The coronovirus vaccine, developed by AstraZeneca and the University of Oxford, provided strong protection against Kovid-19 in a large clinical trial in the United States, completely preventing the worst consequences of the disease, according to the results announced on Monday.
Although no clinical trial is sufficient to rule out very rare side effects, AstraZeneca reported that its study did not pose any serious safety issues. Government officials and public health experts hoped the results would improve global confidence in the vaccine, Who moved This month when the use of the shot was temporarily suspended in more than a dozen countries, mostly in Europe, over concerns about possible rare side effects.
The trial was the largest of its kind for the shot, testing over 32,000 participants. Clinical trials declared by the company showed that the AstraZeneca vaccine was 79 percent effective in preventing symptomatic infections. In a news release. Testing also showed that the vaccine offered strong protection for older people, which was also not represented in earlier studies.
Latest data it’s so late To make a lot of difference in the United States, where the vaccine is not yet authorized and is unlikely to be available before May. By then, federal officials predict, all three of the vaccines will have enough vaccine doses for adults in the nation that are already authorized.
Still, the better-than-expected results are a heartbreaking turn for the shot of AstraZeneca, whose low cost and simple storage requirements make it an important piece of the drive to vaccinate the world.
The results may help ease concerns about the AstraZeneca vaccine in Europe. In an effort to reduce public confidence, Many European political leaders have received injections in recent times.
The British Health Secretary, Matt Hancock, said on Monday, “The results of the US trial of the Oxford-AstraZeneca vaccine provide strong evidence that the vaccine is both safe and highly effective.” “Vaccines are our way out of it, so when you get the call, get the jab.”
Regulators in Europe began a safety review of the AstraZeneca vaccine earlier this month, following a recently developed blood clot and a small number of people with abnormal bleeding. The test gave no indication of such problems, although some safety issues can only be detected in the real world, once millions of people have been given a drug or vaccine.
AstraZeneca said on Monday that it would continue to analyze the new data and prepare to apply for emergency authorization from the Food and Drug Administration in the coming weeks. The vaccine has already been approved in more than 70 countries, but approval from US regulators will affect its global reputation.
Because the United States already has a substantial mix of vaccines from three other manufacturers, however, FDA regulators are unlikely to move on the accelerated timeline that they did with other vaccines.
In November, Oxford and AstraZeneca reported that the vaccine was 70 percent effective in studies in Britain and Brazil. But those results were difficult to interpret. The findings looked very different in participants who received the first dose of the vaccine with a strength they had not previously planned, and then received a second dose several weeks after it was originally intended. There were also relatively young people in those tests. As a result, some public health experts and US health officials cited those studies as inadequate to see how well the vaccine worked.
“It was a very large, well-run study that I think now confirms that this vaccine is a good vaccine,” Dr. Infectious Disease Specialist of the country Dr. Anthony S. Fauci said. He said it was premature to say what the role of the vaccine would be in the United States.
AstraZeneca has stated that it will issue 30 million doses to the United States as soon as it receives authorization. Millions of those doses are already ready to be shipped or discontinued. US officials Agreed to lend four million Dose for Canada and Mexico.
The results announced on Monday were based on 141 Kovid-19 cases that changed between volunteers in a clinical trial. Two-thirds of the participants were given the vaccine, with doses with an interval of four weeks, and the rest received saline placebo. Volunteers were recruited from Chile and Peru in addition to the United States.
None of the volunteers who received the vaccine developed severe symptoms or had to be hospitalized. At a news conference on Monday, Astra Data executive Menelas Pangalos said five participants were severely developed Kovid-19 when interim data were analyzed, and more cases have occurred in that group.
Participants receiving the vaccine in the trial had no risk of blood clots or related diseases. And a specific finding revealed no cases of venous sinus thrombosis of the brain – blood clots in the brain that can result in dangerous bleeding – which raised some of the most serious concerns in Europe.
“In the past few weeks due to the slight beating of the AstraZeneca vaccine – and especially in Europe in the last two or two weeks – new data is showing that it is safe and effective, if you excuse the phrase, a Good shot arm, ”said Michael Head, a senior research fellow in global health at the University of Southampton in the UK.
AstraZeneca said the vaccine worked well across ethnicities and age groups. And the vaccine was 80 percent effective in about 6,000 trial volunteers over the age of 65 – the conclusion being that the elderly are likely to worry about insufficient clinical trial data on how well the vaccine works .
Even though the vaccine is not used in the United States, obtaining emergency authorization from the FDA – whose rigorous review process is considered a global gold standard – would be an important milestone for AstraZeneca.
“The benefit of these results will be primarily for the rest of the world, where trust in the AstraZeneca vaccine has been erased,” said Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine.
Although it is difficult to compare vaccines tested in various clinical trials at various points in the epidemic, the new results put AstraZeneca’s shot at the company of other leading vaccines.
AstraZeneca vaccines can be stored for up to six months when refrigerated. Unlike Messenger RNA vaccines from Pfizer and Modern, it uses the same old approach as Johnson & Johnson’s shot. A delivery vehicle – a weaker version of a chimpanzee adenovirus – is used for Coronavirus virus transport in human cells. This means training the immune system to fight attacks with real coronaviruses.
Several key data points suggest that US regulators will need to investigate the vaccine’s disappearance from the company’s news release.
It was not clear, for example, how up-to-date the data are. If the analysis was conducted on data one or two months ago, it is possible that a more current look would present a different picture of the vaccine’s effectiveness and safety. The company will provide the FDA with a more comprehensive, more recent set of data than that reported by AstraZeneca on Monday.
AstraZeneca’s relationships with US officials have deteriorated since last year, when senior health officials believed the company was unclear about the design of its clinical trials, its results, and safety issues. This suspicion lasted until last week, when senior officials of several federal health agencies became even more suspicious.
According to a person aware of the case, the analysis conducted by the Independent Security Monitoring Board seeking revised reports from those handling the trial data on behalf of the company was delayed several times as the board had to deal with the trial data on behalf of the company Was asked for Discuss this publicly.
A spokesman for AstraZeneca cited the data and security monitoring boards as saying, “As often happens, DSMBs can request new or explicit analysis of data from testing.” “This will enable them to ensure the strength of their determination.”
Nevertheless, the gripe with the data again tested the confidence of US officials in the company. Suspicion was so high last week that some government officials and vaccine experts were speculating that the company was sitting on its results or working to make them more flattering.
In fact, the company did not have its results until last weekend, Drs. Pangalos said.
Sharon Lafranier Contributed to reporting. Ellen Delquarier Contributed to research.