Why the AstraZeneca vaccine is delayed in the U.S. despite a widespread global rollout

Company has yet to submit data to FDA
Posted at 8:58 AM, Mar 08, 2021

SAN DIEGO (KGTV) -- There are now three authorized COVID-19 vaccines in the United States, but what about AstraZeneca?

The Oxford/AstraZeneca vaccine is currently in use in 60 countries, according to Our World in Data. This week, the company announced it is shipping doses to another 140 nations as part of the COVAX initiative.

The two-dose vaccine is authorized by the United Kingdom, the European Union and the World Health Organization. So why isn’t it here in the U.S. yet?

The short answer is that the company hasn’t submitted an application to the Food and Drug Administration yet.

Some critics fault the FDA, saying the agency has taken an unnecessarily slow regulatory approach at a time when thousands of Americans are dying from COVID-19 and vaccines are in short supply.

Others point to missteps by AstraZeneca.

“As a consumer of this information, it's been actually quite confusing to make sense of the AstraZeneca data,” said Dr. Christian Ramers of Family Health Centers of San Diego.

Compared to the clinical trials run by Pfizer, Moderna and Johnson & Johnson, “it’s been a lot messier with AstraZeneca,” Ramers said.

AstraZeneca launched clinical trials in the U.S. and a handful of other countries last summer. A few weeks in, someone had an adverse reaction and the trials were paused worldwide Sept. 6 to investigate.

The company got permission to resume the study in the U.K. six days later. But the FDA didn’t allow the U.S. trials to restart for more than a month, on Oct. 23.

“My understanding is that the clinical trial sites in the U.S. were on pause for a prolonged period because there was not great information sharing between the company and what the FDA asked for,” Dr. Ramers said.

Then in November AstraZeneca revealed there was a mistake in one of the studies. Some British volunteers were accidentally given a half-dose of the shot, rather than a full dose.

Surprisingly, the results were better but that didn’t sit well with many experts.

Dr. Mark Sawyer is a pediatrician at Rady Children’s Hospital and a member of the FDA’s vaccine advisory committee.

“It absolutely raises questions,” Dr. Sawyer said.”Why did that mistake happen? Does it tell us there could have been other shortcomings of the study? That will certainly come under scrutiny I think at the FDA meeting.”

Beacuse AstraZeneca has not yet submitted an application to the FDA , the agency has not scheduled a public meeting. Dr. Sawyer said he anticipated the company will apply in the next few weeks.

The FDA is known for insisting on U.S. clinical trials rather than data from other countries, and the FDA has a history of taking a longer look at drugs than other health agencies.

Famously, European regulators approved a morning sickness pill in the 1950s called thalidomide while the FDA chose to wait for more data.

The FDA’s cautious approach proved wise. The pill turned out to cause birth defects.

AstraZeneca said its U.S. trial has completed enrollment with 32,459 participants. “We expect the data to be available in the coming weeks,” a spokesperson said Friday.

Experts say the vaccine is on track for authorization in the U.S. by April at the earliest.

This story originally reported by Derek Staahl on