AstraZeneca applies for FDA authorisation after study shows vaccine to be safe and effective

22 março 2021

The AstraZeneca vaccine, developed in collaboration with Oxford University, is ‘highly effective’ at preventing COVID-19 in all age groups says the company following a Phase III trial in the US, Chile and Peru.

The trial, run by Columbia University and the University of Rochester, across three countries enrolled over 32,000 volunteers and proved 79% effective at preventing symptomatic COVID-19 and 100% effective at preventing severe cases and deaths.

The trial recorded no safety issues regarding blood clots.

Approximately 20% of the trial volunteers were aged 65 or over and the vaccine, given as two doses four weeks apart, afforded them as much protection as younger people.

The results have been highly anticipated in the US and it is hoped they will clear the way for emergency use authorisation by the FDA following an application from AstraZeneca.

 

Lead investigator of the Oxford University trial of the vaccine, Prof Andrew Pollard said: "'These results are great news as they show the remarkable efficacy of the vaccine in a new population and are consistent with the results from Oxford-led trials.”

"We can expect strong impact against Covid-19 across all ages and for people of all different backgrounds from widespread use of the vaccine."

 

 

 

Autor: Tom Hayes