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August 17, 2020 /--- -- In a new study, researchers from Pfizer reported that a candidate vaccine based on cutting-edge RNA gene technology showed signs of strong resistance to the new coronavirus SARS-CoV-2 in an early clinical trial.
the candidate vaccine, called BNT162b1, triggered a strong immune response in the participants, which increased with dose levels, and a second dose increased the immune response.
results were published online August 12, 2020 in the journal Nature under the title "Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults".
images from CC0 Public Domain.
the early Phase 1/2 clinical trial was led by Dr Judith Absalon of pharmaceutical giant Pfizer.
BNT162b1 is based on messenger RNA (mRNA), which helps initiate the body's immune response when the body encounters a new coronavirus, according to her team.
RNA-focused vaccine development strategy "is generally considered safe and has facilitated the rapid development of vaccines against SARS-CoV-2," the study said.
the new clinical trial involved 45 healthy adults between the ages of 18 and 55.
half were randomly selected to inject low, medium and high doses of BNT162b1, while the other half were given a "fake vaccine" placebo.
clinical result: "This candidate vaccine causes a strong immune response in the participants" and the larger the dose, the stronger the immune response.
a second dose of the "enhanced" vaccine also boosts the immune system's response.
in fact, among the participants who received this candidate vaccine, "the levels of the antibody in the coronavirus were 1.9 to 4.6 times higher than in those recovering from SARS-CoV-2 infections."
, however, the Absalon team stressed the need for Phase III clinical trials ---testing the candidate vaccine in a larger population--- to verify the safety of the candidate vaccine, the strength and duration of the protective effects it provides.
According to the study, the vaccine candidates were "generally well-to-do," although some participants did experience temporary side effects, such as soreness, fatigue, headache, fever and sleep problems at the injection site.
these side effects tend to disappear within a week of vaccination, the researchers said.
Amesh Adalja is an infectious disease specialist and a senior fellow at the Johns Hopkins University Center for Health and Safety.
this study provides additional evidence that the mRNA candidate COVID vaccine does induce naltivity and antibodies after two doses of injection," he said while reading the paper.
" Adalja notes that there are "many" COVID-19 candidates using RNA technology, suggesting that they can trigger a strong immune response in the body.
it remains to be seen what role these antibodies will play when vaccinated people are infected with wild viruses," Adalja said.
it's still an inference to understand how effective these vaccines are in the real world before we look at Phase 3 clinical data.
" (bioon.com) Reference: 1. Mark J. Mulligan et al. Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults. Nature, 2020, doi:10.1038/s41586-020-2639-4.2.Pfizer's COVID vaccine show 'robust' results in trial.