Inside J&J's Latam COVID vaccine trial, a rush to recruit is followed by disappointment
By Aislinn Laing
SANTIAGO (Reuters) - Earlier this month, Johnson & Johnson abruptly called for an end to registration for its coronavirus vaccine study and urged scientists from six Latin American countries to complete their work within 48 hours, two researchers told Reuters.
The stop was due to the decision by J&J, announced later that same day, December 9, to limit the number of attendees worldwide to about 40,000, compared to an earlier plan of 60,000.
The drug maker said an increase in coronavirus cases in the areas tested would provide enough data to validate the vaccine.
Completing the recruitment faster - while continuing to monitor volunteers already participating - would keep J&J aiming to get U.S. approval for the shot early next year, the company said if it proves successful against a virus that is has already killed nearly 1.7 million people.
J&J told Reuters that it would not comment on its enrollment beyond a Friday statement saying the process was complete.
However, the move has raised questions and disappointed some in Latin America, according to interviews with a dozen researchers, government officials and disease experts.
Dr. Miguel O'Ryan, director of studies at three medical centers in and around Santiago, Chile, told Reuters his studies had been closed abruptly to new volunteers after his team of 50 doctors and nurses rushed to find people ready were able to participate in any age group.
The researchers were "angry" that they had not received a prior warning and had to abandon hundreds of people who were already scheduled to participate, he said.
"First they get in touch with you, say they want all of this, you get ready, and then overnight they tell you it is," he said. "They 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 offered to participate in the study in the hopes that they would get priority access to J & J's vaccine in the global race to stock up on doses. J&J told Reuters in September that these hosting trials would prioritize vaccine delivery.
Now some government circles and public health fear that these businesses could be compromised. And local researchers have wondered if they are being fully compensated for their investment in incomplete studies.
J&J did not disclose where in numbers the cap would have the most impact. The company did not comment on the status of delivery deals or compensation arrangements for researchers.
The drug manufacturer expects an initial analysis of the data by the end of January. If the process proves successful, the company plans to seek US approval in February.
To date, none of the six Latin American countries participating in the study have signed a vaccine supply contract with J&J, although they do not yet have enough doses from other vaccine manufacturers to vaccinate 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 ensuring that both rich and poor countries were "a central issue of social justice for the world" have good access to vaccines.
"Countries in Latin America that are setting up test sites need to put pressure on these businesses when negotiating with industry. But it's also up to companies," he said.
Ko cited AstraZeneca Plc's approach to helping less wealthy nations manufacture and distribute its COVID-19 vaccine candidate developed with Oxford University.
AstraZeneca's vaccine is seen as one of the best hopes for many developing countries because of its lower price and its ability to be shipped at normal refrigerator temperatures.
J&J reached out to Latin America as infection rates there increased to expedite the vaccine trial and measure its effectiveness in different populations. The drugmaker shared its plans for the region with Reuters in September, saying it would welcome 20,000 participants in the six countries by November.
The J&J vaccine is easier to carry and store, and is administered in a single shot, unlike front-runner Pfizer Inc and Moderna Inc vaccines that come in two doses.
J&J has signed an agreement in principle that the COVAX vaccination program will receive up to 500 million doses of its vaccine for distribution to lower-income countries by 2022.
"This vaccine would be critical not only for Latin America, but also for Asia, South Asia, sub-Saharan Africa and much of the world because of that single dose," Ko said. "Giving two doses is exponentially more difficult. I would imagine that countries would have access to it when a safe and effective vaccine came on board with one dose."
Brazil has signed non-binding letters of intent to purchase vaccines from four companies, including J&J, with health officials citing a preference for the J&J single-dose shot.
Mexico's Deputy Health Minister Hugo Lopez-Gatell said at a press conference earlier this month that hosting the Janssen Process would give the country priority access to the vaccine. Foreign Minister Marcelo Ebrard said last week that Mexico could order 22 million cans under a memorandum of understanding.
The Mexican government declined to comment on the cessation of trial recruitment and the likelihood of a priority vaccine deal.
A Peruvian government source told Reuters that new deals may be announced in the coming days but declined to comment on which companies they could include.
The source said that in the fast-paced negotiations between governments and pharmaceutical companies around the world, there were constant surprises to close deals, with an intense and regular back-and-forth on price, quantity, delivery times and contract terms.
"Things are changing so quickly that I can tell you something now and tomorrow that will be out of date," he said.
During a conference call that Janssen - the pharmaceuticals division of J & J - held on December 9th with scientists from 100 Latin American trial sites, local researchers who had worked hard to help the company achieve its ambitious goals suddenly said their anger announcement that they should complete their operations now if their target volunteer numbers have not yet been reached and hundreds of people should be screened and vaccinated, according to two participants.
J & J expressed "thanks to all participants, trial sites and health professionals involved in the ENSEMBLE study" in the statement released on Friday. The angry response to the conference call was not commented on.
In total, around 16,000 people appear to be enrolled at the Latin American locations. This comes from a Reuters tally, reported by process leaders and governments.
Any shortage would be significant to individual research sites, which are paid based on the number of people they hire. Reuters was unable to determine the amount of remuneration paid to researchers, which varies based on a number of factors including their specific locations, third-party partners, and the target size of studies.
The urgency to register quickly became apparent in late November at a location in Colina, Chile, where a Reuters journalist was among the dozen of volunteers queuing in a narrow waiting room.
Most of the volunteers were medical workers worst hit by the pandemic and their families. The test staff have also signed up their own families and friends to come up with their numbers, they told Reuters.
The start of the trials in Chile, Peru and Mexico was delayed by several weeks, which was delayed by factors such as regulatory controls, technical problems and a problem with the procurement of supplies.
In Brazil, efforts began smoothly in October, involving people from all walks of life, a researcher said.
"There have been thousands who have volunteered. People are very excited to help and to put up with long waiting times," said Eduardo Vasconcellos, study director at the L2iP clinical research institute in Brasilia.
Alejandra Camino, an investigator at privately owned DIM clinics in the Argentine capital, Buenos Aires, said it was important to remain flexible in the fight against COVID-19, although the abrupt end of enrollment is not ideal.
"It's a disappointment because if you set it up and find a venue, your operation will now be out of pocket," she said of her colleagues' work on their legal process. "But we're talking about a pandemic."
(Reporting by Aislinn Laing in Santiago; additional reporting by Marco Aquino in Peru, Julia Symmes Cobb in Bogota, Anthony Boadle in Brasilia, Eliana Raszewski in Buenos Aires and Anthony Esposito in Mexico City; editing by Michele Gershberg and Rosalba O'Brien)
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