ImportanceThe COVID-19 pandemic has caused millions of infections and deaths and resulted in unprecedented international public health social and economic crises. As SARS-CoV-2 spread across the globe and its impact became evident, the development of safe and effective vaccines became a priority. Outlining the processes used to establish and support the conduct of the phase 3 randomized clinical trials that led to the rapid emergency use authorization and approval of several COVID-19 vaccines is of major significance for current and future pandemic response efforts.ObservationsTo support the rapid development of vaccines for the US population and the rest of the world, the National Institute of Allergy and Infectious Diseases established the COVID-19 Prevention Network (CoVPN) to assist in the coordination and implementation of phase 3 efficacy trials for COVID-19 vaccine candidates and monoclonal antibodies. By bringing together multiple networks, CoVPN was able to draw on existing clinical and laboratory infrastructure, community partnerships, and research expertise to quickly pivot clinical trial sites to conduct COVID-19 vaccine trials as soon as the investigational products were ready for phase 3 testing. The mission of CoVPN was to operationalize phase 3 vaccine trials using harmonized protocols, laboratory assays, and a single data and safety monitoring board to oversee the various studies. These trials, while staggered in time of initiation, overlapped in time and course of conduct and ultimately led to the successful completion of multiple studies and US Food and Drug Administration–licensed or –authorized vaccines, the first of which was available to the public less than 1 year from the discovery of the virus.Conclusions and RelevanceThis Special Communication describes the design, geographic distribution, and underlying principles of conduct of these efficacy trials and summarizes data from 136 382 prospectively followed-up participants, including more than 2500 with documented COVID-19. These successful efforts can be replicated for other important research initiatives and point to the importance of investments in clinical trial infrastructure integral to pandemic preparedness.
Erden des Gaflolinits (]]rbinerde and Yttererde). Bekanntlieh hat 0. P opp *) auf Grund seiner Untersuehung der Gadoliniterden die l~einung ausgesprochen, dass Erbin-und Terbinerde nicht existiren, uad dass Alles, was man fiir diese Erden gehalten hat, eine unreine, mit Ceritoxyden gemischte Yttererde gewesen sei. D e l a f o n t a i n e * *) kam zu entgegengesetzten Resultaten. Er h/ilt die Existenz beider Erden aufrecht. Er sehied das Erbin durch sehr h~ufig wiederholte fi'aetionirte F~llung mit zweifaeh-oxalsaurem Kali und Reinigung des durch Gliihen erhaltenen Oxydgemenges ab, welches naeh seiner Angabe Erbinoxyd in gr6sster, Terbinoxyd in ge-ringere1.-, ¥ttererde in geringster Menge enthielt. Die salpetersaure L6sung des Gemenges, mit schwefelsaurem Kali heiss ges~ttigt, scheidet schwefelsaures Erbinoxydkali aus, welches zwar in heissem Wasser, aber nicht in einer ges/~ttigten L6sung yon schwefelsaurem Kali 16slich ist. Naeh Abscheidung desselben l~sst sieh naeh dem Verf. Terbinund "Yttererde auf Grund der Thatsache trennen, dass das oxalsaure Terbinoxydkali in verdilnnter Schwefelsi~ure sehwerer 16slich ist als das oxalsaure Yttererdekali ***). Der Terbinerde schreibt D e 1 a f o n t ai n e ein eigenthiimliches Absorptionsspeetrum zu, dessert Hauptstreifen mit zwei Didymstreifen zusammenfallen~ aber bei gleicher Concentration der LSsungen weniger breit sind als diese. B a h r und B u n s e n t) haben die Gadoliniterden einer neuen und sehr eingehenden Untersuehung unterworfen, aus weleher hervorgeht, dass z~war die Erbinerde als Oxyd eines besonderen Elementes, aber nicht die Terbinerde existirt. Dieselben fanden im Gadolinit die Kieselsiiure (22,61 Prec.
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