As the fall respiratory illness season looms ahead, the FDA has granted regulatory approval for two updated Covid-19 vaccines that leverage messenger RNA (mRNA) technology. This significant development paves the way for the availability of these new shots in the near future.
Previously approved for use in adults, Covid-19 vaccines developed by Pfizer and BioNTech, along with Moderna, have received an extension of approval to include their updated versions. While emergency use authorizations for infants aged six months and older, as well as children up to age 17, already existed, the FDA’s decision now expands these authorizations to cover the updated vaccines.
It is worth noting that Novavax’s protein-based vaccine, the only non mRNA Covid-19 vaccine available in the U.S., was not included in the FDA’s recent announcement. The company has reported that the updated version of its vaccine is currently under FDA review for emergency use authorization in individuals aged 12 and older.
One of the central advantages of mRNA vaccine technology is their capacity to address multiple variants with a single shot. With the recent round of booster shots designed to tackle the original strain and the Omicron variant, the updated vaccines approved and authorized on Monday are now monovalent shots. These versions of the vaccine carry a single component specifically tailored to combat the omicron variant XBB.1.5.
The FDA’s decision to approve monovalent vaccines for XBB.1.5 was guided by available evidence and the recommendation of an advisory committee in June. However, the current data from the Centers for Disease Control and Prevention (CDC) points to a different omicron subvariant, EG.5, accounting for 21.5% of total cases, making it the most prevalent variant. Recent studies conducted by BioNTech and Moderna indicate that the updated shots exhibit neutralization against EG.5 and another circulating variant, BA.2.86. In light of this, the FDA has expressed confidence that “the vaccines are a good match for protecting against the currently circulating Covid-19 variants.” The FDA anticipates that Covid-19 vaccines will follow an annual update schedule, aligning with the established practices of the biopharmaceutical industry and the public’s familiarity with the seasonal influenza vaccine.
With its regulatory actions, the FDA has also introduced some changes to dosing schedules. Initially, both mRNA vaccines required a two-shot series administered weeks apart for individuals aged 12 and older. The approval for the updated vaccines has now streamlined the dosing schedule to a single shot for those aged 12 and older. Additionally, the Moderna vaccine’s eligibility age for a single dose has been lowered from 6 to 5 years old. Certain immunocompromised children aged 6 months to 11 years old may also receive additional doses of both mRNA vaccines.
While the regulatory approval sets the stage for wider use of these updated vaccines, their administration still awaits the recommendation of the Advisory Committee on Immunization Practices (ACIP), which serves as a consultative body to the CDC. The committee, scheduled to convene on Tuesday, will deliberate on key topics, including vaccine recipients, particularly in specific groups like older adults and individuals with weaker immune systems. Novavax will present the latest data on its vaccine during the meeting, indicating the company’s involvement. Following the committee’s vote, the recommendations will be forwarded to CDC Director Mandy Cohen, who must issue the final sign-off on the vaccines. Once the CDC provides its recommendation, Moderna and Pfizer have confirmed that the updated versions of their respective Covid-19 vaccines could soon be available in pharmacies and other healthcare settings.
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