The World Health Organization (WHO) welcomes the addition of another therapeutic to the world’s arsenal against COVID-19, but urges producing companies and governments to address the high price and limited production of the Regeneron antibody combination and ensure safe and appropriate handling of the medicine.
Given the high cost and low availability of the combination therapy, UNITAID is negotiating with Roche Pharmaceutical, which is currently manufacturing the drug for lower prices and equitable distribution across all regions, especially in low- and middle-income countries. WHO is also in discussions with the company for a donation and distribution of the drug through UNICEF, following an allocation criteria set by WHO.
In parallel, WHO has launched a call to manufacturers who may wish to submit their products for pre-qualification, which would allow for a ramping up of production and therefore greater availability of the treatment and expanded access. ACT-A partners are also working with WHO on an equitable access framework for recommended COVID-19 therapeutics.
WHO also calls for the sharing of technology to allow for the manufacturing of biosimilar versions so all patients who may need this treatment have access to it.
In addition, there are feasibility challenges linked to the antibodies, such as in intravenous administration; based on the trials with non-severe and severe/critical patients. In the outpatient setting, this may be a challenge; and thus subcutaneous administration may be an option at the lowest dose. Administration requires specialized clinics, and will need adequate amounts of the antibodies, as well as trained staff to ensure safe and effective administration of the drug.
WHO cautions that in order not to exacerbate health inequity and limited availability of the therapy, patients who are non-severe and at higher risk for hospitalization be treated and those that are severe or critical with seronegative status (those who have not developed natural antibodies against COVID-19 determined through accurate rapid tests) be treated; as these two patient groups are the patients that stand to benefit most from the treatment.