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AstraZeneca: Evidence from the United States reveals that the vaccine is safe for all adults.

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AstraZeneca: Evidence from the United States reveals that the vaccine is safe for all adults.
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AstraZeneca: Evidence from the United States reveals that the vaccine is safe for all adults.

AstraZeneca: Evidence from the United States reveals that the vaccine is safe for all adults.

 

AstraZeneca announced Monday that its COVID-19 vaccine offered good safety for all adults in a long-awaited U.S. trial, raising expectations that the results would help restore public trust in the beleaguered vaccine in other countries while also bringing it closer to approval for use in the United States.

The vaccine, according to AstraZeneca, was 79 percent successful in preventing symptomatic COVID-19 outbreaks, even in older adults, and none of the study participants who were vaccinated were hospitalized or developed serious disease. The company also stated that its experts found no safety issues with the vaccine, including no increased risk of unusual blood clots that have been reported in Europe.

The results back up AstraZeneca’s previous studies in the United Kingdom and other countries, and they add to real-world proof that the shots are successful as they become more commonly used. However, public trust in the vaccine has been shaken by doubts about how data from previous studies are reported, as well as questions about its effectiveness in older adults and a recent clotting scare.

AstraZeneca said it will seek clearance in the United States “in the coming weeks,” putting it on track to arrive at the same time as three other vaccines already in use — from Pfizer, Moderna, and Johnson & Johnson — are expected to see a significant increase in supply.

AstraZeneca’s interim results are based on 141 COVID-19 cases in the 30,000-person trial, but officials refused to say how many were in study volunteers who received the vaccine and how many were in those who received dummy shots during a news conference on Monday. The vaccine was given to two-thirds of the volunteers.

“These findings corroborate previous findings,” said Ann Falsey, a trial co-leader from the University of Rochester School of Medicine. “It’s exciting to see similar effectiveness outcomes for the first time in people over 65.”

Until deciding whether to approve emergency use, a Food and Drug Administration advisory committee will debate the facts behind the shots in public. AstraZeneca executive vice president Ruud Dobber said that if the FDA approves the vaccine, the company would immediately supply 30 million doses, followed by another 20 million within the first month.

The AstraZeneca vaccine, which has been approved in over 70 countries, is a cornerstone of the United Nations-backed COVAX project, which aims to get COVID-19 vaccines to poorer countries, and it has also become a key tool in European countries’ efforts to speed up their sluggish vaccine rollouts. The shot’s significance in the global plan to end the pandemic makes any questions about it all the more alarming.

The new data, according to Stephen Evans of the London School of Hygiene & Tropical Medicine, could help to alleviate vaccine concerns.

“These findings will primarily benefit the rest of the world, where confidence in the AZ (AstraZeneca) vaccine has been eroded, largely as a result of political and media commentary,” he said.

The findings were reassuring, but more information were needed to back up AstraZeneca’s argument that the vaccine was fully successful at preventing serious disease and hospitalization, according to Dr. Paul Hunter, a professor of medicine at the University of East Anglia.

”It would be interesting to know how many severe cases occurred in the control group and what the confidence intervals are for this 100% figure,” Hunter, who was not involved in the study, said. “However, this should give people more hope that the vaccine is doing its job.”

Scientists hoped that the study from the United States would clear up some of the uncertainty about how successful the shots are, especially in older people. Previous research suggested the vaccine was effective in younger populations, but there was no solid evidence that it was effective in those over 65, who are often the COVID-19’s most vulnerable victims.

The vaccine was first approved in the United Kingdom based on preliminary findings from studies performed in the United Kingdom, Brazil, and South Africa, which indicated that the shots were around 70% successful. However, those findings were tainted by a manufacturing error that resulted in some participants receiving only a half-dose in their first shot — an oversight that the researchers failed to acknowledge right away.

More concerns followed, including how well the vaccine protected older adults and how long they could wait before receiving the second dose. Some European countries, such as Germany, France, and Belgium, initially refused to give the shot to older people, only to reverse their decisions after new evidence suggested that it provided protection to seniors.

In the United States, too, AstraZeneca’s vaccine production was rocky. Last fall, the FDA put a six-week hold on the company’s research as irritated regulators requested information about some neurologic complaints identified in the United Kingdom; eventually, there was no proof that the vaccine was to blame.

More than a dozen nations, mainly in Europe, briefly stopped use of the AstraZeneca vaccine last week after news that it was related to unusual blood clots, despite international health agencies insisting that the vaccine’s benefits outweighed the risks. The European Medicines Agency announced on Thursday that, while the vaccine did not increase the overall risk of blood clots, it could not rule out the possibility that it was linked to two extremely rare types of clots. It was proposed that the vaccine’s leaflet contain a warning about these events.

It’s not uncommon for such uncommon issues to arise when vaccines are carried out, as trials usually include tens of thousands of patients, and some issues are only discovered after the shot has been administered to millions of people.

On Friday, France, Germany, Italy, and other countries resumed using the vaccine, with senior politicians rolling up their sleeves to demonstrate the vaccine’s safety.

The AstraZeneca vaccine is a “viral vector” vaccine, according to scientists. The vaccines are made with a virus that infects chimps and is completely safe. It acts as a Trojan horse, carrying the genetic material of the coronavirus’s spike protein into the body, which then produces a harmless protein. This prepares the immune system to fight the real virus when it appears.

COVID-19 vaccines are produced by two other firms, Johnson & Johnson and CanSino Biologics of China, using the same technology but different cold viruses.

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