Moderna announced on Aug. 23 that it has requested emergency use authorization from the Food and Drug Administration (FDA) for its bivalent COVID-19 booster vaccine targeted for the Omicron subvariants BA.4 and BA.5.
The company’s latest so-called bivalent vaccine dose, mRNA-1273.222, targets the BA.4/BA.5 subvariants of the Omicron strain as well as the original strain of SARS-CoV-2 that first emerged in Wuhan, China, in 2019.
The Massachusetts-based drugmaker said that if its FDA application is cleared quickly, it would be ready to deliver the doses in the United States in September. The United States, as well as Britain and EU members, has been preparing for vaccination campaigns in the fall season in hopes of preventing future surges in COVID-19 cases.
Stephane Bancel, the CEO of Moderna, said the latest booster “may offer higher, broader, and more durable protection against COVID-19 compared to the currently authorized booster.”
A mid-to-late-stage trial for the BA.4/BA.5-targeting vaccine is also underway, according to the company.
According to Moderna, clinical trial data for the BA.1-targeting bivalent booster showed that it “met all primary endpoints, including superior neutralizing antibody response against Omicron (BA.1) when compared to a 50 µg booster dose of mRNA-1273 in previously uninfected participants.” The vaccine also showed “potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the currently authorized booster (mRNA-1273) regardless of prior infection status or age.”
Deals Inked With Biden AdministrationThe request comes a day after Pfizer-BioNTech also announced it had applied for FDA emergency use authorization for its own BA.4/BA.5-targeting bivalent COVID-19 vaccine, which it is seeking for people aged 12 and over.
Heart InflammationCOVID-19 vaccines have remained a controversial topic amid reports of adverse effects. The previously-authorized COVID-19 vaccines from both Pfizer-BioNTech and Moderna have been linked with heart inflammation, including myocarditis and pericarditis, data from around the world have suggested.
A small number of deaths from heart inflammation after the COVID-19 vaccine have also been reported.