WXXI AM News

AstraZeneca vaccine deemed safe, waiting FDA approval

Mar 22, 2021

Credit Lance McCord/Flickr / wnyc.org

UPDATE: A safety board overseeing AstraZeneca's COVID-19 vaccine trial is raising concerns about the company's data. In an unusual post-midnight statement released on March 23, the National Institute of Allergy and Infectious Diseases said the Data Safety and Monitoring Board, which monitors the trial, is concerned "outdated information" may have been included in the trial results.  

----

A clinical trial confirmed that the new AstraZeneca two-dose vaccine is safe and highly effective although the National Institute of Allergy and Infectious Diseases said the Data Safety and Monitoring Board, which monitors the trial, is concerned "outdated information" may have been included in the trial results.  .

The University of Rochester Medical Center was part of the late-stage trial, which included over 32,000 volunteers in 88 sites across the United States.

The released results showed that the vaccine is 100% effective at preventing severe COVID-19 ailments like hospitalization and death, and almost 80% effective at preventing milder symptoms.

Dr. Angela Branche, who helped lead the local clinical trial, said the vaccine is very scalable, which is important as different strains appear. 

“As the virus changes and mutates, the shape and the character of the pandemic has changed,” said Branche. “With the emergence of these new variants, it’s always been about doing what we can to get as many people vaccinated as possible as quickly as possible.”

Dr. Ann Falsey, who also helped lead the local clinical trial, said the results gives her confidence that people who are unsure about the vaccine choices now, may choose the AstraZeneca vaccine. 

“There are different groups of people who may be hesitant for an RNA vaccine, and may be actually more accepting of this type of vaccine, which is similar to the J & J (Johnson & Johnson) vaccine,” said Falsey.

A thorough review of the vaccine’s safety data was performed, and no recent issue of blood-clotting was found, according to Falsey.

The vaccine still needs FDA emergency use authorization; researchers anticipated achieving that status by mid-April, but now that may be in doubt with questionable data possibly part of the results.