U.S. data: Astrazeneca vaccine is effective
WASHINGTON — Astrazeneca reported Monday that its COVID-19 vaccine provided strong protection among adults of all ages in a long-anticipated U.S. study, a finding that could help rebuild public confidence in the shot around the world and move it a step closer to clearance in the U.S.
In the study of 30,000 people, the vaccine was 79 percent effective at preventing symptomatic cases of COVID-19 — including in older adults. There were no severe illnesses or hospitalizations among vaccinated volunteers, compared with five such cases in participants who received dummy shots — a small number, but consistent with findings from Britain and other countries that the vaccine protects against the worst of the disease.
Astrazeneca also said the study’s independent safety monitors found no serious side effects, including no increased risk of rare blood clots like those identified in Europe, a scare that led numerous countries to briefly suspend vaccinations last week.
“I do hope it puts to bed any doubts about the vaccine efficacy,” Mene Pangalos, Astrazeneca’s biopharmaceuticals research chief, told the Associated Press. “Overall where the vaccine is being used, it’s been shown to be highly effective. So I hope that the U.S. study now will continue to give the vaccine some momentum and get it used even further around the world.”
The company aims to file an application with the Food and Drug Administration in the coming weeks, and the government’s outside advisers will publicly debate the evidence before the agency makes a decision. Pangalos said the vaccine could win emergency authorization toward the second half of April. If so, the company would deliver 30 million doses immediately and an additional 20 million within the first month.
What that will mean for America’s vaccination plans is unclear. The Biden administration already projects there will be enough doses for all adults by the end of May thanks to increasing supplies from the makers of the three vaccines already in use in the U.S. — Pfizer, Moderna and Johnson & Johnson.
Federal officials said they didn’t want to prejudge the FDA’S review but cast the Astrazeneca findings as a victory both for the U.S. supply and the global fight against the virus.
France, Germany, Italy and other countries have resumed their use of the Astrazeneca vaccine after the suspension last week to investigate clots. On Thursday, the European Medicines Agency concluded the vaccine did not raise the overall risk of clots, but could not rule out that it was connected to two very rare types.
In the U.S., as in Britain and Europe, major efforts already are underway to watch for any unexpected problems. And as the U.S. considers Astrazeneca’s vaccine, Dr. Anthony Fauci, the top U.S. infectious disease expert, said, “You can rest assured that the FDA will put a great deal of scrutiny in every aspect of these data.”