As the clinical observations of Moderna’s COVID-19 vaccine continue—and with the FDA’s review decision approaching fast—Roche will supply the study with its sensitive antibody blood test to help track how well the shot performs.
The partnership aims to measure the levels of coronavirus antibodies present in the blood following inoculation and to help draw the line where vaccine-induced protection begins.
A previous Roche antibody diagnostic was used in earlier stages of Moderna’s work, specifically linked to the virus’ nucleocapsid protein, to determine only whether or not a person had previously been exposed to the pathogen.
Now the company’s latest, quantitative Elecsys test, authorized by the FDA last week, will be used to measure antibodies that can block the coronavirus’ cell-unlocking spike protein—the same antibodies that Moderna’s mRNA-based vaccine is designed to spur.
In addition, measuring antibody levels could provide answers on which amounts are necessary to maintain immunity—including whether a person may need a subsequent booster shot—but to also understand how antibodies could prevent COVID-19 infections from developing into the most severe, life-threatening cases, according to Roche.
In a recent publicized study data, Moderna said that people’s antibody levels remained high for at least three months after taking its two-dose vaccine, though they declined slightly over time.
The early research, from the company’s phase 1/2 trial, suggests that the shot may offer protection for at least six months—and that people may need to revaccinate against the disease on an annual basis, not unlike the flu.
However, it will take more time for clearer antibody data to come from Moderna’s larger phase 3 studies, which last month posted an efficacy of 94.5% and no severe cases. The vaccine itself is currently slated for a public appraisal by the FDA and its vaccine advisory committee Dec. 17, with an agency authorization decision expected to follow.
Meanwhile, a separate pre-print study by the University of Oxford—highlighted this week in NIH Director Francis Collins' official blog—tracked antibody levels among frontline healthcare professionals in the U.K., showing protection could last for several months after being exposed to the virus on the job. Only three of more than 1,400 workers who tested positive for antibodies would later receive positive results of an active infection, and none of them showed any symptoms.