In our view, the expansion phase 3 data evaluating Nuvaxovid in older pediatric subjects (12-17yos) disclosed this evening solidly affirm the vaccine’s efficacy/safety profile, though it’s hard to see this as being more than a box-check on the road to broadening the vaccine’s label across all age cohorts. As would be expected, the company is planning to submit the data as supplements to the global authorizations of Nuvaxovid/Covavax with regulators within 1Q22, while subsequent studies in school-age pediatric subjects (6-11yos) are slated to begin in 2Q22. Notwithstanding the steady clinical execution with Nuvaxovid, it remains unclear whether (and perhaps unlikely) these data are meaningfully differentiating from either of the mRNA vaccines. As such, we expect focus to continue on the intrinsic commercial and regulatory aspects of the Nuvaxovid story, namely 1) confirmed dose orders across the higher income countries where authorizations have been announced (UK, NZ, AUS), and 2) EUA eligibility in US. With limited visibility on these fronts, we continue to see shares trading range bound, with the potential implementation of FY22 guidance as a touchstone for shares to become more constructive.
Nuvaxovid demonstrates consistent clinical activity and safety profile in adolescent population. Of note, the phase 3 PREVENT-19 expansion study data in adolescents (12-17yos) show an overall 79.5% efficacy against COVID- 19 and a 82% efficacy against the Delta variant (≥7 days after 2nd dose), alongside a well-tolerated safety profile with rare SAEs balanced between vaccine and placebo group. Meanwhile, the adolescent neutralization responses were observed to be ~1.5-fold higher than adults from the main study measured by day 35 IgG levels, meeting the effectiveness endpoint.
That said, differentiation over approved mRNA vaccines is an outstanding question. With all the caveats of cross study comparisons, we view Nuvaxovid's new data in adolescents being largely in-line with the approved mRNA vaccine relating to its 82% efficacy against the Delta variant. Indeed, an Israel study on BNT162b2 vaccine in adolescents during a Delta variant outbreak has shown a crude vaccine effectiveness of 91.2% after 2 weeks past the 2nd dose (article here). In another study (article here), mRNA-1273 vaccine has shown a pooled effectiveness of 91% against the Delta variant after 2 weeks past the 2nd dose. Meanwhile, a Qatar study (article here) of BNT162b2 and mRNA-1273 vaccines showed a relatively inferior effectiveness against the Delta variant, at 52% and 73%, respectively (≥14 d after 2nd dose). Taken together, in the absence of a clear efficacy advantage, Nuvaxovid's competitive position remains uncertain among the approved COVID vaccines.
Sam’s comment: Interesting that JPM hasn’t adjusted their PT from $209 but remains neutral on the stock. They appear to be setting themselves up for an upgrade if the company can provide some clarity on revenue streams and/or possible additional orders. Q1 earnings should be extremely interesting. It appears they may be correct about the stock price being range-bound until we see some clarity on manufacturing, demand, and recurring revenue in 2022 and beyond.