In the trial of J&J’s Latam COVID vaccine, the rush to recruit is followed by disappointment

Completing the recruitment more quickly, while continuing to monitor the volunteers who were already involved, would keep J&J in the goal of seeking U.S. authorization for the shooting early next year, the company said. it is successful against a virus that has already killed nearly 1.7 million people.

J&J told Reuters he would not comment on his registration beyond a statement Friday that said the trial had closed.

But the move has raised questions and sparked disappointment in some in Latin America, according to interviews with a dozen researchers, government officials and disease experts.

Dr. Miguel O’Ryan, leader of trials at three medical centers in and around Santiago, told Reuters that his trials were abruptly closed to new volunteers after his team of 50 doctors and nurses rushed in. to find people willing to participate at every age. group.

Investigators had become “furious” because they had not been notified in advance and had to disappoint hundreds of people who had already planned to participate, he said.

“At first they get in touch with you, they say they want all this, they prepare you, and overnight they tell you‘ it’s over, ’” he said. “You understand the need to be more flexible … but it’s difficult for the research community in a study like this when the rules of the game change so quickly. “

Peru, Chile, Mexico, Argentina, Brazil and Colombia had offered to participate in the trial, hoping to give them preferential access to the J&J vaccine in the world race to store doses. J&J told Reuters in September that those conducting trials would have priority for the supply of vaccines.

Now some government and public health community circles fear these agreements could be compromised. And local researchers have been left wondering if they will be fully compensated for their investment in incomplete trials.

J&J has not provided details on where the figure limit would be most affected. The company did not comment on the status of supply bids or on compensation agreements for researchers.

The drug maker expects an initial analysis of the data in late January. If the trial is successful, the company plans to apply for U.S. clearance in February.

LOOKING FOR SUPPLY

To date, none of the six Latin American countries participating in the trial have finalized a vaccine supply agreement with J&J, although they still do not have enough doses from other vaccine manufacturers to inoculate all their citizens. . Health officials in the six countries said negotiations were still ongoing.

Albert Ko, a professor of epidemiology at Yale School of Public Health who has extensive experience in disease research in Latin America, said ensuring that rich and poor countries had good access to vaccines was a ” key issue of social justice for the world “.

“Latin American countries, as they establish test sites, need to press for these agreements when they are negotiating with industry. But it is also in companies,” he said.

Ko cited AstraZeneca Plc’s approach to helping less wealthy nations produce and distribute their candidate for the COVID-19 vaccine, developed with Oxford University.

The AstraZeneca vaccine is considered one of the best hopes for many developing countries because of its lower price and its ability to be transported at the normal temperature of the refrigerator.

J&J went to Latin America when infection rates rose, as a way to speed up vaccine testing and evaluate its effectiveness in several populations. The drug maker shared its plans for the region with Reuters in September, saying it intended to register 20,000 participants in the six countries in November.

The J&J vaccine is easier to transport and store and is administered in a single shot, unlike the Pfizer Inc and Moderna Inc vaccines, which are delivered in two doses.

J&J has signed an agreement in principle to provide the COVAX vaccine program with up to 500 million doses of its vaccine by 2022 for distribution to lower-income countries.

“This vaccine would be a game changer because of this single dose, not just for Latin America, but for Asia, South Asia, sub-Saharan Africa and much of the world,” Ko said. “Two doses are exponentially more difficult to administer. I think countries would jump in if a safe and effective dose vaccine is incorporated. “

Brazil has signed non-binding letters of intent to buy vaccines from four companies, including J&J, and health officials indicate a preference for starting a single dose of J&J.

Mexican Deputy Health Minister Hugo Lopez-Gatell said earlier this month at a news conference that holding the Janssen trial would give the country priority access to the vaccine. Foreign Secretary Marcelo Ebrard said last week Mexico could order 22 million doses under a memorandum of understanding.

The Mexican government declined to comment on the halt in the recruitment of evidence and the likelihood that there will now be a priority vaccine supply agreement.

A Peruvian government source told Reuters that new deals could be announced in the coming days, but declined to comment on which companies could be involved.

The source said there were constant surprises in the quick negotiations that were taking place between governments and pharmaceutical companies around the world in the race to close deals, with an intense and regular back and forth around price, quantity, delivery times and contracts. conditions.

“Things are changing so fast that I could tell you something now and tomorrow will become obsolete,” he said.

FAMILY MATTER

During a conference call that Janssen, J & J’s pharmaceutical division, convened with scientists from 100 Latin American test centers on December 9, local researchers, who had been working at full speed to help the company achieve its ambitious goals, went expressing their furious announcement that they should now end their operations when their target volunteers had not yet been met and that they had hundreds of people scheduled to be examined and vaccinated, according to two participants.

J&J in the statement issued Friday expressed “its gratitude to all participants, test sites and health professionals involved in the ENSEMBLE study.” He did not comment on the angry reaction from the conference call.

In all, Latin American sites appear to have registered about 16,000 people, according to a Reuters account of figures reported by process leaders and governments.

Any deficit would be significant for individual research sites, which are paid based on the number of people they hire. Reuters was unable to determine the scope of what is paid to researchers, which varies based on several factors, including specific locations, third-party partners, and the target size of the trials.

The urgency to sign up quickly became apparent at a place in Colina, Chile, in late November, where a Reuters reporter was among dozens of volunteers who moved along the queue in a narrow room. just wait.

Most of these volunteers were medical workers, those most affected by the pandemic, and their families. Test staff also signed up their own families and friends to help make their numbers, they told Reuters.

The start of trials in Chile, Peru and Mexico was delayed by several weeks, motivated by factors such as regulatory control, technical problems and a struggle to get supplies.

In Brazil, the effort began smoothly in October, with the participation of people from all walks of life, a researcher said.

“There were thousands of volunteers. People are very enthusiastic about helping and enduring long waits, ”said Eduardo Vasconcellos, trial leader at the L2iP clinical research institute in Brasilia.

Alejandra Camino, a trial researcher at the DIM health clinics in the Argentine capital, Buenos Aires, said that while the abrupt end to enrollment was not ideal, it was important to remain flexible in the fight against COVID -19.

“It’s a disappointment because if you installed it and found a place, your operation will no longer be out of pocket,” he said about the work of his colleagues in his trials. “But we’re talking about a pandemic.”