Pharmaceutical and biotechnology company Moderna has said preliminary results from its study on a COVID-19 vaccine intended to protect against variants of the virus show that it outperformed its currently authorized booster shot, mRNA-1273.
The company announced on April 19 that its first bivalent booster vaccine candidate, mRNA-1273.211—which includes mutations found in the Beta variant of concern—demonstrated “superiority” against the Beta, Delta, and Omicron variants of COVID-19 one month after being administered, compared to the booster shot of its original vaccine currently in use.
It also demonstrated superiority against the Beta and highly transmissible Omicron variants six months after the shot was given, compared to its current booster jab.
Moderna said the booster dose of mRNA-1273.211 was “generally well tolerated” in the 300 study participants who received the 50 microgram dose and 595 participants who received the 100 microgram dose.
It noted that the 50 microgram dose had “a similar incidence of solicited adverse reactions and unsolicited adverse events” to that of Moderna’s mRNA-1273 vaccine, also known as Spikevax, which is currently approved under Emergency Use Authorization for adults who are 18 years of age or older.
The Centers for Disease Control and Prevention states that serious adverse events after COVID-19 vaccination are rare but may occur and can include Anaphylaxis, Myocarditis, and pericarditis, among others.
At the 1 and 6 month mark, the increase in the neutralizing antibody titers against Omicron following a 50 microgram booster dose of mRNA-1273.211 stood at 2.20-fold (95 percent CI: 1.74, 2.79) and 2.15-fold (95 percent CI: 1.66, 2.78) compared to the mRNA-1273 booster dose, respectively, the company said.
Moderna’s new bivalent booster vaccine includes four mutations that are present in the Omicron variant of COVID-19, the company said.
Stéphane Bancel, Chief Executive Officer of Moderna, said the company is pleased with the data from its first bivalent booster candidate and believed the results “validate our bivalent strategy, which we announced and began pursuing in February 2021”
“The results indicate that mRNA-1273.211 at the 50 µg dose level induced higher antibody responses than the 50 µg mRNA-1273 booster, even when additional variants of concern were not included in the booster vaccine,” Bancel said.
Moderna is also advancing a Phase 2/3 clinical study for an updated bivalent booster called mRNA-1273.214, which includes 32 mutations present in the Omicron variant and the company said it expects initial data on the shot to be released in the second quarter of this year.
“Our latest bivalent booster candidate, mRNA-1273.214, which combines the currently authorized Moderna COVID-19 booster with our Omicron-specific booster candidate, remains our lead candidate for the fall 2022 Northern Hemisphere booster.”
The company added that if a new bivalent booster vaccine is granted authorization, it will “create a new tool as we continue to respond to emerging variants.”
The announcement comes after Moderna earlier this month issued a recall in Europe involving 764,900 doses of its “Spikevax” COVID-19 vaccine after contaminants were discovered in a vial, although the drugmaker did not specify what kind of foreign substance was found.