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The Moderna COVID‑19 vaccine, sold under the brand name Spikevax, is a COVID-19 vaccine developed by the American company Moderna, the United States National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA).
While these factors can’t be ruled out, the consistency of the relationship between COVID-19 vaccines and lupus flares indicates that some low percentage of patients will experience an increase ...
The Moderna COVID-19 vaccine, also known as Spikevax, [318] is an mRNA vaccine [319] produced by the American company Moderna, the U.S. National Institute of Allergy and Infectious Diseases, the U.S. Biomedical Advanced Research and Development Authority, and the Coalition for Epidemic Preparedness Innovations.
In contrast to other mRNA COVID-19 vaccines, such as those by Pfizer-BioNTech and Moderna, this vaccine primarily targets the SARS-CoV-2 receptor-binding domain of the spike protein, rather than the entire spike protein. [4] It is approved for Phase III trials in China, [5] Mexico, [6] Indonesia, [7] and Nepal. [8]
ATC code J07 Vaccines is a therapeutic subgroup of the Anatomical Therapeutic Chemical Classification System, a system of alphanumeric codes developed by the World Health Organization (WHO) for the classification of drugs and other medical products. [1] [2] [3] Subgroup J07 is part of the anatomical group J Antiinfectives for systemic use. [4]
During the COVID-19 pandemic, Samsung Biologics partnered with Moderna for fill-finish, packaging and labeling of its mRNA vaccine, Spikevax. [21] [22] The company was also contracted to manufacture Eli Lilly's COVID-19 antibody therapeutic [23] and AstraZeneca's long-acting antibody therapeutic as part of a larger multi-product deal. [24]
In March 2020, the Food and Drug Administration approved clinical trials for the Moderna COVID‑19 vaccine candidate, and in December, the vaccine, mRNA-1273, was issued an emergency use authorization in the United States. [35] [36] In 2022, it gained FDA approval both for the monovalent vaccine, Spikevax, and a bivalent booster. [37]
The purpose of this study is to determine if the investigational COVID-19 vaccines are safe and can stimulate and broaden the immune response against the different COVID-19 variants that cause COVID-19 when given as a single booster injection in participants who have previously been vaccinated with a full course of an authorized COVID-19 vaccine.