In this week’s meeting, FDA is expected to ask their advisory committee to consider changes to simplify the vaccination schedule and look at delivering it annually, much like an influenza vaccine.
The FDA has its first Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting for 2023, which is this Thursday. And in preparation for the meeting, the agency posted their agenda. In it, they are recommending some significant changes so they can simplify the immunization schedule, and periodically update the composition of COVID-19 vaccines as needed.
“Review of the totality of the available evidence on prior exposure to and vaccination against SARS-CoV-2 suggests that, moving forward, most individuals may only need to receive one dose of an approved or authorized COVID-19 vaccine to restore protective immunity for a period of time,” the FDA wrote in its agenda materials.
In the past, a primary series of 2 vaccines was administered followed by a booster dose given months later.
Now, they are going to ask the committee to consider an annual vaccine given much like the current influenza vaccines that are recommended each fall.
“FDA anticipates conducting an assessment of SARS-CoV-2 strains at least annually and to engage VRBPAC in about early June of each year regarding strain selection for the fall season," the authors of the FDA agenda wrote.
The FDA expects there to be exceptions. “Two doses of an approved or authorized COVID-19 vaccine may be needed to induce the expected protective immunity for those who have a low likelihood of prior exposure (the very young) or those who may not generate a protective immune response (older and immunocompromised individuals).”
The agency laid out the objectives of the VRBPAC meeting and for the committee to consider the following:
• Transitioning to a single vaccine composition for primary series and booster vaccination;
• Harmonizing the strain composition of all COVID-19 vaccines (mRNA, protein-based);
• Simplifying the immunization schedule for future vaccination campaigns to administer a two-dose series in certain young children, and in older adults and persons with compromised immunity, and only one dose in all other individuals;
• Establishing a process for vaccine strain selection recommendations, similar in many ways to that used for seasonal influenza vaccines, based on prevailing and predicted variants that would take place by June to allow for vaccine production by September 5.
• Convening a strain selection meeting at any time in between routine periodic strain selections to address a more pathogenic escape variant.
In addition, to the aforementioned items on the agenda, they are going to be discussing recent safety signal data and analysis on the Pfizer-BioNTech vaccine during the meeting.
When the meeting was announced last month, FDA alluded to the fact changes might be coming. “COVID-19 vaccines remain our best available protection against COVID-19, particularly the most devastating consequences of the disease, including hospitalization and death. Since the initial authorizations of these vaccines, we have learned that protection wanes over time, especially as the virus rapidly mutates and new variants and subvariants emerge,” Peter Marks, MD, PhD, director, Center for Biologics Evaluation and Research (CBER), FDA,said in the statement. “Therefore, it’s important to continue discussions about the optimal composition of COVID-19 vaccines for primary and booster vaccination, as well as the optimal interval for booster vaccination.”
The agenda for the VRBPAC meeting and other materials can be found here.