The Food and Drug Administration (FDA) is holding a meeting with the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday to discuss simplifying the COVID vaccine schedule. They are wanting to allow individuals to get the current booster available, regardless of how many they have received previously.
In a briefing document released on Monday, the FDA outlines its planned discussion. They admit that the “COVID-19 pandemic continues to present an extraordinary challenge to global health, complicated by rapidly evolving epidemiology.”
The VRBPAC met twice last year — April 6 and June 28 — to discuss the framework around updated COVID vaccines and boosters. This was essential due to all the various strains and variants emerging and still coming to light. On June 30, 2022, the FDA advised COVID-19 vaccine manufacturers on developing a bivalent vaccine.
The Four Approved FDA Monovalent COVID Vaccines
In the United States, the four authorized or approved monovalent COVID-19 vaccines are:
- Spikevax (COVID-19 Vaccine, mRNA), referred to as Moderna COVID-19 Vaccine under Emergency Use Authorization (EUA). ModernaTX manufactures this medication.
- Comirnaty (COVID-19 Vaccine, mRNA), referred to as Pfizer-BioNTech COVID-19 Vaccine under the EUA. Pfizer Inc. and BioNTech collectively make this medication.
- The Janssen COVID-19 Vaccine. Which is a nonreplicating adenovirus type 26-vectored vaccine encoding the S protein of the SARS-CoV-2 original strain. Janssen Biotech, Inc. manufactures this version of the vaccine.
- The Novavax COVID-19 Vaccine, Adjuvanted. It has recombinant S protein of the SARS-CoV-2 original strain and Matrix-M adjuvant. Novavax, Inc. created this vaccine.
There have been multiple studies that say the current bivalent mRNA boosters available have “neutralizing antibody responses,” according to the FDA. Additionally, researchers have “clinical effectiveness data” from several sources on the boosters. However, the sources have “limitations specific to each of these effectiveness assessments, these data provide preliminary real-world evidence that [supports] the use of the bivalent mRNA boosters.”
The data shows that older individuals benefit the most from preventative death scenarios as they are the most susceptible. The new booster prevents major symptoms that are attributed to COVID.
“Given the evolution of SARS-CoV-2 variants and associated changes in the epidemiology, susceptibility to reinfection, and waning of vaccine-induced immunity, barring [the] development of a significantly improved vaccine, periodic future updates to the S protein sequence(s) contained or encoded in COVID-19 vaccines and revaccination will likely be needed to induce and maintain vaccine effectiveness (VE), respectively. Therefore, an approach to both simplifying the immunization schedule, and periodically updating the composition of COVID-19 vaccines as needed, requires consideration,” added the FDA document.
Treat It Like the Flu
Many are hopeful that one day soon the world will be able to put COVID-19 in the “rearview mirror” and treat it like the common flu. Until then it is wise to continue safety measures to keep family, friends, and the community healthy. Some places are still offering incentives to individuals who have yet to receive the COVID-19 vaccine and/or booster. Individuals 6 months and older are able to receive the COVID-19 vaccine.
By Sheena Robertson
FDA Briefing Document: Future Vaccination Regimens Addressing COVID-19
NBC News: FDA proposes simplifying the Covid vaccine schedule, making it similar to the flu shot