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Moderna first global company to introduce bivalent vaccine against Omicron variants
Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, is the first global company to introduce a bivalent vaccine for protection against Omicron variants.
Moderna announced new clinical data on its Omicron containing bivalent COVID booster candidate, mRNA-1273.214, containing mRNA-1273 (Spikevax) and a vaccine candidate targeting the Omicron variant of concern.
A 50 μg booster dose of mRNA-1273.214 met all pre-specified endpoints including superior neutralizing antibody response (geometric mean ratio) against the Omicron variant,
One month after administration when compared to the original mRNA-1273 vaccine. The booster dose of mRNA-1273.214 was generally well tolerated, with side effects comparable to a booster dose of mRNA-1273 at the 50 μg dose level.
“We are thrilled to share the preliminary data analysis on mRNA-1273.214, which is the second demonstration of superiority of our bivalent booster platform against variants of concern and represents an innovation in the fight against COVID,” said Stéphane Bancel, Chief Executive officer of Moderna.
“Looking at these data alongside the durability we saw with our _first bivalent booster candidate, mRNA-1273.211, we anticipate more durable protection against variants of concern with mRNA-1273.214, making it our lead candidate for a Fall 2022 booster. We are submitting our preliminary data and analysis to regulators with the hope that the Omicron-containing bivalent booster will be available in the late summer. Taken together, our bivalent booster candidates demonstrate the power of Moderna’s mRNA platform to develop vaccines that meet immediate, global public health threats.”
Dr. Nibal Dahaba, Managing director & cofounder of Gennecs Holding & Gennvax Moderna’s legal exclusive representative in Egypt, expressed her pride in the new bivalent vaccine’s remarkable achievements, and affirmed that the findings will result in massive protection against the virus and its mutations.
A booster dose of mRNA-1273.214 increased neutralizing geometric mean titers (GMT) against Omicron approximately 8-fold above baseline levels. Primary endpoints of non-inferiority against ancestral SARS-CoV-2 were also met, with GMR against ancestral SAR-COV-2 (D614G) of 1.22 (1.08-1.37).
Binding antibody titers (MSD) were also significantly higher (nominal alpha of 0.05) against all other variants of concern (Alpha, Beta, Gamma, Delta, Omicron) for mRNA-1273.214 when compared to mRNA-1273.
The mRNA-1273.214 50 μg booster dose was well-tolerated in the 437 study participants. The safety and reactogenicity profile of the mRNA-1273.214 50μ g booster dose was similar to that of mRNA-1273 50μ g dose when these vaccines were administered as a second booster dose.
In February 2021, Moderna announced its strategy to update booster candidates to address the ongoing evolution of the SARS-CoV-2 virus, including monovalent and bivalent candidates targeting multiple variants of concern. The Company’s primary focus has been on the bivalent booster approach, which are boosters that address two viral strains simultaneously.
Results from the Company’s Beta-containing bivalent booster candidate, mRNA-1273.211 announced in April 2022, demonstrated superiority against Beta, Delta and Omicron variants of concern one month after administration, with continued superiority that was durable against Beta and Omicron variants of concern six months after administration. Given the significantly higher antibody titers induced by mRNA-1273.214 compared to mRNA-1273,
Moderna anticipates that antibody titers induced by mRNA-1273.214 will be more durable over time against Omicron as compared to mRNA-1273. Moderna will report data from Day 91 after vaccination later in the summer.
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