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LONDON (AP) – AstraZeneca’s COVID-19 vaccine provided strong protection against the disease and eliminated hospitalizations and deaths from the disease, including among the elderly, in end-stage testing in the United States United, the company said on Monday.
AstraZeneca said its experts had identified no vaccine-related safety issues, including finding an increased risk of rare blood clots identified in Europe.. The question now is whether the results will help restore public confidence in the vaccine around the world, as the company seeks clearance in the United States.
In a statement, AstraZeneca said its COVID-19 vaccine was 79% effective in preventing symptomatic COVID-19 and was 100% effective in stopping serious illness and hospitalization, although it has yet to published full data, so it is not clear whether there were enough severe cases. to make this conclusion meaningful. Investigators said the vaccine worked in adults of all ages, including the elderly – on which experts wanted better data.
AstraZeneca’s interim results are based on 141 cases of COVID-19, but officials declined to tell reporters at a press conference on Monday how many of the study volunteers had received the vaccine and how many of those who had received dummy injections.
“These results confirm the previous results observed,” said Ann Falsey, of the University of Rochester School of Medicine, who helped lead the trial. “It’s exciting to see for the first time similar efficacy results in people over 65.”
AstraZeneca will seek permission to use the vaccine in the United States from the Food and Drug Administration during the first half of April, Ruud Dobber, the company’s executive vice president, told reporters on Monday. An FDA advisory committee will publicly debate the evidence behind the shots before the agency decides whether or not to allow emergency use. Dobber said that if the FDA accepts the vaccine, the company will deliver 30 million doses immediately – and 20 more in the first month.
The AstraZeneca shot, which has been licensed in more than 70 countries, is a pillar of a UN-backed project known as COVAX that aims to deliver COVID-19 vaccines to poorer countries, and it has also become a key tool in European countries. efforts to boost their slow vaccine deployments. But confidence in the shot has taken repeated hits due to concerns about how the data was reported in some previous trials, confusion over its effectiveness in the elderly, and a recent fear of clotting.
Stephen Evans, of the London School of Hygiene & Tropical Medicine, said the new data could help allay concerns about the vaccine.
“The benefits of these results will primarily be for the rest of the world where confidence in the AZ vaccine (AstraZeneca) has been eroded, largely by political and media commentary,” he said.
The study included more than 30,000 volunteers, two-thirds of whom received the vaccine while the rest received dummy injections. Two doses were given to people four weeks apart.
Dr Paul Hunter, professor of medicine at the University of East Anglia, said the results were reassuring, but more details were needed to support AstraZeneca’s claim that the vaccine was fully effective in preventing serious illnesses and hospitalization.
“It would be good to know how many severe cases occurred in the control group and therefore what the confidence intervals are for that 100% figure,” said Hunter, who was not connected to the study. “But it should build confidence that the vaccine is doing what it’s needed most.”
Scientists had hoped the US study would clear up some of the confusion about the plans’ effectiveness, especially among older people. Previous research suggested the vaccine was effective in younger populations, but there was no strong data proving its effectiveness in those over 65, often the most vulnerable to COVID-19.
Britain first cleared the vaccine based on partial test results in the UK, Brazil and South Africa which suggested the vaccines were around 70% effective. But those results were clouded by a manufacturing error that led some participants to receive only half a dose on their first shot – a mistake the researchers did not immediately recognize.
Then came more questions about how the vaccine protected the elderly. and how long to wait before the second dose. Some European countries, including Germany, France and Belgium, initially denied the vaccine to older people and only reversed their decisions after new data suggested it offered protection to older people.
The development of the AstraZeneca vaccine has also been difficult in the United States. Last fall, the FDA suspended the company’s study for an unusual six weeks, as frustrated regulators sought information on some neurological complaints reported in Britain; in the end, there was no evidence that the vaccine was to blame.
Last week, more than a dozen countries, mostly in Europe, temporarily suspended their use of the AstraZeneca vaccine after reporting it was linked to rare blood clots – even as international health agencies insisted on it. fact that the benefits of the vaccine outweighed the risks. On Thursday, the European Medicines Agency concluded after an investigation that the vaccine did not increase the overall risk of blood clots, but could not rule out that it was linked to two very rare types of clots. He recommended adding a warning about these cases to the vaccine package insert.
It is not uncommon for such rare problems to arise as vaccines are deployed, as trials typically involve tens of thousands of people, and some problems do not appear until the vaccine is used by people. millions of people.
France, Germany, Italy and other countries then resumed their use of shooting Friday, with senior politicians rolling up their sleeves to show the vaccine was safe.
AstraZeneca said it will continue to analyze the US data before submitting it to the FDA in the coming weeks. He said the data will also soon be published in a peer-reviewed journal.
The AstraZeneca vaccine is what scientists call a “viral vector” vaccine. The shots are made with a harmless virus, a cold virus that normally infects chimpanzees. It acts like a Trojan horse to transport the genetic material of the coronavirus spike protein around the body, which in turn produces a harmless protein. This prepares the immune system to fight if the real virus does arise.
Two other companies, Johnson & Johnson and CanSino Biologics in China, are making COVID-19 vaccines using the same technology but using different cold viruses.
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Neergaard reported from Washington.
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Follow AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus-vaccine and https://apnews.com/UnderstandingtheOutbreak.
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