WASHINGTON (Reuters) – The Trump administration’s coronavirus vaccine project is recruiting scientists in South Africa and Latin America to test for possible vaccines in U.S.-backed clinical trials, and deploying them to access their countries to all successful products , Reuters has learned.
FILE PHOTO: A volunteer receives an injection from a medical worker during the country’s first human clinical trial for a potential vaccine against the new coronavirus, at Baragwanath Hospital in Soweto, South Africa, June 24, 2020. REUTERS / Siphiwe Sibeko
Moncef Slaoui, a former pharmaceutical executive who heads Operation Warp Speed, a multibillion-dollar collaboration in the U.S. between the federal government and drugmakers, made the promise to international scientists late last month, saying two people familiar with the case.
Researchers in South Africa, Mexico, Brazil, Peru and Argentina are in talks to involve American colleagues in conducting large-scale human trials of an experimental Johnson & Johnson vaccine (JNJ.N) beginning next month, according to half a dozen officials and scientists with knowledge of the effort.
The U.S. government has so far allocated nearly $ 11 billion to fund the development, testing, production and storage of hundreds of millions of doses of COVID-19. In addition to J&J, it is working with drug manufacturers including Moderna Inc (MRNA.O), Novavax Inc (NVAX.O) and AstraZeneca PLC (AZN.L) to coordinate large-scale, as Phase 3, clinical trials.
Tens of thousands of volunteers need to be recruited and involved scientists say it makes sense to test the vaccines for safety and effectiveness in various populations, including in other nations. U.S. health officials expect by early 2021 that a successful vaccine will be identified.
It is not yet clear what specific commitments, if any, have been made to South Africa and the Latin American countries. The advantage of working with Operation Warp Speed, which supports at least half a dozen potential faxes, is that it increases the chances that international partners would get an effective product.
President Donald Trump took the opportunity to share the U.S. fax service when he announced the formation of Operation Warp Speed in May, without giving details. Earlier this week, Secretary of Health and Human Services (HHS) Alex Azar said that every US vaccine for COVID-19 around the world would be “fairly” shared after meeting US needs.
The international scientists who are collaborating to participate have worked for years with American fax researchers and want the guarantees that their countries would have access to Operation Warp Speed faxes.
“International sites have made sure that we roll up our sleeves and contribute to the vaccine tribute, and we do not want to be in a position where these faxes are available and our countries cannot obtain them,” said Dr Glenda Gray, the President and CEO of the South African Medical Research Council, which is preparing to set up sites for the vaccine developed by J & J’s Janssen division.
A spokeswoman for HHS, which helps oversee Operation Warp Speed, did not respond to questions about the project’s work with specific countries, but confirmed that Slaoui was committed to ensuring that international partners had access to faxes.
In a statement, J & J’s Janssen unit said that a number of countries are seeking regulatory approval to conduct a trial of their vaccine, but that it could not confirm individual pages.
“Once proven to be safe and effective, Johnson & Johnson is working to make its vaccine accessible worldwide,” the company said.
The U.S. National Institutes of Health, which helps coordinate the trials, declined to comment. The White House did not immediately respond to questions.
A blaze is needed
Global health agencies have lamented the rush by the United States and other rich nations to close vaccine doses in advance through direct agreements with drugmakers. They say there should be a worldwide distribution of vaccines based on infection risk, and want to ensure that poorer countries have access. The coronavirus has infected nearly 21 million people and killed close to 750,000 worldwide.
“Anything short of a global strategy to vaccinate at-risk populations will be a less effective strategy,” said Stephen Thomas, a vaccine developer leading head of infectious disease at SUNY Upstate Medical University.
Slaoui has publicly stated that between 70 and 75 million people in the United States, including health care workers and elderly patients with underlying chronic conditions, are at greatest risk for coronavirus.
He told scientists late last month that those groups at risk could be immunized in the first quarter of 2021, the two people familiar with the matter said. He then told them, Operation Warp Speed, and that companies could arrange donations or access fax deliveries to the participating countries.
The NIH and Operation Warp Speed are considering holding a scientific summit this summer to discuss how all successful COVID-19 vaccines can be distributed, both nationally and globally, the sources said.
Countries such as Brazil and Mexico, hot spots for the virus, are not waiting for the US vaccine project to help. They also make deals directly with drugmakers who promise to deliver vaccines after they perform clinical trials.
Several pharmaceutical companies and countries, including China, are also courting international partners. South Africa and Brazil, for example, have developed medical infrastructure for clinical trials. They have a choice of partners and a chance to get access back for faxes.
“We are a prime site for any vaccine trial,” said Gray, a vaccine scientist renowned for her work on HIV. “There are many countries approaching South Africa.”
South African scientists are expected to enroll between 10,000 and 12,000 people at about 30 locations for J & J’s Janssen division, Gray said. The trials will receive funding from both J&J and the NIH.
The South African Ministry of Health did not comment.
A FLURRY OF DEALS
With an explosion of coronavirus cases in Latin America, countries are also announcing drug dealers, some involved in Operation Warp Speed. In addition, they plan to participate in fax research supported by China and other countries.
On Tuesday, Mexico announced that it would provide test sites for vaccines developed by J&J, as well as for Chinese companies CanSino Biologics Inc (6185.HK) and Walvax Biotechnology Co Ltd (300142.SZ).
An important reason behind Mexico’s move to participate in these trials is to gain access to a fax machine, according to its foreign minister, Marcelo Ebrard.
Brazilian medical research institute Fiocruz is in talks to take part in the J&J trial, Marco Krieger, a vice president at the federally funded institute, told Reuters. He said there were no assurances about vaccine access yet.
Argentina also plans to be a site for the J&J trial, Pedro Cahn, director of the Argentine Fundación Huesped, said in an email to Reuters. But when asked if he received specific assurances about supply, he said “not so far.”
The Ministry of Health in Argentina did not comment.
José Sánchez, coordinator of the Biomedical Research Center at the National University of San Marcos in Peru, said in an interview with the university’s own channel on Tuesday that the center is evaluating agreements with J&J, AstraZeneca and Moderna to conduct clinical trials in Peru. celebrate. Modern refused to comment.
The center receives funding from the U.S. government and the agreements are coordinated with Peru’s National Institutes of Health (INS), Sánchez said.
“Janssen will definitely come to Peru,” said Sánchez.
Marisa Taylor reported from Washington, DC; Participating were Pedro Fonseca in Rio de Janeiro, Marina Lammertyn in Buenos Aires, Marco Aquino in Lima, Frank Jack Daniel in Mexico City and Alexander Winning in Johannesburg .; Edited by Michele Gershberg and Julie Marquis
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