Maintaining Our Vaccine Forecast

With the spread of the delta variant of the coronavirus, countries around the world are weighing or already implementing the use of third doses to previous recipients of Pfizer/BioNTech's mRNA vaccine, and an advisory committee to the Food and Drug Administration held a meeting on Sept. 17 to discuss Pfizer's PFE application for supplemental approval for such a booster shot in the U.S.

The committee voted 3-15 that the safety and efficacy data from a single trial, C4591001, in 330 patients, does not support approval of a booster at least six months after a second dose of Comirnaty in ages 16 and up. But subsequent votes for use of a booster as part of an emergency use authorization in seniors and high-risk populations (due to health or occupation) were unanimously positive. Comirnaty was granted full FDA approval in August for the initial two doses, and Pfizer filed for supplemental approval of a booster dose two days later.

If the FDA approves Pfizer's third dose, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Sept. 22 and Sept. 23 to discuss its recommendations for the rollout.

We're not making any changes to our fair value estimates for Moderna MRNA ($159), BioNTech BNTX ($172), or Pfizer ($42) as a result of this vote, and we continue to see no-moat Moderna and BioNTech as significantly overvalued at recent prices. Wide-moat Pfizer looks more fairly valued relative to our fair value estimate. We still model broad use of third-dose boosters, with $4 billion Pfizer and $2 billion Moderna sales from boosters later this year, and $26 billion Pfizer and $14 billion Moderna sales from boosters in 2022. While Pfizer and Moderna third-dose boosters are now authorized in the U.S. only for immunocompromised individuals, we expect additional data later this year to allow for broader recommendations, and other countries (Israel and several European countries) are already in the midst of a third-dose rollout.

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