After pausing trials to investigate a ‘serious adverse reaction’, Oxford University and AstraZeneca will resume clinical trials of the last phase of their vaccine.
This Saturday morning, the University of Oxford reported through a statement that will resume clinical trials carried out to demonstrate the safety and efficacy of the ChAdOx1 nCov-19 vaccine against the novel coronavirus in the UK.
On September 8, Statnews reported the provisional suspension of phase 3 clinical trials in the United Kingdom, due to the suspected ‘serious adverse reaction’ in a study participant, applied in 18 thousand people so far in the United States, South Africa, Brazil and England.
The company rated the hiatus as a routine procedure and in favor of the integrity of clinical trials, a policy consistent with the WHO, which has expressed on different occasions its position to avoid rushing the progress of a vaccine by risking its safety:
“18,000 people have received the study vaccine as part of the trial. In large trials like this one, some participants are expected to feel unwell and each case must be carefully evaluated to ensure a careful assessment of safety, ”explained Oxford.
The University revealed that studies will resume in the UK after following the recommendations of the Regulatory Agency for Medicines and Health Products of that country (MHRA, for its acronym in English) and a independent safety review committee:
“Our standard review process caused a pause in the study of vaccination in all our global trials to allow for review of safety data by an independent safety review committee and national regulators.”
ChAdOx1 nCov-19 is an immunization based on ChAdOx1 technology, with an attenuated and genetically modified adenovirus vector, which in the clinical trials of the first two phases demonstrated its ability to generate a strong immune response.
In addition to producing antibodies, the vaccine by immunologist Sarah Gilbert elicits the immune response of T cells, lymphocytes that develop long-term cellular memory to fight pathogens.
The University in charge of one of the most advanced vaccines against Covid-19 reaffirmed its commitment to the safety and efficacy of ChAdOx1 nCov-19, which will probably be the first immunization to be administered to the public:
“We are committed to the safety of our participants and to the highest standards of conduct in our studies and will continue to monitor safety closely.”
Sarah Gilbert, the scientist who tested the COVID-19 vaccine on her children
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