(CN) — March has been a confidence-shaking one for AstraZeneca, but details emerging Monday about its American drug trials suggest a strong contender for the country’s fourth vaccine against Covid-19.
The vaccine was 79% effective at stopping Covid-19 symptoms, the company reported, and no study participants developed severe illness from the virus or had to be hospitalized. The interim results were based on a 30,000-person trial and 141 Covid-19 cases.
Ann Falsey, professor at the University of Rochester School of Medicine, co-led the newly announced vaccine trial. She said the findings reconfirm previous results, “but it’s exciting to see similar efficacy results in people over 65 for the first time,” Falsey said in a press release.
AstraZeneca’s vaccine was approved by the World Health Organization the for ages 18 and older. Because of a dearth of clinical trial data for older adults, however, some countries have hesitated giving the vaccine to people older than 65.
“This analysis validates the AstraZeneca Covid-19 vaccine as a much-needed additional vaccination option,” Falsey said, “offering confidence that adults of all ages can benefit from protection against the virus.”
While the company prepares to submit its data to U.S. regulators for approval, the results’ implications for the rest of the world could be even more significant.
AstraZeneca said experts did not indicate there were safety concerns for the vaccine, and found no increased risk of the rare blood clots — a concern that has surrounded the vaccine and has prompted several European countries to stop using it.
Those included France, Germany, Ireland, Italy, Norway and the Netherlands, all of which last week paused use of the vaccine, calling it a “purely precautionary measure” while the European Medicines Agency investigated reported cases of blood clots.
While the EMA did not rule out a link between the vaccine and the small number of blood clot cases, countries resumed using it last week.
Politicians including United Kingdom Prime Minister Boris Johnson, who himself recovered from a bout with Covid-19, publicly got the AstraZeneca vaccine to demonstrate their confidence in its safety.
AstraZeneca’s designers have touted their product as a global vaccine, meaning one that is affordable to low- and middle-income countries, and can easily be shipped and stored at refrigeration temperatures.
The second shot of the vaccine can be administered four weeks, or as long as 12 weeks, after the initial dose — another plus for scheduling vaccine distribution to remote areas.
Designed by Oxford University researchers, the vaccine has been approved by the WHO for more than a month but its potential use in the U.S. is on a longer timeline.
The company plans to submit its data to the FDA for review “in the coming weeks,” it said Monday.
By the time the vaccine is submitted for authorization and, if found to be safe by U.S. experts, approved for emergency use, “we probably would be into May,” said Dr. Leana Wen, Baltimore’s former health commissioner, during an interview Monday on CNN.
“In which case, we have all these other vaccines that probably would be in enough supply,” Wen said. “So I don’t think that this affects us in the U.S. as much as it does worldwide.”
Still, the global effort is actually part of ending the health emergency in the United States, as other experts have pointed out.
“Pandemics don’t end when one country gets vaccinated,” said Dr. Ashish Jha, dean of the Brown University School of Public Health.
Even with 90% vaccination of adults in the U.S. — a figure that Jha said is unlikely — the work won’t be over by addressing the coronavirus in one country.
“We will continue to suffer, and face challenges as a country, if the rest of the world continues to have high levels of infection,” Jha said during a recent call with reporters.
Mutation is a cornerstone of virus behavior, and variants will continue to emerge whenever the coronavirus is given a chance to persist and spread: the more rapid, the better for the virus.
“The most obvious threat that I think Americans need to be aware of and understand,” Jha said, is a scenario where much of the U.S. is vaccinated, perhaps by fall of this year. It could be that, as Americans are starting a return to normal life, “we’re seeing large outbreaks in places like Brazil — and you see the rise of a new variant that is truly resistant to our vaccines.”
In that scenario, “the entire American population is a sitting duck,” Jha said, “and people can get infected and get sick again.”
“Is that likely? No. Is that a possibility? Absolutely,” he continued, advocating for the Biden administration to ramp up its efforts on getting the rest of the globe vaccinated.
“Given that we’re going to have plenty of vaccines,” Jha said, “we’ve really got to push on getting more vaccines out to the rest of the world.”
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