AstraZeneca trial shows success.
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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% effective at preventing symptomatic cases of COVID-19 — including in older adults. The trial found the vaccine was 100% effective in preventing hospitalizations and deaths from COVID-19.
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.
The University of Wisconsin-Madison was one of the spots that participated in the trial.
The vaccine’s makers must still apply for emergency use authorization from the U.S. Food and Drug Administration, something that could happen in the coming weeks.
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.
“There were no issues with blood clots in the U.S. trial, including at University of Wisconsin-Madison,” said William Hartman, who was in charge of the UW portion of the trial.
He said a key takeaway is that the vaccine was 100% effective against hospitalizations and deaths from COVID-19. AstraZeneca doesn’t have results that were specific to the UW participants, he said.
Hartman said he was pleased with the results but also expected them since the vaccine is very similar to the Johnson & Johnson vaccine, which was found to be 72% effective in the U.S.
The only complications they saw at UW were the same ones other vaccines have experienced: some arm pain, some fever and chills and some insomnia.
He said a United Kingdom trial has indicated that AstraZeneca’s vaccine is even more effective when there is a three-month gap between the first and the second shot.
He said it will probably be at least a few weeks before the vaccine receives emergency use authorization in the United States. AstraZeneca still has to put together the report it will submit for the authorization.
Hartman noted a neurologist is looking at a clotting issue, so both the FDA and the board are taking the issue very seriously.
“If the vaccine is given emergency use authorization, people can be as
sured it will be as safe a product as they can put out there,” he said.
“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.
The Associated Press contributed to this report.