Within J & J’s Latam COVID Vaccine Research, a rush to recruit recruits is followed by disappointment

By completing recruitment faster – while continuing to monitor volunteers already participating – J&J would remain on track to seek US approval for the admission early next year, the company has said, if it proves successful against a virus that has already killed nearly 1.7 million people. .

J&J told Reuters it would not comment on its entry after a statement released Friday saying the trial was closed.

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

Dr. Miguel O’Ryan, leader of studies at three medical centers in and around Santiago, Chile, told Reuters his studies were abruptly closed to new volunteers after his team of 50 doctors and nurses rushed to find people who wanted to join each era. Participate. group.

Investigators were left “furious” for not being forewarned and disappointed hundreds of people already scheduled to participate, he said.

“First they contact you, say they want all this, you get ready and then overnight they tell you ‘that’s it,’” 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 all volunteered to participate in the trial, hoping it would give them preferential access to J & J’s vaccine in the global race to stockpile doses. J&J told Reuters in September that those guest trials would take precedence in the delivery of vaccines.

Now some in government circles and the public health community fear those deals could be jeopardized. And local researchers wonder if they will be fully compensated for their investment in incomplete trials.

J&J did not provide details on where the limit in numbers would have the most impact. The company did not comment on the status of supply agreements or on compensation schemes for researchers.

The drugmaker expects a first analysis of the data at the end of January. If the trial proves successful, the company plans to seek US clearance in February.

SEARCH REQUEST

To date, none of the six countries in Latin America participating in the trial have entered into a vaccine supply agreement with J&J, even though they still don’t have enough doses from other vaccine manufacturers to inoculate all of their citizens. Health officials in all six countries said negotiations were still ongoing.

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

“Countries in Latin America setting up pilot sites must put pressure on these deals when negotiating with the industry. But it’s also on farms, ”he said.

Ko cited AstraZeneca Plc’s approach to help less wealthy countries produce and distribute the COVID-19 vaccine, developed in collaboration with the University of Oxford.

AstraZeneca’s vaccine is seen as one of the best hopes for many developing countries due to its cheaper price and ability to be transported at normal refrigerator temperatures.

J&J turned to Latin America when infection rates there soared, as a way to speed up vaccine testing and measure its effectiveness in different populations. The drug company shared its plans for the region with Reuters in September, saying it plans to enroll 20,000 participants in the six countries by November.

The J&J vaccine is easier to transport and store and is given in one go, unlike vaccines from frontrunners Pfizer Inc and Moderna Inc, which come in two doses.

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

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

Brazil has signed non-binding letters of intent to purchase vaccines from four companies, including J&J, with health officials expressing a preference for the J&J single dose.

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

The Mexican government declined to comment on the trial’s halting of recruitment and the likelihood that a priority vaccination deal will now come.

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

The source said there were constant surprises in the fast-moving negotiations taking place between governments and pharmaceutical companies around the world in the race to strike deals, with intense and regular back and forth over price, quantity, delivery times and contractual arrangements. requirements.

“Things are changing so fast that I can tell you something now and tomorrow it will be outdated,” he said.

FAMILY OPPORTUNITY

During a conference call that Janssen – J & J’s pharmaceutical division – met with scientists from 100 Latin American pilot sites on Dec. 9, local researchers, who had worked at full speed to help the company achieve its ambitious goals, expressed their anger. the sudden announcement that they must now complete their surgeries if their target number of volunteers has not yet been reached and hundreds of people are scheduled to be screened and vaccinated, according to two participants.

J&J in Friday’s statement “expressed its gratitude to all participants, trial sites, and healthcare providers involved in the ENSEMBLE trial.” It did not comment on the angry response during the conference call.

In total, the Latin American sites appear to have enrolled about 16,000 people, according to a Reuters census of figures reported by litigation leaders and governments.

Any shortage would make sense for individual research sites, which are paid based on the number of people they recruit. Reuters could not determine how much researchers are paid, which varies depending on a number of factors, including their specific location, external partners, and the intended scope of investigations.

The urgency to report people quickly was evident at a location in Colina, Chile, in late November, where a Reuters reporter found himself among the dozens of volunteers walking along the line in a narrow waiting room.

Most of those volunteers were medical personnel most affected by the pandemic and their families. Process employees have also signed up their own family and friends to help create their songs, they told Reuters.

The start of the trials in Chile, Peru and Mexico was delayed for several weeks due to factors such as regulatory oversight, technical issues and a struggle to obtain supplies.

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

“There were thousands who volunteered. People are very excited to help and have to wait a long time, ”said Eduardo Vasconcellos, research leader at the L2iP clinical research institute in Brasilia.

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

“It’s a disappointment because once you set it up and found a location, your operation is now out of pocket,” she said of her colleagues’ work on their processes. “But we are talking about a pandemic.”