LONDON (AP) – The AstraZeneca COVID-19 vaccine has provided strong protection against the disease and eliminated hospitalizations and deaths caused by the disease, including in older adults, in final tests in the US, the company announced on Monday.
AstraZeneca said its experts did not identify vaccine-related safety issues, including that they did not find an increased risk of rare blood clots in Europe.. The question now is whether the findings will help rebuild public confidence in the vaccine around the world as the company seeks to obtain authorization 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 severe disease and hospitalization, although it has not yet released full data, so no it is clear whether there were sufficient severe cases. to make this finding significant. Investigators said the vaccine worked in adults of all ages, including the elderly – something the experts wanted better data on.
AstraZeneca’s provisional results are based on 141 COVID-19 cases, but officials declined to tell reporters at a news conference Monday how many study volunteers received the vaccine and how many took photos. inactive.
“These findings reconfirm previous findings,” said Ann Falsey of the University of Rochester School of Medicine, who helped lead the process. “It’s exciting to see similar efficacy results in people over 65 for the first time.”
AstraZeneca will apply for authorization to use the vaccine in the United States from the Food and Drug Administration in 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 shootings before the agency decides whether to allow emergency use. Dobber said that if the FDA is the vaccine, the company will immediately deliver 30 million doses – and another 20 in the first month.
The AstraZeneca blow, which has been licensed in more than 70 countries, is a pillar of a UN-backed project known as COVAX, which aims to bring COVID-19 vaccines to poorer countries and has also become a key tool in European countries. efforts to stimulate the slow release of the vaccine. But confidence in the shot took repeated blows due to concerns about how data from some previous studies were reported, confusion about its effectiveness in older adults, and a recent scare about coagulation.
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 be mainly for the rest of the world, where confidence in the AZ vaccine (AstraZeneca) has been eroded, largely through political comments and the media,” he said.
The study included more than 30,000 volunteers, two-thirds of whom received the vaccine, while the rest received fictitious photos. Two doses were given to people four weeks apart.
Dr. Paul Hunter, a 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 is completely effective in preventing severe disease and hospitalization.
“It would be good to know how many severe cases occurred in the control group and therefore what are the confidence intervals for this 100% figure,” said Hunter, who was not connected to the study. “But this should add confidence that the vaccine does what is most needed.”
The scientists hoped the US study would clear up some of the confusion over how well photos work, especially in the elderly. Previous research has suggested that the vaccine has been effective in younger populations, but there have been no solid data to prove its effectiveness in those over 65, often the most vulnerable to COVID-19.
The United Kingdom first authorized the vaccine based on partial results from tests in the United Kingdom, Brazil and South Africa, which suggested that the fires were about 70% effective. But these results were clouded by a production error that caused some participants to receive only half a dose in their first shot – an error that the researchers did not immediately recognize.
Then came more questions about how well the vaccine protected the elderly and how long to wait before the second dose. Some European countries, including Germany, France and Belgium, initially withheld shooting from older adults and overturned their decisions only after new data suggested they were protecting the elderly.
The development of the AstraZeneca vaccine was also rocky in the USA. 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 the UK; Finally, there was no evidence that the vaccine was to blame.
Last week, more than a dozen countries, mostly in Europe, temporarily suspended the use of AstraZeneca fire after reporting it was linked to rare blood clots – even though international health agencies insisted the vaccine’s benefits outweigh 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 connected to two very rare types of clots. He recommended adding a warning about these cases to the vaccine leaflet.
It is not uncommon for such rare problems to occur because vaccines are released, as studies usually cover tens of thousands of people, and some problems are seen only after the shot is used on millions of people.
France, Germany, Italy and other countries later resumed the use of photography on Friday, with elderly politicians rolling up their sleeves to show that the vaccine is safe.
AstraZeneca said it will continue to analyze US data before submitting it to the FDA in the coming weeks. He said the data would soon be published in a peer-reviewed journal.
The AstraZeneca shot is what scientists call a “viral vector” vaccine. The photos are taken with a harmless virus, a cold virus that normally infects chimpanzees. It acts like a Trojan horse to carry the genetic material of the coronavirus tip protein into the body, which in turn produces harmless proteins. It prepares the immune system to fight if the real virus appears.
Two other companies, Johnson & Johnson and China’s CanSino Biologics, produce COVID-19 vaccines using the same technology, but using different cold viruses.
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Neergaard reported from Washington.
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