FDA Approves Three-Monthly Antibody Infusion to Protect Immunocompromised From Covid

Written by Dr Peter McCullough MD, MPH on June 1, 2024. Posted in Current News

Most Americans including the immunocompromised have had at least one episode of acute SARS-CoV-2 infection, and therefore have negligible risk of hospitalization or death on a subsequent infection

However, those who are very vulnerable and have not encountered COVID-19, could benefit from a new, longer-acting monoclonal antibody recently approved by the US FDA.

The FDA has authorized pemivibart (Pemgarda; Invivyd) for emergency use in the prevention—or pre-exposure prophylaxis (PREP)—of COVID-19 in adults and adolescents who are 12 years of age and older who either have moderate to severe immune compromise because of medical conditions or receive certain immunosuppressive medications.

It is an alternative to the failed COVID-19 vaccines.

Pemivibart, which was formerly known as VYD222, is a half-life extended monoclonal antibody (mAb). The EUA for pemivibart is based on data from the CANOPY (NCT06039449) clinical trial, which demonstrated positive results.

The CANOPY trial is an ongoing phase 3 trial that enrolled patients to receive either pemivibart or placebo. Cohort A was an open-label, single-arm trial which enrolled patients aged 18 years or older with moderate to severe immune compromise (n = 306) facing relevant SARS-CoV-2 variants (eg, JN.1) in the analyses of neutralizing titers and the primary immunobridging endpoint for cohort A.

The results indicated an expected 70 percent relative risk reduction in the development of symptomatic COVID-19 between treatment and placebo arms. With additional agents in the McCullough Protocol, even the most severely immunocompromised should get through the illness without risks for hospitalization or death.

The most serious safety event was anaphylaxis occuring in four participants (0.6 percent). Of these patients, two experienced anaphylaxis during the first infusion of pemivibart, and the remaining two during the second infusion.

I will consider patients with oxygen-dependent severe lung disease who are immunocompromised without natural immunity for these infusions.

I anticipate cases such as these will be very rare.

See more here substack.com

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