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Oct 8, 2020 /--- people need an effective vaccine to stop the spread of the SARS-CoV-2 pandemic.
recently, researchers from Pfizer reported on the safety, toerability and antibody response data from an ongoing placebo-controlled, observer-blind 1/2 phase 2019 coronavirus disease (COVID-19) vaccine (known as BNT162b1) clinical trial (Nature, 2020, doi:10.1038/s41586-020-2639-4).
the 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 results show that the 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, the levels of SARS-CoV-2 and antibodies were 1.9 to 4.6 times higher among participants who received the vaccine candidate than those recovering from SARS-CoV-2 infection.
, however, the researchers 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.
picture source: .
BNT162b1 is a nucleotide-modified messenger RNA (mRNA) made of lipid nanoparticles (LNP), a mRNA-encoded subject binding domain (RBD) of SARS-CoV-2 hedgehog protein (S protein).
in a new study, the researchers conducted the second phase 1/2 clinical trial of the non-randomized open-label BNT162b1 vaccine among healthy adults ages 18 to 55, evaluating the antibody response and T-cell response of these participants after being vaccinated against BNT162b1.
results were published online September 30, 2020 in the journal Nature under the title "COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T-cell responses".
two doses of BNT162b1 of 1 to 50 μg caused a strong CD4-plus T-cell response, CD8-plus T-cell response, and a strong antibody response, and the concentration of IgG antibodies in combination with RBD was significantly higher than the concentration of antibodies in the recovery serum sample plate (convalescent sample panel) in patients with COVID-19.
of serum SARS-CoV-2 on the 43rd day of the study was 0.7 times (1 sg) to 3.5 times (50 sg) of the recovery serum sample plate in patients with COVID-19.
a prosthetic virus with different variants of SARS-CoV-2 prickly proteins was widely mediated in immune serums.
most of the participants had a T-cell immune response that was biased toward type 1 auxiliary T-cells (TH1), and their RBD-specific CD8-plus T-cells and CD4-plus-T cells expanded.
a large proportion of RBD-specific CD8-plus T cells and CD4-plus T cells produce interferon γ (IFN-γ).
strong RBD-specific antibodies, T-cells, and beneficial cytokine reactions induced by the BNT162b1 mRNA vaccine suggest that the vaccine's many beneficial mechanisms have the potential to prevent COVID-19.
(bioon.com) Reference: Ugur Sahin et al. COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T-cell responses. Nature, 2020, doi:10.1038/s41586-020-2814-7.