Due to Omicron, FDA limiting use of COVID-19 antibody treatments

Photo: seskan MonKhonkhamsao/Getty Images

The U.S. Food and Drug Administration has subtracted a pair of COVID-19 monoclonal antibody treatments from the approved list due to what the agency has deemed "ineffectiveness" against the Omicron variant, which has spread rapidly throughout the U.S. and the world.

Bamlanivimab and etesevimab, which are administered in tandem, and REGEN-COV are no longer authorized for use, the agency said this week. Their use will be limited to when the patient is likely to have been infected with or exposed to a different variant – one that's susceptible to these treatments.

While they're currently not authorized for use in any U.S. states, territories or jurisdictions, the treatments may once more be authorized in specific regions depending on whether a susceptible variant is currently spreading in those areas, the FDA said.

WHAT'S THE IMPACT

Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful pathogens such as viruses, like SARS-CoV-2, the virus that causes COVID-19. And like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in certain treatments not working against certain variants such as Omicron. 

Based on Centers for Disease Control and Prevention data, the Omicron variant is estimated to account for more than 99% of cases in the United States as of January 15. Because of that, the FDA said it's "highly unlikely" that coronavirus patients currently seeking care in the U.S. are infected with a variant other than omicron. 

Removing the treatments from the approved list, the FDA said, avoids exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious.    

The NIH COVID-19 Treatment Guidelines Panel, an independent panel of national experts, recently recommended against the use of bamlanivimab and etesevimab and REGEN-COV because of markedly reduced activity against the omicron variant, and because real-time testing to identify rare, non-Omicron variants is not routinely available.  

Importantly, there are several other therapies – Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir – that are expected to work against Omicron, and that are authorized or approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. 

Healthcare providers should consult the NIH panel's COVID-19 treatment guidelines and assess whether these treatments are right for their patients, the FDA said.

The agency stressed that the authorized treatments are not a substitute for vaccination in those for whom COVID-19 vaccination and a booster dose are recommended. Its own internal data has demonstrated that the vaccines can lower a person's risk of developing COVID-19 and experiencing the potential associated disease progression, including hospitalization and death.

THE LARGER TREND

The World Health Organization declared Omicron a "variant of concern" in November, and many unknowns remain, such as how effective vaccines will be at mitigating its spread.

The news is mixed on the vaccination front. On the one hand, the threat of the new variant may be encouraging some vaccinated adults to get a booster dose. According to the Kaiser Family Foundation, half of vaccinated adults who have not yet received a booster dose (27% of all vaccinated adults) say the news about the new Omicron variant makes them more likely to get a booster dose. There's some confusion around the CDC recommendation that all vaccinated adults receive a booster dose, with 23% of adults (including 21% of vaccinated adults) saying they're unsure about the CDC's recommendation or incorrectly saying the CDC has not recommended this.

On the other hand, unvaccinated adults remain relatively unmoved by the recent news of the Omicron variant, with a large majority of unvaccinated adults (87%) saying the news about Omicron doesn't make them more likely to get vaccinated. Twelve percent of unvaccinated adults say news of the Omicron variant makes them more likely to get a vaccine.

Nationally, the U.S. has struggled to shake the pandemic, which is currently experiencing yet another surge. As of Tuesday morning, the Johns Hopkins coronavirus tracker shows the country's 28-day case total at about 19 million, bringing the overall total to almost 72 million. In the past 28 days, 48,062 Americans have died of COVID-19 or a combination of the coronavirus and other comorbidities.

Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com