ASTRAZENECA EYES ADDITIONAL VACCINE TRIAL
Manufacturing discrepancy has spurred questions
AstraZeneca’s COVID-19 vaccine looks as if it’s headed for an additional global trial as the drugmaker tries to clear up uncertainty and confusion surrounding favorable results in its current study.
The company wants the new test to confirm the 90 percent efficacy rate that the shot showed in a portion of an existing trial, Chief Executive Officer Pascal Soriot said. It’s favoring that option rather than adding an arm to a separate study that’s already under way in the U.S.
Questions are mounting over one of the fastest-moving shots after the company acknowledged that a lower dosage level that appeared more effective resulted from a manufacturing discrepancy. The company and its partner, the University of Oxford, didn’t initially disclose the error and other key details, leading to concern over their transparency.
Soriot said he didn’t expect the additional trial to hold up regulatory approvals in the U.K. and European Union.
U.K. Health Secretary Matt Hancock asked the nation’s medical regulator to potentially bypass its EU counterpart and approve the supply of AstraZeneca’s vaccine to speed its deployment. Until the end of the year, when the U.K. exits a post-Brexit transition period, vaccines must be authorized by the European Medicines Agency. But on Friday, Hancock said he invoked a special rule allowing Britain’s regulator to authorize a temporary supply of the vaccine if the data is robust enough.
Clearance from the U.S. Food and Drug Administration may take longer because the regulator is unlikely to approve the vaccine on the basis of studies conducted elsewhere, especially given the questions over the results, Soriot said. Authorization in some countries is still expected before the end of the year, he said.
“The question for us was, will we need the U.S. data to get approval in the U.S. or can we get approval in the U.S. with international data, and it was never clear,” said Soriot, who is in quarantine after arriving in Australia. “Now with those results it’s more likely that we will need the U.S. data.”
Astra and its CEO are facing scrutiny as the drugmaker responds to growing confusion over the vaccine. The company’s late-stage data initially increased confidence that the world would soon have multiple shots to combat the pathogen, following positive reports from front-runners Pfizer Inc. and Moderna Inc. But scant disclosures and the manufacturing discrepancy have sparked doubts among scientists and investors.