[News] Peru suspends trials of Sinopharm vaccine against coronavirus due to "adverse event"

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The Peruvian Ministry of Health announced this Saturday that it supports the decision of the National Institute of Health to temporarily suspend clinical trials of the Sinopharm coronavirus vaccine.

Through a bulletin, the ministry explains that the measure responds to the security contemplated in the regulation of clinical trials in order to "protect the health of research subjects during the third phase of testing of candidates for the vaccine against covid- 19, for the identification of an adverse event in one of the research subjects ".

German Málaga, head of clinical trials at Sinopharm laboratories in Peru, told CNN that the adverse event for which the trials were suspended, part of a 64-year-old patient, with more than 20 years of apparently poor control diabetes , who presented a decrease in muscle strength in the legs.

The side effect is under investigation to determine if it is related to the vaccine or for some other reason.

"A few days ago we duly reported to the regulatory entities that one of our participants had some neurological symptoms that could correspond to a complication called Guillain-Barré," said Germán Málaga, principal investigator of the clinical trials of the Sinopharm vaccine.

Guillain-Barré Syndrome is a rare, non-contagious disorder that affects the nerves that control movement of the arms and legs. In mid-2019, Peru declared a temporary health emergency in several regions due to the incidence of cases of this syndrome, in an outbreak registered since 2018.

 

Caution
"It seems very unlikely to us due to the clinical characteristics, the background of the person, the form of presentation. However, the safety of these studies is above all things, so after an evaluation; the National Institute Health has determined a temporary suspension of the study, "added Malaga.

The trial of the potential vaccine was to conclude this week, in a first phase that contemplated the application to 12,000 volunteers. If positive results were obtained, which would only be known in the first weeks of 2021, the Peruvian government intended to buy 20 million vaccines to immunize two-thirds of the Peruvian po[CENSORED]tion.

The Chinese group Sinopharm's vaccine consists of two doses that are given to each volunteer one month apart. The trial is conducted by medical personnel from two Peruvian universities.

As of Friday, Peru reported 979,111 confirmed cases of covid-19, with 36,499 deaths.