Infectious disease
The FDA informed Moderna that it would need more time to evaluate the company’s Emergency Use Authorization (EUA) submission for its COVID-19 vaccine for adolescents 12 to 17 years of age.
As the world marks a grim milestone of 5 million COVID-19 deaths, public health officials are keeping a close watch on a substrain of the Delta variant.
The U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine for children ages 5 to 11.
Yet another busy week for clinical trial news. Here’s a look.
In the face of Delta, the actual efficacy of the vaccines has come into question, while global cases and deaths from COVID-19 increased for the first time in two months, primarily in Europe.
Emergent BioSolutions, the manufacturer responsible for the doses in question, is reportedly just waiting for the U.S. FDA’s signal to start shipping the vaccines.
Researchers believe the drug PUL-042 may work against COVID-19 and other respiratory infections, including all existing and future variants of SARS-CoV-2.
Pennsylvania-based Ocugen has submitted an Investigational New Drug (IND) to the FDA to run a Phase III trial of India’s BBV152 (Covaxin), a vaccine against COVID-19.
In documents prepared for the meeting, the vaccine demonstrated 90.7% effectiveness for the children in this age group.
BioNTech plans to increase its manufacturing capacity in Africa over time through the supplementation of new manufacturing lines and construction of additional manufacturing sites.
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