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FDA Panel Endorses Simplification of COVID-19 Vaccine Strategy

On Jan 26, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously recommended moving toward a uniform vaccine strain composition for all COVID-19 vaccine doses (whether as primary series or booster).

The FDA intends to harmonize the strain composition of all COVID-19 vaccines, despite the vaccine being mRNA-based developed by Pfizer PFE/BioNTech BNTX and Moderna MRNA or protein-based vaccine developed by Novavax NVAX. It also recommended simplifying the immunization schedule for the administration of these vaccines.

The VRBPAC suggested that, based on available immunogenicity and effectiveness data, the bivalent vaccines fulfill this criterion. Data from multiple studies conducted by vaccine developers have suggested that bivalent vaccines improve antibody response compared with monovalent vaccines.

In the United States, the currently authorized bivalent vaccines contain an mRNA encoding the spike protein in the original/monovalent vaccine and an mRNA encoding the spike protein common in the Omicron BA.4 and BA.5 variants.

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The approved/authorized COVID-19 vaccines have different compositions and immunization schedules. This has led to multiple complexities regarding using the vaccine, thereby leading to complications in vaccine administration and uptake. For instance, the vaccines developed by Pfizer/BioNTech, Modernaand Novavax must be administered as two-dose series for the primary regimen, while J&J’s COVID vaccine only requires a single dose administration. The vaccines developed by Moderna, Novavax and Pfizer/BioNTech also have different dosing regimens for different age groups. Hence, there is a need to simplify the current COVID-19 vaccination regimen.

The committee believes this simplification could be achieved by designing an age- and risk-based immunization schedule. The VRBPAC members suggested administering a single dose to the general population who have already been immunized and additional doses to individuals who are either at high risk or are yet to be immunized.

While Pfizer/BioNTech and Moderna already have authorized bivalent vaccines for use in individuals aged six months and older, Novavax has stated that it requires six months to produce a new version of its protein-based COVID-19 vaccine designed to match circulating COVID-19 variants.

In addition, the VRBPAC also considered proposals to adopt an annual COVID vaccination schedule similar to that adopted in the case of influenza vaccines. However, the FDA committee could not arrive at a decision due to a lack of available data supporting this proposal. The VRBPAC plans to meet later this year to discuss the same.

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