Moderna announced that initial human data on its updated Covid-19 vaccine indicate its efficacy against anticipated fall variants.
Boosting Neutralizing Antibodies:
Although specific results weren’t disclosed in Thursday’s release, Moderna stated that its revised vaccine substantially enhanced neutralizing antibodies against two variants – Eris (EG.5) and Fornax (FL.1.5.1).
Context of Rising Covid Cases:
This news coincides with a recent rise in Covid cases across the US. Yet, uncertainty surrounds the projected vaccine demand for the upcoming fall season.
Competitive Positioning:
Leerink Partners analyst Mani Foroohar commented that while these results are encouraging, they’re not unexpected, positioning Moderna to compete in the forthcoming Fall/Winter period. However, translating these immunological biomarker findings into commercial success could be challenged by Covid vaccine demand.
As the Covid boom recedes, drugmakers are preparing to cut costs, anticipating the industry’s next phase.
In June, the FDA’s vaccine advisory committee, VRBPAC, recommended updates to Covid vaccines to address the Omicron variant XBB.1.5. Both Moderna and Pfizer/BioNTech anticipate FDA approval for their adjusted shots by fall.
Pfizer’s Study in Mice:
In a Thursday update, Pfizer shared that recent mouse studies showed their updated XBB 1.5 vaccine effectively neutralized various Omicron XBB variants, including XBB.1.5 and EG.5.1.
Novavax’s Hopes for Emergency Use Authorization:
Unlike its mRNA competitors, Novavax developed a protein-based vaccine targeting XBB. It aims for FDA emergency use authorization in the fall, though its application is pending. Novavax believes its XBB COVID vaccine can combat the EG.5 strain, similar to XBB.1.5, and is conducting tests to prove its efficacy.
Regulatory Submissions by Moderna:
Moderna revealed it had submitted the updated Covid vaccine data to the FDA, the EU’s drug authority EMA, and other regulatory bodies.
Cost-Cutting Measures:
Pfizer has hinted at cost reductions if Covid-19 sales disappoint. Companies that thrived during the pandemic are already announcing significant cuts. Pfizer’s partner BioNTech plans to trim research & development spending by around €400 million this year. Novavax cautioned investors about its potential sustainability challenges.
Moderna’s Future Focus:
While Moderna hasn’t disclosed any cuts, Leerink Partners analyst Mani Foroohar noted earlier in August that Moderna might be a strong contender for restructuring and staff reductions. Moderna envisions its future in a range of mRNA projects, encompassing RSV and cancer vaccines, and treatments for rare diseases.
Focus on Rare Diseases:
Moderna’s CEO mentioned that the company is moving towards specializing in rare diseases, expanding its genetic disease initiatives, and exploring n-of-1 treatments.
Moderna’s Response:
Moderna declined to provide further comments beyond the press release for this story.
Moderna’s Upgraded Covid Vaccine, Moderna’s Upgraded Covid Vaccine
