Moderna’s RSV Vaccine Snags FDA Breakthrough Therapy Nod

The FDA granted Moderna’s RSV vaccine candidate Breakthrough Therapy Designation Monday.

Courtesy of Getty Images

The FDA granted Moderna‘s RSV vaccine candidate Breakthrough Therapy Designation Monday.

The regulatory honor is based on the pivotal Phase III ConquerRSV trial, in which the mRNA-based vaccine, mRNA-1345, demonstrated 83.7% efficacy against RSV lower respiratory tract disease in older adults.

These results were announced by Moderna on Jan. 17th.

Moderna " look[s] forward to productive conversations with the FDA in the hopes of bringing our RSV vaccine candidate for older adults to the market safely and quickly,” said Stephane Bancel, CEO, in a prepared statement.

The company plans to submit for regulatory approval in the first half of 2023.

mRNA-1345 employs the same lipid nanoparticle envelope as Moderna’s COVID-19 vaccine, Spikevax.

Bancel touted the technology along with the Phase III data reveal, saying that they “represent the second demonstration of positive Phase III trial results from our mRNA infectious disease vaccine platform after Spikevax.”

The ConquerRSV trial enrolled 37,000 patients who were at least 60 years old. Investigators conducted an interim analysis once there were 64 cases of RSV-associated lower respiratory tract disease (RSV-LRTD) as defined by two or more symptoms.

They found 55 cases among patients who received a placebo and nine cases among participants who received mRNA-1345.

At this year’s J.P. Morgan Healthcare Conference, Moderna officials told investors that COVID-19 vaccine sales reached an unaudited $18.4 billion. Company representatives expect this figure to shrink to $5 billion in 2023 based on existing purchase agreements.

Moderna’s RSV vaccine candidate is a few steps behind the competition.

In November, the FDA granted priority review to GlaxoSmithKline’s RSV vaccine candidate for older adults.

The FDA recently began reviewing RSV vaccine candidates from Pfizer and BioNTech; they will likely decide whether to approve them in May.

Featured Jobs on BioSpace