbard, Jan. 26-28, 2022
Email interview, Ira Longini, professor of biostatistics at the University of Florida, Jan. 27, 2022
Email interview, Cindy Prins, clinical associate professor of epidemiology at the University of Florida, Jan. 27, 2022
Email interview, Chanapa Tantibanchachai, press officer at the U.S. Food & Drug Administration, Jan. 27, 2022
Phone interview, Dr. Marissa Levine, Professor, Director, Center for Leadership in Public Health Practice at University of South Florida, Jan. 27, 2022
Phone interview, Dr. Aileen Marty infectious disease specialist at Florida International University, Jan. 27, 2022
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