Virus World

The program allows people in the Seattle area to easily take a coronavirus test at home. Researchers say such testing is essential for future monitoring of the virus. An innovative coronavirus testing program in the Seattle area — promoted by the billionaire Bill Gates and local public health officials as a way of conducting wider surveillance on the invisible spread of the virus — has been ordered by the federal government to stop its work pending additional reviews.

The program involved sending home test kits to both healthy and sick people in the hope of conducting the kind of widespread monitoring that could help communities safely reopen from lockdowns. Researchers and public health authorities already had tested thousands of samples, finding dozens of previously undetected cases. But the program, a partnership between research groups and the Seattle and King County public health department that had been operating under authorization from the state, was notified this week that it now needs approval directly from the federal government. Officials with the Food and Drug Administration told the partnership to cease its testing and reporting until the agency grants further approval.

“Please discontinue patient testing and return of diagnostic results to patients until proper authorization is obtained,” the F.D.A. wrote in a memo. The delay is the latest evidence of how a splintered national effort to develop, distribute and ramp up testing has left federal regulators struggling to keep up. Amid concerns about the reliability of a burgeoning number of coronavirus antibody tests — which check whether someone may have previously had the virus — the F.D.A. responded last week by ordering companies to submit data proving the tests’ accuracy. But the Seattle program does not test for antibodies and has wide backing, including from public health leaders, the Fred Hutchinson Cancer Research Center and Mr. Gates, whose foundation has been deeply involved in fighting the pandemic. The Centers for Disease Control and Prevention also provided an in-person technical adviser to the project.

The National Institutes of Health and the Bill and Melinda Gates Foundation will together invest at least $200 million over the next four years to develop gene-based cures for sickle cell disease and HIV with an attribute even rarer in the world of genetic medicine than efficacy, the groups announced on Wednesday: The cures, they vowed, will be affordable and available in the resource-poor countries hit hardest by the two diseases, particularly in Africa.

The effort reflects growing concerns that scientific advances in genetic medicine, both traditional gene therapies and genome-editing approaches such as CRISPR, are and will continue to be prohibitively expensive and therefore beyond the reach of the vast majority of patients. Spark Therapeutics’ Luxturna, a gene therapy for a rare form of blindness, costs $425,000 per eye, for instance, and genetically engineered T cells (CAR-Ts) to treat some blood cancers cost about the same.  With CRISPR-based treatments already being tested in clinical trials for sickle cell disease, the blood disorder beta thalassemia, and another form of blindness, and with additional CRISPR treatments in development, scientists, ethicists, and health policy experts have grown increasingly concerned that the divide between haves and have-nots will grow ever-wider.

Gene-based treatments “are largely inaccessible to most of the world by virtue of the complexity and cost of treatment requirements, which currently limit their administration to hospitals in wealthy countries,” the NIH said in a statement. To help right that, its collaboration with the Gates Foundation aims to develop “curative therapies that can be delivered safely, effectively and affordably in low-resource settings.” Scientists whose research focuses on gene-based cures welcomed the infusion of funding and the recognition that genetic cures are on track to be unaffordable to the majority of patients. But they noted one irony. The most effective sickle cell drug, hydroxyurea, has hardly even been studied in sub-Saharan Africa, let alone made widely available. Yet a 2019 study found that giving children the drug cut their death rate by two-thirds and halved the pain crises that are common in sickle cell disease, caused by misshapen red blood cells that cannot flow through blood vessels. The NIH-Gates collaboration “is tremendously exciting and has the potential to have a great impact on sickle cell disease in sub-Saharan Africa,” said Dr. Vijay Sankaran of the Dana-Farber/Boston Children’s Cancer and Blood Disorders Center, who has done pioneering research on genetic cures for the disease. “But my hesitation is that even the inexpensive therapies we have today, such as hydroxyurea, are largely unavailable there. The question is, how do we best approach this disease, with therapies that are working today or with genetic therapies that might work?”...

A trial in South Africa was halted after early analysis found no protection.  The failure-ridden search for a vaccine that can stop the AIDS virus has delivered yet another frustrating defeat. The HIV vaccine that had moved furthest along in human testing does not work, and the $104 million trial in South Africa evaluating it has been stopped early. “There’s absolutely no evidence of efficacy,” says Glenda Gray, who heads the study and is president of the South African Medical Research Council (MRC). “Years of work went into this. It’s a huge disappointment.”

The efficacy study, which began in October 2016, is known as HVTN 702. It enrolled 5407 sexually active, HIV-uninfected men and women between 18 and 35 years of age at 14 sites across the country. Researchers randomly assigned half of the participants to receive a pair of HIV vaccines used in a one-two punch called a prime boost, whereas the other half received placebo shots. The trial was supposed to last until July 2022. But on 23 January, an independent monitoring board that takes scheduled, sneak peaks at the data to evaluate safety and efficacy, informed Gray and the other leaders of the study that it was “futile” to continue. There were 129 infections in the vaccinated group and 123 in those who received the placebo. “I was catatonic,” Gray says. No evidence exists that the vaccine caused harm, as happened in a different large HIV vaccine study that was abruptly halted in 2007. Susan Buchbinder, an epidemiologist at the University of California, San Francisco, who co-chaired that earlier sobering study, congratulates her colleagues in South Africa for conducting a scientifically rigorous, complex trial. “The trial was incredibly well done and we got a definitive answer, and that’s what science is about,” says Buchbinder, who is the chair of a multicountry trial, Mosaico, that now is the most advanced large-scale HIV vaccine study underway.

In the halted trial, funded by MRC, the U.S. National Institute of Allergy and Infectious Diseases (NIAID), and the Bill & Melinda Gates Foundation, the “prime” was a harmless canarypox virus that carries genes for HIV’s surface protein and two of its other structural proteins. The boost contained a recombinant version of the surface protein mixed with an immune system booster, or adjuvant, called MF59. Many HIV scientists had doubted the South Africa study would succeed because the vaccines used in the prime-boost scheme had only produced lackluster results in an efficacy study in Thailand. In that study, which ended in 2009, HIV infections totaled 51 in the vaccine group and 74 in the placebo arm—an efficacy of 31%. The field widely agreed that this wasn’t a high enough level of protection to bring the vaccine to market, but researchers were divided as to whether it made sense to try to build on the vaccine or abandon it.....