By Aislinn Laing
SANTIAGO, 21 dec. (Reuters) – Earlier this month, Johnson & Johnson abruptly called for an end to enrollment in its coronavirus vaccine trial and told scientists in six Latin American countries to complete their work within 48 hours, two said researchers for Reuters.
The shutdown was due to J & J’s decision, announced later that day on December 9, to limit the number of participants to about 40,000 people globally, compared to a previous plan of 60,000.
The pharmacist said that an increase in coronavirus cases in the areas he tested would give him enough data to examine the vaccine.
Ending recruitment sooner – continuing to monitor already participating volunteers – would keep J&J on target to apply for U.S. shooting authorization early next year, the company said, if successful against a virus that has already killed nearly 1.7 millions of people.
J&J told Reuters it would not comment on its registration beyond a statement on Friday saying the trial was over.
But 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, leader of studies at three medical centers in and around Santiago, Chile, told Reuters that his studies were abruptly closed to new volunteers after his team of 50 doctors and nurses they hurried to find people willing to participate in each age group.
The researchers were left “angry” that they had not been given any prior warning and had to disappoint hundreds of people already scheduled to participate, he said.
“At first they contact you, they say they want all this, you prepare and overnight they tell you ‘that’s it,'” he said. “You understand the need to be more flexible … but it’s hard 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 have all offered to take part in the trial, hoping to give them preferential access to the J&J vaccine in the global dose storage race. J&J told Reuters in September that hosting studies would take precedence in providing vaccines.
Now, some government circles and the public health community fear that these agreements could be compromised. Local researchers have also been asked whether they will be fully compensated for their investment in incomplete studies.
J&J did not provide details on where the ceiling number would have the greatest impact. The company did not comment on the status of supply bids or compensation agreements for researchers.
The doctor expects an initial analysis of the data by the end of January. If the process proves successful, the company plans to apply for US authorization in February.
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To date, none of the six Latin American countries that participated in the study have finalized a vaccine supply agreement with J&J, even though they still do not have enough doses from other vaccine manufacturers to inoculate all their citizens. Health officials from all 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 both rich and poor countries had good access to vaccines was a “key issue of social justice for the world”.
“Latin American countries, while setting up test sites, need to put pressure on these transactions when negotiating with the industry. But it is also on companies,” he said.
Ko cited AstraZeneca Plc’s approach to helping less affluent nations produce and distribute its candidate for the COVID-19 vaccine, developed in conjunction with Oxford University.
The AstraZeneca vaccine is seen as one of the best hopes for many developing countries, due to its cheaper price and its ability to be transported at normal refrigerator temperatures.
J&J turned to Latin America when infection rates rose there, as a way to speed up vaccine testing and evaluate its effectiveness in various populations. The drug maker shared 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 administered in a single shot, unlike the first vaccines from Pfizer Inc and Moderna Inc, 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 change the game because of that single dose, not only for Latin America, but also 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 skip this if a safe and effective single-dose vaccine comes on board.”
Brazil has signed non-binding letters of intent to buy vaccines from four companies, including J&J, with health officials indicating a preference for the J&J single-dose vaccine.
Mexican Deputy Health Minister Hugo Lopez-Gatell told a news conference earlier this month that hosting the Janssen trial would give the country priority access to the vaccine. Foreign Minister Marcelo Ebrard said last week that Mexico could order 22 million doses based on a memorandum of understanding.
The Mexican government declined to comment on stopping process recruitment and the likelihood of a priority vaccine supply agreement now.
A Peruvian government source told Reuters that new transactions could be announced in the coming days, but declined to comment on which companies could be involved.
The source said there have been constant surprises in the quick negotiations taking place between governments and pharmaceutical companies around the world in the race to block transactions, with an intense and regular back and forth around price, quantity, delivery terms and contractual conditions. .
“Things are changing so fast that I could tell you something now and tomorrow it will be over,” he said.
During a conference call that Janssen – J & J’s pharmaceutical division – convened on Dec. 9 with scientists from 100 test sites in Latin America, local researchers, who had been working at full speed to help the company meet its ambitious goals, suddenly expressed anger that they should now end their operations when their target number of volunteers had not yet been reached and had hundreds of people scheduled to be examined and vaccinated, according to the two participants.
J & J in its statement issued on Friday expressed its gratitude to all participants, study sites and health professionals involved in the ENSEMBLE study. He did not comment on the angry reaction during the conference.
In all, Latin American sites appear to have registered about 16,000 people, according to a number of Reuters figures reported by process leaders and governments.
Any shortfall would be significant for individual research sites, which are paid based on the number of people they recruit. Reuters could not determine the researchers’ pay range, which varies depending on a number of factors, including their specific locations, third-party partners and the target size of the studies.
The urgency to enroll people quickly was evident at a site in Colina, Chile, in late November, where a Reuters reporter was among dozens of volunteers who walked along the queue in a narrow waiting room.
Most of the volunteers were medical workers, the most affected by the pandemic and their families. The trial staff signed up their own families and friends to help with their numbers, they told Reuters.
The start of trials in Chile, Peru and Mexico has been delayed by a few weeks, backed by factors such as regulatory oversight, technical errors and a struggle for supplies.
In Brazil, the effort began smoothly in October, with people from all walks of life participating, a researcher said.
“There were thousands who volunteered. People are very enthusiastic to help and endure long waits,” said Eduardo Vasconcellos, trial leader at the L2iP clinical research institute in Brasilia.
Alejandra Camino, a trial investigator at privately run 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 set it up and found a place, your operation will now be out of pocket,” she said of her colleagues’ work on their trials. “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)