Infectious disease
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.
Axcella announced it is initiating a new clinical program to study AXA1125 in patients with Long Covid. The trial will be conducted at the Oxford Centre for Clinical Magnetic Resonance Research.
If the panel votes in favor of the vaccine for children, it will move to the U.S. CDC. If both agencies support the data, children this age would be likely to receive their first shots in early November.
Initial results showed a strong neutralizing antibody response and favorable safety profile among the participants.
Some fear potential side effects, and more just aren’t sure about the quality and risks associated with a vaccine developed in an unprecedented nine months.
The U.S. Food and Drug Administration posted analyses of the Pfizer-BioNTech COVID-19 vaccine in children ages 5 to 11 years old ahead of Tuesday’s vaccines advisory committee meeting.
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