The company’s investigational mRNA-1273.214 vaccine has now demonstrated significantly higher antibody titers against all tested variants.
Moderna announced yesterday results from its topline line data stating its investigational booster, mRNA-1273.214, showed greater protection against the Omicron BA.1 and BA.4/5 subvariants, as well as previous variants, than its authorized booster, mRNA-1273.
According to the company, 1 month after a 50 µg booster dose of mRNA-1273.214 was given to people previously vaccinated and boosted, the new dose resulted in significantly higher neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to Moderna’s authorized booster. And this was regardless of prior infection status or age in adults over 18, greater or less than 65 years old.
In addition, when the bivalent mRNA-1273.214 booster was given to people without previous COVID-19 infections, this also resulted in significantly higher neutralizing titers against BA.4/5 compared to the authorized booster, with a geometric mean ratio of 1.69 (95% CI: 1.51-1.90).
"We are very pleased that our bivalent platform continues to demonstrate better performance than the current booster,” Moderna CEO Stephane Bancel, said in a statement. “Today's update extends the remarkable performance of mRNA-1273.214, demonstrating significantly higher titers against all tested variants, including the BA.4/5 and BA.1 Omicron subvariants, and adds to the largest body of data confirming the superiority of a bivalent approach. This superior breadth and durability of immune response following a bivalent booster has now been shown in multiple phase 2/3 studies involving thousands of participants."
The company also said 1 month after the mRNA-1273.214 booster was administered, BA.4/5 neutralizing titers were 776 (95% CI: 719, 838), and 458 (95% CI: 421, 499) for the currently authorized booster. The BA.4/5 geometric mean fold rise (GMFR) from pre-booster levels was 6.3-fold (95% CI: 5.7, 6.9) for mRNA-1273.214 recipients, and 3.5-fold (95% CI: 3.2, 3.9) for mRNA-1273 recipients. Consistent results were demonstrated across subgroups, including in those age 65 and older.
Moderna has completed regulatory submissions for mRNA-1273.214 in the European Union, United Kingdom, and Australia. And they expect to complete most remaining filings this week.
The company said it is also developing its candidate mRNA-1273.222, a bivalent booster based on BA.4/5 subvariants.
“We are working with regulators to advance 2 bivalent vaccine candidates, mRNA-1273.214 and mRNA-1273.222, based on different market preferences for Omicron subvariants, clinical data requirements, and urgency of starting fall booster campaigns for vulnerable populations," Bancel said.