'Interesting Timing': Fauci Touts Monoclonal Antibody Treatments One Day After FDA Approves Pfizer Vax

Aug 23, 2021: COVID vaccine EUA, conditional upon there being "no adequate and approved available alternatives," is removed. Vaccines receive full FDA approval.

Aug 24, 2021: Fauci finally touts monoclonal antibodies as an effective treatment.

Interesting timing. https://t.co/YdUNRfYkxj

— Don Wolt (@tlowdon) August 25, 2021

COVID-19 sufferers can reduce their risk of hospitalization and death by up to 85 percent if they receive monoclonal antibody treatments in the early stages of their illness, Dr. Anthony Fauci said Tuesday.

The White House chief medical adviser said that using the lab-made antibodies to fight the virus before a patient is hospitalized can prevent the chances of severe illness by between 70 and 85 percent.

"It is important to emphasize that this must be done early in infection and not wait, of course, until a person is sick enough to be hospitalized," Fauci said at a COVID-19 press briefing.

The data supporting this EUA for [GlaxoSmithKline's antibody treatment] sotrovimab are based on an interim analysis from a phase 1/2/3 randomized, double-blind, placebo-controlled clinical trial in 583 non-hospitalized adults with mild-to-moderate COVID-19 symptoms and a positive SARS-CoV-2 test result. Of these patients, 291 received sotrovimab and 292 received a placebo within five days of onset of COVID-19 symptoms. The primary endpoint was progression of COVID-19 (defined as hospitalization for greater than 24 hours for acute management of any illness or death from any cause) through day 29. Hospitalization or death occurred in 21 (7%) patients who received placebo compared to 3 (1%) patients treated with sotrovimab, an 85% reduction.

The FDA is carefully monitoring circulating viral variants and their sensitivity to monoclonal antibodies authorized to treat COVID-19, including sotrovimab. Laboratory testing showed that sotrovimab retains activity against the current circulating variants first reported in the United Kingdom, South Africa, Brazil, California, New York and India.

The EUA allows for sotrovimab to be distributed and administered as a 500 milligram single dose intravenously by health care providers. The EUA requires that fact sheets that provide important information about using sotrovimab in treating COVID-19 be made available to health care providers and to patients, parents and caregivers, including dosing instructions, potential side effects and drug interactions. Potential side effects of sotrovimab include anaphylaxis and infusion-related reactions, rash and diarrhea.