LONDON (AP) – AstraZeneca’s COVID-19 vaccine provided strong disease protection and eliminated hospitalizations and deaths due to the disease, including older adults, in the final stages of the US testing, the company announced Monday.
AstraZeneca said its experts did not identify any safety concerns about the vaccine, including finding 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 approval in the United States.
In a statement, AstraZeneca stated that the COVID-19 vaccine was 79% effective in preventing symptomatic COVID-19 and that it was 100% effective in stopping serious diseases and hospitalization, although it has not yet published complete data. thus, it is unclear whether there were enough serious cases to make the finding meaningful. Investigators said the vaccine works in adults of all ages, including the elderly – something experts want better information about.
AstraZeneca’s interim results are based on 141 COVID-19 cases, but officials declined to tell reporters at a news conference on Monday how many were in the study volunteers who received the vaccine, and how many in those who received a shot. has.
“These findings 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 similar efficacy results in people over 65 for the first time.”
AstraZeneca will apply for permission to use the vaccine in the United States in the first half of April, Ruud Dobber, an executive vice president of the company, told reporters on Monday. An FDA advisory committee will discuss the evidence behind the shootings in public before the agency decides to allow emergency use. Dobber said that if the FDA were the vaccine, the company would immediately deliver 30 million doses – and another 20 within the first month.
The AstraZeneca shot, approved in more than 70 countries, is a pillar of a UN-backed project known as COVAX, which aims to get COVID-19 vaccines to poorer countries, and it has also has become an important tool in European countries. efforts to promote their sluggish vaccines. But the confidence in the shot yielded repeated hits due to concerns about how data from some previous trials have been reported, confusion about its efficacy in older adults, and a recent fear of 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 vaccine AZ (AstraZeneca) has been eroded, mainly through political and media comments,” he said.
The study consisted of more than 30,000 volunteers, two-thirds of whom received the vaccine, while the rest received dummy shots. Two doses were given to humans four weeks apart.
Dr. Paul Hunter, a professor of medicine at the University of East Anglia, said the results were reassuring, but that more details were needed to support AstraZeneca’s claim that the vaccine was completely effective in preventing serious illness and hospitalization.
“It would be good to know how many serious cases occurred in the control group and what the confidence intervals are for this 100% figure,” said Hunter, who was not linked to the study. “But it must give confidence that the vaccine is doing what is most needed.”
Scientists hoped the US study would clear up the confusion about how well the shots work, especially in older people. Previous research has suggested that the vaccine was effective in younger populations, but there was no solid data proving its efficacy in those older than 65, often those most vulnerable to COVID-19.
Britain first approved the vaccine based on partial test results in the United Kingdom, Brazil and South Africa, which suggested that the shots were about 70% effective. But the results were clouded by a manufacturing error that caused some participants in their first survey to receive only half a dose – a mistake the researchers did not immediately acknowledge.
Then came questions about how well the vaccine protects older adults. and how long to wait before the second dose. Some European countries, including Germany, France and Belgium, initially withheld the shot from older adults and only reversed their decisions after new data suggested it provided protection for seniors.
AstraZeneca’s vaccine development was also rocky in the US. Last fall, the FDA suspended the company’s study for an unusual six weeks, as frustrated regulators seek information on some neurological complaints reported in Britain; finally, 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 shot after reports that it was linked to rare blood clots – even though international health agencies have insisted that the benefits of the vaccine outweigh the risks. The European Medicines Agency concluded on Thursday after an investigation that the vaccine does not increase the overall risk of blood clots, but could not rule out that it is associated with two very rare types of blood clots. It is recommended to add a warning about these cases to the vaccination of the vaccine.
It is not unheard of for such rare problems to arise as vaccines are expanded, as trials usually look at tens of thousands of people, and some problems are only seen when the shot is used in millions of people.
France, Germany, Italy and other countries then resumed their use of the shot Friday, with senior politicians rolling up their sleeves to show the vaccine is safe.
AstraZeneca has said it will continue to analyze the US data before submitting it to the FDA in the coming weeks. It is said that the data will soon be published in a peer-reviewed journal.
The AstraZeneca shot is what scientists call a “viral vector” vaccine. The shots are made with a harmless virus, a cold virus that usually infects chimpanzees. It works like a Trojan horse to carry the genetic material of the coronavirus’ field protein in the body which in turn produces harmless proteins. This causes the immune system to fight when the real virus emerges.
Two other companies, Johnson & Johnson and China’s CanSino Biologics, make COVID-19 vaccines with the same technology but use different cold viruses.
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Neergaard reports from Washington.
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