Dr. Cynthia Brown, an IU doctor who led an AstraZeneca COVID-19 vaccine study site at the IU School of Medicine, said in a Tuesday press conference the AstraZeneca vaccine’s storage requirements could make the vaccine distinctively beneficial to the United States.
IU announced last year it would seek trial participants for the vaccination research site, which was part of AstraZeneca’s plan to select more than 30,000 Americans for its vaccine trial.
IU’s site in the research study was one of the top 15 enrolling sites across the country with more than 500 people participating in the study, Brown said.
“As the largest medical school in the country, taking on something like this was really important to us,” she said. “I think this is the largest and fastest enrolling trial we've ever done here.”
AstraZeneca has not yet joined Pfizer, Moderna and Johnson & Johnson in receiving emergency use authorization for their vaccine in the United States. AstraZeneca’s vaccine, which can be stored and handled at normal refrigerated conditions, has been released in a few European countries. Pfizer’s vaccine has a preferred storage temperature between -76 and -112 degrees.
Canada suspended the use of the AstraZeneca vaccine for those 55 and under after concerns it may be linked to blood clots. A health official in Canada said blood clots affect one in every 100,000 people, mostly in women under 55. The official also said that the fatality rate among those who develop clots is 40%. Brown said she believes the vaccine is safe.
“I think if you do not have a history of a clotting disorder in the past, I would not have a hesitancy to take it myself,” she said.
Two European teams of scientists recently said they've identified the cause of rare but serious blood clots in those who took the AstraZeneca vaccine. That could mean those blood clots could be easily treated in the future.
Earlier this month, the company was forced to revise the vaccine’s reported efficacy to 76% rather than the originally reported 79%, but maintained that it protects against severe disease and hospitalization.
Brown said the vaccine continues to show a decline in hospitalizations and has similar success as the Pfizer vaccine.
NBC reported earlier this month that AstraZeneca is hoping to submit its vaccine for FDA approval by early April. If approved, it would become the fourth COVID-19 vaccine available in the United States.
One of the recruiter’s priorities for the study was for the makeup of the study’s participants to come as close to matching Indiana’s demographic as possible, Brown said. The study had a higher share of Asian, Hispanic and elderly populations compared to the rest of the state, according to a press release. However, the study failed to match the proportion of Black Americans living in Indiana.
“We're really proud to be able to recruit strongly in our Latinx and [aged] over 65 communities, but it also showed us that we still have continuing work to do among our Black population in Indiana to ensure that we can enroll those individuals in trials,” Brown said.
