Moderna Gives COVID-19, RSV, Flu Shot Updates on their Vaccines Day

Today, the biotechnology company Moderna announced updates to its mRNA pipeline. Their mRNA COVID-19 vaccine made Moderna a household name, and the company is expanding their messenger RNA technology to other vaccine candidates.

“Our mRNA platform has changed medicine and will continue to have a major impact on global health,” said Stéphane Bancel, CEO of Moderna. “Today we are excited to announce multiple new vaccine candidates, including for enteric viruses, such as norovirus, and targeting Lyme disease, our first bacterial vaccine.”

In addition to these new endeavors, Moderna has other mRNA vaccines in development. Investigational influenza and respiratory syncytial virus (RSV) vaccines are the farthest along, with the latter receiving breakthrough therapy designation from the US Food and Drug Administration (FDA) at the beginning of this year.

There is currently no approved RSV vaccine, though this could be the year that changes. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend RSV vaccine candidates from both Pfizer and GSK, but these recommendations have yet to receive a stamp of approval from the FDA and Centers for Disease Control and Prevention (CDC).

Moderna’s RSV vaccine candidate, mRNA-1345, is not as advanced in the approval pipeline. mRNA-1345 is undergoing phase 2/3 clinical trials in adults 60 years and older, but has so far met primary efficacy endpoints with a vaccine efficacy of 83.7%. This past year saw an unprecedented spike in RSV infections in older adults and young children, and the world’s first-ever RSV vaccine is now more needed than ever.

There are some doubts, however, as to the efficacy of the mRNA flu vaccine. Moderna shared phase 3 trial data suggesting their mRNA-1010 vaccine was more protective than existing flu shots against circulating strains of influenza A, but the mRNA flu shot candidate was not statistically noninferior against 2 influenza B strains.

mRNA-1010 demonstrated an acceptable safety and tolerability profile, but because it did not meet the requisite statistical threshold, the phase 3 trial was recommended to continue with efficacy follow-up toward the next analysis.

Moderna noted preliminary analyses proved the mRNA-1010 flu shot generated robust immune responses, but investigators could not determine whether the candidate was statistically noninferior to existing approved vaccines.

“With mRNA-1010, our first investigational vaccine against seasonal flu, we are encouraged by the consistently strong immunogenicity results against influenza A, and titers consistent with noninferiority against influenza B strains in the most recent Phase 3 trial,” stated Bancel.

On the COVID-19 front, Moderna recently began dosing the first participants in a phase 3 trial for their next-generation, refrigerator-stable COVID-19 vaccine, mRNA-1283. Other mRNA vaccine candidates are in development to combat norovirus, Lyme disease, cytomegalovirus, and HIV.

“With our mRNA platform and technology, as well as our agile manufacturing capabilities, we are confident that we can quickly develop safe and effective vaccines to address critical unmet needs,” Bancel said.

Read Moderna’s full update here.