AstraZeneca will likely conduct an additional global trial of its Covid-19 vaccine candidate, according to a Bloomberg report, after questions were raised about its trial results — where the company claimed up to 90% efficacy in preventing the disease — and after the company acknowledged a manufacturing error.
The new trial would be run separately instead of adding a new arm to ongoing U.S. trials of the vaccine and it would evaluate why people who received lower doses of the vaccine appeared to have better protection against Covid-19, the Bloomberg report noted.
In an interview with Bloomberg, AstraZeneca CEO Pascal Soriot said that the company has now found what looks like a more effective dose and it has to validate this, “so we need to do an additional study,” which would be outside the U.S. and faster since it would need a smaller number of patients.
Soriot acknowledged that data from the new trial is unlikely to hold up to regulatory scrutiny in the U.K. and the European Union, and noted that the U.S. Food and Drug Administration (FDA) is also unlikely to approve a vaccine based on a study conducted outside the U.S.
The company however expects authorization in some other countries before the end of 2020.
62%. That’s the efficacy rate of the vaccine among people who received two full doses of the AstraZeneca vaccine the company announced on Monday. Compared to that, 90% of the people who received an initial lower dose — which the company acknowledged was due to a manufacturing error — followed by a full dose were protected against Covid-19. Pfizer and Moderna have both announced that their vaccines are 95% and 94.5% effective in preventing the disease.
The AstraZeneca vaccine is also being trialed in the U.S. and in his interview, Soriot acknowledged that data from that trial would now be necessary for U.S. approval stating: “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. Now with those results, it’s more likely that we will need the U.S. data.”