Oxford experimental vaccine will be tested in Peru
The clinical trials will be in charge of the Specialized Neurology Polyclinic and it is projected that it will bring together 5,000 Peruvians who have not been infected by the COVID-19 virus. Epidemiologist Sergio Recuenco will lead this process.
The National Institute of Health (INS) published the technical sheet that approves the clinical trials of the experimental vaccine of the University of Oxford and the AstraZeneca laboratory in the United Kingdom, thus becoming the third study that will test a vaccine against COVID-19 in Peruvian population.
The multinational trial, which will take place in the US, Chile and now also Peru, plans to recruit 30,000 volunteers. The technical sheet validated by the INS specifies that the study will summon 5,000 Peruvians between 18 and 65 years of age.
The sponsor in Peru is IQVIA RDS Peru S.R.L, a company specialized in experimental research in the field of natural sciences and engineering; while the Center for Medical Research of the Polyclinic Specialized in Neurology will be the place where clinical trials and vaccination will take place.
Initially, in the document published by the INS, the internist César Gamarra, who does not have the Concytec researcher seal that is requested for a study of this magnitude, was listed as responsible for the investigation in Peru.
Faced with this dilemma, La República consulted with the director of the INS General Office for Research and Technology Transfer, Franco Romaní, who assured that changes would be made to the details of the trial: “It is likely that the sponsor has registered an investigator who is not the most suitable. The official thing is that the main investigator is Dr. Sergio Recuenco ”.
At the end of this note, the change was already listed on the INS website. Sergio Recuenco is an epidemiologist and doctor in Public Health, specializing in zoonoses and rabies disease. He has participated in clinical trials related to this last topic. He is currently an assistant professor at the University of San Marcos and a researcher at the Center for Technological, Biomedical and Environmental Research.
On September 6, AstraZeneca halted its worldwide clinical trials after detecting an adverse reaction in one of its UK volunteers. After a week of review of the case, the Health Regulatory Authority of Medicines of that country approved the resumption of the trials, although to date the restart of the study has occurred only in England and Brazil, but not in the United States.
This study tests ChAdOx1, an adenovirus that traditionally causes colds in chimpanzees and has served in tests of potential vaccines against Ebola and MERS.
Covax Facility secures 13 million vaccines
The Foreign Ministry signed with the World Alliance for Vaccines (GAVI) the acquisition of 13 million doses of vaccines against the coronavirus. This alliance represents the multilateral mechanism Covax Facility, co-led with the WHO.
Through this signature, Peru will be able to immunize 20% of the population by the end of 2021.
Volunteers. Adults between 18 and 65 years old, medically stable.
Women. They must not be pregnant or lactating. A negative pregnancy test will be requested on the day of vaccination.
Fever. Volunteers must be below 38 ° C the day prior to vaccination.
No pre-existing diseases. Cardiovascular, respiratory, gastrointestinal, liver, kidney, endocrine or neurological.
Blood donation. Participation in the trial inhibits them from donating blood for up to 90 days after vaccination.
Guillain barre. Volunteers with no history of this syndrome.