- AstraZeneca and the University of Oxford have restarted an early-stage test of their experimental coronavirus vaccine in Japan following discussions with the country's drug regulator.
- The trial was one of several across the globe that was halted earlier this month after a participant in a U.K. study contracted an unexplained neurological illness, triggering a safety review. AstraZeneca has since been cleared to resume testing in the U.K., Brazil, South Africa and India. But it still has only disclosed limited details about the incident; an updated patient information brochure indicated investigators couldn't conclusively determine whether vaccination was to blame.
- AstraZeneca still, however, hasn't been able to get its largest study — a 30,000-participant trial in the U.S. — back on track. A Reuters report said the Food and Drug Administration has broadened its investigation into the matter, which could cause further delay.
Just a month ago it was AstraZeneca, not Pfizer, whose vaccine was being swept up in the political drama leading up to the U.S. presidential election in November.
The British drugmaker's shot was one of the first to reach Phase 3 trials. Its fast progress, and AstraZeneca's quick ramp-up of large-scale production, made it highly sought after by governments looking to quickly gain access to a vaccine for their citizens. Reports emerged over the summer, for instance, that the Trump administration was considering fast-tracking AstraZeneca and Oxford's experimental shot for emergency use before the election.
But things have changed significantly since then. Days after starting its Phase 3 trial in the U.S., AstraZeneca voluntarily paused all of its studies across the globe when a U.K. study participant developed what were believed to be symptoms of a neurological condition known as transverse myelitis. The incident, and AstraZeneca's sparse communication about the matter, cast some doubt on the shot's viability and stoked fears that rare side effects might be missed amidst the ultra-fast push to get a vaccine to market.
Testing was restarted in the U.K. shortly after the study was halted — and other trials have now followed — but AstraZeneca and Oxford, citing patient confidentiality, have provided few details. That is typical in vaccine trials, but the secrecy has nonetheless drawn sharp criticism given the public's already hesitant stance regarding vaccines being developed in record time.
The situation appears to have struck a nerve with other drugmakers, as calls have since been heightened for vaccine developers to be more transparent about their trials. Several of them, including AstraZeneca, have since made their Phase 3 study protocols public. Pfizer has also taken the unusual step of disclosing some of the blinded safety results it has collected so far.
Even as testing has restarted elsewhere, AstraZeneca's U.S. study remains on hold. Reuters reported Wednesday that the FDA wants to see if similar side effects have been found in tests of other, similar vaccines developed by Oxford scientists. The agency was expected to receive that information this week and begin analyzing it, according to the report.
"AstraZeneca continues to work with the [FDA] to facilitate review of the information needed to make a decision regarding resumption of the U.S. trial," the company said in a statement Friday. "The safety of trial participants is of paramount importance and we are committed to upholding the highest standards of conduct in clinical trials."
AstraZeneca's delay has put Pfizer in the spotlight, as the company said it could report interim data from its trial by the end of the month. That has ratcheted up pressure on Pfizer from both sides of the political aisle. CEO Albert Bourla acknowledged that pressure, writing in a memo posted on LinkedIn that "in this hyper-partisan year, there are some who would like us to move more quickly and others who argue for delay."
"Neither of those options are acceptable to me," Bourla wrote. "We are moving at the speed of science."