Approval for Eli Lilly antibodies and HHS issues $55m for virtual care
WASHINGTON D.C. : The Department of Health and Human Services (HHS) is doling out $55 million to boost virtual care access at 29 community health centers. HHS secretary Xavier Beccara also announced that the agency had purchased 600,000 doses of monoclonal antibodies to treat the Omicron variant.
Meanwhile, the Food and Drug Administration (FDA) has postponed a meeting to authorize Pfizer’s vaccine for young children, pending additional data. Additionally, the agency has been active these past weeks issuing guidance for non-opioid analgesics and granting an emergency use authorization for coronavirus monoclonal antibodies.
HHS Boosts Virtual Care Access with $55M
The Department of Health and Human Services has dedicated $55 million to 29 community health centers to improve virtual care access. This influx of funding will help facilities offer care for populations of patients who cannot easily access care facilities. Additional funding will also support the massive increase in virtual care that exploded during the pandemic and has continued to grow since.
FDA Issues Guidance for Non-Opioid Analgesics
New Guidance from the FDA is pushing the development of non-addictive opioid alternatives. These non-opioid analgesics address acute pain stemming from surgeries, tissue damage, or other injury lasting up to 30 days.
“Opioid misuse and abuse remain a serious public health crisis facing the country. Preventing new addiction through fostering the development of novel non-opioid analgesics is an important priority for the FDA,” Patrizia Cavazzoni, MD, director of the FDA’s center for drug evaluation and research, said in the guidance announcement. Support provided by the FDA includes steps for testing drugs and creating data that illustrates non-addictive properties.
FDA Grants Eli Lilly Emergency Use Authorization
The FDA has granted Eli Lilly’s bebtelovimab emergency use authorization based on its effectiveness against the Omicron variant. The treatment, available to those 12 and up, is approved for patients at high risk of severe disease. Clinical trial results demonstrated that the antibody reduced time to symptom resolution compared to a placebo and other monoclonal antibodies.
HHS Secures 600,000 Monoclonal Antibody Treatments for Omicron
In a promising step, HHS has secured 600,000 antibody treatments with effectiveness against the Omicron Variant. Previous antibody treatments were ineffective against the new variant and were subsequently pulled off the market. The new monoclonal antibody, bebtelovimab made by Eli Lily, has also been shown to effectively counteract the BA.2 sub-variant of omicron.
“We want to make sure if an American gets sick with COVID-19, they can get a treatment that works,” explained HHS Secretary Xavier Becerra in a statement. The contract with Eli Lily includes stipulations for 500,000 additional doses for future use.
