U.S. Food and Drug Administration

Dec

2020

“20-million Americans could be vaccinated this year”

THE U.S. Food and Drug Administration (FDA) expects to move quickly after a December 10 review of the coronavirus vaccine developed by Pfizer and 20 million Americans could be vaccinated this year, its commissioner has revealed. FDA Commissioner Stephen Hahn declined to give a specific timeline of how long approval of the vaccine developed by Pfizer and BioNTech would take but said that he hoped there would be a decision by the regulator in December. As soon as the FDA approves a vaccine, "I will be first in line and I will encourage my family to take this vaccine," Hahn…

Dec

2020

By The African Mirror

Novavax sees start of U.S. COVID-19 vaccine trial in coming weeks after second delay

COVID-19

VACCINE maker Novavax Inc has pushed back the start of a U.S.-based, late-stage trial for its experimental COVID-19 vaccine and now expects it to begin in the coming weeks instead of November, the company has announced. It is the second time that Novavax, which already has a late-stage UK trial underway, has rescheduled the Phase 3 trial after first flagging an October start, hampered by issues in scaling up its manufacturing. Shares of the U.S.-based company, which lags behind larger rivals Pfizer Inc and Moderna Inc in their COVID-19 vaccine development timelines, fell 6% on the latest delay. Novavax plans…

Nov

2020

By The African Mirror

AstraZeneca aims to bring non-U.S. vaccine data before the FDA

COVID-19

ASTRAZENECA will start discussing emergency approval of its experimental COVID-19 vaccine with U.S. regulators once it has good trial data from Britain, South Africa and Brazil, as it has no indication the watchdog would favour U.S. data. If and when AstraZeneca reaches the first statistically reliable efficacy and safety results from those trials, based on more than 25,000 volunteers in total, it would present them to the U.S. Food and Drug Administration (FDA) even though any read-out from an ongoing U.S. trial will be months later. "If you hit those thresholds we are going to have a conversation with them,"…