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Shares of Moderna (NASDAQ:MRNA) are trading more than 7% higher in pre-market Wednesday after the vaccine maker announced positive topline data for its respiratory syncytial virus (RSV) vaccine.
The positive results pave the way for Moderna to request the first approval outside COVID-19 after Phase 3 results showed that mRNA-1345 proved highly effective in preventing lung disease in older people.
The vaccine efficacy was 83.7% against RSV-associated lower respiratory tract disease.
“These data are encouraging, and represent the second demonstration of positive phase 3 trial results from our mRNA infectious disease vaccine platform after, Spikevax, our COVID-19 vaccine. We look forward to publishing the full data set and sharing the results at an upcoming infectious disease medical conference,” said Stephane Bancel, Moderna’s chief executive officer.
Cantor Fitzgerald analysts said the outcome was “in-line” with the company’s and Street’s expectations.
“We believe the most significant implication of this data readout is that this is the first data we have seen from an mRNA-based RSV vaccine, and it gives MRNA the possibility to combine its RSV vaccine with other common, annual routine vaccinations,” they said.
Morgan Stanley analysts added:
“Vaccine Efficacy (VE) at IA1 appears to beat the high-end of our expectations. We note that the data is still immature and we await further data for a definite comparison. Based on a cross-trial definition of severe AEs, safety broadly appears in-line with Pfizer and GSK.”
