One year of Ebola in the DRC: who to believe in the controversy over the second vaccine? - RFI

By Sonia RolleyPosted on 02-08-2019Modified on 02-08-2019 at 19:54

One after the start of the Ebola epidemic in the Democratic Republic of Congo (DRC), the recent statements by the outgoing Health Minister on the introduction of a second vaccine have created controversy. Dr. Oly Ilunga assured that pressure had been exerted on his ministry by a "malicious lobby", which denies the new boss of the coordination of the response, Professor Jean-Jacques Muyembe, co-discoverer of the Ebola virus. Investigation.

On August 26, 1976, Mabalo Lokela came with a high fever to the hospital of the Mission of the Sisters of Our Lady of the Sacred Heart of Gravenwezel Yambuku. This 44-year-old school principal has just returned from travel. With a few friends, he went to explore the north of his province, Ecuador. On the banks of the Ebola River, he had eaten bushmeat, antelope and monkey. But he believes he is suffering from malaria, endemic in this forest region of northwestern Zaire during the Mobutu years. Despite all the care given by the good sisters of the Belgian mission, Mabalo Lokela died a week later. He is the "index patient" of the first Ebola outbreak, named after the river he visited a few days earlier.

When Jean-Jacques Muyembe, a young doctoral student in virology, just graduated from the University of Leuven, arrives from Kinshasa with his colleague Dr. Omombo, Mabalo Lokela has been buried for a long time. The two doctors are mandated in Yambuku by the Minister of Health to investigate a mysterious disease that decimates its inhabitants. There is urgency, people panic. Jean-Jacques Muyembe discovers in this month of September 1976 a locality almost deserted. Even the mission hospital is empty.

The young virologist makes some biopsies on the bodies of the victims, carries out blood tests, especially on a Flemish nun who has a high fever. Jean-Jacques Muyembe notes without worrying that by withdrawing the needle, the patient bleeds profusely. He has his hands full and just wash them with a piece of soap. It is on the basis of this sample that Dr. Peter Piot of the Institute of Tropical Diseases of Antwerp succeeds in isolating the Ebola virus. Their investigation reveals that nuns inadvertently spread the epidemic. They had in all and for all five syringes that they used without sterilizing them.

Muyembe, " a globally recognized authority "

When 42 years later, Professor Jean-Jacques Muyembe, Director of the National Institute of Biomedical Research (INRB) takes the lead in coordinating the response, the now Democratic Republic of Congo is experiencing its tenth Ebola outbreak since and has become a " global health emergency ", according to the World Health Organization (WHO). More than 1,800 Congolese have died, including several in Goma, the main city in the East.

" Jean-Jacques Muyembe has been involved in the management of the nine other epidemics, he is a world-renowned authority, " says Giscard Kusema, the deputy director of communication of the presidency, sent to Goma to assist the new boss of the response in communication around efforts. The new head of state has officially taken over the response, disavowing in passing the outgoing health minister and former doctor of his father, Dr. Oly Ilunga. The latter slams the door and replies with a letter dated July 22, 2019, addressed to Felix Tshisekedi himself.

In this missive, Dr. Oly Ilunga denounces " interference ", pressure to introduce a second vaccine in the arsenal of the riposte in Congo, he evokes " actors who have demonstrated a manifest lack of ethics by hiding voluntarily important information to the health authorities ". A few days later in the columns of the newspaper Le Monde , the resigning minister speaks of a " malicious lobby " which " tried by all means to impose, in the DRC, the experimental vaccine of the pharmaceutical manufacturer Johnson & Johnson ". Dr. Oly Ilunga complains that the vaccine is only in " phase 2 " and requires " two injections given 56 days apart ", which would have little impact to control the disease.

Regardless of Dr. Ilunga's statements, on July 24, 2019, Peter Piot, who became director of the prestigious Faculty of Hygiene and Tropical Medicine in London, publicly commented on the reorganization that placed his friend in control of Ebola in Congo and " In recent months, we have been working with local and national authorities in the DRC, including the Ministry of Health, to support the deployment of a second experimental vaccine manufactured by Johnson & Johnson ." He welcomed the role of Professor Jean-Jacques Muyembe and the fact that the experimental protocols for this second vaccine have already been submitted to the Ethics Committee and other institutions responsible for authorizing the use of new drugs. " The DRC should remain at the forefront of research and innovation in this area, " says the co-discoverer of Ebola. At the same time, since Kinshasa, Jean-Jacques Muyembe tempered at the microphone of RFI that " nothing is decided, it is only a proposal ".

The idea of ​​a second vaccine is actually a recommendation from the WHO Strategic Advisory Group of Experts (SAGE). In a statement dated May 7, 2019, these experts already advocated " to introduce an additional experimental vaccine (developed by Johnson & Johnson) " and dismissed its Russian and Chinese competitors. Since the Ebola outbreak in West Africa between 2013 and 2016, with the prospect of widespread contagion to other countries or even continents, the five permanent members of the Security Council have all developed vaccines and Experimental treatments for the strain Zaire of the virus, it is the race for the homologation and the new field of this commercial battle is the Democratic Republic of the Congo.

"Dealing with a shortage of stock"

In the wake, May 23, 2019, the Congolese Ministry of Health receives a clinical study protocol for this vaccine. This confidential 86-page document is prepared by a certain "PREVAC Consortium". On the third page is the name of Professor Jean-Jacques Muyembe under the title "RDC principal investigator". He and Peter Piot, the two discoverers of Ebola, are part of the steering committee of this study whose objective is to " measure the effectiveness of a vaccination campaign based on a selected population ."

We learn that in December 2018, " about 6,500 received the first vaccination ", that " phase 2 and 3 studies were conducted ". Of 2,390 adults who received both doses, " serious adverse events " were seen in 64 patients, although " overall, " this vaccine produced " mild to moderate short-term adverse events without sequelae ". This clinical study aims to " up to 1 million subjects " to vaccinate " until the end of the current Ebola outbreak for the evaluation of vaccine efficacy ".

On August 1, 2019, it has been one year since the Ebola outbreak was under way in the DRC. The controversy over the second vaccine is growing. Congolese and foreign experts in coordinating the response are meeting in Goma around Professor Jean-Jacques Muyembe to formulate a new strategy. Upon his release, Dr. Abdourahamane Diallo, the WHO expert in charge of immunization issues, said: " The WHO expert group, SAGE, has advocated the use of a second vaccine, but in risk areas, not in the affected areas ". The WHO fears a shortage of the first experimental vaccine, the rVSV-ZEBOV from another US pharmaceutical company Merck, co-introduced in May 2018 in the DRC to vaccinate at-risk contacts.

The use of this first vaccine had given rise to little debate, it had been tested on 16 000 people in 2015, particularly in West Africa during the Ebola outbreak, but also in Europe and other countries. United States. But for the introduction of a second vaccine, citizen movements like Lucha rise to the challenge and challenge the new boss of the response. " The urgency is to stop the spread of the epidemic and not to experiment with all kinds of drugs and vaccines developed by some multinationals that you represent, " reads Lucha's Twitter account.

Mr @MTamfum, with all due respect, the urgency is to stop the spread of the ongoing Ebola epidemic, not to experiment with all kinds of medicines and vaccines developed by multinationals, some of which you represent. We are #NotVosCobayes! https://t.co/eYFiCjToXu

" The Johnson & Johnson vaccine has also been the subject of a clinical study in Guinea, but after the epidemic, " says Dr. Diallo. This clinical trial was itself led by the so-called "PREVAC Consortium" created in 2017, which presents itself as the "Partnership for Ebola Vaccination" and brings together three countries, France, the United States and Great Britain. and their main research institutes: the National Institute of Health and Medical Research (INSERM) in France, the US National Institutes of Health and the Faculty of Medicine. Three companies " provide vaccines tested, " according to Inserm : Johnson & Johnson, Merck and Co (MSD) and Bavarian Nordic. The NGO Alima was responsible for its implementation.

The rVSV ZEBOV vaccine stockpiled by WHO " to deal with any emergencies " would have been " underestimated ". " At the pace of the epidemic, if we continue to use a single vaccine, we could face a shortage of stock, " says the WHO expert in charge of vaccination. According to a close associate of Dr. Oly Ilunga, " Merck assures that it can produce 500 000 doses by the end of the year and add 100 000 right now ." The company quoted by Reuters for its part has assured to deliver 900 00 doses within 6 to 18 months, in addition to the 195 000 doses already provided. In one year, more than 170,000 people have been vaccinated in the affected areas.

"I do not know who gave you the right"

To anticipate a possible shortage, the SAGE had recommended at its meeting of May 7, 2019 to divide the doses of rVSV ZEBOV vaccine " by 2 and by 5 " and to widen the vaccination. According to a protocol of study dated the day before, also classified as confidential and to which RFI had access, it was still considered to use this vaccine to practice a campaign of " vaccination belt " extended to " all subjects resident in the same village or in the same residential area "affected areas" on compassionate grounds ". Children from six months, pregnant women after the first trimester of pregnancy and breastfeeding women were to be involved in this clinical study.

However, if this vaccine is considered at the time as " safe and effective for children aged 6 to 17 ," the authors of this report specify that " data for the youngest children (1-6 years) " are not " easily " available. As with the Johnson & Johnson vaccine, in this document, Professor Jean-Claude Muyembe is presented as the lead investigator of this study. He is also one of the four experimental treatments used in the response, the mAb114, which he is one of the inventors.

These SAGE recommendations cause tensions between the Ministry of Health and the National Institute of Biomedical Research Professor Muyembe. The Immunization Commission, which meets on May 20, 2019, under the aegis of Dr Ilunga, decides to extend vaccination to pregnant women over three months of age or breastfeeding and to children over six months old, but rejects the proposal of " a third ring in minimal dose , "according to his report. In an email dated May 22, 2019, Professor Jean-Jacques Muyembe lashes out against this " revision of the vaccination protocol belt with the rVSV vaccine " to which he says he was not associated. " I do not know who gave you the right, unbeknownst to the PI (principal investigator, editor-in-chief) that I am, " recalls the director of the INRB The vaccination belt for Ebola is not , according to him a " routine vaccination, but rather a study, a research ".

Dr. Abdourahamane Diallo remembers very well this meeting of May 20, 2019. " Each vaccine was represented by its promoter, all the laboratories had come to Kinshasa, " he says. Johnson & Johnson was not the only company represented, even though its vaccine was " judged better ". There was also a representative of CanSino-Beijing Institute of Biotechnology. " For the Chinese vaccine, they had sent a simple presentation to the minister's office at the end of May, they explained that they had wanted to introduce a file with the INRB, but Muyembe never answered them ".

Finally, the Chinese and American vaccines will both be rejected by the vaccination commission of the Ministry of Health because of their " split dose " and the " communicative difficulty that characterizes this context " of rejection by the affected communities of the teams of the response. " In my personal opinion, if we communicate clearly, it will not be a problem, " said the WHO expert while reaffirming that it is the health authorities of the country that decide.

"Ebola is not the preserve of an expert"

Since July 20, 2019, the new boss of the coordination of the response is called Jean-Jacques Muyembe and his choice was the vaccine Johnson & Johnson. Will it be introduced in Congo despite the controversy created since the words of the Minister resigning from Health? On the presidency side, we are tempering. " Professor Muyembe does not work alone. Today the Ebola outbreak is not the preserve of an expert, "says Kusema.

Félix Tshisekedi's Deputy Director of Communications brushes aside allegations of conflict of interest, saying that in the fight against Ebola, " there is a reference called Professor Muyembe " and that choosing a new vaccine remains a " technical matter ". The new boss of the response also denies too many functions today: " There is no conflict of interest because we are there simply as scientists ". Professor Jean-Jacques Muyembe adds: " I do not win anything for that ".

In October 2018, an ad hoc committee was commissioned by WHO to make recommendations on clinical trials of "compassionate" treatments for Ebola. Of the experts asked for, four had been considered to be in a " conflict of interest " . Among them, professors Jean-Jacques Muyembe-Tamfum and Sabue Mulangu of the National Institute for Biomedical Research, "listed as inventors" of the use of mAb114 in the treatment of Ebola. The WHO notes, however, that the US government remains " the owner of this invention " and the two Congolese researchers " did not receive any money and, given the low commercial value of the products obtained (limited to use during epidemics of Ebola Zaire), they consider unlikely that they receive any income as inventors in the future .

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