Moderna Inc MRNA

Moderna presented data at a Food and Drug Administration advisory committee meeting on Oct. 14 supporting the use of a third-dose 50 ug booster of its COVID-19 vaccine. In Moderna's study 201B, booster recipients saw a 13-fold increase in neutralizing antibodies against the original virus and 17-fold increase in neutralizing antibodies against the delta variant, compared with levels achieved in a subset of patients from the key phase 3 trial after the initial series, and this response was relatively consistent across age groups. Moderna asked the FDA for authorization of its booster at least six months after the two-dose initial series in seniors (over age 65) and other high-risk populations over age 18 (due to pre-existing conditions or high-exposure settings), mirroring the groups that received FDA authorization on Sept. 22 for the Pfizer/BioNTech booster dose. The 19 voting committee members voted unanimously to authorize the Moderna booster in this setting but still appeared unconvinced when asked to consider use of mRNA vaccine boosters more broadly across the general adult population. While this appears to reflect more restricted use of a third-dose booster than our base-case scenario, we continue to expect a third dose could eventually be recommended more broadly, as supported by data from Israel and the recent broader European authorization of third-dose boosters. Therefore, we're maintaining our $159 Moderna fair value estimate, and we continue to think that Moderna is still in the process of building a moat.