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The Federal University of São Paulo (Unifesp), one of the entities responsible for testing the Oxford vaccine against the new coronavirus in Brazil, said on Tuesday (8) that there was no record of serious reactions immunization in the 5,000 Brazilian volunteers already vaccinated.
Testing of the Covid-19 vaccine has been temporarily suspended at all research centers after a patient in the UK experiences a reaction that may be related to the vaccine.
“In Brazil, the study involves 5,000 volunteers and is progressing as expected,” Unifesp said in a note. “Many have already received the second dose and so far there has been no record of serious health complications.”
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According to Unifesp, the break follows the safety standards present in the study protocol of the Oxford vaccine. “This is a common practice in clinical studies involving drugs,” said the São Paulo institution.
The Brazilian university explained that a safety surveillance committee must analyze whether the British case was related to the vaccine. After this analysis, phase 3 should be resumed.
The third phase of clinical trials is the last before the vaccine is approved for the population. It is performed on a large scale in order to make a definitive evaluation of its efficacy and safety in larger populations. Only after this phase can a medical history be taken.
British Pharmacist AstraZeneca clarified that the security protocol was activated after one of the volunteers in the UK experiences an adverse reaction that may be related to the vaccine.
According to AstraZeneca, the “standard review procedure” of the studies was activated and vaccination was paused “voluntarily (…) to allow review of safety data by an independent committee.”
“This is a routine action that should occur whenever a possible unexpected adverse reaction is identified in one of the clinical trials.” – AstraZeneca
In the same note, the pharmacist also stressed that he works on the review of the patient’s case.
Oxford Covid-19 Vaccine Studies and Tests Temporarily Suspended
Nine vaccines in the last phase of testing
In addition to the Oxford University candidate with British pharmaceutical company AstraZeneca, eight more vaccines are in the third and final phase of human testing, the last before launch.
- Janssen Pharmaceutical Companies (USA)
- Moderna / National Institute of Allergy and Infectious Diseases (USA)
- BioNTech / Fosun Pharma / Pfizer (Germany and USA)
- Sinovac (China)
- Wuhan / Sinopharm Institute of Biological Products (China)
- Beijing Institute of Biological Products / Sinopharm (China)
- CanSino Biological Inc./ Beijing Institute of Biotechnology (China)
- Gamaleya Research Institute (Russia)
