FDA Approves New COVID-19 mRNA Vaccine Formulas for 2023-2024

• A new round of COVID-19 boosters have been approved in alignment similar to the annual influenza season, reflecting the evolving transmissibility and infectiousness of SARS-CoV-2 variants.¹
• mRNA vaccines from Moderna and Pfizer will be updated to include a monovalent component corresponding to the circulating Omicron variant XBB.1.5.
• The US Food and Drug Administration (FDA) anticipates this strategy will become adopted annually, with updates to COVID-19 vaccines reflecting dominant variants of SARS-CoV-2.
• Children aged 6 months to 5 years old are eligible to receive up to 2 doses of the updated mRNA COVID-19 vaccines, based on their prior vaccination status.
• The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) will convene Tuesday to review vaccination recommendations reflective of the new formulary updates, as well as for specific subgroups including immunocompromised and/or older adults.

The US’ health care system appears to be adopting an endemic prevention strategy to COVID-19 in its post-pandemic era. The FDA announced a series of authorizations on Monday that re-introduces single-component mRNA vaccine doses from Pfizer and Moderna to the market that are designed to better address SARS-CoV-2 Omicron variant XBB 1.5., a virus that which one investigators previously described to HCPLive as an “evolutionary jump” from the past iterations of SARS-CoV-2.

According to the FDA on Monday, the new formulations of Pfizer’s BNT-162b2 (Corminaty) and Moderna’s mRNA-1273 (Spikevax) vaccines are designed to provide improved protection of severe outcome risks including deaths and hospitalizations due to this and other circulating variants of SARS-CoV-2.

Along with the approval of single-dose formulas for 2023 – 2024, the FDA additionally authorized the Moderna vaccine formula for emergency use in children aged 6 months to 11 years old, and to lower the eligibility for receipt of a single dose from 6 to 5 years old. Additionally, the Pfizer-BioNTech vaccine formula has been authorized for emergency use in children 6 months to 11 years old, as well as for certain immunocompromised children 6 months to 11 years old.

“The updated mRNA vaccines are manufactured using a similar process as previous formulations,” the FDA stated in the announcement. “In studies that have been recently conducted, the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5 and BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with prior versions of the vaccines against corresponding prior variants against which they had been developed to provide protection. This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants.”

The CDC ACIP will meet on Tuesday to consider recommendation of the new vaccine formulas for populations with varying COVID-19 susceptibility and risk. Hospitalizations and deaths due to COVID-19 have increased 15.7% and 10.5% in the past week of most recently available national data, per the CDC.²

Pfizer chairman and chief executive officer Albert Bourla acknowledged the recent climb in COVID-19 cases in the US when emphasizing the value of the newly available vaccine formulas reflective of more dominant variants of SARS-CoV-2.

“We expect this season’s vaccine to be available in the coming days, pending recommendation from public health authorities, so people can ask their doctor about receiving their COVID-19 vaccine during the same appointment as their annual flu shot, saving time now and helping to prevent severe disease later when respiratory viruses are at their peak,” Bourla said in a statement.³

Stephane Bancel, chief executive officer of Moderna, echoed Bourla’s sentiment on the timing of the new formulas—not only due to the impending flu season, but for risk of respiratory syncytial virus (RSV) as well.

“COVID-19 remains a leading cause of death in the U.S. and poses a significant threat to vulnerable populations, particularly as we enter peak respiratory virus season,” Bancel said in a statement. “As the primary circulating strain continues to evolve, updated vaccines will be critical to protecting the population this season.”⁴

In a recent interview with HCPLive, Donald J. Alcendor, PhD, associate professor, department of pathology microbiology and immunology, division of infectious diseases, Vanderbilt University Medical Center, and HCPLive Editorial Advisory Board member, forecasted the growing need for annual COVID-19 vaccination formulas despite the conclusion to the national public health emergency in May this year.

“We’re in a position where we’re trying to chase this virus with boosters—and we’re losing in a lot of ways, because it stays ahead,” Alcendor said. “Even if you’ve been boosted, it’s been months since you’ve been boosted and we know these vaccines provide you with 4-6 months of protection. We know that protection wanes over time, and the virus continues to change.”⁵

Though Alcendor expressed frustration with the lack of financial assistance anticipated due to the marketed vaccine formulas—combined with the significantly reduced federal funding toward COVID-19 preventive measures—that will significantly impact some of the highest-risk populations in the US, he did stress the need for more updated and refined protection against circulating viruses including COVID-19 in this upcoming fall and winter seasons.

“We might have to be content—and I think it’s unacceptable at this point—with losing 40,000 - 60,000 people every year due to COVID,” Alcendor said. “And when you add that to RSV and influenza…we could be losing in excess of 120,000 people as part of a baseline mortality in America (annually).”

References

1. ^{FDA. FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants. Press release. Published September 11, 2023. https://www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna-covid-19-vaccines-better-protect-against-currently-circulating}
2. ^{Centers for Disease Control and Prevention. COVID Data Tracker. Last updated September 7, 2023. Accessed September 11, 2023. https://covid.cdc.gov/covid-data-tracker/#datatracker-home}
3. ^{Pfizer. Pfizer and BioNTech Receive U.S. FDA Approval for 2023-2024 COVID-19 Vaccine. Press release. Published September 11, 2023. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-us-fda-approval-2023-2024-covid}
4. ^{Moderna. Moderna Receives U.S. FDA Approval for Updated Covid-19 Vaccine. Press release. Published September 11, 2023. https://investors.modernatx.com/news/news-details/2023/Moderna-Receives-U.S.-FDA-Approval-for-Updated-COVID-19-Vaccine/default.aspx}
5. ^{Kunzmann K. COVID-19 Cases Are Climbing, with Donald Alcendor, PhD. HCPLive. Published September 1, 2023. https://www.hcplive.com/view/covid-19-cases-climbing-donald-alcendor-phd}