WASHINGTON (AP) – AstraZeneca reported on Monday that its COVID-19 vaccine provided strong protection among adults of all ages in a long-awaited American study, a finding that may help rebuild public confidence in injection across the board. the world and take it one step closer to liberation in the USA
In the study of 30,000 people, the vaccine was 79% effective in preventing symptomatic cases of COVID-19 – including in the elderly. There were no serious illnesses or hospitalizations among vaccinated volunteers, compared with five of these cases in participants who received false injections – a small number, but consistent with the findings in Britain and other countries that the vaccine protects against the worst of disease.
AstraZeneca also said that the study’s independent safety monitors found no serious side effects, including no increase in the risk of rare blood clots like those identified in Europe, a scare that prompted several countries to halt vaccines briefly last week.
“I hope this eliminates any doubts about the vaccine’s effectiveness,” Mene Pangalos, head of biopharmaceutical research at AstraZeneca, told the Associated Press. “In general, where the vaccine is being used, it has proven to be highly effective. So I hope that the study in the US will now continue to give the vaccine a boost and use it even more around the world. ”
The company plans to file an order with the Food and Drug Administration in the coming weeks, and external government consultants will publicly debate the evidence before the agency makes a decision. Pangalos said the vaccine could gain emergency clearance in the second half of April. In that case, the company would deliver 30 million doses immediately and another 20 million in the first month.
What this will mean for America’s vaccination plans is unclear. The Biden government already projects that there will be sufficient doses for all adults by the end of May, thanks to the increased supply from manufacturers of the three vaccines already in use in the USA – Pfizer, Moderna and Johnson & Johnson.
Federal officials said they did not want to prejudge the FDA review, but considered AstraZeneca’s findings a victory for both US supplies and the global fight against the virus.
“There are many countries in Europe and around the world that have already authorized this, so the fact that a study conducted by the United States confirmed the efficacy and safety of this vaccine is an important contribution to global health in general,” said Dr Anthony Fauci, the leading infectious disease specialist in the United States.
The AstraZeneca injection, which has been authorized in more than 70 countries, is a pillar of a UN-supported project known as COVAX, which aims to take COVID-19 vaccines to the poorest countries. It has also become a key tool in European countries’ efforts to boost their slow vaccine implementations. This made doubts about the photos especially worrying.
Even before the blood clot scare, scientists hoped the US study would clear up some confusion about how well the vaccine really works. Although previous research has suggested that it was effective in younger populations, there were doubts about how well it protects those over 65, usually the most vulnerable to COVID-19.
In addition, Britain authorized the vaccine based on partial test results in the United Kingdom, Brazil and South Africa that suggested that the vaccines were about 70% effective. But these results were overshadowed by a manufacturing error that led some participants to obtain only half a dose on their first attempt.
Stephen Evans, of the London School of Hygiene & Tropical Medicine, said the new data could help to allay concerns.
“The benefits of these results will be mainly for the rest of the world, where confidence in the AZ vaccine has been eroded, in large part by political and media comments,” he said.
Two-thirds of the volunteers in the US study received the vaccine and the rest were false injections, and Monday’s report is based on the first 141 COVID-19 cases reported after the start of the second dose of the vaccine. AstraZeneca declined to provide an analysis of these cases, while continuing to prepare its submission to the FDA.
But Fauci said the study was careful to include different ages, racial and ethnic minorities and people with underlying health problems, and found “effectiveness comparable between ethnicities and ages”.
Dr. Paul Hunter, a professor of medicine at the University of East Anglia, said the results were reassuring, but more details are needed to support AstraZeneca’s claims.
“But that should increase confidence that the vaccine is doing what is most needed,” said Hunter, who was not involved in the study.
In terms of safety, France, Germany, Italy and other countries resumed the use of the AstraZeneca vaccine after the suspension last week to investigate clots. On Thursday, the European Medicines Agency concluded that the vaccine does not increase the overall risk of clots, but cannot rule out that it is linked to two very rare types.
In the United States, as well as in Britain and Europe, major efforts are already underway to observe any unexpected problems while the first vaccines are being launched. And while the United States is considering the AstraZeneca vaccine, Fauci said, “You can be sure that the FDA will do a thorough scrutiny of all aspects of this data.”
The AstraZeneca injection is what scientists call a “viral vector” vaccine. Vaccines are made with a harmless cold virus that normally infects chimpanzees. It acts like a Trojan horse to transport the genetic material from the coronavirus spiny protein to the body. This prepares the immune system to react if the real virus appears.
Two other companies, Johnson & Johnson and CanSino Biologics from China, make COVID-19 vaccines using the same technology, but using different cold viruses.
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Neergaard reported from Washington.
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