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A dose error and a stroke of luck paved the way for the vaccine produced by the pharmaceutical company AstraZeneca and the University of Oxford to achieve 90% effectiveness when administered in half a dose, followed by a dose a month later.
“The reason we took half a dose was a fluke”Mene Pangalos, head of non-cancer research and development at AstraZeneca, told Reuters.
A larger group that had received two full doses, as originally planned, showed a 62% efficacy rate, leading to the vaccine having an overall efficacy of 70% including both dosage patterns.
When Astrazeneca was beginning its partnership with the University of Oxford in late April, researchers dosing test volunteers in the UK found that symptoms such as fatigue, headaches, and arms were milder than expected.
“So we checked again and found that we had only given half the dose of the vaccine.”Pangalos explained.
Following this discovery, the company decided to continue with the half dose and administer the full dose booster vaccine at the scheduled time.
The vaccine against covid-19 developed by the British laboratory AstraZeneca and the University of Oxford has an average effectiveness of 70%, according to a statement released on Monday.
These are interim results from large-scale clinical trials developed in the UK and Brazil, says AstraZeneca.
In relation to the data already available, this vaccine has an average efficacy rate lower than those reported by Pfizer / BioNTech or Moderna, which exceed 90%.
According to the note released this Monday, no hospitalizations or serious cases of the disease were reported among the participants in the tests who received the vaccine and there were 131 cases of covid-19 registered in the intermediate analysis.
One dosing regimen showed 90% vaccine efficacy when initially administered in half the dose, followed by a full dose at least one month apart.
Another dosing regimen showed 62% efficacy when administered in two full doses at least one month apart.
The combined analysis of both dosage regimens shows an average effectiveness of 70%, the company explains, adding that “more data will continue to be accumulated and additional analyzes will be developed, refining the reading of effectiveness to establish the duration of protection” conferred.
An independent Data Safety Monitoring Council determined that the analysis showed protection against the disease 14 days or more after receiving the two doses of the vaccine, says AstraZenca, who stresses that it has not seen serious side effects and that the vaccine developed has been “well tolerated in both dosage regimens”.
“AstraZeneca will now prepare the regulatory submission of data to authorities around the world so that they have a structure for their conditional or early approval,” says the laboratory, which will seek to include this vaccine on the World Organization’s emergency use list. health. Health to accelerate the availability of vaccines in underdeveloped countries.
In parallel, the full analysis of the interim results will be sent for publication after peer review, it adds.
Andrew Pollard, chief investigator at the Oxford office of vaccine testing, quoted in the statement, says: “These findings show that we have an effective vaccine that will save many lives. Unbelievably, we found that one of our dosing regimens may be around 90% effective and if this dosing regimen is used, more people could be vaccinated with the planned vaccine supply. Today’s announcement is only made possible by the many volunteers in our trial and the talented and hardworking team of researchers from around the world ” .
AstraZeneca Executive Director Pascal Soriot considers today “an important milestone” in the fight against the pandemic, highlighting: “The effectiveness and safety of this vaccine confirm that it will be highly effective against covid-19 and will have an immediate impact on this public health emergency. “
“In addition, the simple vaccine supply chain and our non-profit promise and commitment to broad, equitable and timely access means it will be affordable and available globally, providing hundreds of millions of approved doses,” he adds. .
More than 23,000 volunteers participated in the third phase of clinical trials organized by the University of Oxford. The global tests evaluate participants 18 years of age or older from various racial groups and geographies, who are healthy or who have stable underlying medical conditions.
Clinical trials are also underway in the US, Japan, Russia, South Africa, Kenya, and Latin America with trials planned in other European and Asian countries. In total, the company expects to enroll up to 60,000 participants worldwide, the note adds.
The company is progressing rapidly in production, with a capacity of up to three billion doses of the vaccine in 2021, on a continuous basis, pending regulatory approval.
The vaccine developed by the British laboratory AstraZeneca and the University of Oxford can be stored, transported and handled under normal refrigeration conditions (2-8 degrees Celsius) for at least six months.
AstraZeneca remains committed to collaborating with governments, multilateral organizations and partners around the world to ensure broad and equitable access to the non-profit vaccine during the pandemic, it adds.
