- AstraZeneca executives on Friday said the company will ask the Food and Drug Administration in the "coming weeks" to authorize emergency use of its coronavirus vaccine, denying reporting that it's having difficulty with its application. CEO Pascal Soriot said the delay is because they are submitting data from multiple trials, along with real-world safety and efficacy information.
- The company reported data from a crucial U.S. Phase 3 trial five weeks ago. Vaccine rivals Pfizer, Moderna and Johnson & Johnson both sought emergency authorization within two weeks of their trial readouts, so AstraZeneca's delay in filing has drawn questions.
- The costs of developing the vaccine, which AstraZeneca's is selling on a not-for-profit basis, have reduced profits. In reporting its first-quarter results, the company said associated expenses reduced per-share earnings by three cents, although executives expect to break even in coming quarters.
With three vaccines authorized for use, the U.S. has managed to fully immunize more than one-third of the adult population, and has hundreds of millions more doses either waiting to be administered or committed for delivery by the end of the year. The U.S. therefore may not need AstraZeneca's vaccine to achieve herd immunity, as demonstrated by the Biden administration's willingness to share pre-ordered vaccines with other countries.
However, FDA authorization would still represent important regulatory validation of the AstraZeneca shot's safety and efficacy as it has become a key part of the plans of many countries around the world. So far, the company has distributed 300 million doses of the two-shot vaccine to 265 countries.
The FDA filing will contain data from the 32,449-enrollee Phase 3 trial the company designated as its U.S. registration trial as well as results from studies around the world. AstraZeneca also plans to submit real-world evidence from countries that have already authorized the drug.
Among the concerns the FDA will have is the rare occurrence of blood clots accompanied by low platelet counts, which disrupted immunization campaigns in Europe and bears similarities to adverse events reported in recipients of J&J's vaccines. Several European countries briefly suspended use of AstraZeneca's vaccine, as did the U.S. with J&J's, which has affected uptake.
"There's a lot more data than just the Phase 3 study, and so we're working as fast as we can to pull it all together and submit." Mene Pangalos, executive vice president of AstraZeneca's biopharmaceutical research and development, said in a call with reporters. "It's understandably taking longer because it's a much bigger than any file that we would normally submit."
On the financial side, executives disclosed the three cent hit on per-share earnings, but declined to reveal the total losses. CFO Marc Dunoyer said the company expects "small variations, quarter to quarter, but these variations will equalize around the breakeven" point, which will help it maintain its no-profit, no-loss pledge on developing and selling the vaccine.