Cleveland Doctor Concerned AstraZeneca Missteps Weakening Trust Of Vaccine

The COVID-19 vaccine from European pharmaceutical company AstraZeneca has hit several roadblocks on its way to authorization across the world, and is battling more bumps in the U.S.

Researchers are set to release updated information about the vaccine’s clinical trial results in the U.S. this week after top health experts, including Dr. Anthony Fauci, questioned the accuracy of trial resultsreleased Monday.

The pharmaceutical company may have included “outdated information” in its results, which could provide an "incomplete view of the efficacy data," the National Institute of Allergy and Infectious Diseases (NIAID) said Tuesday.

One of the U.S. trials was held here in Cleveland at University Hospitals, and Dr. Robert Salata, chair of medicine at UH, said it was “unprecedented” for the NIAID and National Institutes of Health to make such a public comment on AstraZeneca’s data.

“Perhaps, AstraZeneca … was using some older, outdated data to make their calculations in their analysis,” Salata said.

The issue at hand, Salata said, is that AstraZeneca released interim data, but the company was not transparent about the fact that it was preliminary, he said.

AstraZeneca is working with the Data Safety and Monitoring Board, an independent group responsible for evaluating clinical trials, to review the data and release more updated information in the coming days, Salata said.

The preliminary analysis showed the vaccine had nearly 80 percent efficacy in preventing COVID-19 symptoms, which is promising, he added.

“We’ll see if the data holds up, and if it’s as good … we expect they’ll present their full analysis to the FDA in April, and it could conceivably get early emergency use authorization like the other vaccines have gotten,” Salata said.

Transparency concerns are not the only issues that have plagued the rollout of the AstraZeneca vaccine.

Earlier in March, vaccine distribution was halted in several countries in Europe, where the shot has already been authorized, after some recipients experienced blood clots, some of them fatal.

After investigating, regulatory boards found no causal link between the vaccine and the blood clots, and the countries resumed distribution, Salata said.

“We have no definitive information to suggest it was a side effect from the vaccine itself,” he said. “With the over 34,000 individuals vaccinated in the United States with none of that being seen, I think that’s further reassurance.”

None of the participants in the University Hospitals trial reported serious side effects or adverse reactions, he added.

Still, these safety concerns and lack of transparency about the AstraZeneca vaccine may cloud public trust in the vaccine if it is eventually authorized for emergency use in the U.S., Salata said.

“AstraZeneca will have their hands full in terms of… an educational campaign, given all the headlines in and around this,” he said.

While at this point, individuals do not have a choice on which COVID-19 vaccine they will receive due to limited supply, there may be a point where there is enough vaccine to go around and people will be able to pick, Salata said. If the AstraZeneca vaccine’s reputation does not improve, Salata is concerned people will not want to take this shot, he added.

“[AstraZeneca is] going to have to be very forthcoming and transparent. I think that’s very critical if someone is going to consider taking that vaccine, at least in the U.S. going forward,” he said.

However, if the vetted clinical trial results show the vaccine to be safe and effective, Salata said people should feel comfortable getting this shot down the line, but more information is needed to make that determination.

Plus, the vaccine will be even more carefully vetted by the Food and Drug Administration once the company applies for emergency use authorization, Salata added.