Moderna’s mRNA COVID-19 vaccine candidate was the first U.S. shot to enter late-stage testing, but that does not necessarily mean it has the brightest future of all.
The high possibility of multiple emergency authorizations for coronavirus vaccines towards the end of the year speaks to a lot of competition – and a prospect for Moderna that is less rosy than expected, SVB Leerink analyst Geoffrey Porges and his team wrote in an investor note, and named R&D and fax experts.
“[E]fairer entry from another major, established global pharmacy competitor adds an extra degree of uncertainty to the potential sale for Moderna’s candidate, mRNA-1273, according to the note, which summarized comments from experts at a virtual event of an international society for vaccines and of a separate call with three key opinion leaders in immunology and vaccine development.
The FDA’s emergency authorizations are likely to be granted on data from relatively small numbers of patients and limited follow-up time, so there will likely be “limited differentiation” between the various sets of vaccine data, the analysts wrote.
And that, in turn, will “increase the importance of clinical and commercial execution, a disadvantage for Moderna against entrenched players of Big Pharma,” the note stated.
Moderna launched its Phase 3 trial of mRNA-1273 in late July and is expected to complete it by the end of 2021, suggesting a potential full approval in early 2022. But like the biotech itself, Bullish experts were concerned about the possibility of an emergency authorization based on preliminary data at the end of 2020.
Moderna is probably not the only one looking at that kind of timeline. The Financial Times reported on Monday that the US government was already considering a possible emergency authorization for AstraZeneca’s adenovirus vector based vaccine, although the UK government and AstraZeneca themselves denied that it was in such talks with the administration.
That report, combined with the view of experts, prompted the SVB Leerink team to adjust their forecast to allow for earlier competition from non-mRNA faxes, likely even at the end of the year.
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In fact, all three specialists from Porges’ interviews mentioned the protein subunit vaccines with an adjuvant as their favorite class among the various COVID-19 vaccine approaches.
Leaders in this field include a collaboration between two of the world’s largest vaccine makers – Sanofi and GlaxoSmithKline – which is expected to receive potential approval as early as June 2021. Maryland biotech Novavax is looking for a similar shot forward in Phase 3 testing this fall, with $ 1.6 billion in subsidy funding from Operation Warp Speed.
Competition also breeds within the mRNA class, with Pfizer and German partner BioNTech close to Moderna; their BNT162b2 candidate is also in large-scale phase 3 testing. And the Pfizer / BioNTech shot is currently the only vaccine that has shown responses in both CD4 + and CD8 + T cells in human studies, Porges noted.
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The first wave of emergency authorizations will likely be based on limited data, which could make it difficult for products to differentiate between them, Porges said. That means commercial expertise and infrastructure can be the key. Moderna, which has no single market, has the commercial skills of a Big Pharma player such as Sanofi, Pfizer or AstraZeneca.
That lack of other products also means that mRNA-1273 represents the bulk of Moderna’s long-term revenue potential. The Porges team says it will most likely get an FDA approval “given the permissible regulatory environment” around COVID-19 vaccine candidates in general, and that it could attract “a substantial early bolus of patients”.
But the medium or long term could be a different story, analysts noted, “seeing the breadth of competitors expected to enter the market.”
In addition, mRNA-1273 must be shipped and stored at -20 ° C, and it can only be stored for a maximum of one week at 2 ° C to 8 ° C in a clinic office. That complexity in shipping and storage requirements, compared to some traditional vaccines, could be a “particularly relevant consideration after the immediate pandemic period and for patient populations outside high-income countries,” Porges wrote.
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