The world’s attention is rightly focused on news of COVID-19 vaccine updates, from eligibility to supply. But we will make a critical error if we ignore the need for treatments as well as vaccines. Vaccines may not reach everyone for many years. Vaccines will not protect everyone. And as infection surges threaten to overwhelm hospitals and nursing homes, immediate remedies are needed. So, it is vitally important we continue to research treatments to limit and cure COVID-19.
Consider the flu, which is targeted annually with widely available and effective vaccines. But since no vaccine is perfect, there remains a significant need for flu therapies such as Tamiflu and Relenza because these drugs prevent hospitalizations and save lives. We need Tamiflu-like and Relenza-like drugs for COVID-19.
To date, the Food and Drug Administration (FDA) has only fully approved one treatment, intravenous remdesivir, for hospitalized patients. The FDA has also approved other intravenous therapies including convalescent plasma; a monoclonal antibody drug called bamlanivimab, and a cocktail of the monoclonal antibodies casirivimab and imdevimab for outpatient care under emergency use authorization (EUA). While these drugs can be helpful, their requirement for intravenous administration severely hampers their widespread use. Because EUAs are issued during an emergency, the data for drug risks and benefits are much less than required for full FDA approval. The widespread and uncontrolled use of numerous EUA drugs has made it difficult to perform proper randomized clinical trials for other new experimental treatments because it is unethical to ask a patient to participate in a clinical trial when they may or may not receive a EUA-approved treatment. The overuse of EUAs makes it difficult or impossible to know if these therapies truly are actually effective and safe. What is badly needed is more randomized clinical trials.