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A dosing error and a stroke of luck paved the way for the vaccine manufactured by pharmaceutical company AstraZeneca and the University of Oxford to achieve 90% efficacy when given in half a dose, followed by one dose one month later.
“The reason we took half a dose was a stroke of luck”Mene Pangalos, chief of non-cancer research and development at AstraZeneca, told Reuters.
A larger group that had received two full doses, as originally planned, showed an efficacy rate of 62%, which resulted in the vaccine having an overall efficacy of 70% including both dosing models.
When Astrazeneca began its collaboration with the University of Oxford in late April, researchers who were administering doses to test volunteers in the UK found that symptoms such as fatigue, headaches and arms were milder than expected.
“So we went back to check and found we had only given half a dose of the vaccine”, explained Pangalos.
Following this discovery, the company decided to continue with the half dose and administer the full dose booster vaccine at the scheduled time.
The covid-19 vaccine developed by the British AstraZeneca laboratory and the University of Oxford has an average efficacy of 70%, according to a statement released on Monday.
These are provisional results of large-scale clinical trials developed in the UK and Brazil, says AstraZeneca.
In relation to the data already available, this vaccine has a lower average efficacy rate than those reported by Pfizer / BioNTech or Moderna, which exceed 90%.
According to the note released this Monday, there were no reported hospitalizations or severe cases of the disease among test participants who received the vaccine and there were 131 cases of covid-19 recorded in the interim analysis.
A dosing regimen showed that the vaccine was 90% effective when it was initially given at half the dose, followed by a full dose at least one month apart.
Another dosing regimen showed 62% efficacy when given in two full doses at least one month apart.
The combined analysis of both dosing regimens results in an average efficacy of 70%, the company explains, adding that “more data will continue to accumulate and further analyzes will be developed, refining the efficacy reading to establish the duration of the protection conferred “.
An independent Data Safety Monitoring Board determined that the analysis showed protection against the disease 14 days or more after receiving the two doses of the vaccine, says AstraZenca, which points out that it saw no serious side effects and that the developed vaccine was “well tolerated in both dosage regimens”.
“AstraZeneca will now prepare regulatory submission of data to authorities around the world so that they have a facility in place for conditional or advance approval,” says the lab, which will seek to include this vaccine in the emergency case list. of the World Health Organization. Health to accelerate the availability of vaccines in underdeveloped countries.
In parallel, the full analysis of the interim results is presented for publication after the peer review, he adds.
Andrew Pollard, lead researcher at the Oxford Office of Vaccine Testing, quoted in the statement, says: “These results show that we have an effective vaccine that will save many lives. Incredibly, we have found that one of our dosing regimens could be of approximately 90% effective and if this dosage regimen is used, more people could be vaccinated with the planned vaccine supply. Today’s announcement is only possible thanks to the numerous volunteers in our test and the talented and hardworking team of researchers throughout. the world ” .
The executive director of AstraZeneca, Pascal Soriot, regards today as “an important milestone” in the fight against the pandemic, noting: “The efficacy and safety of this vaccine confirms that it will be highly effective against covid-19 and will have an immediate impact. in this public health emergency “.
“Additionally, the vaccine’s simple supply chain and our nonprofit promise and commitment to broad, fair and timely access means it will be accessible and available globally, providing hundreds of millions of doses for approval,” he adds. .
More than 23,000 volunteers participated in the third phase of the clinical trials organized by the University of Oxford. Global testing is evaluating participants aged 18 and over from different racial groups and geographic areas, who are healthy or who have stable underlying medical conditions.
Clinical trials are also underway in the United States, Japan, Russia, South Africa, Kenya and Latin America with tests scheduled in other European and Asian countries. In total, the company plans to enroll up to 60,000 attendees globally, the note added.
The company is making rapid progress in manufacturing, with a capacity of up to three billion doses of the vaccine in 2021, on an ongoing basis, pending regulatory approval.
The vaccine developed by the British AstraZeneca laboratory and the University of Oxford can be stored, transported and handled under normal refrigerated conditions (2-8 degrees Celsius) for at least six months.
AstraZeneca remains committed to working with governments, multilateral organizations and collaborators around the world to ensure broad and equal access to the nonprofit vaccine during the pandemic, it adds.
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