Roche to Include COVID-19 Antibody Test in Moderna’s Trials
Including the COVID-19 antibody test will offer easier quantitative measurement of antibodies and help establish a correlation between vaccine-induced protection and levels of anti-receptor binding domain antibodies, the companies said.
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By - Roche recently announced a partnership with Moderna to utilize the Elecsys COVID-19 antibody test in Moderna’s mRNA-1273 vaccine research clinical trials.
The partnership will allow for easier quantitative measurement of SARS-CoV-2 antibodies and help to establish a correlation between vaccine-induced protection and levels of anti-receptor binding domain (RBD) antibodies, the companies stated.
This announcement comes at the heels of a Roche announcement that it received Emergency Use Authorization (EUA) from FDA for the Elecsys Anti-SARS-CoV-2 S antibody test.
Elecsys Anti-SARS-CoV-2 S measures the level of antibodies to the spike protein of COVID-19, which can uncover whether an individual has already been infected and has developed immunity to the virus.
“Roche values the collaboration with Moderna, which has already included the successful use of our qualitative Elecsys Anti-SARS-CoV-2 test, targeting the nucleocapsid protein, in an earlier part of the studies,” Thomas Schinecker, CEO of Roche, said in the announcement.
“We are pleased to see that our quantitative Elecsys SARS-CoV-2 S test, which targets the spike protein, is now also being used as part of the Moderna vaccine trials, which could ultimately help to end this pandemic,” he continued.
Early data from a Phase 3 clinical trial in mid-November shows that Moderna’s mRNA COVID-19 vaccine is 95 percent effective.
The primary endpoint of the trial, referred to as COVE, was based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks after the second dose of the vaccine.
Moderna stated that it will request a EUA from FDA in the coming weeks for the vaccine, when it anticipates it will have the final safety and efficacy data for the EUA.
Measuring the quantitative levels of anti-RBD SARS-CoV-2 antibodies using Roche’s test will help Moderna to gain important insights into the correlation between protection from vaccination and antibody levels.
The information could help to assess if or when an individual needs revaccination or help to answer any clinical or research questions, Roche said.
“To enhance our understanding of vaccines against SARS-CoV-2 there would be a benefit in knowing the starting levels of antibodies a person has, prior to vaccination, in order to evaluate any change in antibody levels that the vaccine induces,” a Roche spokesperson said in the recent announcement.
“This is particularly relevant in the case of antibodies directed against the SARS-CoV-2 spike protein, since these antibodies have been shown to have potent antiviral activity and correlate to potential immunity. Measuring antibody levels can also play a role in establishing vaccine efficacy in the prevention of infection and/or the development of severe COVID-19.”
Antibodies are important because they can provide valuable public health information to uncover if an individual’s immune system can fight off infections, particularly the coronavirus.
Throughout the pandemic, top pharmaceutical companies have launched antibody drugs, antibody cocktails, and antibody tests to combat COVID-19.
In mid-October, AstraZeneca announced that its long-acting COVID-19 antibody combination will advance into two Phase 3 clinical trials at sites inside and outside the US.
The first trial will evaluate the safety and efficacy of AZD7442 to prevent infection for up to 12 months in nearly 5,000 participants and the second trial will evaluate post-exposure prophylaxis and pre-emptive treatment in approximately 1,100 participants.
Then in mid-November, FDA issued a EUA for Eli Lilly & Company’s COVID-19 antibody treatment for use in mild-to-moderate coronavirus in adults and pediatric patients.
The EUA allows healthcare providers to administer a single-dose of LY-CoV555 to infected patients 12 years of age or older as long as they weigh at least 88 pounds, as well as individuals who are at risk for severe COVID-19 or hospitalization.
But FDA did not authorize the antibody treatment for use in hospitalized patients or patients who require oxygen therapy due to the virus.
