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Approximately two-thirds of Americans have received at least one dose of a COVID-19 vaccine.
But COVID-19 cases remain elevated following the spread of a series of omicron sublineages, which pose a threat to those vaccinated and naturally infected with various lineages of the coronavirus.
A variety of companies are developing next-generation COVID-19 vaccines that could potentially optimize the strength and durability of immune protection compared to the first crop of vaccines.
Here, we round up notable COVID-19 vaccine candidates that, at least, could help pave the way for the fall 2022 booster drive.
BNT162b5
Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) are developing a bivalent COVID-19 vaccine candidate known as BNT162b5 based on the ancestral strain and a BA.1 Omicron variant. The vaccine has a modified spike protein design to optimize the immune response against various COVID-19 variants.
The BNT162b5 vaccine candidate is now in a Phase 2 trial.
The companies recently filed a submission with the European Medicines Agency (EMA) for an Omicron-adapted bivalent COVID-19 vaccine candidate. In addition, the companies announced that the vaccine candidate was based on the BA.1 sub-lineage of omicron. The companies are pursuing authorization for individuals 12 years old and up.
mRNA-1273.214
Moderna’s (Nasdaq:MRNA) bivalent vaccine mRNA-1273.214 is based on the original SARS-CoV-2 virus and the first omicron version. It outperformed the company’s original vaccine in a June 2022 analysis, offering significantly higher omicron neutralizing titers when administered as a fourth dose compared to its original vaccine, mRNA-1273. Moderna also noted that a fourth dose of mRNA-1273.214 yielded similar local reactogenicity to the second and third doses of mRNA-1273 vaccine. According to a presentation shared with FDA, a dose of mRNA-1273.214 bolstered protection against omicron BA.4/BA.5 one month after administration in recipients who had received three initial doses of mRNA-1273.
mRNA-1273.529
Moderna’s (Nasdaq:MRNA) omicron-based vaccine candidate mRNA-1273.529 is now the focus of a Phase 2 study. With the FDA, however, backing a bivalent booster vaccine design, mRNA-1273.529 is more likely to provide content to the study of mRNA-1273.214, a vaccine with a bivalent design targeting the first version of omicron and the original virus.
Sanofi-GSK next-generation COVID-19 booster
Based on the beta variant, the Sanofi-GSK COVID-19 booster candidate offered a significant boost in antibody titers against the omicron BA.1 lineage. The companies also noted that, in the independent COVIBOOST (VAT013) study, the booster candidate yielded a superior immune response than the first-generation Pfizer-BioNTech vaccine booster. The companies’ first-generation vaccine stalled in late 2020 after it failed to generate a sufficient immune response in recipients over 50.