Research Roundup: Antibody level tests, monoclonal antibody research, and funding for vaccine distribution in LMICs
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The US Food and Drug Administration (FDA) authorized last week its first COVID-19 antibody tests that estimate the level of antibodies in a person’s bloodstream, indicating the strength of their immune response. Since April, FDA has greenlit 33 antibody tests, all of which provide a basic positive or negative result. The two recently approved tests, developed by Siemens Healthineers, are new versions of previous yes-or-no antibody tests that provide “semi-quantitative” readings of a patient’s antibody levels. Both tests are chemiluminescent immunoassays, tagging antibodies with reagent markers and producing more light when more antibodies are present. The new tests will provide an additional tool in evaluating COVID-19 immune response, but FDA also warned that results from these tests do not provide reason to stop following COVID-19 prevention guidelines and emphasized the remaining unknowns about antibodies and protective immunity.
Research on monoclonal antibodies—lab-made imitations of natural antibodies—to treat COVID-19 is accelerating as two National Institutes of Health (NIH) clinical trials were launched last week. The trials, one focusing on patients early in disease progression and one on sicker, hospitalized patients, are intended to determine whether a monoclonal antibody developed by Eli Lilly has an effect on symptom duration and recovery time. Success as a COVID-19 treatment could also lead to exploration of monoclonal antibodies as an infection prevention measure. Scientists hope monoclonal antibody treatment can provide a “bridge” of immunity before a vaccine is available.
The Serum Institute of India announced it will be receiving US$150 million in funding from the Bill & Melinda Gates Foundation in partnership with Gavi, the Vaccine Alliance, to produce 100 million COVID-19 vaccine doses for low- and middle-income countries. The Serum Institute will manufacture vaccines from developers AstraZeneca and Novavax once approved and make them available for procurement, priced at $3 per dose, in 92 countries via a Gavi advance purchase commitment as part of the COVID-19 Global Vaccine Access (COVAX) Facility initiative, co-led by Gavi, the Coalition for Epidemic Preparedness Innovations, and the World Health Organization. COVAX aims to deliver 2 billion doses of approved, effective vaccines against COVID-19 by the end of 2021.