The old military maxim of "hurry up and wait" may apply to the promising new COVID-19 vaccine the Army is developing.
Word that scientists at the Walter Reed Army Institute of Research have developed a vaccine that offers promising early results against all COVID-19 strains got out Wednesday, sparking fresh optimism amid the raging omicron variant. But experts caution further clinical research is needed to prove its efficacy in humans and that America may be a long way from new shots.
EARLY SIGNS INDICATE OMICRON MAY POSE LESS OF THREAT
“Scientists from WRAIR remain encouraged by the early data from preclinical studies and testing against the variants is ongoing in a neutralization assay in the laboratory,” a WRAIR press release provided to the Washington Examiner read. “Final phase 1 study results will be made public once the analysis is complete and published in a peer-reviewed journal.”
Nevertheless, the early indications are promising.
Walter Reed scientists say the Spike Ferritin Nanoparticle vaccine has already shown promise in studies with nonhuman primates. Not only did two doses of the vaccine given 28 days apart protect against the strain of virus that was first sequenced at the outset of the pandemic in 2020, but it also produced antibody responses against the alpha, beta, gamma, and delta variants of COVID-19. The vaccine has not been tested against the omicron variant.
The WRAIR Infectious Diseases Branch responsible for the vaccine recently wrapped up Phase 1 trials in humans that began in April 2021. Results from early trials in humans are imminent, but the vaccine itself is farther off.
While the army has concluded early Phase 1 human trials, the results of which are due to be out later this month, considerably more robust clinical trial data will be required before the researchers can get regulatory authorization from the federal government.
“We need to evaluate it in the real-world setting and try to understand how does the vaccine perform in much larger numbers of individuals who have already been vaccinated with something else initially … or already been sick,” said Dr. Kayvon Modjarrad, the director of the Emerging Infectious Diseases Branch and a co-inventor of the vaccine.
The two-dose vaccine is technically different from the two mRNA vaccines currently available in the United States from Pfizer-BioNTech and Moderna. The vaccine uses a platform called a self-assembling protein nanoparticle, a ball-shaped molecule with 24 faces all over it so that it resembles a soccer ball. Scientists can place pieces of spike proteins from various coronavirus strains on each face of the soccer ball, triggering an immune response to many strains at once rather than relying on multiple iterations of the mRNA vaccine.
“Researchers hypothesize that presenting multiple copies of Spike in an ordered fashion may be the key to inducing a potent and broad immune response,” the WRAIR said. “The platform also has advantages as a potentially global vaccine because it remains stable at a wide range of temperatures.”
OMICRON OVERTAKES DELTA AS DOMINANT CORONAVIRUS STRAIN IN US
The vaccine remains in early development, but it is welcome news as the U.S. enters into a fifth wave of COVID-19 spurred by the new and highly contagious omicron variant. Omicron has supplanted the delta variant in the U.S. about a month after its discovery in Botswana last month.
The rapid rise in cases due to omicron has sparked anxiety over the magnitude of protection afforded by the mRNA vaccines against the omicron variant, as well as unknown future variants. Despite growing evidence that the protection from the mRNA vaccines against omicron has weakened, the Biden administration does not yet believe an omicron-specific vaccine is necessary.