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J Neurosurg Anesthesiol ; 34(1): 101-106, 2022 Jan 01.
Article in English | MEDLINE | ID: covidwho-1555739


Dr. Emanuel Papper, the founding chairman of the Department of Anesthesiology at Columbia University, was passionate about research, training, and innovation. At an event held in his honor on March 20, 2021, experts came together to discuss the coronavirus disease 2019 (COVID-19) pandemic and its myriad challenges. Dr. Wellington Sun, MD, of Vaxcellerant LLC, an expert in infectious disease and vaccine research and development, presented a "Primer of COVID-19 vaccines for the perioperative physician." Operation Warp Speed was successful in producing multiple efficacious and safe vaccines for use in the United States and around the globe. Their development and authorization for emergency use occurred in an unprecedented timespan of <1 year. Technology such as V-SAFE has helped to accrue extensive postdevelopment safety data that will be utilized for licensure of these vaccines. The COVID-19 vaccine success is tempered by the knowledge that severe acute respiratory syndrome coronavirus 2 continues its natural selection of variants that threaten the efficacy of vaccines. Important questions remain regarding the future of the COVID-19 pandemic, severe acute respiratory syndrome coronavirus 2 variants, successful vaccination strategies, and preparedness for future pandemics.

COVID-19 , Physicians , COVID-19 Vaccines , Humans , Pandemics , SARS-CoV-2
N Engl J Med ; 383(20): 1920-1931, 2020 11 12.
Article in English | MEDLINE | ID: covidwho-971502


BACKGROUND: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in late 2019 and spread globally, prompting an international effort to accelerate development of a vaccine. The candidate vaccine mRNA-1273 encodes the stabilized prefusion SARS-CoV-2 spike protein. METHODS: We conducted a phase 1, dose-escalation, open-label trial including 45 healthy adults, 18 to 55 years of age, who received two vaccinations, 28 days apart, with mRNA-1273 in a dose of 25 µg, 100 µg, or 250 µg. There were 15 participants in each dose group. RESULTS: After the first vaccination, antibody responses were higher with higher dose (day 29 enzyme-linked immunosorbent assay anti-S-2P antibody geometric mean titer [GMT], 40,227 in the 25-µg group, 109,209 in the 100-µg group, and 213,526 in the 250-µg group). After the second vaccination, the titers increased (day 57 GMT, 299,751, 782,719, and 1,192,154, respectively). After the second vaccination, serum-neutralizing activity was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum specimens. Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-µg dose group reported one or more severe adverse events. CONCLUSIONS: The mRNA-1273 vaccine induced anti-SARS-CoV-2 immune responses in all participants, and no trial-limiting safety concerns were identified. These findings support further development of this vaccine. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 number, NCT04283461).

Coronavirus Infections/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , RNA, Messenger/immunology , Spike Glycoprotein, Coronavirus/immunology , Viral Vaccines/therapeutic use , Adult , Antibodies, Neutralizing/blood , Antibodies, Viral/blood , Antibody Formation , Betacoronavirus , COVID-19 , COVID-19 Vaccines , Female , Humans , Immunization, Secondary , Male , SARS-CoV-2 , T-Lymphocytes/immunology , Viral Vaccines/adverse effects , Young Adult