Pandemics: Past and future
The Vaccinegate case: business and clinical trial of a vaccine during a health emergency.
Fabiola Torres
2023
Vaccinegate: The trafficking of Sinopharm vaccines for the benefit of a group of people from the scientific, business and political elite of Peru.
�What can we learn from Vaccinegate?��What facts should we take into account to investigate irregularities and crimes in clinical trials?��
The clinical trial:
Sinopharm is a Chinese state company that in 2020 obtained licenses from the Peruvian government (from the National Institute of Health) to test its experimental COVID vaccines on 12,000 volunteers.
Sinopharm also import 3,200 doses of the vaccine for the research team. This, in addition to any scientific and altruistic purpose, with the aim of closing agreements with the Peruvian State, as actually happened in January 2021.
�����������1. “Courtesy doses”?��The local and international legislation on clinical trials does not provide for courtesy doses. Products tested cannot be offered as complimentary products either.�
Irregular vaccine diplomacy efforts��At least 13,500 excess doses were sent to Chile, Peru, and Argentina by three Chinese vaccine makers: Sinopharm, Cansino and Sinovac.�� It was a policy from Chinese pharmaceuticals to get these vaccines to our elites in order to have an advantage afterwards when negotiating the purchase of these vaccines.�
2. The donation:
Between August 2020 and January 2021, Sinopharm donated mechanical ventilators, oxygen concentrators, thermometers, masks and protective suits valued at US$861,040 to the Ministry of Health and the Cayetano Heredia University.
The crime:
The clinical trial vaccines were provided as “courtesies” or “perks.”
In Peru, according to the Code of Ethics of the Public Service, Law No. 27815, authorities are expressly prohibited from “obtaining or procuring undue benefits or advantages, for themselves or for others, through the use of their position, authority, influence or appearance of influence.”
3. The supervisory company
The company Gotuzzo Asociados was hired to supervise the clinical trial.
In the list of the 487 people part of Vaccinegate, we identify 8 people linked to Gotuzzo. His wife, Mirtha Oliva Elías and seven workers from Gotuzzo Asociados.
Dr. Eduardo Gotuzzo appears in the registry of the UPCH research committee as a consultant for the clinical trial of the Sinopharm vaccine.
The CRO (Contract Research Organizations)
These companies are usually hired by multinational sponsors to carry out Phase III clinical trials.
In Latin America, the goals of enrolling volunteers in clinical trials often cross the ethical lines of clinical research.
The Peruvian Registry of Clinical Trials (REPEC) is a publicly accessible database, available on the INS website (https://ensayosclinicos-repec.ins.gob.pe).
REPEC is a primary registry of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) since 2016.
4. An exclusive national ethics committee was formed for COVID-19 clinical trials.
How are these committees formed?
Who are they members?
Many ethical dilemmas arise during a clinical trial and the monitoring of volunteers
5. What happened to the clinical trial volunteers?
The opening of their file was delayed to find out if they received the vaccine or placebo. This delay meant that they could not be incorporated into the national vaccination plan on time.
Despite being health workers, a group of volunteers who received placebo in the Sinopharm clinical trial could not vaccinate against covid-19 on time.
Three volunteers died of Covid-19. Among them, an older man with a disease profile that made him very vulnerable to the clinical trial. These volunteers received a placebo.
One of the big problems of the National Institute of Health in Peru is that it is a supervisory institution that lacks sanctioning power.
The Vaccinegate case broke the population's trust in science in the middle of a national vaccination process. This case also forced a review of the regulatory framework for the execution of clinical trials.
The number of clinical trials conducted in Peru has suffered a dramatic drop in the last 14 years.
In 2009, 134 clinical trials were authorized in Peru, while by 2022, only 35 were approved, that is, a reduction of 74%.
THANKS�
@fabiolatorres
fabiolatorres@saludconlupa.com