In a noteworthy development, the U.S. Food and Drug Administration (FDA) has selected Pfizer, Moderna, and Novavax as the manufacturers for the next round of COVID-19 booster shots. This decision sets the stage for a competitive race among the vaccine makers as they strive to deliver their new jabs by fall. The FDA has advised the three companies to produce single-strain vaccines targeting the omicron subvariant XBB.1.5, which is known to be highly immune-evasive.
The omicron variant, specifically XBB.1.5, accounted for nearly 40% of COVID-19 cases in the U.S. in early June. However, its prevalence is gradually declining. To ensure timely delivery of the new shots, Pfizer, Moderna, and Novavax had already begun developing versions of their vaccines targeting XBB.1.5 even before the FDA’s official announcement. Preliminary data presented by these companies indicates that their vaccines elicit strong immune responses against all XBB variants.
By selecting the same strain, the FDA has eliminated the need for the companies to redirect their efforts toward manufacturing shots for a different strain. This will prevent delays in the delivery timeline. Pfizer has announced that it will be able to deliver a vaccine targeting XBB.1.5 by July, while Moderna and Novavax have not provided specific timelines for their versions. Nevertheless, it is expected that all three companies will successfully deliver their updated vaccines on time.
According to Dr. Melinda Wharton from the National Center for Immunization and Respiratory Diseases, targeting XBB.1.5 seems to be the most feasible option without causing delays in availability. Looking ahead, the U.S. is planning to shift COVID-19 vaccine distribution to the private sector by fall. This means that manufacturers will sell their updated vaccines directly to healthcare providers instead of the government.
It should be noted that Johnson & Johnson, a once-leading vaccine developer, is no longer part of the equation due to reports of rare but serious blood-clotting side effects associated with their shots. For Pfizer and Moderna, the commercial market brings opportunities to tap into more distribution channels compared to government contracts. However, both companies anticipate a decline in COVID-19-related sales as the world emerges from the pandemic and reliance on vaccines and treatments decreases. Pfizer expects its COVID-19 shot revenue to drop from $37.8 billion in 2022 to $13.5 billion this year, while Moderna predicts at least $5 billion in revenue from its COVID vaccine, which was its sole product in 2022.
As for Novavax, the commercial market is crucial for its survival beyond 2023. The company, which faced regulatory and manufacturing delays, obtained U.S. approval for its COVID-19 vaccine under emergency use just last year. Now, with the FDA’s strain selection, Novavax has positioned itself as a viable competitor against industry giants like Pfizer and Moderna. The company aims to achieve sales of $1.06 billion to $1.24 billion this year, slightly lower than the $1.5 billion generated by its shot in the previous year.
Despite these optimistic prospects, the companies still face uncertainties regarding the willingness of Americans to receive the updated vaccines. Only about 17% of the U.S. population, equivalent to around 56 million people, have received Pfizer and Moderna’s latest boosters since their approval in September, according to the CDC.
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