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Pharmaceutical AstraZeneca interrupted a clinical trial to achieve a vaccine against covid-19, because one of the participants suffers from “a potentially inexplicable disease,” a company spokesperson told US media.
“This is a routine action that happens whenever there is a potentially unexplained disease in one of the trials while it is being investigated, ensuring that the integrity of the studies is maintained,” the spokesperson told CNBC and the specialized media Stat.
The volunteer who fell ill resides in the United Kingdom, according to Stat, who said he did not know the nature of the adverse reaction suffered by the individual, although he is expected to recover.
This is the vaccine that AstraZeneca, based in Cambridge (United Kingdom), had developed together with the University of Oxford and whose efficacy was being tested in the USA, Brazil and South Africa after the trial had given positive results in its initial phases, when it was tested with a thousand people in the UK.
The spokesman for the pharmaceutical company assured that “it is working to accelerate the review of this unique incident in order to minimize any potential impact on the trial plans.”
AstraZeneca had started phase 3 of its trial in the US in late August, according to clinicaltrials.gov, a US government registry; while in the UK, Brazil and South Africa, the vaccine study was between phases 2 and 3, according to Stat.
AstraZeneca was scheduled to have its vaccine available by the first half of 2021 and was considered one of the most advanced in the world by the World Health Organization (WHO).
Along with pharmaceutical companies Pfizer and Moderna, AstraZeneca is one of three companies with phase 3 studies in the US.
This is the first time that one of those trials to achieve the COVID-19 vaccine has to be put on hold for safety reasons.
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Other measures
Nine pharmaceutical companies that are developing vaccines against covid-19 in a race under international pressure signed a commitment to “guarantee” and “prioritize” the safety and well-being of vaccinated people, in an attempt to dispel possible misgivings that those who see that the rush to achieve a drug as soon as possible may lead to the relaxation of scientific and safety standards.
“We, the undersigned biopharmaceutical companies, want to make clear our continued commitment to the development and testing of potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles,” say the pharmaceutical companies.
Likewise, they express their hope that the signing of this commitment “will help ensure public confidence in the rigorous scientific and regulatory process with which COVID-19 vaccines are being evaluated and that they can eventually be approved.”
The signatory companies are Moderna, AstraZeneca, Pfizer, Sanofi, Johnson & Johnson, GlaxoSmithKline, Merck, Novvax and Sanoti.
In the document, they insist that the safety and efficacy of vaccines, including any potential vaccine, is reviewed and determined by regulatory agencies around the world such as the US Food and Drug Administration (FDA, for its acronym in English). ).
“The agency requires that scientific evidence for regulatory approval come from large, high-quality, randomized clinical trials (…), with the expectation of appropriately designed studies with a significant number of participants spread across diverse populations.” says the note.
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Four days ago, Moderna, one of the pharmaceutical companies trying to develop a vaccine, announced that it has slowed down the enrollment of volunteers for the trial of the coronavirus vaccine it wants to develop, with the aim of guaranteeing the representation of minorities, according to the CEO of the company, Stephane Bancel.
The biotech company announced last July that it would begin, in collaboration with the US Government, one of the largest trials in the world to test the effectiveness of an experimental vaccine against COVID-19 in 30,000 volunteers, who would be recruited in 89 places in the country.
The company has stressed that the elderly, non-white communities and people with previous health conditions are a priority in vaccine trials, given their increased risk of the disease.
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