The pharmaceutical company AstraZeneca confirmed the suspension of the tests of its vaccine against Covid-19 after a suspicion of “serious adverse reaction”. With that, the research developed in partnership with the University of Oxford was officially paralyzed in the United Kingdom and also in Brazil.
In an official statement sent to UOL, the company explained that this is a routine action and that an independent committee will review the safety data:
This is a routine action that should happen whenever a potential unexpected adverse reaction is identified in one of the clinical trials, while it is being investigated, ensuring the maintenance of the integrity of the studies.
The pharmaceutical company also explains that the stoppage is temporary and that it works so that the vaccine is totally safe:
In large trials, adverse events happen by chance, but they must be reviewed independently to check this carefully. We are working to accelerate the review of a single event to minimize any potential impact on the test schedule. We are committed to the safety of our participants and the highest standards of conduct in our tests.
As much as some experts consider the strike to be “plenty of care,” the NYT reports that a study volunteer had transverse myelitis – an inflammation of the spinal cord. However, it is still not possible to know if the disease is directly related to the vaccine.
With studies halting, other research centers should use the extra time to review data on related adverse events. In any case, the Oxford vaccine is far from free of side effects. Data from phases 1 and 2 confirm that about 60% of the volunteers had an adverse event.
Most reported low fever and headaches, something that can be alleviated with the use of Paracetamol. It is worth remembering that the Brazilian government has already agreed on a protocol of intentions that provides for the availability of 30 million doses of the vaccine by the end of the year.
It is important to clarify that, in the clinical trial of the Oxford / AstraZeneca vaccine, approximately 18 thousand participants have already been included. The study pause means that there will be no inclusion of new participants at this time. However, those already included are being monitored to assess safety and effectiveness, the Ministry of Health said in a note.