Futures are up 1% this morning on news of Moderna’s (MRNA) COVID-19 vaccine showing 94.5% efficacy in their Phase 3. Last week Pfizer reported >90% efficacy for their COVID-19 vaccine. It seems we now have 2 highly effective vaccines on the verge of approval.
Moderna’s study, called “COVE”, enrolled more than 30,000 participants. The participants were picked from a diverse set, including high risk patients for COVID like obese, cardiac patients and diabetics. The “high-risk” groups represented 42% of the total participants in Phase 3. This makes the 94.5% efficacy against COVID even more impressive because the vaccine is able to protect even those with “pre-existing” conditions.
MRNA’s interim analysis was based on 95 cases. So, out of the 30,000 participants enrolled, 95 were infected with COVID. 90 of these cases of COVID were observed in the placebo group versus 5 cases observed in the vaccine group. This resulted in vaccine efficacy of 94.5% (p <0.0001).
11/95 were considered “severe” cases of COVID, all of which occurred in the placebo arm and none in vaccine. This data around severe cases, albeit VERY early, shows potential of the vaccine to provide immunity against “severe” disease.
Interim Safety Was Relatively Clean
The majority of adverse events were mild or moderate in severity. The common Grade 3 (severe) events included injection site pain (2.7%), and after the second dose included fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%) and erythema/redness at the injection site (2.0%).
Manufacturing & Shipping Superiority Over Pfizer
Moderna’s vaccine has shown better commerciality features over Pfizer because of storage temperatures. Moderna expects the candidate to remain stable at standard refrigerator temperatures of 36° to 46°F (2° to 8°C) for 30 days. This compares favorably to Pfizer’s vaccine which needed -94°F (-70°C). The storage temperature will make Moderna’s vaccine easier to transport, especially in rural areas and developing countries that do not have industrial level freezers.
By the end of 2020, the Moderna expects to have approximately 20 million doses of vaccine ready to ship in the U.S. The Company remains on track to manufacture 500 million to 1 billion doses globally in 2021.
Outstanding Questions That Remain
Moderna released topline data, which is collected after a median follow up of ~2 months. In order to get a better understanding of vaccine, T cell responses will need to be presented to show how the immune system is adapting the vaccine. Duration (how long protection lasts) will also need to be addressed, as well as longer term safety data greater than 2 months.
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