The pharmaceutical company AstraZeneca has released additional data that they said confirms the effectiveness of the Covid-19 vaccine after questions about the results of an interim clinical trial were raised in the U.S. by an independent body. However, the additional data show that the vaccine is slightly – but not significantly – as effective as the recommended interim results.
Interim results released by AstraZeneca on Monday from the phase-3 clinical trial of more than 32,000 people concluded that the vaccine was 79% effective against symptomatic disease and 100% effective against serious disease and death. But shortly after the results were published, the U.S. Data and Security Review Board said they were concerned that AstraZeneca may have given “outdated” information from the test, which gave an “incomplete view” of the results.
The U.S. National Institutes of Health (NIH) outlined the concerns raised by the board in a press release.
In response, AstraZeneca on Thursday released the additional data, which it said confirmed validation results from the interim study. The data was provided to the Data Security Monitoring Board. A further 49 cases were added to the previously reported findings.
Astrazeneca said in a statement, when the new data was added, they found: “The key endpoint was vaccine efficacy at a 76% symbolic Covid-19 inhibition occurring 15 days or more after two days. get a dose four weeks apart. “
This is slightly lower than the 79% efficiency originally reported.
“In addition, results were comparable across age groups, with vaccine efficacy 85% in adults 65 years and older,” the statement said. “A primary secondary completion area, preventing serious or emergency disease and hospitalization, has shown 100% efficiency.”
The vaccine was well received and no safety concerns related to the vaccine have been identified, the findings show. While the result appears to show slightly lower efficiency, the latest figure has a confidence interval ranging from 68% to 82%. This means that there is a 95% chance that the true efficacy of the vaccine ranges from 68% to 82%, making it similar to other vaccines including Pfizer’s. As more data is added, the confidence interval tends to tighten and provide more certainty.
Hassan Vally, a professor of epidemiology with La Trobe University in Australia, said the difference between 76% and 79% was not significant.
“In the scheme of things it changes nothing when you pay attention to the moments of confidence,” Vally said.
Mene Pangalos, executive vice president of AstraZeneca biotechnology research and development, said: “The main study is consistent with the previously released interim analysis, and confirms that Our Covid-19 vaccine is very effective in adults, including those aged 65 and over. “
AstraZeneca will also submit the analysis for peer-reviewed publication in the coming weeks.
Professional Professor Paul Griffin, director of infectious diseases at Mater Health Services in Australia, said people could believe in the vaccine and that it was safe and effective.
“We are ashamed that a vaccine with so much evidence supporting safety as well as effectiveness is still reduced in controversy,” he said.
“We heard very positive news almost a week ago that the European Medical Authority’s safety committee had claimed that the vaccine was not linked to an increase in the overall risk of blood clots and so the benefits of getting vaccination still outweighs risk of side effects. . “
The demand for more vaccine data was the norm in drug licensing processes but was played out in public because of the intense focus on Covid and the need for transparency, Griffin said, but it was important not to do too much when questions have been raised.
“Unfortunately, after it emerged that all the cases seen have been addressed, NIH’s report yesterday has allayed suspicions regarding this vaccine,” he said.
“This was based on a concern reported by the Data Protection Review Board that outdated information may have been introduced, thus providing an incomplete view of effectiveness. To me, this seems like a very strange way to solve an issue like this and it is very unfortunate in terms of the idea of this vaccine. “