New updates on vaccines in the United States! Recently, Johnson & Johnson (JNJ) announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking emergency use authorization for its experimental single-dose Janssen COVID-19 vaccine. If approved, JNJ will be the third COVID-19 vaccine to receive emergency use authorization in the U.S., following those developed by Pfizer-BioNTech and Moderna.
It is reported that the report submitted by Johnson & Johnson is based on the efficacy and safety data from comprehensive Phase III clinical trials, indicating that the single-dose investigational vaccine meets all primary and key secondary endpoints.
Johnson & Johnson stated that it is prepared to begin shipping the vaccine for emergency use once authorized, adding that it expects to supply 100 million doses to the U.S. in the first half of 2021.
The company also mentioned that it has submitted rolling applications to several health authorities outside the U.S. and stated that it will submit a conditional marketing authorization application to the European Medicines Agency in the coming weeks.
As we know, the social welfare and healthcare system in the United States is well-developed, and medical technology is quite advanced. The potential introduction of this third COVID-19 vaccine is undoubtedly a significant breakthrough.
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