Manufacturing error raises questions about AstraZeneca vaccine testing



[ad_1]

OR statement, acknowledging the error, occurs days after the company and the university rated the vaccine as “highly effective”, not to mention why some participants in clinical trials did not receive the same amount of vaccine in the first of the two injection, as expected, reports the AP agency.

Surprisingly, the group of volunteers who received one lower dose appeared to be much more protected than the volunteers who received two full doses.

In the low-dose group, the AstraZeneca, the vaccine appears to be 90% effective, while in the group that received two full doses the efficacy appears to be 62%.

With these results combined, the manufacturers revealed that the vaccine appears to be 70% effective, but how they were obtained raised questions from experts.

The partial results announced Monday are the result of massive ongoing clinical trials in the UK and Brazil. designed to determine the ideal dose of the vaccine, as well as to examine safety and efficacy.

Various combinations and doses were administered to the volunteers and the results were compared with others who received a meningitis vaccine or saline solution.

Before starting the trials, the researchers explained all the steps to take and how to analyze the results. Any deviation from this protocol can jeopardize the results.

In a statement released today, the University of Oxford said that some of the vials used in the test did not have the proper concentration of vaccine, meaning that some volunteers received half a dose.

The university added that it discussed the issue with regulators and agreed to complete the test. The manufacturing issue was corrected, according to the statement.

For experts, the relatively low number of people in the low-dose group makes it difficult to understand whether the observed effectiveness in the group is real or a statistical peculiarity.

About 2,741 people received half a dose of the vaccine followed by a full dose, the report revealed. AstraZeneca, with a total of 8,895 people receiving both full doses.

Other factor The problem is that none of the participants in the low-dose group is older than 55 years, and younger people tend to have stronger immune responses than older people.

As a discussion remains the union of the two participating groups that received different dosage levels to achieve an average effectiveness of 70%, said one of the members of the global health program. Chatham House, David Salisbury.

One of the Oxford scientists leading the research believes that the greater effectiveness in the group that took the reduced dose may be related to supplying the amount exact of the vaccine to trigger the best immune response.

“Not too little, not too much. Too much can also give a low-quality response,” he said.

Details of clinical trial results will be published in medical journals and provided to UK regulators, who will decide on marketing authorization for the vaccine.

These reports will include a detailed analysis with demographic information or information on who got sick in each group, which will provide a more complete picture of the vaccine’s effectiveness.

A pandemic from COVID-19-19 caused at least 1,415,258 deaths as a result of more than 60 million cases of infection around the world, according to a report by the French agency AFP.

Always be the first to know.
Follow the chosen site for the fourth consecutive year Consumer Choice.
Download our free app.

Download Apple Store
Download from Google Play



[ad_2]