Moderna is completing regulatory submissions for mRNA-1273.214 in preparation for the fall booster season, based on clinical data showing that the booster candidate has a significantly higher neutralizing antibody response against all tested variants including Omicron BA.4/5.
The Omicron booster candidate mRNA-1273.214 has demonstrated a significantly higher neutralizing antibody response against Omicron subvariants compared with the currently approved booster, according to a recent announcement from Moderna.
According to Moderna, mRNA-1273.214 has now demonstrated significantly higher antibody titers against all tested variants, including Omicron BA.1 and BA.4/5 subvariant, ancestral virus, Alpha, Beta, Delta, and Gamma.
The company shared clinical data showing that 1 month after administration in participants who were previously vaccinated and boosted, a 50-µg booster does of mRNA-1273.214 elicited significantly higher neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the currently authorized booster, mRNA-1273.
Bivalent mRNA-1273.214 resulted in significantly higher neutralizing titers against Ba.4/5 compared to the currently authorized booster for participants without prior infection, with a geometric mean ratio of 1.69 (95% CI: 1.51-1.90). BA.4/5 neutralizing titers were 776 for mRNA 1273.214 (95% CI: 719, 838) compared with 458 for the currently authorized booster (95% CI: 421, 499) at 1 month after 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 participants who received mRNA-1273.214 and 3.5-fold (95% CI: 3.2, 3.9) for participants who received mRNA-1273.
Consistent results were demonstrated across subgroups. These findings showed that the dose of mRNA-1273.214 elicited significantly higher neutralizing antibody response against the Omicron subvariants BA.4/5 compared to the current booster regardless of prior infection status or age, according to Moderna.
“We are very pleased that our bivalent platform continues to demonstrate better performance than the current booster. 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,” said Stéphane Bancel, Moderna chief executive officer of Moderna, in a press release.
Moderna has submitted the data for peer reviewed publication and shared their findings with regulators. Thus far far, Moderna has completed regulatory submissions for mRNA-1273.214 in Europe, the UK, and Australia.
This clinical data adds to results shared last month from Moderna’s ongoing phase 2/3 study in approximately 800 participants. Previous results showed a 50-µg booster dose of mRNA-1273.214 met all pre-specified primary end points. The booster does was generally well tolerated by patients, with a reactogenicity and safety profile considered consistent with the currently authorized booster.
“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,” Bancel said.
Moderna is advancing 2 bivalent candidates for the fall based on different market preferences for Omicron subvariants. The company is simultaneously developing the second booster candidate, mRNA-1273.222, in addition to mRNA-1273.214. Both candidates contain 25 µg of mRNA-1273 and 25 µg of an Omicron subvariant.
“We are working with regulators to advance two 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.
Currently, the mRNA-1273.214 bivalent booster is the only candidate expected to have demonstrated significantly higher titers against the BA.4/5 strain in a clinical trial, compared to the currently authorized booster, before the fall booster season.
Moderna’s Omicron-containing bivalent booster candidate, MRNA-1273.214, demonstrates significantly higher neutralizing antibody response against Omicron subvariants BA.4/5 compared to currently authorized booster [press release]. Cambridge, MA: Moderna, Inc; July 11, 2022. https://investors.modernatx.com/news/news-details/2022/Modernas-Omicron-Containing-Bivalent-Booster-Candidate-mRNA-1273.214-Demonstrates-Significantly-Higher-Neutralizing-Antibody-Response-Against-Omicron-Subvariants-BA.45-Compared-To-Currently-Authorized-Booster/default.aspx. Accessed July 13, 2022.